StemCell Therapy

Genedata and the Crohns & Colitis Foundation completed a project aimed at advancing precision care for Crohns disease patients.Genedata, a biopharmaceutical research and development software company, worked with foundation investigators and clinicians to integrate and study multi-omic and clinical data culled from patients with Crohns, which, along with ulcerative colitis, is among the most common forms of inflammatory bowel disease (IBD).The data will be used to identify the biomarkers that can be the most useful in evaluating, within five years of IBD diagnosis, a person's risk of developing disease complications that require surgery.Crohns disease is a chronic, often debilitating disease, for which there is currently no cure, Andres Hurtado-Lorenzo, PhD, the foundations senior director of translational research, said in a press release. Despite several treatment options, currently we lack predictive tests to determine the optimal treatment strategy early in the disease process, when the opportunity to improve outcomes is greatest.""There is a significant unmet need to advance new diagnostic tools to enable precision medicine approaches and to optimize patient care according to the severity of the disease course," he said.The foundation sought help with leveraging abundant clinical and molecular data. Multi-omics is an approach in which multiple datasets (such as genes or protein profiles) are combined and analyzed for new associations.Genedata used its precision medicine software platform, Genedata Profiler, to provide data analysis that could advance biomarker research efforts. Biomarkers are useful in predicting disease trajectory, which is crucial to personalized treatment plan development.We decided to im

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Precision Medicine is Focus of Genedata, Crohn's Foundation Project - IBD News Today

Editors note:Brooks Bell is the founder and CEO of her eponymous brand consulting firm.

RALEIGH A year ago, I was diagnosed with stage 3 colon cancer. Its been a tough year: 6 months of surgery and chemotherapy, followed by intense health recovery. I have made dramatic changes to my diet, fitness routine, and stress. This month, I received the news Ive been fantasizing about all year: Im cancer-free. A groundbreaking blood test determined that there is not a single molecule of my tumor cells currently in my blood. That, combined with a clear CT scan, means that there is a 95% chance that my cancer is gone and wont return. I am overjoyed.

When I received the news, Jes and I were just waking up in the Dominican Republic after celebrating our 21st anniversary together. I burst into tears of joy, and felt the burden of uncertainty lifting off my chest. It was a surreal moment. Id gotten accustomed to clawing back my health, questioning feelings of wellbeing.It was easy to imagine being one of the unlucky ones who has the cancer come back and spread (after all, I was already unlucky enough to get cancer in the first place).

This is what makes cancer so hard for many: even when youre done with your treatment, it takes years to fully relax again because up until now our existing technology has prevented us from knowing if the treatment was truly successful.

Not anymore.

The molecular test that I took is a cutting-edge technology calledNatera. It gives cancer patients personalized testing that involves doing ultra-deep DNA sequencing on your tumor cells, and then matching those to your blood to see if they are still floating around in your body.

It just got FDA breakthrough status in May, and I was the first patient at Duke Cancer Center to receive it.

I believe this test may be part of a paradigm shift in the cancer industry. Its a perfect example of the promise of personalized medicine and machine learning. It is going to give patients clear insight on whether their treatment has been successful, and maybe even if chemotherapy is even necessary for them. Its pretty incredible, and I am so lucky to be able to benefit from it. Go Duke! Go Natera!

Brooks Bells new cause. (Brooks Bell image)

I will be celebrating toasting my health and the50 Colonoscopies Under 50 honorees with my friends and supporters at The Colonoscopy Gala on Feb. 28 at CAM Raleigh. I would love for you to be there with me (especially if you are based in NC).

This may be the first ever Colonoscopy Gala in the history of time. A colonoscopy is the most effective way to protect yourself from colon cancer, and it deserves a night to be celebrated.

Itll be an evening to remember. We will have asuper talented chefdoing a five-course seated dinner for us, and you may be able to even get bring home a one-of-a-kind street-artist designedTushy Ottoman..

And of course, its for a good cause; all proceeds go to the astonishingly underfunded Colorectal Cancer Alliance.

Tickets are $175 each, and are available until Feb. 17. RSVP or donate here.

Brooks Bell: I finished my chemo treatment, feeling fantastic

Six months after cancer diagnosis, Brooks Bell appoints successor to run her brand consulting firm

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Brooks Bell: 'Groundbreaking blood test determined there is 95% chance my cancer is gone and won't return' - WRAL Tech Wire

Parsippany, NJ, Feb. 11, 2020 (GLOBE NEWSWIRE) -- Interpace Biosciences, Inc. (Nasdaq:IDXG) today announced that the Center for Medicare and Medicaid Services (CMS) has modified the reimbursement for Interpace Diagnostics ThyraMIR miRNA classifier for evaluating indeterminate thyroid nodules retroactively to January 1, 2020. This determination increases the Medicare reimbursement for ThyraMIR from approximately $1800 to $3000 reflecting a re-evaluation of the technical and clinical performance of the test relative to other molecular tests in the market and their respective prices. Today, approximately 30% of the Companys ThyraMIR volume is attributable to Medicare eligible patients.

According to Jack Stover, CEO of Interpace, We are pleased with the thorough assessment given by CMS in evaluating one of our key products with the result of improved pricing for ThyraMIR. We believe this modification represents value-based pricing and reflects the critical impact ThyraMIR has on identifying a surgical need from surveillance. This price improvement is particularly noteworthy in light of our recent announcement surrounding the preliminary approval from CMS for a price increase in Interpaces biomarker companion product ThyGeNEXT.

About ThyGeNEXT and ThyraMIR

ThyGeNEXT utilizes state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer, as well as Medullary Thyroid Carcinoma. ThyraMIR is the first microRNA gene expression classifier. MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyraMIR measures the expression of 10 microRNAs. Both ThyGeNEXT and ThyraMIR are covered by Medicare and Commercial insurers, with more than 280 million members covered.

According to the American Thyroid Association, approximately 20% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGeNEXT and ThyraMIR.

ThyGeNEXT and ThyraMIR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules. The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis.

About Interpace Biosciences

Interpace Biosciences is a leader in enabling personalized medicine, offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.

Interpace Diagnostics is a fully integrated commercial and bioinformatics business unit of Interpace Biosciences that provides clinically useful molecular diagnostic tests, bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. Interpace has four commercialized molecular tests and one test in a clinical evaluation process (CEP): PancraGEN for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGeNEXT for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay; ThyraMIR for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay; and RespriDX that differentiates lung cancer of primary vs. metastatic origin. In addition, BarreGEN for Barretts Esophagus, is currently in a clinical evaluation program whereby we gather information from physicians using BarreGEN to assist us in positioning the product for full launch, partnering and potentially supporting reimbursement with payers.

Interpace Pharma Solutions Is a business unit of Interpace Biosciences that provides pharmacogenomics testing, genotyping, biorepository and other customized services to the pharmaceutical and biotech industries. The Pharma Solutions Business also advances personalized medicine by partnering with pharmaceutical, academic, and technology leaders to effectively integrate pharmacogenomics into their drug development and clinical trial programs with the goals of delivering safer, more effective drugs to market more quickly, and improving patient care.

Story continues

For more information, please visit Interpace Biosciences website at http://www.interpace.com.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to the Company's future financial and operating performance. The Company has attempted to identify forward looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from those expressed or implied by any forward-looking statement. Additionally, all forward-looking statements are subject to the Risk Factors detailed from time to time in the Company's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10Q. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

CONTACTS:Investor Relations - Edison GroupJoseph Green(646) 653-7030jgreen@edisongroup.com

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Interpace Biosciences Announces Another Pricing improvement for its Thyroid Assay - Yahoo Finance

Dataintelo.com, has added the latest research on Personalized Medicines Market, which offers a concise outline of the market valuation, industry size, SWOT analysis, revenue approximation, and the regional outlook of this business vertical. The report precisely features the key opportunities and challenges faced by contenders of this industry and presents the existing competitive setting and corporate strategies enforced by the Personalized Medicines Market players.

As per the Personalized Medicines Market report, this industry is predicted to grow substantial returns by the end of the forecast duration, recording a profitable yearly growth in the upcoming years. Shedding light on brief of this industry, the report offers considerable details concerning complete valuation of the market as well as detailed analysis of the Personalized Medicines Market along with existing growth opportunities in the business vertical.

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Concepts and ideas in the report:Analysis of the region- based segment in the Personalized Medicines Market: As per the report, in terms of provincial scope, the Personalized Medicines Market is divided into USA, Europe, Japan, China, India and South East Asia. It also includes particulars related to the products usage throughout the geographical landscape. Data related to the evaluations held by all the zones mentioned as well as the market share registered by each region is included in the report. Sum of all the product consumption growth rate across the applicable regions as well as consumption market share is described in the report. The report speaks about consumption rate of all regions, based on product types and applications.

Brief of the market segmentation: As per the product type, the Personalized Medicines Market is categorized intoPM DiagnosticsPM TherapeuticsPersonalized Medical CarePersonalized Nutrition & Wellness

Furthermore, the market share of each product along with the project valuation is mentioned in the report. The report consists of facts related to every single products sale price, revenue, growth rate over the estimation time period.

The Personalized Medicines Market, according to the application spectrum, is categorized intoHospitals PharmaciesRetail PharmaciesDietary Care CentersOthers

Data pertaining the market share of each product application as well as estimated revenue that each application registers for is slated in the report.

Propelling factors & challenges: The report provides data concerning the forces influencing the commercialization scale of the Personalized Medicines Market and their effect on the revenue graph of this business vertical. Data pertaining to latest trends driving the Personalized Medicines Market along with the challenges this industry is about to experience in the upcoming years is mentioned in the report.

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Implementing marketing tactics: Ideas about numerous marketing strategies implemented by the renowned shareholders with respect to product marketing is present in the report. Information related to the sales channels that companies select is also included in the report. Along with the dealers of these products, it also presents the summary of the top customers for the same.

Analysis of the major competitors in the market:An outline of the manufacturers active in the Personalized Medicines Market, consisting of3G BiotechQuest DiagnosticsLaboratory Corporation of AmericaAbbottAgendia NVAsuragen IncBecton DickinsonCardioDx Inc.Foundation MedicineQiagenSiemens HealthcareAmgenBristol-Myers SquibbGE HealthcarePfizerSanofi23andMeIlluminaalong with the distribution limits and sales area is reported. Particulars of each competitor including company profile, overview, as well as their range of products is inculcated in the report. The report also gives importance to product sales, price models, gross margins, and revenue generations. The Personalized Medicines Market report consists of details such as estimation of the geographical landscape, study related to the market concentration rate as well as concentration ratio over the estimated time period.

