StemCell Therapy

A Chinese court sentenced biomedical scientist He Jiankui and two accomplices to prison on Monday for illegal medical practice for genetically engineering three babies.

In November 2018, He announced the birth of the first two children, twin girls named Lulu and Nana, as well as the pregnancy of a second woman carrying a genetically engineered fetus. The news created a scientific firestorm, with human genetic engineering experiments widely viewed as dangerous and unethical by scientific organizations worldwide. The third baby has now been born, according to reporting from Chinas state news agency.

The genetic engineering team fabricated an ethics review of their experiment, according to the Nanshan District People's Court of Shenzhen City ruling. They used the faked permissions to recruit couples living with HIV in hopes of helping them to conceive children genetically engineered to receive a mutation giving them immunity to some forms of the disease.

He, formerly a biomedical scientist at the Southern University of Science and Technology in Shenzen, received a prison sentence of three years and a fine equivalent to $480,000. His associates, Zhang Renli and Qin Jinzhou, received jail terms of two years and 18 months with a two-year reprieve, according to the ruling, for practicing medicine without a license and violating Chinese regulations governing assisted reproduction.

The prison sentence and stiff financial penalty sends a message to other Chinese scientists that unsanctioned efforts at human germline editing will not be tolerated, University of Pennsylvania Perelman School of Medicine researcher Kiran Musunuru told BuzzFeed News, by email. I expect that it will have a deterrent effect, certainly in China and possibly elsewhere.

At an October conference, Musunuru had reported that a draft study submitted to a scientific journal about the twins by Hes team suggested that the genetic engineering attempt had badly misfired, targeting the wrong location for the mutation and potentially seeding other mutations throughout the DNA of the children.

Science academies worldwide formed an oversight commission in March, following widespread condemnation of the experiments.

The court ruling found the three sentenced scientists acted "in the pursuit of personal fame and gain" and have seriously "disrupted medical order, according to Chinese state media.

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The Chinese Scientist Who Made The First Genetically Engineered Babies Is Going To Prison - BuzzFeed News

(KARK) An Arkansas infant born with a life-threatening genetic disorder has received a multi-million dollar treatment that could save her.

Its also a big milestone since shes the first baby in the state that had the pricey one-time injection paid for by insurance.

When Josephine Gilmore was 4-months-old, doctors found she was born with Spinal Muscular Atrophy, also known as SMA. Its a rare genetic disorder that causes a persons nerves to start dying before theyre born.

How could I let this happen to my kid? Why didnt I see the signs? But you dont know, says Josephines mom Casey Gilmore. Theres not enough education about SMA and how horrible of a disease it is.

The earlier doctors detect the disorder, the better the outcome. Unfortunately many times SMA is not found until a child is a few months old, and that can be too late.

At 6 months nearly 90 percent of the motor neurons in a childs body are dead, Gilmore explains.

There is a gene therapy drug that can help reverse the effects of SMA. Its a one time injection that costs around $2.1 million. Doctors call it life-saving.

Read more:http://bit.ly/35UVgCo

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Infant with life-threatening genetic disorder receives $2.1M injection - KVOA Tucson News

What Can Genes Tell Me About My Cancer Risk?

Before pursuing any kind of genetic testing, it is important to understand that the majority of cancers are not the direct result of genes passed down from your parents. Inherited gene changes sometimes called mutations or variants contribute to somewhere between 5 and 10 percent of all cancers. For that reason, genetic testing and counseling is typically recommended only for people who have had certain types of inherited cancer or who have histories of cancer within their family.

Genetic testing allows healthcare providers to look for inherited gene mutations associated with increased cancer risk, such as BRCA1 and BRCA2 gene changes that have a clear tie to breast and ovarian cancer. For example, women in the general population have roughly a 12 percent chance of developing breast cancer in their lifetime; for women with BRCA mutations, it is closer to 70 percent, according to the NCI. Understanding that risk can help a woman and her healthcare providers plan prevention strategies.

RELATED: My Genetic Test Came Back BRCA Positive. Now What?

