StemCell Therapy

Cancer is a disease caused by unhealthy cells inside the body growing out of control. Lung cancer is the uncontrolled growth of abnormal cells that start off in one or both lungs.

In the United States, is the form of . It is also the most common cause of cancer death in the U.S.

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Lung cancer can cause a number of complications in the lungs and in other parts of the body. Here are some of the most common complications:

Some of the more common lung cancer symptoms are caused by complications in the lungs.

According to , these complications can lead to the following symptoms:

Pneumonia is a possible symptom of complications in the lungs caused by cancer.

is numbness and tingling feelings in the hands and feet due to damaged nerve tissue. It can be a .

Neuropathy is caused by tumors that grow near the nerves in the arm or shoulder. A compresses the nerves leading to pain and weakness.

This is the in the membrane that covers the lungs. The fluid can then press against the lungs causing breathlessness.

Lung cancers can sometimes affect the heart when they develop near it or close to major blood vessels. This can cause fluid to press against the heart, which may lead to a number of issues.

These issues include:

Depending on its location, a tumor may block a persons airways or food pipe.

A tumor may grow into an airway in the lung and block it. This may lead to other issues, such as pneumonia or shortness of breath.

Lung cancers that grow near a persons food pipe can cause complications, making it difficult for the person to swallow.

Cancers near a foodpipe may lead to a person feeling pain when food passes through to their stomach.

Another serious complication of lung cancer is that it may spread to other parts of the body. Some lung cancer cells can travel through the lymphatic system or through the bloodstream.

If this happens, the cells can become lodged somewhere else in the body. Cancerous cells can then grow in these new locations, causing further cancers.

According to , lung cancer is most likely to spread to:

There are a number of ways to treat all of these different complications. The choice of treatment will vary depending on a number of factors, which include the type of complication, the age, and the general health of the patient.

Here are different treatments for the variety of complications listed above:

Numbness and tingling in the hands or feet may be treated with medication.

Neuropathy as a complication of lung cancer can lead to discomfort. There are many ways to treat the symptoms of neuropathy, including:

Pleural effusion can be treated by slowly draining away the fluid. In order to do this, a tube is inserted into the chest through a small cut.

A person may spend a few days in hospital after this treatment. If the fluid builds up again, they may need to have it drained a further time.

A person with pleural effusion may also have one of the following procedures:

Heart complications can occur if fluid presses against blood vessels because of a tumor. This can be treated in the following ways:

There are a number of procedures to treat lung cancer if it blocks a persons airways. These include the following:

Complications caused by lung cancer can occur over time. They tend to appear as the disease develops.

If a persons lung cancer is detected early, then they have a much higher chance of surviving the disease. Its important for a person to understand the symptoms so that they can get an early diagnosis.

Unfortunately, most cases of lung cancer are diagnosed in the later stages. This is because many of the symptoms or complications of the disease tend not to occur until the cancer is advanced.

Therefore, the individual outlook depends on a number of factors including the type of cancer, how far it has developed, and the persons age and general health.

Written by Adam Rowden

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Medical News Today: Lung cancer complications: Signs, treatment, and outlook - Stock Daily Dish

December 12, 2019 -Payers are using coordinated care and precision medicine to make diagnoses more quickly and ensure a strong treatment plan for severe and chronic disease management.

Early detection of chronic and severe diseases can mean the difference between life and death. It can also mean the difference between affordable therapies and crippling medical bills.

A March 2018 study found that early cancer diagnosis could result in significant cost savings nationally. Researchers looked at 17 types of cancer and estimated that early detection could save, conservatively, $26 billion nationally.

Recognizing what is at stake, payers take different approaches to catching severe or chronic illnesses in their formative stages.

Coordinated care is a simple, well-tested method for both chronic disease prevention and chronic disease management.

READ MORE: Chronic Disease Coordinated Care May Not Impact Pediatric Spending

Humana recently announced that it would pursue a traditional approach to ensure that patients in danger of chronic kidney and end of life renal disease find out early and get the support they need.

Humana will task skilled provider teams with catching these diseases earlier and implementing personalized treatments.

This coordinated care strategy builds a team of nephrologists, nurses, dietitians, and social workers from one of Humanas two partnerseither Monogram Health or Somatus, depending on geographic location.

The providers will work with the patients primary care physician to determine the best treatments and provide home healthcare options, patient education, and mental healthcare support through counseling.

This multidisciplinary approach will focus on detecting kidney disease earlier, slowing disease progression, and utilizing therapies that enable members to receive care in the convenience of their own home, said William Shrank, MD, MPHS, Humanas chief medical and corporate affairs officer.

READ MORE: Cigna and MSK Start Value-Based, Coordinated Cancer Care Program

Through this collaboration, we will strengthen care coordination for Humana members with kidney disease. Our partnerships will offer customized care options, and will empower patients with education and engagement tools to better manage their condition.

In February, Humana took a similar approach with its oncology program, enhancing its coordinated care strategy and using analytics to ensure quality care.

With new advancements every day in genetic therapies, precision medicine is another method payers use to ensure that patients receive a quick diagnosis and the best treatment plan.

CVS Health launched an oncology care program called Transform Oncology Care, which uses precision medicine to identify and treat cancer patients. The program is rolling out to Aetna members in 12 states but is also available for use by other payers.

Due to CVS Healths geographic and data footprint, it can assess the likelihood that a patient will get cancer. With that information, the patients provider can intervene early on to pursue preventive care, screenings, or therapies.

READ MORE: Precision Medicine Challenges Persist, Aetna Leads Response

When it comes to identifying the appropriate therapies, the program allows providers to use genetics to identify the best course of treatment for a patient recently diagnosed with cancer.

Timing in cancer care is everything and when a patient does not get started on the right treatment it can result in progression and higher costs, said Alan Lotvin, MD, executive vice president and chief transformation officer at CVS Health.

We are the first company working to make the latest in precision medicine accessible to more patients and further empower informed treatment decision-making based on a patient's genetic profile to give them the best chance for successful treatment and improved quality-of-life.

Working in coordination with its third-party vendor, Tempus, CVS Healths new program will enable patients to undergo a broad-panel gene sequencing test once diagnosed to determine the best treatment. This is ideal not only for patients in early stages of cancer, but especially for patients in more advanced stages who need to start treatment as soon as possible.

Because genomic sequencing has certain eligibility requirements, providers are not always aware that gene sequencing is an option open to their patient.

In order to ensure that oncologists prescribe gene sequencing to eligible patients, CVS Health introduced a web-based provider portal into its e-prescribing software which allows oncologists to see the patients eligibility for the broad-panel gene sequencing tests among other functions.

For those who qualify, the program identifies the best treatment options based on genetic makeup. It also alerts providers to potential clinical trials that patients can enroll in and makes the enrollment process easier and faster.

The program integrates National Comprehensive Cancer Network guidelines which are constantly updated for the most recent suggested prescribing and treatment options.

Critically, this service can be employed at the point of detection, so treatments can be identified immediately, and a therapeutic strategy quickly determined.

CVS Health combines this digital solution with a nurse-led coordinated care team to continue quality of care after the diagnosis.

This service is available for only fully insured commercial members.

Among its other chronic disease management developments, earlier this year, CVS Health used preventive care to improve diabetes treatment.

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Care Coordination and Precision Medicine Improve Early Diagnoses - HealthPayerIntelligence.com

BOSTON, Dec. 11, 2019 /PRNewswire/ --Proteostasis Therapeutics, Inc. (NASDAQ: PTI), a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF), today announced positive, initial ex-vivo results of PTI's proprietary cystic fibrosis transmembrane conductance regulator (CFTR) modulators, PTI-801, PTI-808, and PTI-428, in individuals with CF who are ineligible for the current standard of care CFTR modulator therapies due to their genotype. The data are part of a pan-European strategic initiative, known as HIT-CF (Human Individualized Therapy of CF), which seeks to accelerate the development of, and access to, personalized therapies for CF patients, beginning with those for whom no currently approved CFTR modulator therapy is indicated.

HIT-CF is sponsored by the European Commission Horizon 2020 program, in which CF-Europe, a patient organization representing more than 48,000 individuals with CF, collaborates and with the European Cystic Fibrosis Society Clinical Trial Network (ECFS-CTN), which is recruiting adult CF patients into the ex- vivo study through its 43 clinical trial centers. HIT-CF collects tissue samples from CF patients and develops organoids, or miniaturized organs, that are genetically identical to the patient donor, and share the same micro-anatomy as the organ from which they were derived.

As of today, rectal organoids from over 300 subjects have been collected for functional profiling and of those, 65 have been tested for response to PTI's investigational drugs. Early results support the initiation of enrollment of responding subjects into HIT-CF's clinical trial known as "CHOICES" (Crossover trial based on Human Organoid Individual response in CF - Efficacy Study), which is designed to evaluate the translation of organoid ex-vivo response to potential clinical benefit, such as changes in FEV1 and sweat chloride. CHOICES, which is expected to initiate in mid-2020, will be the first ever personalized medicine-based study in CF, with initial data expected by the end of 2020. Fully funded by the HIT-CF, this trial is a placebo controlled, double blind, crossover study with an 8-week treatment period and 6 months of uninterrupted dosing. The results may serve as the basis for a potential Marketing Authorization Application with the European Medicines Agency (EMA) in 2021 through a novel regulatory pathway which is being pursued jointly by Proteostasis and HIT-CF. The CHOICES clinical study is part of PTI's broader clinical development strategy for its CFTR modulator candidates that is already separately funded for the common genotypes.

Results from the HIT-CF project to date will be presented at the Keystone Symposia on Tissue Organoids titled "Tissue Organoids as Models of Host Physiology and Pathophysiology of Disease (J1)" taking place on January 19-23, 2020 in Vancouver, BC, Canada.

"Proteostasis is honored to have been invited to participate in the HIT-CF project and is the only company in the group with a combination of novel CFTR modulators being tested ex-vivo. We are very enthusiastic about the progress of the study," said Geoffrey Gilmartin, M.D., M.M.Sc., Chief Medical Officer of Proteostasis Therapeutics. "In Europe alone, there are more than 2,300 adult patients whose genotypes render them ineligible for approved CFTR modulators and exclude them from participating in clinical trials with this drug class. This project's proposed personalized medicine approach is paving a potential new way to develop and provide access to novel CFTR modulators for patients with the most dire need for treatment options that target the cause of the disease. Additionally, based on an individual patient's disease phenotype and not just the genetic designation, this approach could also create a new path towards more effective treatment for all people with CF."

"The inequality in access to CFTR modulators is an acute problem across Europe where 1 in 5 individuals do not have a F508del mutation. In addition, drug reimbursement policies are leading to an ever-growing gap between patients who do, and those who do not have effective treatment options," said Christiane De Boeck, Work Package Leader at HIT-CF, and Former President of ECFS. "At HIT-CF Europe, we believe that novel strategies such as personalized medicine and development of new treatment options are central to addressing the inequality of access across the continent. We are thrilled with these initial results and look forward to providing additional updates."

About Organoids

Organoids are cell cultures that grow in a culture dish and look similar to the organ from which they are derived. Because organoids are made from stem cells, they contain the same mutations as the person from whom the biopsies are derived. Investigational drugs which target the basic defect of CF can be used in an organoid system to evaluate rare mutations where the drugs may have a positive effect.

Unlike in vitro systems such as human bronchial epithelial (HBE) cells, which are derived from lungs that have been removed from CF patients, or the engineered, rat-derived FRT cell line, the latter has resulted in false positive clinical results, rectal organoids are cultured from tissues obtained through a minimally invasive and painless procedure from donors who then become eligible to participate in a clinical study. Organoids can provide valuable insights for donors, including their likelihood of achieving improvements in pulmonary function and reductions in sweat chloride concentration with CFTR modulators based on the ex-vivo response to those drugs.1

About HIT-CF Europe

HIT-CF Europe is a research project which aims to provide better treatment and better lives for people with cystic fibrosis (CF) and rare mutations. To achieve this, drug candidates are first tested on patient-derived organoids in qualified laboratories across Europe. Subsequently, based on the measured signal in the organoids, a smaller group of patients will be invited to participate in a clinical trial with one or more investigational molecules from a participating pharmaceutical company.