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Some of the Major Highlights of TOC covers:Personalized Medicines Regional Market Analysis Personalized Medicines Production by Regions Global Personalized Medicines Production by Regions Global Personalized Medicines Revenue by Regions Personalized Medicines Consumption by Regions

Personalized Medicines Segment Market Analysis (by Type) Global Personalized Medicines Production by Type Global Personalized Medicines Revenue by Type Personalized Medicines Price by Type

Personalized Medicines Segment Market Analysis (by Application) Global Personalized Medicines Consumption by Application Global Personalized Medicines Consumption Market Share by Application (2014-2019)

Personalized Medicines Major Manufacturers Analysis Personalized Medicines Production Sites and Area Served Product Introduction, Application and Specification Personalized Medicines Production, Revenue, Ex-factory Price and Gross Margin (2014-2019) Main Business and Markets Served

For More Information on this report, Request Inquiry At https://dataintelo.com/enquiry-before-buying/?reportId=98645

About DataIntelo: DATAINTELO has set its benchmark in the market research industry by providing syndicated and customized research report to the clients. The database of the company is updated on a daily basis to prompt the clients with the latest trends and in-depth analysis of the industry. Our pool of database contains various industry verticals that include: IT & Telecom, Food Beverage, Automotive, Healthcare, Chemicals and Energy, Consumer foods, Food and beverages, and many more. Each and every report goes through the proper research methodology, validated from the professionals and analysts to ensure the eminent quality reports.

Contact Info DataIntelo Name Alex Mathews Email [emailprotected] Website https://dataintelo.com Address 500 East E Street, Ontario, CA 91764, United States.

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Personalized Medicines Market, Share, Growth, Trends And Forecast To 2025 DataIntelo - Keep Reading

lacaosa via Getty Images

Prolon provides dieters with bars, soups, drinks, and supplements said to deliver the benefits of intermittent fasting byusing ingredients that "are not recognized as food by your body," according to its website.

Intermittent fasting of any kind has promising health benefits, including potentially slowing aging and diseases like cancer and diabetes.

But more research is needed before experts can be sure it's beneficial, or even not harmful, long term. Plus, it's unsafe for certain populations, like people at risk for eating disorders.

Dr. Caroline Apovian, professor of medicine in endocrinology, diabetes, nutrition and weight management at Boston University School of Medicine, previously told Insider that the only studies done on fasting diets have been small.

"We are getting insight into early time restricted eating but there is no solid research there yet it may be that a period of fasting during night hours is good for your metabolism but studies are still coming," Apovian said.

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Oscars 2020: The science behind the wellness swag in nominee gift bags - Insider - INSIDER

Global Precision Medicine Market By Application (Diagnostics, Therapeutics and Others), Technologies (Pharmacogenomics, Point-of-Care Testing, Stem Cell Therapy, Pharmacoproteomics and Others), Indication (Oncology, Central Nervous System (CNS) Disorders, Immunology Disorders, Respiratory Disorders, Others), Drugs (Alectinib, Osimertinib, Mepolizumab,Aripiprazole lauroxil and Others), Route of Administration (Oral,Injectable), End- Users (Hospitals, Homecare, Specialty Clinics, Others), Geography (North America, South America, Europe, Asia-Pacific, Middle East and Africa) Industry Trends and Forecast to 2026

Precision Medicine Marketto grow with a substantial CAGR in the forecast period of 2019-2026. Growing prevalence of cancer worldwide and accelerating demand of novel therapies to prevent of cancer related disorders are the key factors for lucrative growth of market

Download Free PDF Sample Copy of Report@http://databridgemarketresearch.com/request-a-sample/?dbmr=global-precision-medicine-market

Key Market Players:

Few of the major competitors currently working in the global precision medicine market are Neon Therapeutics, Moderna, Inc, Merck & Co., Inc, Bayer AG, PERSONALIS INC, GENOCEA BIOSCIENCES, INC., F. Hoffmann-La Roche Ltd, CureVac AG, CELLDEX THERAPEUTICS, BIONTECH SE, Advaxis, Inc, GlaxoSmithKline plc, Bioven International Sdn Bhd, Agenus Inc., Immatics Biotechnologies GmbH, Immunovative Therapies, Bristol-Myers Squibb Company, Gritstone Oncology, NantKwest, Inc among others.

Competitive Analysis:

Theprecision medicine marketis highly fragmented and is based on new product launches and clinical results of products. Hence the major players have used various strategies such as new product launches, clinical trials, market initiatives, high expense on research and development, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of mass spectrometry market for global, Europe, North America, Asia Pacific and South America.

Market Definition:

Precision medicines is also known as personalized medicines is an innovative approach to the patient care for disease treatment, diagnosis and prevention base on the persons individual genes. It allows doctors or physicians to select treatment option based on the patients genetic understanding of their disease.

According to the data published in PerMedCoalition, it was estimated that the USFDA has approved 25 novels personalized medicines in the year of 2018. These growing approvals annually by the regulatory authorities and rise in oncology and CNS disorders worldwide are the key factors for market growth.

Talk to The Author of Report @http://databridgemarketresearch.com/speak-to-analyst/?dbmr=global-precision-medicine-market

Market Drivers

Market Restraints

Key Developments in the Market:

Competitive Analysis:

Global precision medicine market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of global precision medicine market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

SHORT Table of Contents

1.1. OVERVIEW OF THE GLOBAL PRECISION MEDICINE MARKET

1.2. CURRENCY AND PRICING

1.3. LIMITATION

1.4. MARKETS COVERED

2 MARKET SEGMENTATION

2.1. KEY TAKEAWAYS

2.2. ARRIVING AT THE GLOBAL PRECISION MEDICINE MARKET SIZE

2.3. GLOBAL PRECISION MEDICINE MARKET: RESEARCH SNAPSHOT

2.4. ASSUMPTIONS

3 MARKET OVERVIEW

3.1. DRIVERS

3.2. RESTRAINTS

3.3. OPPORTUNITIES

3.4. CHALLENGES

4 EXECUTIVE SUMMARY

5 PREMIUM INSIGHTS

6 GLOBAL PRECISION MEDICINE MARKET, BY TECHNOLOGY

6.1. OVERVIEW

6.2. BIG DATA ANALYTICS

6.3. BIOINFORMATICS

6.4. GENE SEQUENCING

6.5. DRUG DISCOVERY

6.6. COMPANION DIAGNOSTICS

6.7. OTHERS

7 GLOBAL PRECISION MEDICINE MARKET, BY APPLICATION

7.1. OVERVIEW

7.2. ONCOLGY

7.3. HEMATOLOGY

7.4. INFECTIOUS DISEASES

7.5. CARDIOLOGY

8 GLOBAL PRECISION MEDICINE MARKET, BY end-user

8.1. OVERVIEW

8.2. PHARMACEUTICALS

8.3. BIOTECHNOLOGY

9 GLOBAL PRECISION MEDICINE MARKET: COMPETITIVE LANDSCAPE

9.1. GLOBAL PRECISION MEDICINE MARKET: COMPANY SHARE ANALYSIS

9.2. MERGERS & ACQUISITIONS

9.3. NEW PRODUCT DEVELOPMENT & APPROVALS

9.4. EXPANSIONS

10 GLOBAL PRECISION MEDICINE MARKET, COMPANY PROFILES

10.1 Orion Health

10.2 ARIEL Precision Medicine, INC.

10.3 Metabolon, Inc.

10.4 Pfizer Inc.

10.5 Biocrates Life Sciences

10.6 Medtronic

10.7 NovartisAG

10.8 Quest Diagnostics Incorporated

10.9 F. Hoffmann-La Roche Ltd

10.10 Teva Pharmaceutical Industries Ltd

11 APPENDIX

12 ABOUT DATA BRIDGE MARKET RESEARCH

Get a Detail TOC @http://databridgemarketresearch.com/toc/?dbmr=global-precision-medicine-market

Market Segmentation:

By technology:-big data analytics, bioinformatics, gene sequencing, drug discovery, companion diagnostics, and others.

By application:- oncology, hematology, infectious diseases, cardiology, neurology, endocrinology, pulmonary diseases, ophthalmology, metabolic diseases, pharmagenomics, and others.

On the basis of end-users:- pharmaceuticals, biotechnology, diagnostic companies, laboratories, and healthcare it specialist.

On the basis of geography:- North America & South America, Europe, Asia-Pacific, and Middle East & Africa. U.S., Canada, Germany, France, U.K., Netherlands, Switzerland, Turkey, Russia, China, India, South Korea, Japan, Australia, Singapore, Saudi Arabia, South Africa, and Brazil among others.

In 2017, North America is expected to dominate the market.

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Data Bridge Market Researchset forth itself as an unconventional and neoteric Market research and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best market opportunities and foster efficient information for your business to thrive in the market. Data Bridge endeavors to provide appropriate solutions to the complex business challenges and initiates an effortless decision-making process.

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Global Precision Medicine Market Analysis And Growth Forecast By Applications, Sales, Size, Types And Competitors By 2020-2026 - Reporting 99

Future Free Trade Agreementsand NHS

Trump has been openly expressing his interest to strike a free trade deal with the UK. The US president has also blamed the freeloading countries benefiting from US pharmaceutical research and extorting unreasonably low prices from US pharma reiterating that the US has great power over the trading partners. While the president denied the UKs NHS being on a trade talk table during the 70th anniversary of NATO, speculations about Trumps interest in the NHS do exist.

The major concern is that the US will want its pharma companies to gain greater commercial access to the NHS as part of a trade deal, which could force UK healthcare services into paying higher prices for US drugs.

The year 2020 will see continued pressure on the UKs medicines supply chain. While the biggest feardrug shortage associated with No Deal Brexit is out of the picture, at least during the transition period, the concerns surrounding the drug supply chain still exists.

If the UK leaves the European Medicines Agencys (EMAs) drug approval system and develops its own, Britain is at risk of getting delayed access to new medicines.

The announcement of the Medicines and Medical Devices Bill, which includes relaxing some regulations around clinical trials, speeding up the approval of innovative medicines, facilitating the prescription process of low-risk medicines and extending the UKs lead in personalized medicine and artificial intelligence, looks promising. Nevertheless, there is not much progress and clarity on what actions will be taken to bring these initiatives forward.

Another risk can derive from the failure to implement EU Clinical Trials Regulation within the UKs regulatory system, which could affect UK participation in multinational clinical trials.

Read more from the original source:
Brexit: It Will Take Years for the UK Healthcare Sector to Stabilize - MedicalExpo e-Magazine

NIH research is working hard to solve the puzzle of how genes and lifestyle connect to affect our lives and our health. Today, researchers can scan and compare entire genomes very quickly. These studies have already turned up disease signatures for type 2 diabetes, heart disorders, prostate cancer, Crohns disease, Parkinsons disease, and age-related macular degeneration. More disease-related gene variants are identified every few months.

The Human Genome Project and thousands of follow-on studies are helping scientists to develop gene-targeted treatments. A poignant example is the case of a woman with lung cancer that had spread to her brain. Diagnosed in 2002, this 44-year-olda vegetarian who had never smokedunderwent various therapies to stave off what seemed inevitable. Then came a miracle: she learned of a clinical trial testing a new drug, getfitinib, that for some tumors appeared to work as a genetic smart weapon. Her tumor was one of those, and she is alive today because of medical research.

Thanks to NIH-funded basic research that gave us genetic engineering and launched the $40 billion biotech industry, DNA is a household name. Virtually every biomedical research lab and pharmaceutical company throughout the world uses the power of the genomic revolution every day to demystify diseases and find new cures. Within 5 years, the complete DNA instruction bookor whole genomeof an individual will read out for less than $1,000, making genetic analysis a routine part of medical care.