Medical-grade genetic cancer testing is typically ordered by your doctor or a specialist, such as a genetic counselor. The tests are noninvasive and typically use a blood or saliva sample.

"Medical-grade testing is developed and approved to answer medical questions [such as]: 'Do I carry a mutation in one of these hereditary cancer genes?'" says Ellen Matloff, the president and CEO of My Gene Counsel, a company that helps clients better understand their genetic testing results, and the former director of the cancer genetic counseling program at Yale University School of Medicine in New Haven, Connecticut. "At-home testing kits are for entertainment and are not developed, or approved, to answer medical questions."

There are several reasons for that. Medical-grade testing is far more thorough, Matloff says. For example, medical-grade testing for BRCA gene mutations analyzes thousands of gene variant options, whereas one leading at-home kit considers just three.

There are also differences in accuracy. A study published in March 2018 in the journal Genetics in Medicine found that 40 percent of gene variants reported in direct-to-consumer tests were false positives and that some of the variants companies told users meant they were at increased risk for certain health conditions are actually considered common gene variants by clinical labs.

An unpublishedstudy presented in October 2019 by Invitae, a medical-grade genetic testing company, found that an individual's ethnicity may have a significant impact on whether their at-home test results are accurate. MUTYH gene mutations, for example, would have been missed in 100 percent of Asian and 75 percent of African American test takers, but only 33 percent of Caucasian individuals.

"Medical-grade testing uses laboratory techniques and validation methods not used by most at-home testing kits," Matloff explains. "So those results are generally more accurate."

Health insurance plans will often cover genetic testing which can cost thousands of dollars but not always, according to the U.S. National Library of Medicine and Breastcancer.org. Direct-to-consumer genetic cancer risk tests tend to be less expensive, so they can be a good starting point for people who are worried about their family history and who do not want to spend too much.

"There are some at-home genetic cancer testing kits that are good, reasonably priced, and convenient for people who do not meet insurance criteria for coverage of traditional medical-grade testing and prefer to pay out of pocket and have the test delivered to their house," Matloff says.

But it is important to remember that everyone from the American Cancer Society to the U.S. Food and Drug Administration (FDA) caution that the tests may provide incomplete or inaccurate information, and urge individuals to talk to their doctors before making any health-related decisions on the basis of those tests.

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What to Know Before You Buy an At-Home Genetic Cancer Risk Test - Everyday Health

NEW YORK, Dec. 30, 2019 /PRNewswire/ --

The Asia Pacific prenatal and newborn genetic testing market is expected to reach US$ 1,679.956 Mn in 2027 from US$ 630.914 in 2018. The market is estimated to grow with a CAGR of 11.6% from 2019-2027.

Read the full report: https://www.reportlinker.com/p05833588/?utm_source=PRN

The key factors responsible for the growth of the market in Asia Pacific are rising burden of genetic diseases among infants, increasing fertility rates and developing healthcare scenario with rising awareness among populace regarding the benefits of prenatal testing.On the other hand, use of digital microfluidics in newborn testing is likely to be a prevalent trend in the future years.

Soaring birth rates among developing economies are responsible for fueling global baby boom.However, the rising birth rate also contributes to rising birth defects and infants suffering from several genetic diseases.

According to a report published by Bill and Melinda Gates Foundation in 2018, there are almost 250 babies born every minute around the globe. Moreover, according to the Centers for Disease Control and Prevention, the fertility rates for Hispanic women was highest in 2017 among Hispanic women with 67.1 births per 1,000 women.Asian countries such as India and China also have high fertility rates due to factors such as effects of religion, inadequate supply of family welfare services, poverty, and others. According to the World Bank in 2016, the fertility rates in India were reported to be 2.23 births per women as compared to 1.80 in the United States and 1.62 in China. Moreover, neighboring countries, such as Pakistan also have alarming rates of fertility. In 2016, the birth rate in Pakistan was reported to be 3.48 births per woman as per the World Bank data. However, the birthrate in India has successfully reduced its high fertility rate, but still is high as compared to other developed nations. According to the United Nations (UN) report published on June 2019, the fertility rate has reduced to 2.1. Therefore, by 2050 additional 273 million people will be added to India's population. The increasing number of parturient women across the world are thus likely to create increasing demand for prenatal and newborn genetic tests across the globe leading to the growth of the market.The Asia Pacific prenatal and newborn genetic testing market, based on the disease indication was segmented into cystic fibrosis, sickle cell anemia, downs syndrome, phenylketonuria, recurrent pregnancy loss, and Antiphospholipid syndrome, and other diseases.In 2018, Down syndrome segment held the largest share of the market, by disease indication.