All participating centers are part of the European Cystic Fibrosis Society Clinical Trial Network (ECFS-CTN). The project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement number 755021. For more information, visit http://www.hitcf.org.

About Proteostasis Therapeutics, Inc.

Proteostasis Therapeutics, Inc. is a clinical stage biopharmaceutical company developing small molecule therapeutics to treat cystic fibrosis and other diseases caused by dysfunctional protein processing. Headquartered in Boston, MA, the Proteostasis Therapeutics team focuses on identifying therapies that restore protein function. For more information, visit http://www.proteostasis.com.

Safe Harbor

To the extent that statements in this release are not historical facts, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "aim," "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements made in this release include, without limitation, statements regarding the expected presentation at an upcoming conference. Forward-looking statements made in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved. Such risks and uncertainties include, without limitation, our expectations regarding our participation in HIT-CF's pan-European strategic initiative,the potential of our proprietary combination therapies for the treatment of CF, the potential benefit of our proprietary combination therapies to patients, expected timing of patient enrollment in, data from, the completion of, and reporting top line results of our clinical studies and cohorts for our clinical programs, including our planned Phase 2 program and initiation of a pivotal or registrational study, the possibility final or future results from our drug candidate trials (including, without limitation, longer duration studies) do not achieve positive results or are materially and negatively different from or not indicative of the preliminary results reported by the Company (noting that these results are based on a small number of patients and small data set), uncertainties inherent in the execution and completion of clinical trials (including, without limitation, the possibility that FDA or other regulatory agency comments delay, change or do not permit trial commencement, or intended label, or the FDA or other regulatory agency requires us to run cohorts sequentially or conduct additional cohorts or pre-clinical or clinical studies), in the enrollment of CF patients in our clinical trials in a competitive clinical environment, in the timing of availability of trial data, in the results of the clinical trials, in possible adverse events from our trials, in the actions of regulatory agencies, in the endorsement, if any, by therapeutic development arms of CF patient advocacy groups (and the maintenance thereof), in the commercialization and acceptance of new therapies, and those set forth in our Annual Report on Form 10-K for the year ended December 31, 2018, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 and our other SEC filings. We assume no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACTS:

Investors: David Pitts / Claudia StyslingerArgot Partners212.600.1902 david@argotpartners.com/ claudia@argotpartners.com

Media:David RosenArgot Partners212.600.1902david.rosen@argotpartners.com

1Berkers et al, Rectal Organoids Enable Personalized Treatment of Cystic Fibrosis Cell Reports 26, 17011708,February 12, 2019

SOURCE Proteostasis Therapeutics, Inc.

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Proteostasis Therapeutics to Initiate First Ever Personalized Medicine-Based Clinical Trial, CHOICES, in European CF Patients with Genotypes...

December 12, 2019 -Seventy-three percent of precision medicine adopters say these initiatives have neared or exceeded their expectations, with organizations using clinical analytics solutions and real-world data to meet their goals, according to a global survey from XIFIN and the Journal of Precision Medicine.

Approximately 59 percent of participants said that their EHR, EMR, or similar solutions did not meet or only partially met the needs of hands-on precision medicine users, indicating that success will require more advanced tools.

The fundamental design of EHRs makes them unsuitable for precision medicine programs because detailed patient data, such as biomarkers, are locked within a PDF, explained Nigel Russell, editor-in-chief of theJournal of Precision Medicine.

Physicians need real-time access to the patient data that will enable them to make the best patient care decisions, and today, investors and providers alike are looking for technologies that provide comprehensive clinical, diagnostic and financial data to ensure and build successful PMI programs.

The survey polled a total of 189 respondents, 62 percent of whom were from the US. The seniority of participants ranged from faculty or departments heads to board members and C-level executives.

Respondents said they are currently using provider-facing clinical analytics solutions, real-world data aggregation technology, business intelligence tools, and clinical data warehouse to advance their precision medicine initiatives, and that their frequency of use is higher than expected.

Just over ten percent of participants said they are currently using real-world data for disease insights or cohort studies, while just over nine percent are using real-world data to inform either clinical trial matching or peer-reviewed publications.

Eleven percent of respondents said that within two years, real-world data will be used for converge decision making. Just over nine percent said that real-world data will be used for drug efficacy and safety within two years, and the same percentage said real-world information will be used for clinical utility evidence development over the next two years.

Within three to five years, 12.4 percent of respondents believe that real-world data will be used for regulatory submissions, while just over ten percent think real-world data will inform claims adjudication or expansion of drug indications.

While precision medicine is becoming more mainstream, it is still a nascent discipline. Sharing the details of initiatives across the healthcare community will serve to accelerate adoption and determine future best practices so that we can truly harness precision medicine informatics for better outcomes, said Lle White, CEO, XIFIN.

For instance, the survey results demonstrate early adopters are already thinking about how high- quality real-world data will support and potentially accelerate clinical utility evidence development, coverage decision making, claims adjudication, expansion of drug indications, and regulatory submissions.

Powerful information like this is essential to reducing the cost of healthcare and improving patient outcomes, White added. It is imperative that organizations have a real-world data strategy both from a real-time access standpoint as well as from an actionable analytical insights perspective.

Precision medicine initiatives were also found to have a positive impact on certain quality metrics. Approximately 74 percent of respondents said precision medicine initiatives are increasing organizations ability to access real-world data. Almost 65 percent noted that precision medicine is improving organizations ability to query this data.

Additionally, 76.7 percent of healthcare professionals said precision medicine initiatives are having a positive impact on patient outcomes, while 53.3 percent said these initiatives are boosting patient satisfaction.

Over 76 percent said that precision medicine projects were helping care teams make better decisions, and 58.8 percent said precision medicine is increasing care teams ability to deliver personalized care. Nearly 56 percent said these initiatives are helping provide clinical decision support to care teams.

These findings indicate that with advanced technologies and comprehensive data, precision medicine could help health systems achieve their care goals. Going forward, if health systems adopt the right tools and develop effective solutions, precision medicine initiatives may become a larger part of the healthcare landscape, enabling organizations to deliver more informed, quality care.

Precision medicine and population health informatics offer the potential to infuse data at its most basic unit, the report concluded.

In addition, they put accompanying insights from aggregated de-identified data into precision medicine practitioners hands via the software that they use every day to support the decisions they need to make as part of the patient care journey.

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Over 70% of Orgs Say Precision Medicine Meets or Tops Expectations - HealthITAnalytics.com

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Genetics just got personal. So boasted the website of 23andMe in 2008, just after launching its DNA testing service.

As we entered this decade, a small cohort of companies 23andMe, its Silicon Valley neighbor Navigenics, and Icelandic competitor deCODE Genetics were selling a future of personalized medicine: Patients would hold the keys to longer and healthier lives by understanding the risks written into their DNA and working with their doctors to reduce them.

We all carry this information, and if we bring it together and democratize it, we could really change health care, 23andMe cofounder Anne Wojcicki told Time magazine when it dubbed the companys DNA test 2008s invention of the year, beating out Elon Musks Tesla Roadster.

But in reality, the 2010s would be when genetics got social. As the decade comes to a close, few of us have discussed our genes with our doctors, but millions of us have uploaded our DNA profiles to online databases to fill in the details of our family trees, explore our ethnic roots, and find people who share overlapping sequences of DNA.

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Its become like Facebook for genes, driven by the same fundamental human desire to connect. And, as with Mark Zuckerbergs social media behemoth, this is the decade we reckoned with what it really means to hand over some of our most personal data in the process.

A 23andMe saliva collection kit for DNA testing.

It all panned out differently from the way I imagined in 2009, when I paid $985 to deCODE and $399 to 23andMe to put my DNA into the service of science journalism. (I spared my then-employer, New Scientist magazine, the $2,500 charge for the boutique service offered by Navigenics.)

I was intrigued by the potential of DNA testing for personalized medicine, but from the beginning, I was also concerned about privacy. I imagined a future in which people could steal our medical secrets by testing the DNA we leave lying around on discarded tissues and coffee cups. In 2009, a colleague and I showed that all it took to hack my genome in this way was a credit card, a private email account, a mailing address, and DNA testing companies willing to do business without asking questions.

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Much of the rest of what I wrote about DNA testing back then reflected pushback from leading geneticists who argued that the companies visions of personalized medicine werent ready for primetime.

As I explored the reports offered by 23andMe and deCODE, I couldnt help but agree especially when deCODE wrongly concluded that I carry two copies of a variant of a gene that would give me a 40% lifetime chance of developing Alzheimers. (Luckily, it wasnt cause for panic. Id pored over my DNA in enough detail by then to know that I carry only one copy, giving me a still-elevated but much less scary lifetime risk of about 13%.)

Despite such glitches, it still seemed that medicine was where the payoffs of mainstream genetic testing were going to be. As costs to sequence the entire genome plummeted, I expected gene-testing firms to switch from using gene chips that scan hundreds of thousands of genetic markers to new sequencing technology that would allow them to record all 3 billion letters of our DNA.

So in 2012, eager to provide our readers with a preview of what was to come, New Scientist paid $999 for me to have my exome sequenced in a pilot project offered by 23andMe. This is the 1.5% of the genome that is read to make proteins and is where the variants that affect our health are most likely to lurk.

Experts at the Medical College of Wisconsin in Milwaukee analyzed my exome. While they werent at that point able to tell me much of medical significance that I didnt already know, the article I wrote from the experience in 2013 predicted a future in which doctors would routinely scour their patients genomes for potential health problems and prescribe drugs that have been specifically designed to correct the biochemical pathways concerned.

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Im glad I included an important caveat: This may take several decades.

By then, the revolution promised by 23andMe and its competitors was faltering. Navigenics and deCODE had both been acquired by bigger companies and stopped selling DNA tests directly to the public.

23andMe, backed by the deep pockets of Google and other Silicon Valley investors, had enough cash to continue. But it fell foul of the FDA, which had decided that the company was selling medical devices that needed official approval to be put on the market. In a 2013 warning letter, the FDA said that 23andMe had failed to provide adequate evidence that its tests produced accurate results. By the end of 2013, 23andMe had stopped offering assessments of health risks to new customers.

Since then, the company has slowly clawed its way back into the business of health. In 2015, it was given FDA approval to tell customers whether they were carriers for a number of inherited diseases; in 2017, it started providing new customers with assessments of health risks once more.

I recently updated my 23andMe account, getting tested on the latest version of its chip. My results included reports on my genetic risk of experiencing 13 medical conditions. Back in 2013, there were more than 100 such reports, plus assessments of my likely responses to a couple dozen drugs.

In the lab, discovery has continued at a pace, but relatively few findings have found their way into the clinic.

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If youve recently been pregnant, you were probably offered blood tests to tell whether your fetus had a serious genetic abnormality. And if youve been diagnosed with cancer, a biopsy may have been sequenced to look for mutations that make some drugs a good bet and other ones a bust. Neither would have been common a decade ago.

But the wider health care revolution envisaged by Wojcicki remains far off.

A few weeks ago, I saw my doctor to discuss my moderately high blood cholesterol and had a conversation that Id once predicted would be common by now. I had signed up for a project called MyGeneRank, which took my 23andMe data and calculated my genetic risk of experiencing coronary artery disease based on 57 genetic markers, identified in a 2015 study involving more than 180,000 people.

My genetic risk turns out to be fairly low. After I pulled out my phone and showed my doctor the app detailing my results, we decided to hold off on taking a statin for now, while I make an effort to improve my diet and exercise more. But it was clear from her reaction that patients dont usually show up wanting to talk about their DNA.