One recent study provides a glimpse of how whole-genome sequencing might eventually be used in the clinic. Scientists evaluated the entire genome of a 40-year-old man to determine his risk for dozens of diseases and his likely response to common drugs. They pinpointed gene variants linked to several diseases in the mans family, including vascular disease and early sudden death. They also found variants linked to conditions not known to be in his family, such as thyroid and parathyroid diseases. Other gene variants predicted the patients likely responses to certain heart medicationsinformation thats especially relevant since hes at risk for cardiovascular disorders.

Remarkable advances in the field of pharmacogenomicshow individuals react differently to medicinesindicate that we are moving away from one-size-fits-all medicine. Scientists can now identify glitches in our DNA scripts that reveal what drugs may be dangerousor completely ineffectivefor certain people. This information will help doctors calculate precise dosages that match a persons DNA.

Collectively, research results in this important area of biomedicine are prompting the U.S. Food and Drug Administration (FDA) to consider changing the labeling requirements for important medicines taken by millions of Americans. Already, pharmacogenomic information is contained in about 10% of labels for drugs approved by the FDA to treat a range of conditions including HIV/AIDS, cancer, seizures, and cardiovascular disorders.

Next: Stem Cells

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Personalized Medicine | National Institutes of Health (NIH)

Say precision medicine and people think of personalized cancer treatment. But this innovation has already begun to revolutionize primary care tooeven though the jury is still out, in many cases, on whether it makes a clear difference in outcomes.

Just what precision (alias personalized) medicine is isnt always spelled out precisely. But usually it is discussed as prevention or treatment that takes into account individual differences among patients, most often genetic differences. Some people expand the concept to consider individual differences in environment and lifestyle.

In adult primary care, two subsets of precision medicine have attracted the most attention recently: predictive genetic testing and pharmacogenomics.

Predictive genetic testing is what it sounds like: A genetic test that forecasts a persons chance of getting a disease. The term is also applied to germline genetic tests that provide some indication of the predisposition being passed down to offspring. Proponents see predictive genetic testing for certain inherited conditions as a way to unearth risks in people who can then get early treatment or take preventive steps to head off serious and possibly costly conditions. Actor Angelina Jolie put BRCA testing as a predictive genetic test into the public consciousness with her announcement in 2013 that she underwent a double mastectomy after testing positive for a BRCA mutation.

Pharmacogenomics studies show how a persons genes can affect his or her response to medications. Ideally, pharmacogenomic (sometimes called pharmacogenetic) results could end some of the trial and error with drugs and help providers and patients choose the most effective drug right off the bat.

Where federal dollars are concerned, precision medicine has already stepped out of the cancer box. In 2015, President Barack Obama committed $215 million to precision medicine research, including a genomic study of more than a million Americans to extend precision medicine from cancer to other diseases. A year later, the 21st Century Cures Act expanded this funding to $1.5 billion over the next 10 years.

Aided by a multibillion-dollar genomic testing industry, some providers have started testing precision medicine beyond oncology. In 2018, Geisinger Health System in central Pennsylvania made a splash by announcing that it would add DNA sequencing to routine primary care. A small number of other hospitals are starting to monetize these tests. In August 2019, STAT reported that a handful of academic medical centers, including Brigham and Womens Hospital and the Mayo Clinic, have started elective genome sequencing clinics for generally healthy patients willing to pay hundreds, sometimes thousands of dollars in cash for a genetic workup.

Skeptics see carts preceding horses; solid evidence that routine genetic testing results in better outcomes is lacking. As one genome-sequencing clinic leader conceded in the STAT article, such testing can lead to expensive follow-up testing. Not surprisingly, payers have been reluctant to cover sequencing tests of various kinds.

Regulators have breathed life into some kinds of testing and poured cold water on others. Last year, 23andMe was the first testing company to get FDA approval to market a direct-to-consumer genetic test for three (of the more than 1,000 known) BRCA gene mutations linked to increased risk of breast, ovarian, and prostate cancer. But in April 2019, the agency issued a warning letter to Inova Health System in Northern Virginia to stop marketing pharmacogenomics tests it claimed could predict patients responses to antidepressants, opioids, and other drugs. The FDA said it was unaware of data to support these claims.

A survey published two years ago in Clinical Pharmacology and Therapeutics found that clopidogrel, a blood thinner, was the medication most commonly tested for a druggene interaction, followed by simvastatin and warfarin. Nearly 40 academic medical centers and community health systems testing ways to implement pharmacogenomics in clinical practice were surveyed.

Some evidence suggests that traditional screening methods may not identify everyone at risk for certain inherited conditions. In a study published in Science three years ago, researchers at Geisinger and Regeneron (which manufactures Praluent, a drug used to treat familial hypercholesterolemia) found that only about one in four people carrying the familial hypercholesterolemia gene variant met the Dutch Lipid Clinic Network criteria (widely used diagnostic criteria) for genetic testing. Still, evidence for the clinical utility of many pharmacogenomic or predictive genetic tests is pretty scanty at this point.

Right now, for the average primary care provider, there are a relatively limited number of situations where pharmacogenomic testing is clearly beneficial to outcomes in a way thats dramatic, says Greg Feero, MD, a faculty member at Maine Dartmouth Family Medicine Residency and a former senior advisor to the director of the NIHs genomics research division.

For predictive genetic testing, there are a few notable exceptionshereditary breast and ovarian cancer, Lynch syndrome, and familial hypercholesterolemiaif certain criteria such as family history of the condition are met. The CDC has designated genomics applications for these conditions as Tier 1, the highest tier on its evidence-based ranking system of genomic applications by their potential for a positive public health impact.

In a 2017 editorial published in American Family Physician, Vinay Prasad, MD, and Adam Obley, MD, of Oregon Health and Science University said that rigorous meta-analyses havent yet shown that genotype-guided dosing for warfarin, clopidogrel, or antidepressant selection is better than usual care. Prasad is a well-known critic of what he sees as the proliferation of medical treatments and therapies without good evidence behind them. We need to know on a broad scale that [these tests] improve outcomes for patients, and dont just reassure physicians theyre choosing a better drug, Obley tells Managed Care.

Prasad and Obley also argued in their editorial that without further proof of improved outcomes, routine genetic testing could just fuel more inappropriate care. Guidelines carve out clear boundaries for who should get tested because there are scenarios in which the risks and benefits of preventive measures arent known, they said, noting that the U.S. Preventive Services Task Force advises against genetic testing for BRCA mutations in women without a family history of BRCA-related cancers.

A small pilot study suggests that genetic testing in primary care may not lead to improved outcomes. In 2017, The Annals of Internal Medicine published the first randomized trial of whole-genome sequencing in primary care. Gene variants were found in 20% of the participants whose genomes were sequenced. But six months later none of them had improved outcomes.

The test produces lots of information, says Obley, who wasnt involved in the study. But its not clear that any patient was managed differently in a way that improved their health.

Without evidence supporting the clinical utility of routine pharmacogenomics or genetic testing, most payers are unwilling to cover them. Some exceptions exist, such as employers that offer routine genetic testing as an employee benefit. In a blog post published in 2018, Color Genomics touted Visa and the German software company SAP as customers. Medicare covers pharmacogenomic testing of two gene variants that predict warfarin responsiveness for beneficiaries enrolled in a randomized, controlled clinical study that meets certain standards.

The high cost of genetic testing has been cited as another reason insurance coverage is limited, but payers may not budge even as testing gets cheaper. The cost of doing the test itself has been declining quite rapidly, says Kathryn Phillips, a health economics professor at University of CaliforniaSan Francisco who researches personalized medicine access, quality, and reimbursement. She has disclosed in recent studies that she is a paid consultant for Illumina, a DNA sequencing company. But she says its hardand its going to take longerto figure out where to use genetics in primary care in healthy populations, and [for insurers] to pay for it.

The current state of evidence and bleak reimbursement prospects havent deterred early adopters from embracing precision medicine in primary care. For Megan Mahoney, MD, chief of general primary care at Stanford Medicine, precision medicine begins with going after data on key determinants of healthnot just genes, but also environmental factors, social determinants, and health behaviors.

In a yearlong pilot of 50 patientsmore than half of whom were at risk for cardiovascular conditionsStanford Medicine care teams created personalized care plans to prevent and manage chronic illness. The plans leveraged data from several sources, including genetic-risk assessments and genetic testing for the three CDC Tier 1 conditions and remote monitoring devices.

Before the pilot, which ended in 2018, Stanford did not offer routine genetic testing in primary care. So far, that hasnt changed. But Stanford is making the genetic-risk assessment tested in the pilot available to its primary care providers, hoping it can increase screening rates for the Tier 1 conditions, says Mahoney. Studies show that many primary care providers are uncomfortable evaluating and addressing genetic risk. Five patients in the pilot discovered through the genetic risk screening that theyre at high risk for breast cancer, demonstrating that this type of tool can help to identify previously unknown risks.

Post-pilot, Stanford is also offering patients with poorly controlled blood pressure connection to a Bluetooth-enabled blood pressure cuff and health coaching as part of a larger study. Genetic testing has dominated the discussion of precision medicine in primary care, but Stanfords experience shows that it isnt the only way to tailor preventive care to individual patients needs.

Even if clinical utility is ultimately shown, folding precision medicine into primary care will likely follow the path of many new developments in medicine: There will be some early adopters, but most practices will have a wait-and-see and depends-on-the-reimbursement attitude.

Educating doctors on how to interpret, use, and communicate genetic testing results to patients will be one of the biggest hurdles. Theyll be learning on the job, says Susanne Haga, associate professor of internal medicine at Duke Universitys medical school, who leads educational activities in genetics and genomics for the Duke Center for Applied Genomics. An obstacle course of other possible barriers awaits: the limited number of certified genetic counselors, concerns about privacy and genetic discrimination, and the potential for the lack of diversity in genomic data sets to exacerbate disparities in care.

Still, Haga sees the convergence of three factors that will force the health care systems hand and usher in precision medicine in primary care: patients increasing ability to influence decisions about their care, the declining cost of testing, and a critical mass of people, numbering in the millions, who will have had their DNA sequenced in genome programs such as Geisingers or several national genomics research initiatives.

Its coming, she says, one way or another.

Read more:
Precision Medicine in Primary Care: Bespoke. Genetic and Genomic. And Maybe Not Ready. - Managed Care magazine

Precision medicine promises a new paradigm in oncology where every patient receives truly personalized treatment. This approach to disease diagnosis, treatment and prevention utilizes a holistic view of the patientfrom their genes and their environment to their lifestyleto make more accurate decisions.

Growing at a rate of 10.7 percent, the precision medicine market is expected to exceed $96 billion by 2024.1 Bioinformatics represent a significant share of the market, as bioinformatics tools enable the data mining necessary for rapid identification of new drug targets and repurposing of existing treatments for new indications.1 (Reuters) The oncology segment of the precision market is expected to experience an 11.1 percent compounded annual growth rate (CAGR) leading up to 2024 due to the success of recent targeted therapies and subsequent high demand.