The highest share of Down syndrome attributes to the high prevalence of this genetic abnormality among fetuses and availability of multiple tests for its screening and diagnostics. However, the sickle cell anemia segment is expected to grow at the fastest rate during the coming year.Some of the major primary and secondary sources for prenatal and newborn genetic testing included in the report are Food & Drug Administration (FDA), Indian Institutes of Technology (IITs), International Trade Administration (ITA), Japan Society of Obstetrics and Gynecology (JSOG), Council of Scientific and Industrial Research (cSIR), Pakistan Down Syndrome Association (PDSA) and others.

Read the full report: https://www.reportlinker.com/p05833588/?utm_source=PRN

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The Asia Pacific prenatal and newborn genetic testing market is expected to reach US$ 1,679.956 Mn in 2027 from US$ 630.914 in 2018 - PRNewswire

Genetic mutations take place deep inside our DNA and can be challenging to identify, let alone treat. Scientists hope that a new deep learning approach will help doctors better combat these disease-causing mutations.

Thanks to their data-crunching abilities, deep learning and A.I. have become increasingly important medical tools in recent years. These models are able to digest and make use of reams of medical data created by the human body by learning patterns from a test data-set and applying those rules to new, incoming data. Far from replacing a physician, these medical machines simply help physicians make connections quicker and more accurately.

While previous deep learning approaches have found success in predicting harmful mutations in the human genome, this new approach is the first to target metal-binding sites of proteins.

The study was published this December in the journal Nature Machine Intelligence and used something called a multichannel convolutional neural network (MCNN) to better understand what kinds of mutations affect disease development. Because metal ions play key structural and physiological roles in the human body, the team focused specifically on the regulation of different metallic nutrients in proteins, something called metalloproteins.

The studys lead author, Hongzhe Sun, a professor and chemistry chair at the University of Hong Kong, said in a statement that this approach can make use of data the team has already collected.

Machine learning and AI play important roles in the current biological and chemical science, said Sun. In my group we worked on metals in biology and medicine using integrative omics approach including metallomics and metalloproteomics, and we already produced a large amount of valuable data using in vivo/vitro experiments. We now develop an artificial intelligence approach based on deep learning to turn these raw data to valuable knowledge, leading to uncover secrets behind the diseases and to fight with them. I believe this novel deep learning approach can be used in other projects, which is undergoing in our laboratory.

But, before bringing in the A.I., the team first had to analyze data collected from these metalloproteins. They found that mutations in different metal ions, usually caused by a change in size or hydrophilic-ness, affected the development of different diseases. For example, zinc-binding site mutations appeared to play a major role in breast, liver, kidney, immune system and prostate diseases while mutations in calcium- and magnesium-binding sites were associated with muscular and immune system diseases. Due to data availability, the research focused on these three metal types.

From there the researchers broke their data into 80 percent training data for the MCNN to learn from and 20 percent testing data to determine how well the MCNN could apply its new knowledge to novel situations. In order to gain useful knowledge from the data sets, the team extracted both spatial and sequential features from the data and fed that to the MCNN.

Using this data the MCNN was able to identify two disease-causing mutations that a previous similar study, PolyPhen-2, had only marked as benign. These mutations were connected to a variety of cancers as well as a rare genetic disorder called JohansonBlizzard syndrome. Apart from these two novel discoveries, the team also found that the MCNN was able to correctly identify disease-causing mutations 82 percent of the time.