We have all these naysayers and an immense body of research that is not being used to help patients, said Eric Topol, director of the Scripps Research Translational Institute in La Jolla, California, which runs the MyGeneRank project.

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Joseph James DeAngelo, the suspected "Golden State Killer," appears in court for his arraignment in Sacramento, April 27, 2018.

23andMes collision with the FDA wound up being a turning point in ways I didnt anticipate at the time. From the start, the company included an assessment of customers ancestries as part of the package. But after the FDA cracked down, it pivoted to make ancestry and finding genetic relatives its main focus. Offering the test at just $99, 23andMe went on a marketing blitz to expand its customer base competing with a new rival.

Ancestry.com launched its genome-scanning service in May 2012 and has since gone head-to-head with 23andMe through dueling TV ads and Black Friday discount deals.

DNA tests became an affordable stocking filler, as millions of customers were sold a journey of self-discovery and human connection. We were introduced to new genetic relatives. And we were told that the results might make us want to trade in our lederhosen for a kilt or connect us to distant African ancestors.

Today, Ancestrys database contains some 15 million DNA profiles; 23andMes more than 10 million. Family Tree DNA and MyHeritage, the two other main players, have about 3.5 million DNA profiles between them. And for the most dedicated family history enthusiasts, there is GEDmatch, where customers can upload DNA profiles from any of the main testing companies and look for potential relatives. It contains about 1.2 million DNA profiles.

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So far, so much fun. But DNA testing can reveal uncomfortable truths, too. Families have been torn apart by the discovery that the man they call Dad is not the biological father of his children. Home DNA tests can also be used to show that a relative is a rapist or a killer.

That possibility burst into the public consciousness in April 2018, with the arrest of Joseph James DeAngelo, alleged to be the Golden State Killer responsible for at least 13 killings and more than 50 rapes in the 1970s and 1980s. DeAngelo was finally tracked down after DNA left at the scene of a 1980 double murder was matched to people in GEDmatch who were the killer's third or fourth cousins. Through months of painstaking work, investigators working with the genealogist Barbara Rae-Venter built family trees that converged on DeAngelo.

Genealogists had long realized that databases like GEDmatch could be used in this way, but had been wary of working with law enforcement fearing that DNA test customers would object to the idea of cops searching their DNA profiles and rummaging around in their family trees.

But the Golden State Killers crimes were so heinous that the anticipated backlash initially failed to materialize. Indeed, a May 2018 survey of more than 1,500 US adults found that 80% backed police using public genealogy databases to solve violent crimes.

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I was very surprised with the Golden State Killer case how positive the reaction was across the board, CeCe Moore, a genealogist known for her appearances on TV, told BuzzFeed News a couple of months after DeAngelos arrest.

The new science of forensic genetic genealogy quickly became a burgeoning business, as a company in Virginia called Parabon NanoLabs, which already had access to more than 100 crime scene samples through its efforts to produce facial reconstructions from DNA, teamed up with Moore to work cold cases through genealogy.

Before long, Parabon and Moore were identifying suspected killers and rapists at the rate of about one a week. Intrigued, my editor and I decided to see how easy it would be to identify 10 BuzzFeed employees from their DNA profiles, mimicking Parabons methods. In the end, I found four through matches to their relatives DNA profiles and another two thanks to their distinctive ancestry. It was clear that genetic genealogy was already a powerful investigative tool and would only get more so as DNA databases continued to grow.

A backlash did come, however, after two developments revealed by BuzzFeed News in 2019. In January, Family Tree DNA disclosed that it had allowed the FBI to search its database for partial matches to crime-scene samples since the previous fall without telling its customers. I feel they have violated my trust, Leah Larkin, a genetic genealogist based in Livermore, California, told BuzzFeed News at the time.

Then, in May, BuzzFeed News reported that police in Centerville, Utah, had convinced Curtis Rogers, a retired Florida businessperson who cofounded GEDmatch, to breach the sites own terms and conditions, which were supposed to restrict law enforcement use to investigations of homicides or sexual assaults. That allowed Parabon to use matches in the database to identify the perpetrator of a violent assault.

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Larkin and other genealogists condemned the move, calling it the start of a slippery slope that would see the method being used to investigate more trivial crimes.

As barbs flew between genealogists working with law enforcement and those who advocate for genetic privacy, GEDmatch responded with new terms of service that extended the definition of violent crime, but also required users to explicitly opt in for their DNA profiles to be included in law enforcement searches.

Overnight, GEDmatch became useless for criminal investigations. Since then, the number of users opting in for matching to crime-scene samples has slowly increased, and now stands at more than 200,000. But progress in cracking criminal cases has remained slow.

Now that cops have seen the power of forensic genetic genealogy, however, they dont want to let it go. In November, the New York Times revealed that a detective in Florida had obtained a warrant to search the entirety of GEDmatch, regardless of opt-ins. It seems only a matter of time before someone tries to serve a warrant to search the huge databases of 23andMe or Ancestry, which dont give cops access sparking legal battles that could go all the way to the Supreme Court.

Genetic privacy, barely mentioned as millions of us signed up to connect with family across the world and dig into our ancestral roots, is suddenly front and center.

This week, Rogers and the other cofounder of GEDmatch, John Olson, removed themselves from the heat when they sold GEDmatch to Verogen, a company in San Diego that makes equipment to sequence crime-scene DNA. Verogen CEO Brett Williams told BuzzFeed News that he sees a business opportunity in charging police for access to the database but promised to respect users privacy. Were not going to force people to opt in, he said.

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But it isnt just whether cops can run searches against your DNA. 23andMe may not share your information with law enforcement, but customers are asked when they signed up whether if they are OK with their de-identified DNA being used for genetic research.

It might not be obvious when you fill in the consent form, but this lies at the heart of 23andMes business model. The reason the company pushed so hard to expand its database of DNA profiles is to use this data in research to develop new drugs, either by itself or by striking deals with pharmaceutical companies.

Ancestry has also asked its users to consent to participate in research, teaming up with partners that have included Calico, a Google spinoff researching ways to extend human lifespan.

You might be comfortable with all of this. You might not. You should definitely think about it because when the information is your own DNA, there really is no such thing as de-identified data.

That DNA profile is inextricably tied to your identity. It might be stripped of your name and decoupled from the credit card you used to pay for the test. But as 23andMe warns in its privacy policy: In the event of a data breach it is possible that your data could be associated with your identity, which could be used against your interests.

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And because you share a large part of your genome with close relatives, when you put your DNA profile into a companys database, you arent only making a decision for yourself: Their privacy is on the line, too.

Whether its due to concerns about privacy, a saturated market, or just that the novelty has worn off, sales of DNA ancestry tests are slowing. Ancestry has responded by offering a new product focused on health risks. Unlike 23andMe, it requires that tests are ordered through PWNHealth, a national network of doctors and genetic counselors.

Will this be the development that takes us back to the future I once imagined? Maybe so, but if the roller coaster of the past decade has taught me anything, its to be wary about making any predictions about our genetic future.

Peter Aldhous is a Science Reporter for BuzzFeed News and is based in San Francisco.

Contact Peter Aldhous at peter.aldhous@buzzfeed.com.

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10 Years Ago, DNA Tests Were The Future Of Medicine. Now Theyre A Social Network And A Data Privacy Mess. - BuzzFeed News

Three investigative therapies by Proteostasis Therapeutics PTI-801, PTI-808, and PTI-428 showed potential to treat cystic fibrosis (CF) patients ineligible for approved CFTR modulators after patient-specific lab models produced promising results that support a future clinical trial.

Funded by the EUs initiative HIT-CF (Human Individualized Therapy of CF), this early study was conducted on patient organoids, which are miniaturized organ models derived from patient cells.

Based on the positive results, a clinical trial in adult CF patients is expected to start in 2020. If successful, the trial results may serve as the basis for a marketing authorization applicationin Europe in 2021.

With the help of CF-Europe (a patient organization) and the European Cystic Fibrosis Society Clinical Trial Network (ECFS-CTN), HIT-CF has been recruiting adult CF patients to collect tissue samples and create organoids, three-dimensional organ models grown in the lab.

Organoids mimic several characteristics of the organ from which they are derived, and are genetically identical to the donor. As such, they allow researchers to study biological processes and response to treatments in an environment that closely resembles human organs. As organoids are basically human cells cultured outside the body, they are said to be ex-vivo models.

The idea is to screen treatment candidates in the lab using intestinal organoids, or mini-intestines, obtained from rectal tissue (biopsies) of patients, which are collected through a quick and painless procedure. Then, based on how the organoids respond to each therapeutic candidate, a group of patients will be selected to enroll in a clinical trial.

Because the organoids can help determine the therapeutic candidate most likely to give the best results, researchers can personalize treatments for each patient before starting the trial.

So far, intestinal organoids from more than 300 patients have been created, of which 65 have been used to test Proteostasis potential CFTR modulators.

Proteostasis is honored to have been invited to participate in the HIT-CF project, and is the only company in the group with a combination of novel CFTR modulators being testedex-vivo. We are very enthusiastic about the progress of the study, Geoffrey Gilmartin, MD, chief medical officer of Proteostasis, said in a press release.

The positive results obtained on organoids support the launch of a clinical trial called CHOICES Crossover trial based on HumanOrganoidIndividual response inCF EfficacyStudy that will test the potential treatments on patients whose organoids responded favorably to the agents.

The study will also evaluate if organoids are good models to identify promising CF therapies, that is, if the responses measured on organoids translate to potential clinical benefits in patients, as reflected by lung function tests (FEV1) or sweat tests.

CHOICES will be a placebo-controlled, double-blind study that includes an eight-week treatment period, plus six months of constant dosing.

The study includes Proteostasis three candidate CFTR modulators, specially intended for patients who carry rarer CFTR genetic defects. All three compounds have different modes of action. PTI-801 works as a CFTR corrector, PTI-808 is a CFTR potentiator, and PTI-428 is a CFTR amplifier.

The trial is planned to start in mid-2020, with its first data anticipated for the end of 2020.

If moving forward, CHOICES will become the first trial based on personalized medicine for CF patients.

The inequality in access to CFTR modulators is an acute problem across Europe where 1 in 5 individuals do not have a F508del mutation [the most common CF-causing mutation]. In addition, drug reimbursement policies are leading to an ever-growing gap between patients who do, and those who do not have effective treatment options, said Christiane De Boeck, Work Package Leader at HIT-CF.

At HIT-CF Europe, we believe that novel strategies such as personalized medicine and development of new treatment options are central to addressing the inequality of access across the continent. We are thrilled with these initial results and look forward to providing additional updates, De Boeck added.

Gilmartin said that in Europe more than 2,300 adult CF patients are ineligible for approved CFTR modulators, and therefore excluded from participating in clinical trials.

This projects proposed personalized medicine approach is paving a potential new way to develop and provide access to novel CFTR modulators for patients with the most dire need for treatment options that target the cause of the disease. Additionally, based on an individual patients disease phenotype, and not just the genetic designation, this approach could also create a new path towards more effective treatment for all people with CF, Gilmartin said.

Proteostasis is also running a clinical trial evaluating a combination of the three candidate therapies for the treatment of CF patients who have at least one copy of the F508del mutation in the CFTR gene.

Ana is a molecular biologist enthusiastic about innovation and communication. In her role as a science writer she wishes to bring the advances in medical science and technology closer to the public, particularly to those most in need of them. Ana holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she focused her research on molecular biology, epigenetics and infectious diseases.

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Patrcia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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Personalized CF Medicine to be Tested for Rare Genetic Defects in Europe - Cystic Fibrosis News Today

Artificial Intelligence has come a long way since it was in its blooming stages in the 1940s. It was a time when the direct interaction between AI and humans seemed impossible and people were even scared by the thought. All sorts of theories started emerging that made artificial intelligence look deadly for humans. The idea of robots or droids were thought of as something that could hurt the human population and even drive them to extinction. In spite of all theories, researchers were able to predict one thing for sure. Artificial intelligence will be able to transform lives and the way humans interact with one another. It will reshape the societies and industries that we know today.