Still, precision medicine is in its infancy, and making personalized treatment a reality for all patients requires a transformation in how novel therapies are developed and delivered. New regulatory, technical, clinical and economic frameworks are needed to ensure that the right patients are able to access the right therapy at the right time. In this article, we review the current state of precision medicine in oncology and explore some of the challenges that must be addressed for precision medicine to reach its full potential.

Great strides toward precision medicine are being made in the area of cancer immunotherapy, which is designed to boost a patients own immunity to combat tumor cells. The introduction of immune checkpoint inhibitors (PD-1/PD-L1 and CTLA-4 inhibitors) revolutionized treatment for certain hematologic malignancies and solid tumors. To date, immune checkpoint inhibitors have been approved by the U.S. Food and Drug Administration (FDA) for more than 15 cancer indications, but their widespread use has been hampered by unpredictable response rates and immune-related adverse events.

The approvals of the first chimeric antigen receptor (CAR)-T cell (CAR-T) therapies in 2017 were the next leap forward in precision medicine. These immunotherapies demonstrated that it was possible to take out a patients own T-cells, genetically modify them, and then put them back in to target cancer cells. With complete remission rates as high as 83 percent within three months of treatment, CAR-T therapies represent a seismic shift in our approach to cancer, bringing the elusive possibility of a cure one step closer. However, longer-term follow-up has shown that these remissions may not be durable2 and prevention of relapse must still be studied.

Ultimately, the goal of cancer immunotherapy is to stimulate the suppressed immune system of a patient with cancer so that it can launch a sustained attack against tumor cells.3 This is complicated, as the interactions between tumors and immune systemsometimes called the Cancer-Immunity Cycle (see Figure 1 in the slider above)4are complex and dynamic. The Cancer-Immunity Cycle manages the delicate balance between the immune systems ability to recognize non-self and the development of autoimmunity.

In some cases, the immune system may fail to recognize tumor cells as non-self and may develop a tolerance to them. Moreover, tumors have an armamentarium of methods for evading the immune system. Given this elaborate interplay between cancer and immunity, there is a wide range of potential cancer immunotherapy approaches:

The immune response to cancer involves a series of carefully regulated events that are optimally addressed as a group, rather than individually.4 The complexity of the immune response to cancer provides a strong rationale for combination therapies, for instance:

Increasingly, the development and deployment of immunotherapy relies on harnessing genomic data to identify the patients most likely to respond to immunotherapy and to customize immunotherapy for a given patient.6 Thus, molecular profiling technologies, such as next-generation sequencing, have become integral to drug development and patient selection. At the same time, researchers are focusing on identifying molecular alterations in tumors that may be linked to response.7 The molecular fingerprints of a tumor can be quite complex and heterogeneous, not only across tumors, but also within a single patient. Consequently, molecular tumor characterization requires both multidimensional data from laboratory and imaging tests and advanced software and computational methods for analyzing these data.8 This emergence of computational precision oncology is associated with both opportunities and challenges, from validation and translation to regulatory oversight and reimbursement.

The regulatory landscape is evolving to keep pace with technological advances in cell engineering and gene editing. Since 2013, the FDA has published four guidance documents on cellular and gene therapy products, as well as two guidance documents providing recommendations on regenerative medicine advanced therapies (RMATs). Specifically, their Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, published in November 2017, provides guidance on the expedited development and review of regenerative medicine therapies for serious or life-threatening diseases and conditions. This document also provides information on the use of the accelerated approval pathway for therapies that have been granted the RMAT designation.9

In the EU, the European Medicines Agency (EMA) published a draft revision of its Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells in July 2018.10 This draft revision includes current thinking on the requirements for nonclinical and clinical studies, as well as specific sections on the scientific principles and clinical aspects of CAR-T products.

Precision medicines such as CAR-T therapies require manufacturers to transform a complex, individualized treatment into a commercial product. In conventional manufacturing, the entire manufacturing process occurs within the confines of the manufacturing facility. With cell therapies, however, the process begins with the collection of cells from the patient and ends with administration of the final product (see Figure 2 in the slider above). In between, the cells are handed off multiple times for the process of genetic modification, creating a complex supply chain that blends manufacturing and administration.11

Moreover, in contrast to traditional manufacturing where the starting materials are standardized or well-defined, the starting materials for cell therapies are derived from patients and, thus, highly variable.

As evidenced by the manufacturing challenges that plagued the launch of Kymriah (tisagenlecleucel), even pharmaceutical giants have struggled with meeting label specifications for commercial use.13 To help address its manufacturing hurdles, Novartis acquired CellforCure, a contract development manufacturing organization, and plans to transform by focusing on data and digital technologies.14,15 What this means for sponsors is that robust, scalable manufacturing must be incorporated into clinical developing planning at its earliest stages.

The high price tags associated with CAR-T therapies illustrate how expensive targeted therapies are in comparison to their traditional counterparts.16 Existing health insurance models have not been structured to reimburse for costly treatments that offer the potential for long-term benefit or even cure. The pricing model for CAR-T therapies may be especially challenging for private insurance companies, which have higher turnover and shorter coverage windows than national health insurance programs. For sponsors of precision medicine therapies, one way to address the challenge of reimbursement is to create innovative, value- or outcomes-based pricing models, rather than focusing on sales volume. The success of these new pricing models will rely on patient selection. To demonstrate value and optimizing outcomes, sponsors will need to develop profiles of patients who are most likely to respond and provide tools for identifying these patients.8

Of note, on August 7, 2019, the Centers for Medicare & Medicaid Services (CMS) finalized the decision to cover FDA-approved CAR-T therapies when provided in healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) for FDA-approved indications. Medicare will also cover FDA-approved CAR-T treatments for off-label uses that are recommended by CMS-approved compendia.17

Beyond the pharmaceutical companies that are working to develop personalized treatments, the precision medicine ecosystem has a number of other key stakeholdersregulators, payers, diagnostic companies, healthcare technology companies, healthcare providers and, of course, patients. Pharmaceutical companies need to engage with each of these stakeholders by providing education or developing partnerships that help demonstrate the need for high-quality data collection, the value of precision medicine, and the process for identifying the right patients.

Sponsors may also benefit from engaging with patient advocacy groups as these groups play a critical role in connecting patients and caregivers with scientific and healthcare experts to learn about how new immunotherapy breakthroughs are changing the standard of care.

Empowered patients pushing for the latest innovations are propelling precision medicine forward, but we still have a way to go before the full potential of precision medicine is realized. In its maturity, precision medicine will not only enable the personalization of treatments for individual patients, but also inform public health at a population level as insights from the genetic and molecular data collected are used to advance our understanding of disease. Robust data collection and analysis, along with standardization, are required for building this foundation of precision medicine, and multi-stakeholder buy-in is necessary for addressing issues around data integration and privacy.

While significant challenges remain, the opportunity to transform patient outcomes and population health with precision medicine is tantalizing. Increasingly, we are seeing advanced technologiessuch as artificial intelligence and machine learningbeing incorporated into the drug discovery and development process. This underscores the critical need for a multidisciplinary approach to precision medicine, from discovery at the bench all the way through to delivery at the bedside, to help ensure that more patients can access the right therapy at the right time, and the right price.

References

Read the original here:
Realizing The Full Potential Of Precision Medicine In Oncology - Contract Pharma

Precision medicine, or personalized medicine as it is sometimes referred to, is a most significant and promising healthcare trend. The National Institutes of Health (NIH) defines precision medicine as an individualized plan that uses a patient's genetic makeup and their environment and lifestyle to deliver the right preventative advice or targeted disease treatment.

For example, precision medicine as it applies to cancer treatment might encompass:

The NIH has also started an ambitious research program designed to advance the study and applications involved in precision medicine, which can have positive ramifications for the future of medicine as a whole. The Precision Medicine Initiative is geared toward learning how genetics, environment, and lifestyle can help determine the best approach to prevent or treat disease.

Through the initiative, for example, scientists at the National Cancer Institute hope that further study of the disease's genetics and biology will lead to better life-extending treatments. The initiative's All of Us Research Program is also using the health data of approximately 1 million volunteers to study many other diseases, and improve prevention, diagnosis, and treatment stats.

Precision medicine has such a huge range of potential applications that the sky is literally the limit in terms of how it may help doctors treat virtually any disease in the future.

But right now, there are several exciting developments that you, as a physician or hospital administrator, should know about and investigate further to see if they may be appropriate for your patients' needs. These developments include:

The Centers for Disease Control has highlighted the fact that that a new small molecule drug, ivacaftor, is improving the outcomes of cystic fibrosis (CF) patients by closely targeting the specifics of why an individual patient has CF, as opposed to treating its symptoms.

Early administration of this therapy has greatly reduced the need for inpatient hospital stays and allowed patients to improve.

The CDC has also highlighted cascade screening, which means a healthcare team contacts the family members of patients with a range of conditions to interview them about and inform them about the hereditary implications of the illness they may all eventually deal with.

Then, patients who wish to be screened for genetic markers or a disease itself can do so. The information that doctors learn from a patient's relative can then be applied to treating the original patient. It's extremely important to take issues of consent and privacy into account in terms of this approach, but if done right, the benefits to patients and their families can be invaluable.

MD Anderson has set up a personalized care therapy resource website, through which any doctor can look up information on a diagnosed genetic marker and find cutting-edge info on clinical trials, disease mutations, and tumor profiling. Patients working with their doctors to better understand their conditions can use the website, too.

It's vitally important to keep up with precision medicine developments in your specialty fields and apply what is available for you as a physician or administrator right now. With precision medicine, you lengthen a patient's odds for a better outcome in so many potential ways. Just as important is that precision medicine can change the way your patients view their disease(s).

Lisa Mulcahy is an internationally established health writer whose credits include the Los Angeles Times, Redbook, Glamour, Elle, Cosmopolitan, Health, Good Housekeeping, Parade, Woman's Day, Family Circle and Seventeen. She is the author of eight best-selling books, including "The Essentials of Theater," an Amazon No. 1 new release.

Her Contemporary Authors biography is available here.

Read more:
New resources in precision medicine that every doctor should know about - MultiBriefs Exclusive

LEIPZIG, Germany and EMERYVILLE, Calif., Jan. 30, 2020 /PRNewswire/ --Profusa, a digital health company that is pioneering the next generation of personalized medicine, today announced research findings that suggest the company's Lumee Oxygen Platform may help improve the clinical management of patients with critical limb ischemia (CLI) who are undergoing endovascular revascularization treatment (EVT). The data, from a recent post-market clinical study called OMNIA (Oxygen Monitoring Near Ischemic Areas), were detailed in a series of presentations at the Leipzig Interventional Course (LINC) in Leipzig, Germany.

The Lumee Oxygen Platform is a tiny, injectable tissue-integrated biosensor with an intelligent data platform intended for continuous, real-time monitoring of tissue oxygen levels.

"Performing revascularization in patients with critical limb ischemia is standard practice, but the tools surgeons and interventionalists typically use to gauge effectiveness of the procedure are not ideal," said Marianne Brodmann, M.D., interim head of the Clinical Division of Angiology, Department of Internal Medicine, at Medical University inGraz, Austria. "These research findings from OMNIA suggest that continuously measuring tissue oxygen may result in better outcomes for these patients."