In addition to being a useful tool to help researchers make sense of genetic data and to better tackle disease-causing mutations, the research team also hopes that their approach could be used to develop new drugs as well by predicting the binding affinity of small molecules and proteins.

Abstract:

Metalloproteins play important roles in many biological processes. Mutations at the metal-binding sites may functionally disrupt metalloproteins, initiating severe diseases; however, there seemed to be no effective approach to predict such mutations until now. Here we develop a deep learning approach to successfully predict disease-associated mutations that occur at the metal-binding sites of metalloproteins. We generate energy-based affinity grid maps and physiochemical features of the metal-binding pockets (obtained from different databases as spatial and sequential features) and subsequently implement these features into a multichannel convolutional neural network. After training the model, the multichannel convolutional neural network can successfully predict disease-associated mutations that occur at the first and second coordination spheres of zinc-binding sites with an area under the curve of 0.90 and an accuracy of 0.82. Our approach stands for the first deep learning approach for the prediction of disease-associated metal-relevant site mutations in metalloproteins, providing a new platform to tackle human diseases.

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Scientists are using A.I. to unlock humanity's most mysterious mutations - Inverse

The days when an inventor sat behind closed doors tinkering with groundbreaking technology are over. Nowadays, scientists from a variety of backgrounds work together to come up with an invention or a product. They also dare to bring it to the market at an ever-increasing rate. By no means are all innovations a success, but one invention is enough to change the world.

Innovation Origins regularly speaks to innovation leaders, trendsetters who are high on the innovation ladder. Steef Blok has the floor today. The director of TU/e Innovation Lab is responsible at Eindhoven University of Technology for valorization. That entails bringing knowledge from the university back to society. He has to deal on a daily basis with technologies that the rest of the world might not become acquainted with until ten years from now. Technology forms the foundation for the growth of prosperity in the Netherlands. Our daily lives are wholly influenced by it, Blok states.

He talks about the impact of technology in the past and its importance for the future: Our ancestors used to spend all day collecting and preparing food. Technology made it possible for food to be produced on a greater scale. As a result, not everyone had to deal with food and people started providing services. This is how the economy as we know it today came into being. Later on, machines began to take over more and more of the heavy work that people had to do, for example on farms. As a result, the economy grew and so did prosperity.

Sticking with that example for a moment, the advent of machines meant that the farms had to continue to grow as well. You cant put a large machine on one hectare of land. More space is needed for that. Besides that, farmers have to produce more in order to recoup the cost of those machines. Thats how mass production came about.

Although Blok believes that this type of mass production is now going to be phased out again with the advent of intelligent systems. We can connect machines through these intelligent systems. This allows us to remotely switch on the heating at home, but it also enables ASMLs machines to communicate with each other. The possibilities are unimaginable. Even for the aforementioned farmers. For example, a Brabant potato farmer flies drones over his land in order to measure the amount of manure and water thats on the land. He only fertilizes the soil that actually needs it. That saves time and money and is also better for the environment. The harvest will be better as a result too.

A potato is still a potato, but this farmer takes care of his land in a tailor-made way. Thanks to smart technologies, the more of the same mentality is a thing of the past. This can have several meanings. As an example, in the future, a machine could make a different product for one customer than for another.

Universities are indispensable when it comes to these kinds of developments. This is where such systems are conceived. Universities are about ten years ahead of the market. But not everything that is designed at a university will survive on the market. Some projects dont even get further developed into a product. If that does happen, it sometimes doesnt yield the results you envisage. Weve come up with inventions that I thought would make the world a better place. And nobody on the market cared.

I heard, for example, that early menopause is one of the main reasons why some women cant have children. Women are already really reduced in their reproductive ability ten years before the onset of menopause. For example, if someone starts menopause prematurely, at around 40 years of age, they would have already had low fertility from the age of 30. The average age at which a woman has a child in The Netherlands is now over 29 years of age. Technology might offer a solution to this problem.