Welcome to 2019, an era where artificial intelligence is vividly present all around us. In other words, we are living in the age of AI. Take a look around you. Be it the smart assistant on our mobile phones, websites, e-commerce platforms, search engine results, home automation appliances, classrooms, and more. Every single element is trying to adopt AI and cause an impact for the good. This is in turn radically transformssocieties and pushespeople to develop emotional bonding with their gadgets and AI devices. Today, when we want to find directions to a place, we do not stop by strangers and ask them. Instead, we turn on Google maps and let technology guide us.

One of the biggest breakthroughs in artificial intelligence has been its implementation in the healthcare sector. One of the most fundamental industries in the world, the healthcare sector is far behind in todays world. Even though technological marvels are constantly fascinating in the world, there is a significant amount of work that needs to be done in the healthcare sector. From diagnosis to medicine and providing healthcare facilities in rural areas, artificial intelligence has a lot of scope for health care support.

However, there has been some significant progress in the healthcare industry. All thanks to artificial intelligence that was powered by the wave of digitization. As more and more organizations are turning digital, its providing an abundance of data for machines to work upon them. Now we have robots that are successfully performing surgery on patients, software programs that are better diagnosing diseases far better than traditional pathological practices, and wearable devices that can monitor our health and send updates about alarming situations in real-time.

Still, theres an emerging need for transformation in the field of medicine. We still have drugs that address the concern of a mass population, only to leave a few with side effects. Similarly, diseases like cancer do not have any permanent remedy or targeted course of medication that treats the patient well without leaving them with any side effects. Similarly, people over the age of 50 are one of the fastest-growing demographic groups around the world. Its creating a lot of challenges for the global economy and the healthcare sector. These people need to be provided with efficient care and medical support that is targeted towards the longevity of their lives.

The Longevity Industry that provides healthcare support to the population above 50 is turning into a multi-trillion dollar industry, with close to 260 companies in the UK alone. Any progress in the longevity distribution at scale will have a huge impact and multiplicative effects on economies and societies around the world. After all, it would be a huge loss if the experienced population who have been responsible for more than a few innovations in the world are facing sudden deterioration in health in a way that reduces their quality of life. Not only will it be a huge loss to the economies but also result in increased dependency on the healthcare system. Having said this, artificial intelligence has a lot of potentials to manifest in this field and come up with solutions that target the emerging needs of the population accurately.

Research indicates that increasing the lifespan of humans even by one year will decrease the suffering of tens of millions of people and improve the quality of life for billions of others. One such effort in this direction is personalized medicine that targets the individual needs of humans with precision. So, lets say that if a person has asthma, precision medicine will only focus and target the cells that are responsible for asthma and help in regenerating them. This would leave other portions or tissues of the human body untouched and treat only what was needed. Therefore, in place of treating generalized symptoms, AI can help shift medicine towards prevention, personalization and ultimately precision.

With the advent of digitization in the healthcare sector, more and more patent records are going digital. This practice is helping researchers and medical experts understand the history of a patient in detail with the past treatments and health support theyve received. The vast amount of data collected from thousands of such medical records can be studied and used by AI to understand how a particular treatment can impact a particular gene inside the human. Moreover, digitization is also enabling researchers from all walks of life to work together, thus, laying an excellent foundation for biotechnology and computer experts to work together towards personalized medicine.

For example, CRISPR is a gene-editing technology that is being used to target the DNA sequences precisely. With this, medical experts can deliberately activate or inhibit certain genes in human beings. This demonstrates that there is a strong ability to target an individuals distinctive molecular and genetic profile, thus opening up new opportunities for personalized medicine.The National Institute of Health describes precision medicine as an emerging approach for the treatment of diseases and their prevention, which takes a persons gene variability, environment and lifestyle into account. It requires the assistance of deep learning algorithms that can learn from the data at an unprecedented rate and combine the knowledge of medical experts to reach a decision.

However, precision medicine will not be the end of human touch. It will still require vast expertise of medical experts to analyze the results obtained from machines and understand its real-world implications for the patient. With wearable devices, electronic health records and information about the geographic and demographic history of the patient, deep learning algorithms in AI have a lot of potential to device personalized medicine for people that target precision issues with high accuracy.

This article was originally published on Towards Data Science byJames Warner, a business intelligence analyst with knowledge on Hadoop/Big data analysis at NexSoftSys.com

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Thanks to AI, medical treatments are becoming more personalized - The Next Web

With help from Rachana Pradhan and Dan Goldberg

House Speaker Nancy Pelosis drug bill passes the House, but the Senates another matter.

President Donald Trumps FDA pick sails through the Senate and into the soup of vaping and other hot issues.

FDA encourages a focus on pediatric cancer with a shift to molecular targets.

A message from the Partnership for Americas Health Care Future:

New polling shows that lowering costs is the top health care priority for American voters, but embracing a one-size-fits-all new government health insurance system be it Medicare for All, Medicare buy-in, or the public option would mean higher taxes for middle-class families. Get the facts: Learn more.

Happy Friday and welcome back to Prescription Pulse! Were in the home stretch of 2019, just need to get a little thing called government funding done. Know what pharma and device provisions could make it in? Send pharma news, tips and fun reads to Sarah Owermohle (sowermohle@politico.com or @owermohle) and Sarah Karlin-Smith (skarlin-smith@politico.com or @sarahkarlin).

PELOSI DRUG BILL PASSES AND ITS OFF TO THE SENATE GRAVEYARD House Democrats overcame infighting within their ranks Thursday, passing a bill that for the first time would require the government to negotiate prices for costly drugs. The sweeping measure from Pelosi, H.R. 3 (116), hands Democrats a legislative victory to tout in the 2020 electionson a Trump administration priority, no less.

The measure passed 230-192, with two Republicans breaking ranks to support the measure. Eight Democrats jumped party lines to vote for a GOP amendment to replace the bill with H.R. 19 (116), a bundle of bipartisan provisions like measures banning pay-for-delay deals or capping seniors out-of-pocket costs, while avoiding controversial moves like negotiation or price hike caps.

In the Senate, Mitch McConnell has already said the bill is dead on arrival. But the majority leader hasnt committed to taking up his chambers alternative, a bipartisan measure from Senate Finance leaders Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.).

Grassley jumped on the House bill Thursday afternoon, saying it would result in dozens fewer therapies coming to market and that his bill was the only way forward. The House has acted and now the Senate must act, Grassley said.

Trump made vague promises to cut drug prices, including allowing government negotiations, during his 2016 campaign. But several promises have since faltered: courts killed a rule to require prices in drug ads, and the administration discarded a rule eliminating rebates over concerns it would increase premiums. The White House has thrown its support behind Grassleys bill, but the senator has been unable to rally the GOP votes.

Democrats aim to seize control of the drug pricing narrative in 2020. I believe we need real, substantive reforms, said Rep. Katie Porter (D-Calif.), a freshman who flipped her Orange County district last year, "and for a while, so did our president.

HAHN SAILS THROUGH SENATE FDA has a new leader. The Senate voted 72-18 Thursday to confirm the nomination of Washington newcomer Stephen Hahn.

Unlike his predecessor Scott Gottlieb who ultimately won much praise from Democrats who hadn't supported his nomination Hahn has no track record of working and profiting from the drug industry. He also lacks the prolific bibliography Gottlieb accumulated over the years writing on FDA-related policy, making it harder for Democrats to oppose him. Plus, Democrats were eager to see the departure of acting FDA chief Brett Giroir, the HHS assistant secretary of health, a conservative who has backed reproductive health policies opposed by the left.

But will his popularity last? Hahns bipartisan support will be tested by challenging political and public health issues, most notably how to regulate the booming e-cigarette industry amid an outbreak of serious lung illnesses associated with some vaping products.

The Trump administration promised a ban of flavored vaping products in September but in November retreated from that position after an outcry from free-market advocates and the vaping industry.

Hahn offered few hints throughout his confirmation process on how he would deal with vaping or other controversial topics like whether FDA should permit the importation of drugs from overseas to lower medication costs.

NEW REQUIREMENTS FOR PEDIATRIC ASSESSMENTS OF CANCER MEDS The agency issued draft guidance Thursday outlining how it will implement a provision in a 2017 law designed to ensure more cancer drugs are studied in children. Earlier laws requiring pediatric studies of drugs developed for adults only applied if children suffered from the same disease. But most adult cancers rarely occur in children, leading to gaps in pediatric cancer drug development.

Molecular targets a game changer: Researchers have found that a molecular-targeted drug that works to treat one cancer in adults may treat a different cancer in children if the same molecular target is relevant to both.

Sponsors of new cancer drugs for adults will now need to submit a report on pediatric cancer investigations for the drug with their marketing application to FDA, if the agency determines the target to be substantially relevant to a pediatric cancer. The requirements apply to drug applications submitted on Aug. 18, 2020 or later.

The guidance described how FDA will determine whether a molecular target is relevant and explains what should be in an initial pediatric study plan. FDA says studies described in the plan should evaluate dosing, safety and preliminary efficacy.

PHRMA SUES OVER OREGON DRUG PRICE LAWS The drug lobby on Monday challenged as unconstitutional two Oregon laws aimed at boosting transparency around prescription drug prices and increases, Portland Business Journals Elizabeth Hayes reports.

A measure passed last year, OR HB4005 (18R), requires manufacturers to submit a report to the Oregon Department of Consumer and Business Services when a drugs price rises over a threshold, explaining the hike and listing costs for making and selling the medicine. A newer provision, OR HB2658 (19R), mandates that drugmakers give 60 days notice on price increases.

A coalition of hospitals, insurers and health care advocates backed the first bill, but PhRMA said both measures were misguided and unconstitutional. The state should focus on capping out-of-pocket costs or give patients more of the negotiated savings on drugs, it said in a release.

Colorado issues report on strategies to lower drug costs Potential quick win policies that the state may pursue include price transparency related to drug price increases or PBM payments; requiring drug rebates to be passed through to employers and patients; and aligning the states importation policy with a potential expansion of federal regulations that the Trump administration is pursuing. Colorado Gov. Jared Polis has made health cost containment a priority and is one of a handful of states pushing the Trump administration to allow importation of prescription drugs from Canada.

SUPREME COURT REJECTS ARIZONAS CASE AGAINST SACKLERS Mark Brnovich, Arizonas AG, had taken the unusual step of asking the nations top court to hear his lawsuit, which accuses the Sacklers, the family behind Oxycontin-maker Purdue Pharma, of funneling $4 billion from the drug company while it faced huge liability for its role in the opioid crisis. Arizona is one of thousands of jurisdictions suing Purdue, which has declared bankruptcy. A bankruptcy judge put a hold on pending lawsuits but Brnovich decided to try his luck with the justices anyway.

RESEARCHERS CRITICIZE FINANCIAL DEPENDENCE ON INDUSTRY A group of researchers has demanded that medical research, education and practice become independent of commercial influences, Politico Europes Judith Mischke reports. The international researchers, clinicians, regulators and citizen advocates warned in a British journal that while everyone wants to ground healthcare decisions in "trustworthy evidence," there are still "widespread financial conflicts of interest across medical research, education, and practice.

In the United States, about 60 percent of medical research is industry funded, they noted. In some cases, "published outcomes of industry-sponsored studies tend to favor sponsors products, creating a 'sponsorship bias' in the evidence base that overplays benefits and underplays harms, the group writes.

They offer two solutions: Governments should pass laws requiring public disclosure of company ties, or regulators should bar public health organizations from receiving industry funding.

A message from the Partnership for Americas Health Care Future:

More than 180 million Americans rely on employer-provided coverage and new polling shows a majority of voters would rather build on whats working in our current health care system than replace it with a one-size-fits-all new government-controlled health insurance system.