CLI is a serious form of peripheral artery disease (PAD), a condition that affects more than 200 million people worldwide and results in the narrowing of blood vessels and reduced blood flow to the lower limbs. Decreased tissue oxygen levels in the lower limbs of PAD patients can lead to disabled walking, or in more advanced cases, gangrene and amputation. CLI can result in severe pain in the feet or toes, even while resting.

OMNIA, a multicenter trial of the Lumee Oxygen Platform, monitored tissue oxygen levels in the affected limbs of 35 CLI patients who underwent EVT procedures, which are designed to clear obstructed arteries. Study participants were injected with four Lumee biosensors, three in the foot and one as a reference sensor in the arm. OMNIA collected measurements of oxygen throughout the revascularization process (with measurements performed before, during, and one, three, six, and twelve months post-procedure). OMNIA also recorded traditional hemodynamic metrics, including ankle-brachial index and toe-brachial index, and clinical assessments of wound healing at each follow-up visit.

The OMNIA data presented by Brodmann showed that increases in tissue oxygen during EVT were significantly higher in patients who experienced wound healing than in those who did not (p<0.01). In addition, tissue oxygen levels during revascularization were a better predictor of wound healing than traditional clinical measures, such as ankle-brachial index or toe-brachial index (p=0.59 and p=0.14, respectively).

"These findings show the importance of further investigating how continuous tissue oxygen measurements may satisfy an unmet clinical need to objectively evaluate how the increases in blood flow offered by EVT actually translate into nutritive oxygen delivery to the injured tissue," added Brodmann.

Martin Werner, M.D., an angiologist at Hanusch Hospital in Vienna, noted that traditional angiography during EVT does not sufficiently measure microvascular blood flow, a special concern for people with diabetes who may have microvascular impairment. He presented results of a retrospective classification analysis from OMNIA in which continuous oxygen traces measured by the Lumee Oxygen Platform were analyzed throughout EVT. Findings showed that oxygen changes between discrete time points, specifically start and end of EVT, may not be predictive of wound healing, but dynamic changes continually assessed throughout the procedure were.

"These results indicate that continuous measurements of blood flow in the foot during EVT may reveal factors that provide clues to treatment outcome that would have been missed if only measured at the start and end of the procedure," said Werner.

Stephen Kanick, Ph.D.,data science lead for Profusa, presented data from OMNIA that evaluated how Lumee biosensors assess long-term tissue viability following EVT treatments in patients with CLI. Results showed that patients who improved showed larger oxygen increases after EVT and maintained larger oxygen values at a three-month follow-up compared to patients who did not improve.

Miguel Montero-Baker, M.D., vascular surgeon and associate professor in the Division of Vascular Surgery and Endovascular Therapy at Baylor College of Medicine in Houston, discussed how tissue oxygen measured before, during and after EVT can be combined to provide a more accurate predictor of patient healing. According to Montero-Baker, "The Lumee Oxygen Platform gives us insights we have not had before about how CLI patients are responding to treatment."

"These findings from OMNIA affirm the emerging role of injectable biosensors in informing the treatment of patients with limb-threatening ischemia," said Ben Hwang, Ph.D.,chairman and CEO of Profusa. "Being able to monitor biochemical data such as tissue oxygen on a real-time basis may mean the difference between effective interventions and a catastrophic worsening of the condition."

Profusa's LumeeOxygen Platform and second-generation product, the Wireless LumeeOxygen Platform, are CE (Conformit Europenne) marked for use in the European Union. In the U.S., the Wireless Lumee Oxygen Platform is an Investigational Device limited by federal law to Investigational Use.

About ProfusaBased in Emeryville, Calif., Profusa is a digital health company led by visionary scientific founders, an experienced management team and a world-class board of directors who share the long-term goal of improving health and well-being for patients worldwide. With its long-lasting, injectable and affordable biosensors and its intelligent data platform, Profusa aims to provide people with a personalized biochemical signature rooted in data that clinicians trust and rely upon. These data may allow people to act as an active and educated participant alongside their care team and understand how their choices and decisions impact health and well-being, day-in and day-out.

"LUMEE", "PROFUSA" and the PROFUSA logo are registered trademarks of Profusa Inc. in the United States, Canada, European Union, China, Japan, South Korea and Australia.

For more, visithttps://profusa.com.

AbouttheLumeeOxygen PlatformProfusa's first clinical offering, the LumeeOxygen Platform, and the next-generation Wireless LumeeOxygen Platform, which are CE marked for use in the European Union, are indicated for use in patients with potential acute and/or chronic changes in tissue oxygen levels who may benefit from monitoring. The Lumee Oxygen sensor provides an opportunity for continuous and long-term monitoring of oxygen changes in subcutaneous tissue. After a single injection, measurement thereafter is obtained non-invasively using an optical reader. In contrast to external pulse oximeters, which measure oxygen bound to the hemoglobin in larger blood vessels, the LumeeOxygen Platform measures dissolved oxygen at the tissue level in the fluid that bathes our cells.

Contact: Sylvia ArandaW2O pure424-201-9464saranda@purecommunications.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/research-presented-at-linc-suggests-the-profusa-lumee-oxygen-platform-may-improve-clinical-management-of-patients-with-critical-limb-ischemia-300995818.html

SOURCE Profusa, Inc.

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Research Presented at LINC Suggests the Profusa Lumee Oxygen Platform May Improve Clinical Management of Patients with Critical Limb Ischemia -...

As we herald in the new decadeone that will be entirely driven by digital transformation and the agile integration of innovative technology at a rapid paceenterprises across the board are re-evaluating their internal and external operations from the ground up. In the past decade, we have witnessed new technologies come to lifefrom cloud and edge capabilities, blockchain, to 5G connectivity and beyond. Industries are fighting tooth and nail to bring these technologies first-to-market, and oftentimes expand upon the previously-determined boundaries of what purposes these technologies were built to serve.

Were at a vital turning point as we enter 2020, where organizations across all industries must not only continue to integrate innovative technology into their internal and external operationsthey must reimagine their businesses entirely and rebuild their foundational infrastructure to adopt agility and the ability to pivot on a dime, for when the next big technological advancement undoubtedly rises to the surface.

The healthcare industry is no different.

To date, the healthcare industry has been actively digitizing at a rapid pace. In fact, a recent study shows that a whopping 84 percent of U.S. based healthcare organizations utilize digital health records.

The benefits of this investment alone have been far-reaching. Those healthcare organizations that have switched to digital health records deliver better patient care, provide patients with better outcomes on an individual basis, improve the workplace experience for staff members, and even are able to offer cost-efficient healthcare servicesall in comparison to their non-digital counterparts.

Over the next decade, these organizations will not only continue to reap the benefits of their pre-existing digital transformation efforts but will begin to significantly invest in other next-gen technologies and capabilities to continue to bring new, innovative patient care solutions to the reshaping and hyperconnected healthcare ecosystem.

Digital Capabilities will BlossomThere have already been significant advancements in digital capabilities, beyond simply digitizing records. Healthcare leaders have successfully implemented other capabilities, such as remote and self-monitoring medical chatbots, smart pills, implants and more. Such innovation is a direct reflection of the highly-advanced levels of digitalization throughout the industry.

That being said, wider adoption of AI and automation has yet to be fully realized. In fact, only a mere 33 percent of U.S. healthcare organizations have adopted AI technology. Thats not to say that the ambition for adoption isnt there. Back in 2018, over half of healthcare professionals believed that by 2023 there would be widespread AI adoption throughout the industry.

Going into 2020, we expect to see these ambitions become fully realized. AI is becoming increasingly mainstream in all aspects of patient carefrom the overhaul of triage and administrative capabilities to diagnostics and beyond. It can then help doctors understand more about a patient, through the strategic analysis and activation of pre-existing patient data.

Personalized Medicine will ThriveOur experience is that more than two-thirds (75%) of life sciences and healthcare organizations can customize products and services to almost every single interaction. This is an amazing feat for the industry at largeespecially when considering the lack of AI investment to-date.

We will see these capabilities continue to grow in 2020, as personalized medicine becomes increasingly high-tech and data-driven. As AI becomes increasingly ingrained in the process of personalized and precise medicine, the personalized solutions that are developed will become smarter, more specific and more custom-tailored than ever previously imaginable.

Furthermore, in 2020 medical implants will become increasingly agile and be able to perform more functions to minimize patient input for treatment. Bioprinting tech will bring prosthetics and stent technology to new heights as wellas new materials and build processes become fully-realized. The aforementioned bio- and precision-tech will make medical implants significantly less invasive and safer than ever before.

While these personalized capabilities are certainly not new to the industry, a majority of Americans are not familiar with what personalized medicine even is. Additionally, those who are familiar express tend to express concern over the cost of personalized care, and increasingly other elements such as privacy and data concerns. As medical-tech and digital transformation further push personalized care to new heights, there will also be a significant effort to inform the public about what these solutions are, how they are beneficial to patients and how they can remain affordable as well.

The healthcare industry is at a significant turning point. While digitizing records has been a focal point for industry players in the past, investment in next-gen technology will become bolder and more widespread. AI will play an integral role in helping healthcare organizations take a leap of faith toward becoming fully-digital, hyper-connected and mass-personalized. Its an exciting time to work within the healthcare industry, and a hopeful time for patients who will have access to smarter, better and more personalized patient services at lower cost.

Photo: Andreus, Getty Images

See original here:
Transforming healthcare practices and patient care in the digital era - MedCity News

DUBLIN--(BUSINESS WIRE)--Jan 30, 2020--

The Molecular Diagnostics Market Share & Global Forecast, By Application, Technology, End User, Regions, Companies report has been added to ResearchAndMarkets.coms offering.

Increasing prevalence of Infectious diseases such as Influenza, HPV, Hepatitis, HIV and Tuberculosis despite rise in sanitation practices globally. In the past, antimicrobials medicines were used to fight powerful infectious disease but slowly in todays time antimicrobial agent is not able to give the desired results because the problem of drug resistant occurs in many people across the world.

Nowadays, a new diagnostic procedure is being followed to fight infectious disease like molecular diagnostic test is very effective which is quite fast and precise. The number of cancer patients is increasing very fast, so it is believed that in the coming time the molecular diagnostic test market will be growing at rapid pace. Global Molecular Diagnostics Market is likely to surpass US$ 22.5 Billion by the end of year 2025.

There are various reasons that will propel the market growth in forecast year; rising incidence rate of infectious disease, increasing incidence rate of cancer of all type, increasing people awareness regarding molecular diagnostic, rapid technological growth, widely acceptance of personalized medicine, rising healthcare infrastructure, increasing healthcare per capita expenditure across the developed and developing nation, accuracy of diagnosis, growing population of cardiovascular and neurological disorder etc. In addition, increasing prevalence of genetic disorder will further boost the market in forecast period of time.