At the university, we designed a diagnostic chip that allows us to detect the gene that can predict a womans early onset of menopause. As a result, women know at an early age whether they will start menopause early, and they can tailor the time when they can begin to have children. The chip costs about 6 million. So it seemed like the ideal solution. Expensive and often unpleasant treatments with hormones and IVF would be used less as a result. But in the end nobody wanted it. Women didnt want to know at all when they were going to go through menopause. Oh well. The world is full of surprises.

Consumers will ultimately use a product. Naturally, they have to want to do that. This is not only true in the field of healthcare, but also in the field of sustainability and circularity. Things are already improving in those areas. For example, we are already using more and more refurbished computers instead of immediately throwing away all our electronics. We are also handling food more carefully. If we dont want to burn waste anymore, but want to re-use everything instead, that should already be taken into account during the production process. In order to achieve this, entire production processes need to change.

Genetic engineering is also one of the topics that we do a lot of research on at the university, but on which public opinion is really divided. Bananas grow in a greenhouse under controlled conditions at the University of Wageningen. This way the plants are no longer affected by disease. This allows for a constant supply of bananas. These plants are genetically manipulated. I wouldnt hesitate for a second to use that on a large scale.

Genetic engineering in humans is also being explored more extensively. Ive worked in the hospital sector. Here Ive seen people suffer from diseases like cancer and Ive seen people die. Suppose theres a child on its way who has a disease or disability. But when you remove one gene, its completely healthy. Id do it. Although genetic manipulation does pose a risk to people. Imagine, for example, that over time youve designed a perfect human being. But thats true for other technologies: Atomic energy isnt bad, but an atomic bomb is. I admit that the engineered human being is a bit scary. But we can t stop technological progress.

Read more here:
How innovation works: 'A perfect human being is the danger that genetic manipulation poses' - Innovation Origins

The 2010s are coming to an end, and looking back there have been some pretty amazing advances and innovations in health and science.

Advances in prosthetic limbs

Prosthetic limbs have been around since ancient times. In Egypt, a prosthetic wooden toe was found on a mummy dating back 3,000 years. By the Dark Ages, inventors could incorporate hinges on prosthetic arms used by knights. In modern times, the field of prosthetics has turned to incorporating more technology into physical stand-ins for limbs. In the last several years, theres been a boom in advances that have led to the best and most useful prosthetics weve ever seen.

Reports from the early 2010s talked about the potential for new technology to allow people to control prosthetics with their minds and to receive sensory information from their devices. It may have been a reach in the early part of the decade, but now it is literally within grasp. There are new prosthetic hands being tested that give the user the ability to grab objects with their thoughts and even to sense the texture of what they are touching. New bionic hands allow the user to feel again by sending signals back to the brain about the things they are touching, like whether its hard or soft. Other research groups have been working on bionic arms that can move based on the users thoughts through a brain-computer interface. While these have demonstrated its possible to accomplish these goals in the lab, theres still more to be done before people can use these devices outside in the real world.

Many of these advanced prosthetics are still prototypes and may not reach the general population for a while. Luckily, cheaper 3D printers have made simple prosthetics more accessible. These are important because a prosthetic device can improve the quality of life for people. For example, this person has been printing prosthetic hands and arms for people in Africa after watching an online tutorial. New materials that go into 3D printers are cheaper than they used to be and are being used in prosthetics to provide a more affordable option for patients.

Although prosthetics have been around for ages in some form or another, they arent always used. One variable to consider is the social acceptance of having a prosthetic. Theres still a lot of stigma around disabilities and many people may reject prosthetics even if they are available. In 2012, an athlete with both feet amputated competed in the mens 400 meter race at the Olympics in London. There was some controversy over whether the runner with a prosthetic foot should be allowed to run in races with people who dont have prosthetics or if they should only be allowed in competitions specifically for people who have them. Prosthetics also need to be comfortable and usable in order to be successfully adopted. In one study, about 4.5 percent of people rejected prosthetics and 13.4 percent stopped using their prosthetics. As the new prosthetics that are more natural and intuitive to use come to market, hopefully more people will benefit, and the social barriers to acceptance will disappear.