Whether its called Medicare for All, Medicare buy-in or the public option, American families would face unaffordable costs and lower quality care under a one-size-fits-all system the exact opposite of what they want. See the results from the tracking poll here:Learn more.

PRESCRIPTION DRUG FACTORIES POLLUTING WATERWAYS Wastewater treatment plants are not typically equipped to remove pharmaceuticals from the waterflow, and drug cocktails have shown up in rivers across the U.S., reports Stat News Natasha Gilbert. In one area downstream of a Morgantown, W. Va., plant, an anti-seizure medication was measured at nearly 90 times the amount considered safe for wildlife. Stat and Type Investigations identified Mylan, Pfizer, Teva and three others as drugmakers dumping substantial levels of pharmaceuticals into the watershed.

CAR-T MANUFACTURING PROBLEMS PLAGUE NOVARTIS Novartis has had to give away some of its CAR-T cell therapy, Kymriah, because the personalized blood cancer treatment, made from a patients immune cells, havent met FDAs specifications, Biopharma Dive reports. In those cases the company delivered the treatment as if were an unapproved drug, through an expanded access protocol. In other cases, the company hasnt been able to use the product its made at all. Novartis presented real-world data this week that showed that even when the product didnt meet specifications it could attack cancer with no increased safety risk. Manufacturing is just one of the hurdles for commercializing the personalized medicine, which costs $475,000 for leukemia and $373,000 for lymphoma.

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Pelosi drug bill passes ... and it's off to the Senate graveyard - Politico

The landscape of precision medicine has changed dramatically over the years. The completion of the Human Genome Project in 2003 has greatly accelerated our understanding of individual genomes, leading to the idea of precision medicine: medical care tailored to the individual.

Since then, science has progressed greatly. Today, we are able to look beyond identifying mutations and instead gain a very comprehensive view of the molecular biology taking place in tumor cells. We nowunderstand that each person has a unique genetic and molecular setup, and each cell in the human body is different. Based on this knowledge, single-cell analysis tools are being developed to analyze the genetic, transcriptomic, proteomic, and epigenetic features of each cell.

As a relatively new suite of technologies, single-cell analysis can greatly improve precision medicine, a feat that is especially important in cancer biology. By providing deeper insights into each individuals disease, single-cell analysis can address many of the current challenges in precision medicine.

One area in which single-cell analysis is starting to make a difference is personalized cancer treatment. Tumors often contain very heterogeneous cell populations, which makes selecting treatments extremely challenging. Conventional diagnostic techniques often rely on the bulk analysis of cells. By taking the average of all cells in a sample, it is easy to miss a cell subpopulation that can become resistant to treatment and cause a relapse.

Now one company has taken it upon itself to improve precision medicine using single-cell analysis: Proteona. Among its first targets are blood cancers, such as multiple myeloma. As one of the most aggressive blood cancers, the treatment of multiple myeloma comes with a number of challenges.

Myeloma is a very difficult disease to treat because it constantly relapses, explains Chng Wee Joo, Senior Consultant and Head of Department of Haematology-Oncology at the National University Cancer Institute Singapore. The tumor cells are highly heterogeneous, and the immune microenvironment also plays an important role, creating additional complexity. Typically, patients are treated with multiple drugs at the same time, which triggers side effects and is extremely costly. There is definitely a need for better precision medicine here.

While the traditional bulk analysis of a tumor biopsy only provides information on the average of all cells present in a sample, single-cell analysis allows clinicians to analyze different tumor cell subpopulations, which might be resistant to a specific treatment and could cause a recurrence of the disease. In the case of multiple myeloma, single-cell proteogenomics can also be used to analyze the malignant plasma cells gene and protein expression and can be used to decide what treatments are plausible for the individual patient.

By adding protein expression analysis to single-cell sequencing, clinicians can gain valuable information on protein and gene expression as well as a better resolution between different cell types compared to analyzing gene expression alone. This is important for understanding patient cell heterogeneity.

For example, single-cell proteogenomics can provide a detailed analysis of the immune cells involved in a disease, can help clinicians understand possible resistance, and can be used for patient stratification in precision medicine trials.

There is a huge value in combining total mRNA profiling and proteomics in single-cell sequencing, says Andreas Schmidt, CEO of Proteona. While single-cell proteogenomics can be applied in various fields, what we find most interesting is the ability to gain a good snapshot of the immune cells as well as of tumor cells in the same sample. And that is valid for solid tumors as well as for liquid tumors. The information we are dealing with is already directly relevant for immuno-oncology, immunotherapy, and cell therapy. But despite the huge clinical value that we can already see on the horizon, there are no commercial solutions that can move single-cell sequencing into the clinic. And that is where we see the sweet spot.

Proteona has developed a suite of technologies called the Enhanced Single-Cell Analysis with Protein Expression (ESCAPETM) platform. ESCAPE uses DNA-barcoded antibodies to obtain protein and gene expression information from individual cells. Available as an in-house service or a kit, the ESCAPE platform has been used extensively for peripheral blood mononuclear cells (PBMC) profiling, whole tumor analysis, and cell therapy characterization.

One of the key challenges of single-cell analysis is the enormous amount of data generated. Even the sequencing of a single tumor results in hundreds of millions of data points that have to be analyzed and interpreted.

Combining datasets from different sources is also challenging. Cross-experimental comparison is often impeded by batch-to-batch differences. Moreover, single-cell analysis often results in the detection of previously unknown cell populations. Manual intervention is often needed for cell clustering and cell annotation, which demands specialist expertise, takes time and is susceptible to human error and bias.

Proteona definitely evolved from being a wet lab company with a bit of IT to a company that is equal parts bio and tech, says Schmidt. With single-cell proteogenomics you end up with thousands of mRNAs and potentially hundreds of proteins. If you were to gate them all by yourself and annotate that data, it would take a long time and it would create a lot of bias. We try to avoid this by using machine learning and automatic algorithms. One key point of our work is that we started with the wet lab and have a very deep understanding of the techniques and biology. At the end of the day, the biology is what informs us, not the algorithms.

In a partnership with AI Singapore, Proteona is further developing its computational workflows to support the knowledge-driven analysis of single-cell proteogenomics data to create unbiased data sets. The collaboration aims to further the development of artificial intelligence (AI) tools for single-cell multi-omics data analysis.

In Autumn 2019, Proteona issued an oncology challenge, co-sponsored by NovogeneAIT, in which it called for proposals from scientists and clinicians working on major clinical problems in oncology. Participants were asked to send in an abstract describing how they would use the ESCAPE platform with the chance to win $50.000 worth of single-cell analysis services from Proteona and NovogeneAIT.

The grant was awarded to Cesar Rodriguez Valdes from the Wake Forest School of Medicine in Winston-Salem, US. The proposal aims to tackle the issue of treatment selection for multiple myeloma.

By applying single-cell proteogenomics in their patient-derived 3D organoid models, the team will compare cell populations in response to multiple drugs, identifying the difference in protein and gene expression patterns. These studies will help to elucidate the mechanism of chemo-sensitivity, and potentially help to choose the suitable chemotherapy combination for each patient.

We are excited about combining Proteonas single-cell proteogenomic analysis with our patient-derived organoid screening platform, says Rodriguez Valdes. Our ambition is to develop a predictive, validated test that will facilitate clinical decision-making and improve the outcome of multiple myeloma treatment. This grant will help us to move closer to that goal.

One major challenge in multiple myeloma management is how to select the most suitable treatment strategy for each patient, given the wide range of available therapies, adds Hartmut Goldschmidt, Head of Hemato-oncology in Heidelberg. Currently, the decision of which drug to use and when depends largely on the clinicians experience. There is an urgent need for tools that help clinicians make evidence-based choices. That is where single-cell multi-omics can be extremely valuable.

Other awardees of Proteonas challenge include the runner-up, Sanjay de Mel (National University Cancer Institute, Singapore), and the finalists Nicholas Gascoigne (National University of Singapore, Singapore), Steve Bilodeau (Universit Laval, Canada), and Aaron Tan (National Cancer Centre Singapore, Singapore).

With the growing complexity of drug development and the advancement of cell therapies and gene editing techniques, the need for single-cell proteogenomics in research and the clinic is increasing. A key application of single-cell proteogenomics will be the quality control of cell therapies.

Furthermore, although there is already genomic monitoring in place for many clinical trials, oncology trials would greatly benefit from single-cell proteogenomics monitoring.

Besides blood cancers, we see multiple potential areas where single-cell multi-omics will make a clinical impact, Schmidt says. By providing in-depth data on cell heterogeneity and combining that with powerful analysis tools, we are in the best position to help clinicians to decipher complex cases, from cell therapy to solid tumors. We are only starting to harness the power of single-cell analysis.

Are you interested in learning more about single-cell proteogenomics? Check out Proteonas website for more information or get in touch with its team of experts at [emailprotected]!

Images via Shutterstock.com and Proteona

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Is Single-Cell Sequencing the Solution to Treating Aggressive Blood... - Labiotech.eu

Graph 1

PRS Significantly Modifies Lifetime Breast Cancer Risk in Mutation Carriers

Myriad Genetics, Inc.

SALT LAKE CITY, Dec. 14, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced that results of a new validation study of the companys polygenic risk score (PRS) for breast cancer were presented at the 2019 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Tx. The key finding is that the PRS significantly improves the precision and accuracy of breast cancer risk estimates for women of European ancestry who have pathogenic variants (PV) in high- and moderate-penetrance breast cancer genes.

Our goal is to help women understand their risk of breast cancer so that they can take steps to live longer, healthier lives. Women who have a family history of breast cancer should consider hereditary cancer testing with the myRisk Hereditary Cancer test, said Jerry Lanchbury, Ph.D., chief scientific officer of Myriad Genetics. In this landmark study, we demonstrated that for women who test positive for a mutation in one of the five most common breast cancer genes, there are additional genetic factors called single nucleotide polymorphisms (SNPs) that can further influence their lifetime risk of breast cancer.

A summary of the study follows below. Follow Myriad on Twitter via @myriadgenetics and keep up to date with SABCS meeting news and updates by using the #SACBS19 hashtag.

Myriad Poster Presentation Title: Polygenic Breast Cancer Risk Modification in Carriers of High and Intermediate Risk Gene Mutations.Presenter: Elisha Hughes, Ph.D.Date: Saturday, Dec. 14, 2019, 7:009:00 a.m. Location: Poster P6-08-07

This validation study evaluated the 86-SNP PRS as a breast cancer risk factor for women who carry PV in the BRCA1, BRCA2, CHEK2, ATM and PALB2 genes and for PV-free women. The analysis included data from 152,012 women of European ancestry who received a myRisk Hereditary Cancer test as part of their clinical hereditary cancer risk assessment. The results demonstrated that the 86-SNP PRS significantly modified the breast cancer risk for women with pathogenic mutations in the five tested breast cancer genes (p-value <10-4). For some women, the PRS significantly increased the gene-based risk of breast cancer, while in others the gene-based risk was reduced (see Graph 1). Importantly, the greatest PRS risk-modification was observed in carriers of CHEK2, ATM and PALB2 mutations with some women reaching the risk levels associated with BRCA1 and BRCA2 mutations.

To viewGraph 1: PRS Significantly Modifies Lifetime Breast Cancer Risk in Mutation Carriers, please visit the following link:https://www.globenewswire.com/NewsRoom/AttachmentNg/d56c93ca-e00f-452d-b051-6325a578454c

These findings mean that we have the potential to significantly improve the precision of hereditary cancer risk assessment for women who test positive for mutations in the high and intermediate risk breast cancer genes, said Elisha Hughes, Ph.D., lead investigator and director of Bioinformatics at Myriad Genetics. We are optimistic that this additional genetic information can help clinicians more accurately predict the risk of breast cancer and provide the best care for their patients in the future.