The report titled Molecular Diagnostics Market Share & Forecast, By Application (Infectious Diseases, Blood Screening, Oncology, Genetic Testing, HLA (Tissue Typing), Microbiology, Cardiovascular Diseases, Neurological Diseases, Pharmacogenomics and Others), By Technology (PCR, Transcription-Mediated Amplification (TMA), Hybridiazation (In-situ Hybridiazation & FISH), DNA Sequencing & NGS, Microarray and Others), By End User (Hospitals & Academic Laboratories, Clinics and Commercial Laboratories, Others), By Regions [United States, Europe (Expect Russia), India, China, Japan, Brazil, South Korea, Mexico, Russia and ROW], Companies (Roche, Abbott, Myriad Genetics, Qiagen, BioMrieux and Others) provides a complete analysis of Molecular Diagnostics Market.

Market Insight by Application

The report provides comprehensive analysis of molecular diagnostic test market by application into ten parts: Infectious Diseases, Genetic Testing, Blood Screening, Oncology, HLA (Tissue Typing), Microbiology, Neurological Diseases, Pharmacogenomics, Cardiovascular Diseases, and Others. This report also provides key opportunities market and specific factors are given by each application market.

Market Insight by Technology

Here the market is fragmented into six parts; PCR, Transcription-Mediated Amplification (TMA), Hybridiazation (In-situ Hybridiazation & FISH), DNA Sequencing & NGS, Microarray and Others. Besides, many factors are analyzed that influence the growth, challenges and opportunities of market in technological context.

Market Insight by End User

The report provides complete insight of market by End User segments: Hospitals & Academic Laboratories, Clinics & Commercial Laboratories and Others. According to the publisher, Hospitals & Academic Laboratories will hold the largest market in global molecular diagnostic test market in forecast period of time.

Market Insight by Regions

This report covers the complete regional profile by 10 geographical market; United States, Europe, India, China, Japan, Brazil, South Korea, Mexico, Russia and Rest of World (ROW).

Key Topics Covered:

1. Executive Summary

2. Global Molecular Diagnostic Market

3. Market Share - Global Molecular Diagnostics

3.1 By Application

3.2 By Technology

3.3 By Countries

3.4 By Companies

4. Application - Molecular Diagnostics Market

4.1 Infectious Diseases

4.1.1 Hospital Acquired Infections (HAI)

4.1.2 HIV / HCV Testing

4.1.3 STD Testing

4.1.4 HPV Testing

4.2 Blood Screening

4.3 Oncology / Cancer

4.3.1 Breast

4.3.2 Colorectal

4.3.3 Prostate

4.3.4 Others

4.4 Genetic Testing

4.5 HLA (Tissue Typing)

4.6 Microbiology

4.7 Cardiovascular Diseases

4.8 Neurological Diseases

4.9 Pharmacogenomics

4.10 Others

5. Technology - Molecular Diagnostics Market

5.1 PCR

5.2 Transcription-Mediated Amplification (TMA)

5.3 Hybridiazation (In-situ Hybridiazation & FISH)

5.4 DNA Sequencing & NGS

5.5 Microarray

5.6 Others

6. Region - Molecular Diagnostics Market

6.1 United States

6.2 Europe

6.3 India

6.4 China

6.5 Japan

6.6 Brazil

6.7 South Korea

6.8 Mexico

6.9 Russia

6.10 Rest of World (ROW)

7. End Users - Molecular Diagnostics Market

7.1 Hospitals & Academic Laboratories

7.2 Clinics and Commercial Laboratories

7.3 Others

8. Roche Diagnostics - Company Analysis

8.1 Merger & Acquisitions

8.2 Sales Analysis

9. Abbott Laboratories - Company Analysis

9.1 Merger & Acquisitions

9.2 Sales Analysis

10. Myriad Genetics - Company Analysis

10.1 Merger & Acquisitions

10.2 Sales Analysis

11. Qiagen - Company Analysis

11.1 Merger & Acquisitions

11.2 Sales Analysis

12. BioMrieuxs Inc - Company Analysis

12.1 Merger & Acquisitions

12.2 Sales Analysis

13. Market Drivers

13.1 Various Developments in the Molecular Diagnostics Landscape

13.2 Integral to Traditional Labs

13.3 Improved Assay / Test Efficiencies

13.4 Targeting Antibiotic Resistance

13.5 Next Generation Ultrasensitive Molecular Diagnostics

13.6 Increasing Investment in Genomics & Proteomics Research

13.7 Technological Advances in Molecular Diagnostics

13.8 Increasing Acceptance of the Personalized Medicine

13.9 Growing Molecular Diagnostics for Food Safety

14. Challenges

14.1 Dearth of Trained Professionals

14.2 Regulatory Issues

14.3 Various Factors Slowing Growth of Molecular Diagnostics

14.4 Reimbursement Capabilities

14.5 Quality Checkpoints, Awareness & Acceptance

For more information about this report visit https://www.researchandmarkets.com/r/j3on5s

View source version on businesswire.com:https://www.businesswire.com/news/home/20200130005474/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

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Global Molecular Diagnostics Market is Likely to Surpass US$ 22.5 Billion by the End of Year 2025 - ResearchAndMarkets.com - Associated Press

1. Siloed Data Is an Opportunity Lost

Data of all types clinical, financial and operational remain siloed for reasons that range from interoperability issues to legacy systems. This becomes further complicated when redundancies are created through mergers (such as multiple electronic health record systems, enterprise resource planning solutions and enterprise imaging systems).

In addition, payers and providers alike continue to struggle with mining unstructured data for clinical and business insights. For example, the Centers for Medicare and Medicaid Services (CMS) calibrates payments to Medicare Advantage plans based on plan population health as determined through diagnosis codes that identify chronic conditions.

Patient conditions, however, are often not included in the codes captured on claims. As such, payers must conduct a tedious exercise each year to retrieve additional data, sometimes from printed medical charts, to fill in the gaps.

The bottom line: Unused data is an opportunity missed in an industry where resources are stretched increasingly thin, especially when it comes to advancing quality of care and establishing new revenue streams.

Precision medicine has been an extraordinarily important quest for the healthcare community. We are now, at long last, making steady and measurable progress in leveraging genomics to improve outcomes.

In cancer care, for example, it is becoming routine to analyze tumors for known gene mutations or expressions to select treatments likely to be most effective. Yet, despite its tangible benefits, the application of precision medicine, specifically in cancer care, still presents significant challenges. This approach can be expensive, invasive and time-intensive as tumors are analyzed through traditional pathology and genomics.

Increasingly, AI-enabled imaging presents a powerful opportunity to accelerate the identification and application of personalized treatments in ways that are often less invasive, faster and potentially more cost-effective. In the past few years, weve started to see several promising applications of AI in imaging to support precision medicine initiatives.

A study published in the Journal of Neuro-Oncology in April 2019 shows strong potential for using machine learning algorithms to reveal multimodal MRI patterns to accurately and rapidly predict the presence of genotypes and mutations in glioma specifically, isocitrate dehydrogenase (IDH) and 1p19q codeletion status which are good predictors of treatment efficacy.

There has also been substantial progress in AI screening for breast cancer, as shown in this recent study published by Nature in January 2020. These are just a few examples, and the potential for others is limitless.

There are a number of factors at play. First, in our daily lives, weve all come to expect unlimited access to information and services whether online or from our mobile phones. These expectations are now carrying over to our healthcare experience.

At last years HIMSS conference, Dr. Donald Rucker, national coordinator for health IT told attendees, Its long overdue for the healthcare industry to be a part of the smartphone economy and enable patients to access their health data through an app of their choice, at no additional cost.

Giving patients access to their data through mobile devices and apps can drive increased levels of patient engagement and better empower their decision-making. In line with expanding expectations for sharing data with patients, CMS has finalized a rule focused on streamlining patient access to health data.

It is also possible that patients expanded access to their health information might help to fuel nascent interest in crowdsourcing of chronic disease data, which could someday present a wealth of information that clinicians and researchers have struggled to access easily.

HIMSS20: Follow us on Twitter as we gear up for the biggest health IT conference of the year in March.

Even as progress accelerates, the industry continues to face challenges as it works to unlock the greatest value from healthcare data. These include hurdles associated with interoperability, security and privacy as technologies advance faster than policy can keep pace.

Healthcare organizations and payers cannot afford to wait for perfection. Instead, they can make solid advances today that will enable them to accelerate at pace with patient expectations, regulations and technology. It all starts with a data foundation that can support the modern data experience that healthcare organizations and consumers crave.

Creating this new type of data experience requires a new type of data hub one that allows organizations to consolidate their systems on a single platform to unify and share data across applications for better insight. Rather than acting as merely a data repository, the data hub must be able to share and deliver data within an organization for modern analytics and AI so patients and clinicians can benefit from the analysis.

As we enter this data decade, the future is bright for healthcare organizations and the patients they serve. By embracing a modern data experience and building a foundation that ensures its success researchers, providers and payers will be well positioned to improve patient outcomes and elevate operational proficiency in the years to come.

Read more:
It's All About the Data in 2020 and Beyond - HealthTech Magazine

A few days ago, I predicted that there would be few if any surprises with Illumina's (NASDAQ:ILMN) fourth-quarter results. This was an easy prediction to make: Illumina CEO Francis deSouza's presentation at the J.P. Morgan Healthcare Conference earlier this month included some sneak peeks at the company's Q4 performance.

Illumina announced its Q4 results after the market closed on Wednesday. I was right that there wouldn't be many surprises. But there was one twist. Here are the three most important things to know about Illumina's Q4 results.

Image source: Getty Images.

Illumina reported Q4 revenue of $953 million, up 10% year over year. This figure was well above the consensus analysts' revenue estimate of $942.9 million. However, Wall Street analysts made their Q4 projections prior to deSouza's presentation at the J.P. Morgan conference.

DeSouza told conference attendees that Illumina expected to report Q4 revenue of around $950 million. The company's actual revenue total came in slightly higher than that level.

Product revenue increased by 10% year over year to $812 million, with solid sales for NovaSeq and NextSeq. Services and other revenue rose by 9.3% year over year to $141 million. As anticipated, headwinds in the direct-to-consumer market weighed on Illumina's overall growth.

DeSouza didn't provide a hint about what Illumina's Q4 earnings would be. The average analysts' estimate projected that the company would generate adjusted earnings per share (EPS) of $1.58. Illumina handily beat that estimate, though, announcing Q4 adjusted EPS of $1.70 -- up nearly 29% year over year.

I wrote earlier this week, "If there's anything unexpected in Illumina's Q4 results, it will probably be related to expenses that impact the bottom line." And that's exactly where the one surprise in the company's quarterly update occurred.

Illumina's total operating costs were basically flat year over year thanks largely to an 8.5% decline in research and development expenses. This, combined with a $15 million reduction in cost of service and other revenue, helped boost the company's bottom line.

Illumina projects full-year 2020 revenue growth of between 9% and 11%. The company expects earnings per diluted share between $6.45 and $6.65 based on generally accepted accounting principles (GAAP), with non-GAAP EPS between $6.80 and $7.00.

The company's guidance didn't contain any surprises. DeSouza said at the J.P. Morgan conference that Illumina expected to deliver revenue growth in the 9% to 11% range for full-year 2020. Wall Street analysts were expecting full-year adjusted EPS to come in between $6.80 and $7.00, with the average analysts' estimate slightly above the midpoint of the range.