CRISPR

The genome modification technique called Clustered Regularly Interspaced Short Palindromic Repeats, aka CRISPR, was a culmination of a few decades of work by scientists, and major studies explaining the method were published in 2013. The version of it called CRISPR-associated protein 9 or CRIPSR-Cas9 is what most researchers are specifically using in most cases. It involves a regular gene editing mechanism that happens in bacteria. The bacteria can take sections of DNA from attacking viruses and essentially use that to remember the viruses if they return. When the virus is back, the bacteria can target the matching sections of DNA in the virus, cut it and disable the virus.

Though 2013 was only six years ago, as far as science goes, CRISPR has been moving at lightning speed towards practical applications. Using CRISPR to edit a gene sequence, researchers can now add, delete or modify DNA segments more quickly and accurately than ever before. Since the technique was developed, researchers have used CRISPR to target diseases caused by a single gene like cystic fibrosis or sickle cell disease.

Probably the most infamous use of CRISPR are the CRISPR babies. In late 2018, a Chinese researcher, He Jiankui, claimed to have used CRISPR to modify the genomes of two babies to include a mutated version of a gene that protects against HIV. This case was and is highly controversial for the ethical concerns with genetically modifying a human genome at the embryo level, or germline, meaning it can be passed down to future generations and has not been done before in humans. Recently, MIT Technology Review obtained excerpts from Hes research, and experts say that the report and data may be untrustworthy. This means it is still unclear if He and collaborators actually successfully modified the babies genomes. The scientific community overall condemns this way of using CRISPR to edit a human germline genome and has called for an international moratorium on it until a framework can be agreed on.The researcher has been sentenced to three years in prison in Shenzhen, China.

As fraught with controversy as the CRISPR babies may be, CRISPR technology still holds a lot of promise and can be used responsibly, supporters say. For example, researchers are using it to target cancer cells by taking a patients immune cells, modifying them using CRISPR and then infusing the patient with the modified cells. For blood diseases, a patient with sickle cell disease is reported to be responding well to a CRISPR treatment that has allowed her body to produce a crucial protein.

Another area that has boomed this decade partly because of CRISPR technology is stem cell therapy, which well get into in the next section.

Stem cell therapy

Technically, the only Federal Drug Administration (FDA)-approved stem cell therapies are blood-forming stem cells derived from umbilical cord blood. Blood-forming stem cells are used to treat patients with cancer after chemotherapy has depleted blood cells, as well as patients with blood disorders like leukemia whose bone marrow tissues are damaged. These types of treatments have been around for about 30 years, but in the 2010s weve seen potential for more uses of stem cells in health care.

The main idea behind stem cell therapy is that because the cells are pluripotent meaning they can become many other types of cells they can be introduced into parts of the body that are damaged and need new cells. On top of that, researchers can now extract some types of stem cells from a persons body, so no need for umbilical cords. This opens up the possibilities for highly personalized treatment where one person can be treated with stem cells from their own body.

Researchers are exploring how stem cells can be used to treat liver disease, cerebral palsy, stroke, brain injury and others. There are many ongoing research-backed clinical trials for stem cell therapy. A quick search for stem cell therapy on the governments clinical trial database turns up 5,638 results. And because of the work necessary to even get to the clinical trial stage, theres likely an order of magnitude more stem cell therapy studies in the pre-clinical trial stages.

Stem cell therapy is also being offered in for-profit clinics around the U.S. In these cases, the clinics are typically taking fat tissue from a patient, isolating the stem cells and then administering the stem cells back to the patient. In some cases, the treatments may lead to health complications, like blindness in a few extreme cases, and the FDA warns that such treatments are unapproved and potentially harmful. The FDA is ramping up regulation of stem cell clinics and earlier this year took a specific clinic in Florida to court.

Although there are many stem cell clinics offering unproven stem cell therapies, its not all hype. Granted that its difficult to pass the clinical trial stage to get FDA approval, stem cell research may lead to new treatments for several health conditions that could completely change the health care landscape.

You can follow Chia-Yi Hou on Twitter.