Next StepsThe company plans to publish these new data in a peer reviewed medical journal and make the PRS available for U.S. women of European ancestry who test positive for mutations in breast cancer genes. The PRS currently is available as part of myRisk Hereditary Cancer enhanced with riskScore for women of European ancestry who test negative for pathogenic mutations in the breast cancer genes. Specifically, the riskScore test combines the PRS with the Tyrer-Cuzick model to estimate a womans 5-year and lifetime risk for developing breast cancer. The company is committed to making myRisk Hereditary Cancer enhanced with riskScore available to all ethnicities and is developing the test for women of Hispanic and African-American ancestry who test negative. The company is currently conducting the largest ever PRS study in African Americans and will present the data at a future meeting.

Please visit Myriad at booth #113 to learn more about our portfolio of genetic tests for breast cancer. Follow Myriad on Twitter via @myriadgenetics and keep up to date with Symposium news by using the hashtag #SABCS19.

AboutriskScoreriskScore is a new clinically validated personalized medicine tool that enhances Myriads myRisk Hereditary Cancer test. riskScore helps to further predict a womens lifetime risk of developing breast cancer using clinical risk factors and genetic-markers throughout the genome. The test incorporates data from more than 80 single nucleotide polymorphisms identified through 20 years of genome wide association studies in breast cancer and was validated in our laboratory to predict breast cancer risk in women of European descent. This data is then combined with a best-in-class family and personal history algorithm, the Tyrer-Cuzick model, to provide every patient with individualized breast cancer risk.

About Myriad myRisk Hereditary CancerThe Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 35 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma.

About Myriad GeneticsMyriad Genetics Inc. is a leading precision medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on five critical success factors: building upon a solid hereditary cancer foundation, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and improving profitability with Elevate 2020. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, EndoPredict, Vectra, GeneSight, riskScore, Prolaris, Foresight and Prequel are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor StatementThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the Companys polygenic risk score and data being featured at the 2019 San Antonio Breast Cancer Symposium being held Dec. 10-14, 2019 in San Antonio, Tx.; the potential to significantly improve the precision of hereditary cancer risk assessment for women who test positive for mutations in the high and intermediate risk breast cancer genes; this additional genetic information helping clinicians more accurately predict the risk of breast cancer and provide the best care for their patients in the future; publishing these new data in a peer reviewed medical journal and making the PRS available for U.S. women of European ancestry who test positive for mutations in breast cancer genes; making myRisk Hereditary Cancer enhanced with riskScore available to all ethnicities and developing the test for women of Hispanic and African-American ancestry who test negative; conducting the largest ever PRS study in African Americans and presenting the data at a future meeting; and the Company's strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2019, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

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Myriad's Polygenic Risk Score Personalizes Risk of Breast Cancer for Woman with a Genetic Mutation in Important Breast Cancer Genes - GlobeNewswire

Thuy Truong thought her aching back was just a pulled muscle from working out. But then came a high fever that wouldnt go away during a visit to Vietnam. When a friend insisted Truong, 30, go to an emergency room, doctors told her the last thing she expected to hear: She had lung cancer. Back in Los Angeles, Truong learned the cancer was at stage 4 and she had about eight months to live.

My whole world was flipped upside down, says Truong, who had been splitting her time between the San Francisco Bay Area and Asia for a new project after selling her startup. Ive been a successful entrepreneur, but Im not married. I dont have kids yet. [The diagnosis] was devastating.

Doctors at the University of Southern California took a blood sample for genetic testing. The liquid biopsy was able to detect tumor cells in her blood, sparing her the risky procedure of collecting cells in her lungs.

Genetic sequencing allowed the lab to isolate the mutation that caused her cancer to produce too much of the EGFR (epidermal growth factor receptor) protein, triggering cancer cells to grow and proliferate. Fortunately, her type of mutation responds to EGFR-targeting drugs, such as Tarceva or Iressa, slowing tumor growth.

Unlike chemotherapy, which blasts all fast-growing cells in its wake,go after specific molecules. That makes them more effective at fighting particular types of cancers, including breast, colorectal and lung cancers. Now the approach is being expanded to fight an even broader range of cancers. Its all part of a new wave in health care called .

This is the future of medicine, says Dr. Massimo Cristofanilli, associate director for translational research and precision medicine at Northwestern University. There is no turning back. The technology is available and there are already so many targeted therapies.

Most medical treatments have been designed for the average patient, leading to a one-size-fits-all approach. But with vast amounts of data at their disposal, researchers now can analyze, our family histories and other health conditions to better understand which types of treatments work best for which segments of the population.

This is a big deal. But it requires the know-how of geneticists, biologists, experts inand computer scientists who understand big-data analytics. Several startups have already begun this work.

, founded by researchers at the University of Toronto, uses AI to predict how genetic mutations will change our cells and the impact those changes will have on the human body., co-founded by scientists and physicians from Stanford University, is building a map of what turns our genes on and off, giving physicians a guide they could use to craft personalized therapies. And, a small San Francisco startup, provides personalized advice on nutrition and wellness based on your DNA.

Just like Facebook learns to automatically recognize Aunt Martha in your family photos, Deep Genomics finds and categorizes patterns in genetic data. Once its found those patterns, the companys deep learning system can infer if and how changes to your DNA affect your body.

Thats a big step forward compared with current genetic tests. Most can only give a probability of, say, getting breast cancer based on data from an entire population. Other tests cant even tell you if the genetic changes theyve detected mean anything.

The work is personal for Brendan Frey, CEO and co-founder of Deep Genomics and a professor at the University of Toronto. Fourteen years ago, he and his wife discovered their unborn baby had a genetic condition.

We knew there was a genetic problem, but our counselor couldnt tell us if it was serious or if it was going to turn out to be nothing, Frey says. We were plunged into this very difficult, emotional situation.

The experience made Frey want to bridge the divide between identifying and understanding what they mean.

Deep learning or machine learning when computers teach themselves as they see more data can also help doctors know which drugs will most effectively treat a patients illness and whether that person is more likely to experience side effects.

It can also help predict how cancer cells will mutate. And that can help drug companies come up with new treatments as tumor cells change and patients no longer respond to the drugs that worked.

That could help turn a disease like cancer into a manageable chronic ailment, says Cristofanilli.

Where Deep Genomics analyzes patterns in genetic data to predict when mutations will make you sick, Epinomics looks at epigenomics, or the study of what turns our genes on and off.

The company describes it like this: If your genome, which shows what genes we have, is the hardware of our bodies, then the epigenome is its software programming. Epinomics aims to decode that programming.

Every cell in the body carries the same genetic code. But cells in the heart, brain, bone and skin function differently based on this programming. It happens because chemical markers attach to DNA to activate or silence genes. These markers, known as the epigenome, vary from one cell type to another and are affected by both nature (inheritance) and nurture, which can include the air we breathe and the food we eat.

Researchers think a disruption to the epigenome can cause illnesses such as,or. Understanding it could give physicians a guide to the best options for each patient, like having a GPS for treatments at the molecular level.

We are focusing on what is happening at the programming level of each cell, says Epinomics co-founder Fergus Chan. Once we understand how genes are being turned on and off, well be able to better predict which treatments will work or whether changes to lifestyle will have an impact on health.

When Vitagene co-founder and CEO Mehdi Maghsoodnia asked a doctor what vitamins he should be taking, he was handed a bottle of pills and told to hope for the best.

That was the beginning of Vitagene, which uses genetic data and other health information culled from a detailed questionnaire to deliver a personalized nutritional supplement plan that lists which vitamins you need and in what doses, as well as what to avoid.

Maghsoodnia offers an alternative to the one-size-fits-all $27 billion US dietary supplement industry. Customers pay $99 to have their DNA tested and blood analyzed. And for $69 a month, Vitagene will package and ship supplements in dosages tailored to your individual needs.

The Food and Drug Administration estimates there are more than 85,000 dietary supplements on the US market, most of which are unregulated. Nearly all are promising everything from anti-aging to weight loss, and no science behind it to tell you what works for you, says Maghsoodnia. We help filter through the noise.

Vitagenes algorithm has been tested on patients whove had bariatric surgery for weight loss, which often leaves them deprived of key nutrients. Vitagene helped develop a supplement regimen to get these patients the nutrition they need after surgery.

Precision medicine is in its early days.

This is especially true for psychiatry and its exploration of how the brain responds to the environment, stress and genetic disorders. Now several companies are selling tests to help psychiatrists select drug treatments by looking at patients DNA mutations and their metabolizing rate.

But critics caution that these genetic tests may be overselling their capabilities.

Precision medicine has been very promising in oncology, says Jose de Leon, a professor of psychiatry at the University of Kentucky who specializes in psychopharmacology. But we know a lot more about cancer and how it works. In psychiatry, its much harder because we dont know enough about how the brain works.

Yes, precision medicine holds enormous promise.

Even so, Northwesterns Cristofanilli cautions clinicians to stay grounded in reality. It can be difficult to understand where reality becomes imagination, he says. We want to make sure we are protecting patients from claims that we may not deliver.

For her part, Truong is grateful to benefit from the work thats already been done. Im an engineer, she says.

I dont believe in miracles. I believe in science.

This story appears in the spring 2017 edition of CNET Magazine. For other magazine stories, click.

: The CNET team reminds us why tech stuff is cool.

: In Europe, millions of refugees are still searching for a safe place to settle. Tech should be part of the solution. But is it? CNET investigates.

This articleoriginallyappeared on.

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Gene therapy: What personalized medicine means for you - Stock Daily Dish

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ALBUQUERQUE, N.M. Decisions, decisions. What books to get as holiday gifts for family and friends?

Here are some suggested books published this year to help narrow your choices.

n New Mexicos Palace of the Governors: Highlights from the Collections edited by Daniel Kosharek and Alicia Romero. (Museum of New Mexico Press). From front to back, this book is source of enjoyment, admiration and enlightenment, containing materials of wildly diverse subjects and many periods in the museums collections. For example, theres the image on the front cover, and on page 157, of five men of the Santa Fe Fire Department bearing intense expressions and wearing smart deep red coats, dark pants and stylish hats. The photo, an ambrotype, was taken between 1861 and 1880, and helps the reader understand the collecting function of the Palace of the Governors in Santa Fe. Ambrotype and tintype, the book states, are cased image processes that followed the ground-breaking daguerreotype. The book is a companion to the exhibit A Past Rediscovered set to open March 6, 2020 at the New Mexico History Museum in Santa Fe. A Race Around the World: The True Story of Nellie Bly & Elizabeth Bisland written by Caroline Starr Rose, illustrated by Alexandra Bye. (Albert Whitman & Company). On Nov. 14, 1889, the two ladies in the title both New York journalists began their competition in a global race against each other and against time. Nellie headed east by steamer. Elizabeth westward by train. Nellie eventually won the race. But there was more at stake. The participants were making a statement about womens independence. As Rose, an Albuquerque resident, writes in conclusion, Both journeyed alone. Both took on the world and triumphed, each on her own terms. Byes illustrations are bright, attractive and draw the reader to the art and the text. The audience is ages 4-8. Our History is the Future: Standing Rock versus the Dakota Access Pipeline, and the Long Tradition of Indigenous Resistance by Nick Estes. (Verso). From his indigenous perspective, the author details how a small 2016 Indian protest of the planned Dakota Access oil pipeline blossomed into the largest indigenous protest movement of this century. Estes also thinks of the anti-pipeline movement as a statement of goals growing out of the tradition within the long history of native resistance in the United States. The context relates in part to the contentious white-indigenous relations stretching back into the 19th century.

Estes is a citizen of the Lower Brule Sioux tribe and an assistant professor of American Studies at the University of New Mexico.