Francis deSouza said that Illumina's management believes "that this is the decade that genomics becomes available to cancer and genetic disease patients on a mass scale and integrates into standard of care." That view could very well be right.Genomic sequencing is a critical part of personalized medicine. Increasingly more new drugs are being developed that target specific types of cancer and that rely on sequencing.

Illumina's dominant position in the genomic sequencing market and its decades of leadership make it the player to beat in capitalizing on the growth that should be on the way. However, the company has some vulnerabilities, notably including its lack of expertise in long-read sequencing. The planned acquisition of Pacific Biosciences of Californiawould have addressed this issue, but it's now off the table.

Perhaps the biggest challenge for Illumina is that, as a growth stock, investors expect higher revenue and earnings growth than the company will be able to deliver over the short term. This could put a damper on the stock at least temporarily. But if deSouza's optimistic view of the future proves to be accurate and Illumina can deliver on its potential, the one-time high-flying stock should take off yet again.

Read this article:
The 3 Most Important Things to Know About Illumina's Q4 Results - Motley Fool

This interview is a translation of a video discussion posted on Medscape France. It has been edited for clarity.

Michel Zeitouni, MD, MSc: Hello. I am Michel Zeitouni, a cardiologist at the Piti-Salptrire Hospital and a researcher with the organization ACTION Cur (Allies in Cardiovascular Trials, Initiatives and Organized Networks). Today I have the pleasure of welcoming Prof Jean-Claude Tardif to Medscape; we are speaking from the American Heart Association (AHA) 2019 meeting in Philadelphia, Pennsylvania.

Prof Tardif is the research director at the Montreal Heart Institute. He presented a study that made a lot of noise at the AHA, the COLCOT study. COLCOT included more than 4000 patients with myocardial infarction (MI) and found a reduction in cardiovascular events in those who received colchicine compared with the placebo group. Prof Tardif, tell us about the results.

Jean-Claude Tardif, MD: Colchicine is a potent anti-inflammatory drug, and there is an accumulation of data suggesting that inflammation is relevant to the progression of atherosclerosis. The COLCOT study included 4745 patients who were recruited within 30 days of their MI. They all received two antiplatelet agents and a statin, and they underwent angioplasty if necessary. Then they were assigned colchicine at a low dose of 0.5 mg/day or placebo. The average follow-up was 23 months, and we found a 23% reduction in the primary efficacy outcome, which was the combination of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring revascularization.

Zeitouni: The inflammation pathway has been in the spotlight ever since the CANTOS study, which used canakinumab, a drug that we have known well for decades and with which we found some benefits for patients with MI. You also looked at tolerability, since it's a question we ask about colchicine; ultimately, it was tolerated rather well.

Tardif: Perhaps it's in part because we used a low dose of 0.5 mg/day, but we saw no difference in the incidence of adverse effects of any cause or severity, and no difference in the occurrence of diarrhea compared with placebo. There was a very slight increase in nausea, with 1.8% in the active group vs 1.0% in the placebo group. There also was a little more pneumonia in the colchicine group (0.9% vs 0.4%).

Zeitouni: You used a rather broad composite endpoint and saw a consistent effect on each component. One thing that struck those who saw your presentation was colchicines effect on stroke. How do you explain the reduction in stroke? Do you anticipate a COLCOT STROKE study?

Tardif: I'm not sure I have all the answers, but we were not the first to see this. There was a meta-analysis of very small, previously published studies that also suggested a benefit for stroke. Now, is this an anti-atherosclerotic effect related to the anti-inflammatory effect of colchicine? Is it an effect that has something to do specifically with the cerebral arteries? Could there be unsuspected effects on central blood pressure? This remains to be seen. It opens up questions that have yet to be answered but deserve to be tested in clinical trials. So, yes, there will be clinical studies on colchicine in stroke.

Zeitouni: Someone mentioned COLCOT-2 in one of the late-breaking trials. Would you tell us about this trial? Colchicine will be used in primary prevention for diabetics.

Tardif: Exactly. Now that COLCOT-1 has been conducted in patients with a recent MI, there is another study called LoDoCo2, in patients with stable coronary disease, that will be presented in 2020. The next frontier will be the high-risk, primary-prevention patients in what we call COLCOT-T2D. This study will involve 10,000 patients with type 2 diabetes who do not have known coronary heart disease. We will assess cardiovascular efficacy, but we will also look at the occurrence of cancer, cognitive disorders, and dementia, because we will be following these patients for 4 years; the COLCOT-1 patients were followed for an average of 23 months.

Zeitouni: So, colchicine may be the new aspirin in these high-risk patients. You saw a reduction in infarct size in the acute phase or the time of remodeling, and a reduction, perhaps, in rhythm disorders. How do you explain the effectiveness?

Tardif: I believe that it is an anti-atherosclerotic effect via the anti-inflammatory effect. I say this because patients were, on average, 13 days post-MI. And when we look at the time at which the events occurthe effect on the stroke, the effect on urgent hospitalizations for anginait seems more related to the anti-atherosclerotic effect than to an effect on ventricular remodeling.

Zeitouni: Another study that was presented at AHA was COLCHICINE-PCI. Those investigators studied patients undergoing angioplasty, to learn whether the administration of colchicine reduced the rate of infarction or periprocedural myocardial damage. The outcomes assessed were biomarkers of myocardial injury. They did not find any difference in these markers, but they did find that inflammation decreased in the colchicine arm as measured by interleukin-6 levels. What are your thoughts on this? Is there a role for colchicine in angioplasty to reduce periprocedural events?

Tardif: The concept was interesting. I think there were, unfortunately, significant methodologic problems in COLCHICINE-PCI. First, the study included only about 400 patients, so the power was extremely limited. Second, the investigators chose to give only one dose of colchicine before angioplasty and not to repeat it afterwards. It was unlikely that we would see any significant longer-term effects. In contrast, COLCOT had not 400 but 4700 patients, and we treated the patients for 23 months. I am struggling to learn from COLCHICINE-PCI. If we want to repeat the experiment, we should do it with longer treatment duration. The finding of a reduction in periprocedural inflammation is the interesting part for me.

Zeitouni: With all of these results from COLCOT, are we a step further in the fight against the residual risk of our coronary patients. Which postinfarction patients would you treat and for how long?

Tardif: First, which patients? If you remember, at the trial presentation people were saying, "Oh, my goodness, are we now going to add another drug on top of the two antiplatelet agents, the statin, and maybe even an ACE inhibitor?" My answer is, really, is this the most intelligent way to practice medicine?

Zeitouni: It should be personalized.

Tardif: Exactly. Instead of saying, "We will give all medicines to everyone," why not try to tailor them by clinical characteristics? We will obviously do subgroup analyses in COLCOT. It is important to understand that not all the data were analyzed because it became available only a few weeks before the conference. We had put a manuscript together for the New England Journal of Medicine and for the AHA presentation. However, we have work to do in the coming months, analyzing the subgroups as well as others, looking at biomarkersis there a particular genetic profile that could show us the patients who would benefit from colchicine?

Personally, I think it's a bad idea to say that we will give six drugs to everyone. In some patients the disease will be mediated by inflammation, whereas in others it will be mediated by diabetes. So I believe it will be necessary to move toward personalized medicine.

Zeitouni: Precisely, with patients who have inflammation and progressive atherothrombotic disease, and occasionally with some young people, who also relapse despite optimal medical treatment. We have a drug now that is well tolerated, accessible, and with strong evidence.

Tardif: I think we could give it to everyone, but with any medications we give, we should make an effort to understand who in particular benefits.

As to your question about duration of treatment, the average follow-up was 23 months, so perhaps we should treat these patients for 2 years. As I noted, COLCOT-T2D will follow patients for 4 years, but for now I would recommend at least 2 years of treatment.

Zeitouni: Prof Tardif, thank you very much for your explanations and for this study, which will improve the prognosis of our patients. We now know more about inflammation and atherothrombosis, thanks to this type of research.

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Could Colchicine Be the New Aspirin? - Medscape

Believe it or not, here we are: already just a month-plus away from the biggest and best health IT show in the world. It's time to formulate a plan of action.

The HIMSS Global Health Conference & Exhibition, which takes place March 9-13 at the Orange County Convention Center in Orlando, Florida.

HIMSS20, as veteran conference-goers know, offers a unique opportunity to spend a week hobnobbing with some 45,000 or so of your closest friends. It plays host to health IT professionals of all stripes: vendors, clinicians, health system executives, policymakers, military health leaders, patient advocates and other healthcare professionals from across the globe.

Its 300-plus education sessions offer not just continuing ed credits but invaluable perspectives and best practices from industry experts tackling the biggest challenges in healthcare. Its slate of well-known keynote speakers bring galvanizing words to spark inspiration. It social and networking opportunities are terrific opportunities to share and learn from innovative new ideas.

As veteran conference-goers also know, careful planning of one's time in Orlando is key to getting the most out of all that activity. With so much going on at once across the sprawling convention center, having a flexible but well-considered to-do list is essential.

Beyond some of the obvious points that are repeated each year wear comfortable shoes, as they will log many miles! here's some other advice and information to get the most from your conference experience.

For those heading to HIMSS20 for the first time, its guide for first time attendees is a must-read.

Among its key tips: Book hotels early! (HIMSS suggests making reservations through OnPeak, its official housing company.) HIMSS also offers an orientation webinar that will take place a week to 10 days before the show.

The HIMSS20 guide also offers other key advice: badge pickup, education certification, onsite information desk and complimentary shuttle service to hotels and the airport.

Full conference registration includes entry to the Monday night opening reception, all keynote and Views from the Top sessions, all general education sessions between March 10 and March 12, as well as access to the exhibition floor for those days.

But an extra fee gains access to a jam-packed day of preconference education and networking on Monday, March 9.

There are stalwarts such as the CHIME-HIMSS CIO Forum, the AMDIS/HIMSS Physicians Executive Symposium and the Nursing Informatics Symposium, of course.

But there are plenty of other daylong sessions to pique the interest of professionals from all corners of the healthcare space: aging technology and AI, big data and blockchain, cloud and consumerism and much, much more.

HIMSS20 gets started in earnest on Tuesday, March 10, with the opening keynote and discussion: Dr. Gianrico Farrugia, president and CEO of Mayo Clinic, George Halvorson, chair and CEO of the Institute for InterGroup Understanding and Dr. Rod Hochman, president & CEO, Providence St. Joseph Health will talk "Digital Health Transformation: The Path Forward."

Throughout the week, other big names scheduled to give keynotes include National Coordinator for Health IT Dr. Donald Rucker, CMS Administrator Seema Verma, former Governors Chris Christie and Terry McAuliffe and baseball great Alex Rodriguez.

When it comes to education sessions, there's no shortage of them. High-level View from the Top presentations will offer industry leaders discussing everything from AI to APIs, value-based care to virtual reality.

And the hundreds of other education session taking place during the week use this handy search function to find the ones most relevant for you cover nearly every topic imaginable: cybersecurity, interoperability, organizational change management, personalized medicine, population health, quality improvement, user experience, venture investment, and much more.