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The most important health innovations of the past decade - The Hill

Stem Cell Assay Market: Snapshot

Stem cell assay refers to the procedure of measuring the potency of antineoplastic drugs, on the basis of their capability of retarding the growth of human tumor cells. The assay consists of qualitative or quantitative analysis or testing of affected tissues and tumors, wherein their toxicity, impurity, and other aspects are studied.

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With the growing number of successful stem cell therapy treatment cases, the global market for stem cell assays will gain substantial momentum. A number of research and development projects are lending a hand to the growth of the market. For instance, the University of Washingtons Institute for Stem Cell and Regenerative Medicine (ISCRM) has attempted to manipulate stem cells to heal eye, kidney, and heart injuries. A number of diseases such as Alzheimers, spinal cord injury, Parkinsons, diabetes, stroke, retinal disease, cancer, rheumatoid arthritis, and neurological diseases can be successfully treated via stem cell therapy. Therefore, stem cell assays will exhibit growing demand.

Another key development in the stem cell assay market is the development of innovative stem cell therapies. In April 2017, for instance, the first participant in an innovative clinical trial at the University of Wisconsin School of Medicine and Public Health was successfully treated with stem cell therapy. CardiAMP, the investigational therapy, has been designed to direct a large dose of the patients own bone-marrow cells to the point of cardiac injury, stimulating the natural healing response of the body.

Newer areas of application in medicine are being explored constantly. Consequently, stem cell assays are likely to play a key role in the formulation of treatments of a number of diseases.

Global Stem Cell Assay Market: Overview

The increasing investment in research and development of novel therapeutics owing to the rising incidence of chronic diseases has led to immense growth in the global stem cell assay market. In the next couple of years, the market is expected to spawn into a multi-billion dollar industry as healthcare sector and governments around the world increase their research spending.

The report analyzes the prevalent opportunities for the markets growth and those that companies should capitalize in the near future to strengthen their position in the market. It presents insights into the growth drivers and lists down the major restraints. Additionally, the report gauges the effect of Porters five forces on the overall stem cell assay market.

Global Stem Cell Assay Market: Key Market Segments

For the purpose of the study, the report segments the global stem cell assay market based on various parameters. For instance, in terms of assay type, the market can be segmented into isolation and purification, viability, cell identification, differentiation, proliferation, apoptosis, and function. By kit, the market can be bifurcated into human embryonic stem cell kits and adult stem cell kits. Based on instruments, flow cytometer, cell imaging systems, automated cell counter, and micro electrode arrays could be the key market segments.

In terms of application, the market can be segmented into drug discovery and development, clinical research, and regenerative medicine and therapy. The growth witnessed across the aforementioned application segments will be influenced by the increasing incidence of chronic ailments which will translate into the rising demand for regenerative medicines. Finally, based on end users, research institutes and industry research constitute the key market segments.

The report includes a detailed assessment of the various factors influencing the markets expansion across its key segments. The ones holding the most lucrative prospects are analyzed, and the factors restraining its trajectory across key segments are also discussed at length.

Global Stem Cell Assay Market: Regional Analysis

Regionally, the market is expected to witness heightened demand in the developed countries across Europe and North America. The increasing incidence of chronic ailments and the subsequently expanding patient population are the chief drivers of the stem cell assay market in North America. Besides this, the market is also expected to witness lucrative opportunities in Asia Pacific and Rest of the World.

Global Stem Cell Assay Market: Vendor Landscape

A major inclusion in the report is the detailed assessment of the markets vendor landscape. For the purpose of the study the report therefore profiles some of the leading players having influence on the overall market dynamics. It also conducts SWOT analysis to study the strengths and weaknesses of the companies profiled and identify threats and opportunities that these enterprises are forecast to witness over the course of the reports forecast period.