Noel Street by Richard Paul Evans. (Gallery) Evans, the author of The Christmas Box and other seasonal bestsellers, is out with a new novel, Noel Street. Set in 1975, the novel is about love, faith, family and forgiveness. Elle is a single mom working as a waitress at the Noel Street Diner in Mistletoe, Utah. She meets William, a recently returned Vietnam POW suffering from war-related mental demons. In spite of his own issues, he may hold the key to unlock Elles secret pain. This is the third book in Evans Noel Christmas collection. The Rabbit Effect: Live Longer, Happier, Healthier with the Groundbreaking Science of Kindness by Dr. Kelli Harding. (Atria) Research in 1978 was the starting point for the authors reportage of investigations into the value of hidden, crucial factors in understanding health, factors such as love, friendship and community.

Theres a social dimension to health weve completely overlooked in our scramble to find the best and most cutting-edge personalized medical care, Dr. Harding writes in the introduction. She isnt the first person to probe medicines connection to kindness or compassion. But her book contributes to a greater understanding of the link. Harding is an assistant clinical professor of psychiatry at Columbia University Irving Medical Center.

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Seasons readings to end this year or start the next with - Albuquerque Journal

New Jersey, United States: The report titled Personalized Medicine Market is one of the most comprehensive and important additions to Verified Market Researchs archive of market research studies. It offers detailed research and analysis of key aspects of the Personalized Medicine market. The market analysts authoring this report have provided in-depth information on leading growth drivers, restraints, challenges, trends, and opportunities to offer a complete analysis of the Personalized Medicine market. Market participants can use the analysis on market dynamics to plan effective growth strategies and prepare for future challenges beforehand. Each trend of the Personalized Medicine market is carefully analyzed and researched about by the market analysts.

Global Personalized Medicine Market was valued at USD 96.97 Billion in 2018 and is expected to witness a growth of 10.67% from 2019-2026 and reach USD 217.90 Billion by 2026.

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A two-day workshop on healthy aging hosted by UCLA is kicking off a five-year partnership between the University of California system and Nanyang Technological University, Singapore.

The workshop is being held at Mong Auditorium in Engineering VI from Dec. 9-10 with several experts from NTU and the majority of UC campuses participating.

The first day focuses on technologies for healthy aging and includes talks on the role of brain-computer interfaces in brain health and on molecular mechanisms of aging and precision medicine. The neurobiology of aging and the impact of lifestyle, prevention and policy is the topic for the second day of the workshop.

UCLA Samueli participants include Jacob Rosen, a professor of mechanical and aerospace engineering, who is presenting on technology for rewiring the brain for stroke patients, and Sam Emaminejad, an assistant professor in electrical and computer engineering, whose main focus is wearable sensors and personalized medicine.

The joint effort between the two organizations fosters an exchange of faculty and students and expands academic and research opportunities in areas including health, technology, innovation and climate change.

NTU President Professor Subra Suresh and UC President Janet Napolitano signed the memorandum of understanding on behalf of their respective institutions earlier this year in February, and the health workshop is one of the initial outcomes of the partnership.

The workshop is organized by a team led by Hal Monbouquette, a UCLA Samueli professor of chemical and biomolecular engineering; NTU Graduate College Associate Dean Sierin Lim; and NTU Graduate College Dean K. Jimmy Hsia.

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Healthy Aging Workshop Launches UC Partnership with Nanyang Technological University, Singapore - UCLA Samueli School of Engineering Newsroom

REDWOOD CITY, Calif., Dec. 11, 2019 (GLOBE NEWSWIRE) -- Despite longstanding medical guidelines recommending biomarker testing for all patients with metastatic colon cancer, a new study published in JCO Precision Oncology shows that only 40 percent of patients are tested according to guidelines.1 These findings are consistent with the rates seen in late-stage lung cancer, where clinical adoption of genomic profiling remains below the recommended standard-of-care guidelines.2 The result is that many patients are potentially being treated with less effective drugs, some having serious side-effects; while others are not being offered highly effective personalized treatment options.

The multi-center retrospective study also found that certain subgroups of patients were less likely to be tested than others. Suboptimal genotyping occurred more often if the patient was male, older than 65, progressed from early stage disease, or treated in a community cancer center. Furthermore, only 28 percent of patients on anti-EGFR treatments received the necessary testing to determine eligibility. This study also showed that using a comprehensive panel, as opposed to single-gene testing, could possibly result in a 50 percent increase in guideline-recommended testing rates.

For over a decade, medical guidelines have recommended multigene mutation testing for metastatic colon and rectal cancer patients to ensure patients receive the optimal treatment available. While the study shows that testing has improved slightly, the disappointing reality is that the majority of patients, including those receiving targeted treatments, are not being comprehensively tested, said Stuart Goldberg, MD, a lead study investigator who served as chief scientific officer at COTA, Inc. during the project. Personalized medicine holds great promise for achieving better outcomes, but we will not see the benefits until genomic testing is routinely adopted into clinical practice.

Newly available therapies routinely help some people with metastatic colorectal cancer gain a year or two of life, but these novel treatments cannot be applied unless comprehensive genotyping is routinely performed, said Richard Lanman, MD, Guardant Health Global Chief Medical Officer. Just as concerning was that 28 percent of patients received targeted treatments without being tested, and for some we would have known in advance that the treatment was not going to work. At Guardant we are committed to helping reverse this trend by helping to educate oncologists and offering a non-invasive and comprehensive genomic testing solution that overcomes the limitations of tissue biopsies with our Guardant360 blood test.

The American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) guidelines recommend biomarker testing for all patients with metastatic colon cancer to screen for genomic alterations in KRAS, NRAS, BRAF, ERBB2 (HER2), NTRK and microsatellite instability (MSI) to help guide more effective treatment decisions. Targeted therapies and immunotherapies have been shown to improve clinical outcomes. For example, anti-EGFR therapies are commonly used in treating metastatic colon cancer but are not efficacious in patients whose tumors harbor KRAS, NRAS, or BRAF V600E mutations.3 Additionally, immunotherapy is effective in patients with MSI and anti-HER2 treatment is effective in patients with ERBB2 (HER2) amplifications.4,5 Professional guidelines continue to be updated as new therapies come to market such as the recent recommendation to test patients for NTRK fusions because they may benefit from treatment with tumor-agnostic NTRK inhibitors.

Study details can be found here.

About Guardant HealthGuardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360 and GuardantOMNI tests for advanced stage cancer patients and LUNAR assay for research use and for use in prospective clinical trials. In parallel, Guardant Health is actively exploring the performance of the LUNAR assay in initial studies related to screening and early detection in asymptomatic individuals.

Forward Looking StatementsThis press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the adoption of Guardant Healths products, which involve risks and uncertainties that could cause Guardant Healths actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Healths financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the caption Risk Factors in Guardant Healths Annual Report on Form 10-K for the year ended December 31, 2018, and in its other reports filed by Guardant Health with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Healths views as of any date subsequent to the date of this press release.

In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Guardant Health.

Investor Contact:Lynn Lewis or Carrie Mendivilinvestors@guardanthealth.com

Media Contact:Anna Czene or Ian Stonepress@guardanthealth.com

References1. Gutierrez ME, Price KS, Lanman RB, et al. Genomic Profiling for KRAS, NRAS, BRAF, Microsatellite Instability (MSI) and Mismatch Repair Deficiency (dMMR) among Patients with Metastatic Colon Cancer. JCO Precision Oncol. December 20192. Leighl NB, Page RD, Raymond VM, et al. Clinical Utility of Comprehensive Cell-Free DNA Analysis to Identify Genomic Biomarkers in Patients with Newly Diagnosed Metastatic Non-Small Cell Lung Cancer. Clin Cancer Res. April 20193. Van Cutsem E, Khne CH, Lng I, et al. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol. May 20114. Overman MJ, Lonardi S, Wong KYM, et al. Durable clinical benefit with nivolumab plus ipilimumab in DNA mismatch repair-deficient/microsatellite instability-high metastatic colorectal cancer. J Clin Oncol. March 20185. Sartore-Bianchi A, Trusolino L, Martino C, et al. Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES): a proof-of-concept, multicentre, open-label, phase 2 trial. Lancet Oncol. April 2016

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Study Shows Only 40 Percent of Patients with Metastatic Colon Cancer Receive Guideline-Recommended Biomarker Testing - GlobeNewswire

On March 8, 2019, the US Food and Drug Administration (FDA) approved the PD-L1 inhibitor atezolizumab for first-line treatment of metastatic triple-negative breast cancer in combination with nab-paclitaxel chemotherapy for patients who are ineligible for surgery and whose tumors express PD-L1. This marks the first time a regimen approved for breast cancer includes an immunomodulator, and represents the first targeted agent approval in triple-negative breast cancer a disease that, historically, has only had chemotherapy as a treatment option.

Triple-negative breast cancer is an especially aggressive subtype of breast cancer that is identified by the absence of expression of estrogen, progesterone, or HER2 protein receptors on the cancers surface. These proteins, when present in other subsets of breast cancer, allow us to target and take advantage of the protein to kill the cancer cell. For patients with triple-negative metastatic cancer, the average survival is only slightly more than a year, meaning that half of women diagnosed with this disease will not live beyond that benchmark.

This groundbreaking approval was based on results of the IMpassion130 trial (ClinicalTrials.gov Identifier: NCT02425891), for which Sarah Cannon, the Cancer Institute of HCA Healthcare in Nashville, Tennessee, participated. The IMpassion130 trial treated 902 women with either nab-paclitaxel alone or nab-paclitaxel in combination with atezolizumab.

A post-hoc update of long-term progression-free survival revealed that in the PD-L1 immune cell-positive population, the updated median progression-free survival was 7.5 months

(95% CI, 6.79.2) with atezolizumab plus nab-paclitaxel and 5.3 months (95% CI, 3.85.6) for nab-paclitaxel alone (stratified hazard ratio [HR], 0.63; 95% CI, 0.500.80; P <.0001).1

In patients with PD-L1positive tumours, median overall survival was 25 months (95% CI, 19.630.7) with atezolizumab and 18 months (13.620.1) with placebo. The stratified hazard ratio for overall survival was 0.71 (95% CI, 0.540.94).1

Immunotherapy treatments help a patients immune system recognize cancer as foreign and attack it. In contrast to chemotherapy, which can be thought of as poison for cancer cells, immunotherapy is essentially a way to boost ones own immune cells to fight cancer. Chemotherapy has known side effects, such as hair loss, nausea, and fatigue; however, the side-effect profile for immunotherapy treatment is different. Patients receiving immunotherapy treatment may experience low thyroid hormone levels or inflammation in the lungs or gastrointestinal system. When treating patients with immunotherapy, it is important to closely monitor patients for these rare side effects and treat them with steroids when appropriate.

The approval of atezolizumab not only represents a win for some patients with triple-negative breast cancer characterized by PD-L1 expression, it also more broadly represents a win for personalized medicine. In the past decade, we have gotten smarter about knowing that every persons cancer may be driven by individual mutations and alterations. We have had access to tests to examine the expression of estrogen receptors, progesterone receptors, and HER2 receptors for some time, but only now do we know to test for PD-L1, which allows us break this broad disease down into smaller subsets using the markers the cancer possesses, and, prescribe more targeted treatments. We have also started looking at a broader profile of the alterations in a cancer through molecular profiling, where hundreds of genes are examined for mistakes and abnormal copy numbers in an attempt to personalize care. Tailoring treatment to each person and their individual cancer characteristics at the cell level will become even more common in the coming years.

IMpassion130 also highlights the benefit of clinical trials not just for future patients, but also for those who are currently enrolled. I treated patients enrolled in this trial, and in fact, we still have patients who are receiving this therapy years after their diagnosis. This trial and this agent highlight the advances we make in cancer treatment every day through the power of clinical trials. Unfortunately, only about 2% to 5% of adults with cancer participate in clinical trials in the US and more than 50% say they are not even aware of the existence of trials.2,3 These studies show us that we need to continue to work toward making clinical trials a well-understood concept through patient education, dispelling misconceptions, and celebrating the big advances, such as the approval ofatezolizumab in this patient group.