The beating heart of HIMSS20 will be the Exhibition Floor, with more than 1,300 vendors showing the latest in technology innovation, hundreds more targeted education sessions and more pedestrian traffic than some mid-sized cities. Plan your perambulation with this interactive map.

Attendees should also be sure to stop by any or all of the many Specialty Pavilions, such as the Career Expo, Cybersecurity Command Center, Debut Square, Innovation Live, University Row and, of course, the venerable Intelligent Health Pavilion and Interoperability Showcase.

Throughout the week, be sure to keep an eye on social media, too. HIMSS and Healthcare IT News will be offering a stream on new updates via Facebook and Twitter, so follow the hashtag #HIMSS20 for all the latest. Following the feeds of HIMSS' newest class of Digital Influencers is another great way to stay in the loop with all the latest buzz.

The official HIMSS Global Health Conference Mobile App expected to be made available in February is another must-download, with all the info on educational sessions, exhibitor listings, floor maps, news, networking opportunities and more.

And speaking of networking events there's a ton of them on tap for Orlando in March: an array of receptions, meet-ups, community events, HIMSS chapter confabs, the annual awards gala, and many more. See a full listing here.

HIMSS20 takes place March 9-13 at the Orange County Convention Center in Orlando.

Continued here:
Some helpful tips to survive and thrive at HIMSS20 - Healthcare IT News

MINNEAPOLIS, Jan. 24, 2020 (GLOBE NEWSWIRE) -- Predictive Oncology Inc. (NASDAQ:POAI) ("Predictive Oncology" or "the Company"), a knowledge-driven company focused on applying artificial intelligence ("AI") to personalized medicine and drug discovery, today announces it has signed a letter of intent to acquire Quantitative Medicine (QM).

Dr. Carl Schwartz, president and CEO of Predictive Oncology, believes the synergies created by the acquisition, if completed, will help the Company accelerate the commercialization of its AI-driven technology and services, "By coupling QM's CoRE predictive modeling platform with our tumor profiling expertise and data we believe we can revolutionize the way precision therapies are developed, said Dr. Schwartz."

QM is a biomedical analytics and computational biology company, founded by Dr. Robert Murphy and Dr. Joshua Kangas, both of Carnegie Mellon University, that has developed a novel, computational drug discovery platform called CoRE. CoRE is designed to dramatically reduce the time, cost and financial risk of discovering new therapeutic drugs by predicting the main effects of drugs on target molecules that mediate disease.

Predictive Oncology's Helomics division has built an AI knowledgebase of drug response profiles from over 150,000 cancer cases, Using AI to leverage that data the information can now be integrated with CoRE to build robust predictive models of how specific types of tumors will react to cancer drug therapies.

"Our goal is to provide researchers in pharma, biopharma and diagnostic companies' with actionable insights that will not only drive the development of new precision therapies, companion diagnostics, and biomarkers, but will also help them design better targeted trials," concluded Schwartz. "Working together, we have the potential to dramatically improve patient outcomes." The transaction is expected to complete in Q1-2020.

Completion of the transaction, which is expected to be completed in the first two quarters of 2020, is subject to the negotiation of a definitive agreement and other terms and conditions.

About Predictive Oncology Inc.

Predictive Oncology (NASDAQ:POAI) operates through five segments (Domestic, International, Clinical, CRO and DCHIP), which contain four subsidiaries; Helomics, TumorGenesis, Skyline Medical and Skyline Europe. Helomics applies artificial intelligence to its rich data gathered from patient tumors to both personalize cancer therapies for patients and drive the development of new targeted therapies in collaborations with pharmaceutical companies. Helomics' CLIA-certified lab provides clinical testing that assists oncologists in individualizing patient treatment decisions, by providing an evidence-based roadmap for therapy. In addition to its proprietary precision oncology platform, Helomics offers boutique CRO services that leverage its TruTumor, patient-derived tumor models coupled to a wide range of multi-omics assays (genomics, proteomics and biochemical), and an AI-powered proprietary bioinformatics platform (D- CHIP) to provide a tailored solution to its clients' specific needs. Predictive Oncology's TumorGenesis subsidiary is developing a new rapid approach to growing tumors in the laboratory, which essentially "fools" cancer cells into thinking they are still growing inside a patient. Its proprietary Oncology Discovery Technology Platform kits will assist researchers and clinicians to identify which cancer cells bind to specific biomarkers. Once the biomarkers are identified they can be used in TumorGenesis' Oncology Capture Technology Platforms which isolate and help categorize an individual patient's heterogeneous tumor samples to enable the development of patient specific treatment options. Helomics and TumorGenesis are focused on ovarian cancer. Predictive Oncology's Skyline Medical division markets its patented and FDA cleared STREAMWAY System, which automates the collection, measurement and disposal of waste fluid, including blood, irrigation fluid and others, within a medical facility, through both domestic and international divisions. The company has achieved sales in five of the seven continents through both direct sales and distributor partners. For more information, please visit http://www.predictive-oncology.com.

About Quantitative Medicine Inc.

Quantitative Medicine is a biomedical analytics and computational biology company offering a novel drug discovery platform which dramatically reduces the time, cost and financial risk of discovering new therapeutic drugs by predicting: the main effects of drugs on target molecules that mediate disease; the effects of drugs on other molecules or pathways in the body that could mediate adverse effects; as well as the interaction of these with underlying genetic variations. The platform identifies similarities in relationships of drug candidates screened against a diverse matrix of pathogenic, cellular, molecular and/or systems biology targets. By iteratively adding new data from other existing research or additional experiments, the predictive model is improved. More accurate predictions can be made for previously unobserved effects of putative compounds on target molecules. "Because of the complexity of biological systems, cutting-edge machine-learning methods will be critical for future drug discovery and development."www.qtmed.com

Forward-looking Statements

Certain of the matters discussed in the press release contain forward-looking statements that involve material risks to and uncertainties in the Company's business that may cause actual results to differ materially from those anticipated by the statements made herein. Risks and uncertainties relating to a transaction with Quantitative Medicine include no assurance that a transaction will be completed or, if completed, no assurance that the acquisition of Quantitative Medicine would result in anticipated benefits. Further, the acquisition could involve unanticipated costs, distractions to Company management or other risks or adverse effects, and any issuance of equity securities in the transaction would result in dilution to the Company's stockholders, which may be significant. Other risks and uncertainties regarding the Company's securities include (i) risks related to the recent merger with Helomics, including the fact that the combined company will not be able to continue operating without additional financing; possible failure to realize anticipated benefits of the merger; costs associated with the merger may be higher than expected; the merger may result in disruption of the Company's and Helomics' existing businesses, distraction of management and diversion of resources; and the market price of the Company's common stock may decline as a result of the merger; (ii) risks related to our partnerships with other companies, including the need to negotiate the definitive agreements; possible failure to realize anticipated benefits of these partnerships; and costs of providing funding to our partner companies, which may never be repaid or provide anticipated returns; and (iii) other risks and uncertainties relating to the Company that include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; unexpected costs and operating deficits, and lower than expected sales and revenues; sales cycles that can be longer than expected, resulting in delays in projected sales or failure to make such sales; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance, if our product is not accepted by our potential customers, it is unlikely that we will ever become profitable; adverse economic conditions; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; Predictive's ability to implement its long range business plan for various applications of its technology; Predictive's ability to enter into agreements with any necessary marketing and/or distribution partners and with any strategic or joint venture partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of Predictive's technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company's reports filed with the SEC, which are available for review at http://www.sec.gov. This is not a solicitation to buy or sell securities and does not purport to be an analysis of Predictive's financial position. See Predictive's most recent Annual Report on Form 10-K, and subsequent reports and other filings at http://www.sec.gov.

Contact:

Bob Myers651-389-4800bmyers@skylinemedical.com

Continue reading here:
Predictive Oncology Inc. Signs Letter of Intent to Acquire Quantitative Medicine (qtmed.com) and an AI Engine (CoRE) that Facilitates Accelerated Drug...

LUND, Sweden, January 28, 2020 / B3C newswire / -- SAGA Diagnostics AB, a cancer liquid biopsy and genomic testing company focused on precision oncology and non-invasive ultrasensitive monitoring of cancer patients, today announces it has entered service agreements with the international pharmaceutical company Servier, based in Paris, France.

These deals exemplify the increased demand we are experiencing for our offerings of ultrasensitive cancer analysis services and analysis kits. We are excited to be working with Servier, who continues to choose us for important translational oncology projects. Lao Saal, CEO of SAGA Diagnostics.

The collaboration will be covering a total of three preclinical/clinical studies and is scheduled to run for approximately two years. In the course of these projects, SAGA Diagnostics will be developing assays and performing liquid biopsy tests on patients from multiple Servier clinical studies using the SAGAsafe technology (formerly known as IBSAFE) to identify and quantify circulating tumor DNA (ctDNA).

SAGAsafe technology is a patented improvement of digital PCR that enables approximately 100-fold increased sensitivity compared to competitor methods, and can be used to quantify mutations in tissue samples as well as liquid biopsies such as blood plasma with unprecedented performance to a limit of detection of ~0.001% mutant allele frequency. The analyses will be run in the SAGA Diagnostics central laboratory in Lund, Sweden.

We have been impressed by the service and ultra-sensitivity performance of SAGAsafes analyses and are looking forward to continue working together. Involving the SAGAsafe technology in these studies means that Servier will now be able to monitor effects at an earlier stage ensuring that we do not miss out on any insights. Brian Lockhart, Director of CentEx-Biotechnology, Servier.

SAGAsafe is part of a portfolio of ultrasensitive technologies, which also includes SAGAsign (formerly known as KROMA) for monitoring chromosomal rearrangements, as well as novel technologies in development. SAGA offers both off-the-shelf analysis services and kits as well as custom-tailored solutions to fit customers needs. SAGAs molecular tools are being used in clinical trials and hospitals for detecting actionable mutations, monitoring treatment response, measuring minimal residual disease, and identifying resistance mechanisms to help direct therapy.

About SAGA Diagnostics ABSAGA Diagnostics AB is a personalized cancer genomics and disease monitoring company that offers molecular genetic testing of tissue biopsies and non-invasive liquid biopsies such as blood samples. With SAGAsafe and SAGAsign services and kits, SAGA helps pharmaceutical companies, scientists, and healthcare providers to detect actionable mutations, stratify patient groups, and monitor treatment response more accurately and to an industry-leading lower limit of detection of 0.001%. Analysis of circulating tumor DNA using these proprietary technologies gives SAGA unique ultrasensitivity, and gives patients peace of mind.Follow us on Twitter@SAGAdiagnosticsandLinkedIn.

Contact

ke Nilsson, BD Director This email address is being protected from spambots. You need JavaScript enabled to view it.+46 733 01 72 42

Keywords: Circulating Tumor DNA; Neoplasm, Residual; Limit of Detection; Precision Medicine; Liquid Biopsy; Medical Oncology; Genetic Testing; Pharmaceutical Preparations

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SAGA Diagnostics Extends its Collaboration with Servier to Use Ultrasensitive SAGAsafe Technology in Cancer Clinical Trials - b3c newswire