Erika Hamilton, MD, is the Director of the Breast Cancer and Gynecologic Cancer Research Program at Sarah Cannon Research Institute in Nashville, Tennessee.

References

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Triple-Negative Breast Cancer Now Has a Targeted Agent - Cancer Therapy Advisor

FREMONT, CA: Diagnostics and treatment have undergone sea changes in recent years. The field which was dominated by traditional medical technologies is now on the cusp of artificial intelligence-driven changes. The area of radiology has also come under the influence of advancement, leading to the emergence of radiomics. The development has been helping the medical industry in dealing with the imminent shortage of qualified radiologists. Innovators have put their brains together and taken diagnostic scanning to the next level with radiomics. Radiomics is still in a developmental phase, but it has already contributed to the healthcare industry. Some ways in which the technology is helping medical fraternity is mentioned in the list below.

Immunohistochemical Evaluations

Patients can be checked for immunohistochemical (IHC) characteristics with the help of radiomics-based imaging. Medical researchers have successfully created unique machine learning models that can detect thyroid nodules in patients with high degrees of accuracy. The development makes the process non-invasive and enables the prediction of hormonal presence in patients. Computer topography imaging techniques cannot present ICH related information. According to experts, these capabilities make a timely diagnosis of thyroid cancers possible and feasible.

Brain Tumor Detection and Treatment

Current technologies for detection and classification of malignant brain tumors are good enough, but with radiomics, the amounts of data that can be extracted increases substantially. Subsequently, radiomic analysis can generate insightful data which are helpful for diagnosis, evaluation, and treatments. The advanced imaging also enables practitioners to adhere to recently announced protocols which vary significantly from the standard ones. One of the significant advantages of using radiomics in brain tumor assessment is that it allows the determination of molecular characteristics which help categorize molecular subtypes.

Diagnosis of Cancers in Breast, Lungs and Neck

Radiomics has been widely adopted by medical fraternity for the neck, lungs, and breast cancer diagnosis, treatment, and prognosis. Predicting the stage of cancer in cancer-afflicted patients with minimum or no invasive procedures is a significant step forward. Radiomics has shown excellent results in projecting the differences which help in classifying the stage of cancer. Even reoccurrence predictions have been benefitted with radiomic signature-based investigations. The ability of radiomics to take into consideration a higher number of factors and features by combining recorded clinical information makes it useful in early detection of breast, lungs, and neck cancers. In the case of breast cancer patients, radiomics is predicting response to therapy with high accuracy and thus optimizing treatment.

Precision Medicine

High sensitivity and high specificity are the remarkable features of radiomics. As the medical industry adopts precision medicine, radiomics is all set to play a very crucial role. Radiomics is powerful because it applies artificial intelligence and deep learning characteristics to radiology, thus helping define tissues with much more accuracy. Every patient can undergo a radiomics-based diagnosis and come up with personalized reports. These reports can relay detailed information which enables doctors to prescribe personalized medication or treatment models. Thus, radiomics is helping extract qualitative and quantitative data which make precision medicine possible.

Reading and interpreting medical data is challenging. However, radiomics is transforming decision-making by bettering identification and characterization. One can expect the diagnosis to become faster and error-free as computerization becomes central to the process. Subsequently, patient care will also improve as doctors gain access to deeper health insights.

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How is Radiomics the Next Wave in Medtech? - Medical Tech Outlook

GMI Research has recently published a report on Global Precision Medicine market, the report highlights the key ongoing market trend, market growth, drivers and restraints of Global Precision Medicine market. The report provides the forecast data for the period of 2019 to 2026. GMI Research analysts have a thorough understanding of the market as they are on top of any market trends and developments, which help them to understand current market dynamics, market competitive landscape and future trends of Global Precision Medicine in a couple of years.According to the report, the Global Precision Medicine Market is projected to grow at a CAGR growth of ~XX% through the forecast period from 2019 to 2026 owing to various key factors such as Precision medicine is being eyed upon as lucrative business investment opportunity by the major pharmaceutical companies owing to the rising patient preference for personalized treatment, advancements in wireless technologies and big data analytics, and tremendous increase in genetic diseases such as cancer. Our analyst knows the importance of data and are also aware of the significance of providing accurate data. The analyst deploys various approaches from primary research to credible secondary research sources and validates the data from multiple sources to make sure that our client gets the accurate picture of the Global Precision Medicine and the market size, market projections, competitive landscape etc.The reports also profile the major market players. The major players are Illumina, Inc., GE Healthcare, Roche Group, bioMerieux SA, IBM Corporation, Novartis AG, and Abbott Laboratories among others.Request Sample Report Now at Link https://www.gmiresearch.com/report/global-precision-medicine-market/sample-requestKey areas the report on Global Precision Medicine market addresses are: What are the major market drivers influence the growth of Global Precision Medicine? Which region provides the maximum growth opportunities? What makes one product more attractive over another and ranking of all the products and the market opportunity they provide? What are the key developments and how they are impacting the Global Precision Medicine market? What are the current key trends of Global Precision Medicine? How the competitive landscape looks like and what strategies companies are adopting to increase their market share?How the insights on Global Precision Medicine will help our clients in critical decision making? Help our client to know all the segments and sub-segments in detail Assessment of competitive landscape of Global Precision Medicine Details of new product launch trend, innovations, market expansions and other strategies adopted by major players Regional market trends and opportunities available in each region North America, Europe, Asia Pacific and RoWSpeak to Research Analyst to Understand more About Research at Link https://www.gmiresearch.com/report/global-precision-medicine-market/Competitive Landscape key players main strategies and their product offerings Major players products strength on each segment and vertical Product Benchmarking analysis of key players Key Players Recent Developments and strategic directionRequest for Customization at Link https://www.gmiresearch.com/report/global-precision-medicine-market/request-for-customizationAbout GMI ResearchGMI Research provides research and consulting solutions to our clients. We help our global clients through independent fact-based insights, ensuring their business achieve success by beating the competition. We provide syndicated research, customized market and competitive intelligence research, sales enablement support and data analytics services.Contact UsGMI ResearchLevel 1, The Chase Carmanhall Road, Sandyford Industrial Estate,Dublin D18 Y3X2, IrelandPh. No: +353 1 442 8820Email: [emailprotected]Web: https://www.gmiresearch.com

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Aspen Neuroscience, a new San Diego biotech company working on stem cell treatment for Parkinsons disease, has come out of stealth mode and raised $6.5 million to pursue clinical testing for its therapy.

Co-founded by well-known stem cell scientist Jeanne Loring, Aspen Neuroscience proposes creating stem cells from modified skin cells of Parkinsons patents via genetic engineering.

The stem cells, which can become any type of cell in the body, then would undergo a process that makes them specialize into dopamine-releasing neurons.

People with Parkinsons lose a large number up to 50 percent at diagnosis of specific brain cells that make the chemical dopamine.

Without dopamine, nerve cells cannot communicate with muscles and people are left with debilitating motor problems.

Once these modified skin cells have been engineered to specialize in producing dopamine, they can be transplanted into the Parkinsons patient to restore the types of neurons lost to the disease.

The reason we called it Aspen is because l was raised in the Rocky Mountain states, said Loring. When there is a forest fire in the Rockies, the evergreens are wiped out but the aspens are the fist that regenerate after the burn. So it is a metaphor for regeneration.

Aspen still has a long way to go before its proposed therapy would be available to Parkinsons patients. It has been meeting with the U.S. Food and Drug Administration to provide animal trial data and other information in hopes of getting permission to start human clinical trials.

But the company expects the earliest it would get the go-ahead from FDA to start human trials would be 2021.

Loring has been working on the therapy for eight years. She is professor emeritus and founding director of the Center for Regenerative Medicine at the Scripps Research Institute.

Loring co-founded the 20-employee company with Andres Bratt-Leal, a former post-doctoral researcher in Lorings lab at Scripps.

Joining them as Aspens Chief Executive is Dr. Howard Federoff, former vice chancellor for health affairs and chief executive of the University of California Irvine Health System.

Federoff said the company is the only one pursuing the use of Parkinsons patients own cells as part of neuron replacement therapy.

Aspens proprietary approach does not require the use of immuno-suppression drugs, which can be given when transplanted cells come from another person and perhaps limit the effectiveness of the treatment.

Aspens approach is a therapy that is likely to benefit from the fact that your own cells know how to make the best connections with their own target cells in the brain, even in the setting of Parkinsons disease, said Federoff. So when transplanted it is able to set back the clock on Parkinsons.

In addition to Aspens main therapy, it is researching a gene-editing treatment for forms of Parkinsons common in certain families.

Aspens research work up to now has been supported by Summit for Stem Cell, a non-profit on which provides a variety of services for people with Parkinsons disease.

The new seed funding round was led by Domain Associates and Axon Ventures, with additional participation from Alexandria Venture Investments, Arch Venture Partners, OrbiMed and Section 32.

Aspens financial backing, combined with its experienced and proven leadership team, positions it well for future success, said Kim Kamdar, a partner at Domain Associates. Domain prides itself on investing in companies that can translate scientific research into innovative medicines and therapies that make a difference in peoples lives. We clearly see Aspen as fitting into that category, as it is the only company using a patients own cells for replacement therapy in Parkinsons disease.

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Aspen Neuroscience gets funding to pursue personalized cell therapy for Parkinsons disease - The San Diego Union-Tribune

ViewRay has inked respective agreements with Elekta AB and Medtronic that aim to increase understanding into and practices of MR-guided radiation therapy.

The partnerships will each include the establishment of clinical studies to assess the impact and benefits provided by the treatment, as well as probes into additional therapeutic areas in which the technology could prove beneficial.

"We are pleased to announce these important collaborations and investments in ViewRay, said ViewRays president and CEO Scott Drake in a statement. Our goal is to concurrently prove the value of MR-guided radiation therapy and strengthen our balance sheet.

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Elekta will also invest in ViewRay, taking on a minority interest with the potential to rise to 9.9 percent.

Elekta believes that competition is crucial to drive the adoption of any new technology, and that is why we are committed to continuing to develop and offer customers our high-field Elekta Unity and promoting this technology to benefit patients worldwide, said Elekta's president and CEO Richard Hausmann in a statement. By investing in ViewRay, we ensure that the two inventors of MR-guided radiation therapy continue to drive the paradigm shift forward.

The deal between Medtronic and ViewRay is a similar clinical collaboration, that will make use of the MRIdian MR-guided radiation therapy system in studies. Medtronic has also committed to investing in a minority share of ViewRay as part of the deal.

"We are well-positioned to drive MRIdian to standard of care, noted Drake, adding that, the ability to see clearly during the procedure, track tumors and soft tissues, and auto-gate the beam is integral to delivering highly precise, personalized medicine."

The agreements with Elekta and Medtronic follow a rough period for ViewRay, which was,hit with an investor lawsuit in September, filed over allegedly false or misleading statements made regarding negative operational and financial issues reported in August.

Specific allegations included failure to disclose that demand for ViewRay systems dropped due, in part, to changes around Medicare reimbursement; overstating reported backlog; and damages suffered by investors because of materially false and misleading statements made by ViewRay at all relevant times. Upon disclosing these challenges, the companys stock price fell by more than 50 percent. It also slashed its previously issued full fiscal year 2019 financial guidance.

In addition to the deals with Elekta and Medtronic, ViewRay's biggest shareholder, Fosun International Limited will be putting in more money in order to keep its ownership percentage at present levels.

The investments from Elekta and Medtronic, however, will only take place if at least $75 million is raised. Elekta's investment will also require an aggregate cap of $36 million.

The deals are non-binding, subject to various terms and conditions.

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ViewRay teams with Elekta and Medtronic on MR-guided radiation therapy - DOTmed HealthCare Business News