Some of the most prominent enterprises operating in the global stem cell assay market are Bio-Rad Laboratories, Inc (U.S.), Thermo Fisher Scientific Inc. (U.S.), GE Healthcare (U.K.), Hemogenix Inc. (U.S.), Promega Corporation (U.S.), Bio-Techne Corporation (U.S.), Merck KGaA (Germany), STEMCELL Technologies Inc. (CA), Cell Biolabs, Inc. (U.S.), and Cellular Dynamics International, Inc. (U.S.).

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Stem Cell Assay Market Expected to Witness a Sustainable Growth over 2025 - Filmi Baba

For a complete list of our obituaries, seehere.

SYDNEY BRENNER SCIENTIFIC SYMPOSIUM

Nobel laureate Sydney Brenner died in April at the age of 92.

Brenner was best known for his discovery of sequences that stop protein translation, mRNA, and his investigation of the nematode C. elegans, which he realized would be an ideal model organism to study cell differentiation and organ development. That work won him the 2002 Nobel Prize for Physiology or Medicine.

[H]is great strength was in experiments, and in particular the choice and execution of ones that were both important and ingenious, Francis Crick, the codiscoverer of DNA who shared an office with Brenner at the MRC Laboratory of Molecular Biology (LMB) in the UK, wrote in atribute to Brenner in The Scientist in 2002.

US DEPARTMENT OF ENERGY, OAK RIDGE NATIONAL LABORATORY

American geneticist Liane Russell, famous for her work on the deleterious effects of prenatal radiation exposure and the chromosomal basis for sex determination in mammals, died in July at age 95.

She and her husband William Russell established the Oak Ridge National Laboratorys (ORNL) Mouse House, an extensive colony of mutant mice bred to model the effects of exposure to radiation.

Russells work led to a healthcare policy to ask women if they are pregnant before X-raying them and also to avoid X-rays shortly after menstruation in women of childbearing age.

Inventor of the polymerase chain reaction technique and winner of the Nobel Prize in Chemistry in 1993, Kary Mullis, died in August at age 74.

Mullis was known as a weird figure in science and a flamboyant philanderer who evangelized the use of LSD, denied the evidence for both global warming and HIV as a cause of AIDS, consulted for O.J. Simpsons legal defense, and formed a company that sold jewelry embedded with celebrities DNA, according to a 1998 profile in The Washington Post.

Mullis wrote in The Scientist in 2003 that his first attempt at PCR in 1983 was a long-shot experiment. . . . so [at midnight] I poured myself a cold Becks into a prechilled 500 ml beaker from the isotope freezer for luck, and went home. I ran a gel the next afternoon [and] stained it with ethidium. It took several months to arrive at conditions [that] would produce a convincing result.

Even still, Science and Natureboth rejected the resulting manuscript, which was ultimately published in Methods in Enzymology in 1987 and helped earn Mullis his Nobel.

Chemical engineer George Rosenkranz, the director of the pharmaceutical company that first synthesized a synthetic form of the hormone progesterone, died in June at the age of 102.

He and colleagues developed norethindrone, a synthetic version of progesterone, which was then used in the combined oral contraceptive pill and approved by the US Food and Drug Administration in 1959. The work, along with efforts in biotech, earned him many awards from scientific organizations and from the Mexican government.

Despite that, he was a very humble man, Roberto Rosenkranz, one of his sons, told the Los Angeles Times. He never was out to take credit.

Ophthalmologist and inventor Patricia Bath, whose research on lasers advanced cataract surgery, died in May at the age of 76.

During her medical internship in New York, she conducted an epidemiological study on blindness and found the rate of the condition among the black population was twice that of the white population. The finding led her to start the field of community ophthalmology, caring for underserved populations. She promoted the field by traveling to perform surgeries, training clinicians, and donating equipment.

Bath then moved to the University of California, Los Angeles, medical center in 1974 and in the 1980s began studying lasers for their potential to treat eye disorders. In 1988, she patented a device called Laserphaco Probe, which removes cataracts.

I had a few obstacles but I had to shake it off, Bath told ABC News in 2018. Hater-ation, segregation, racism, thats the noise you have to ignore that and keep your eyes focused on the prize, its just like Dr. Martin Luther King said, so thats what I did.

Nobel laureate Paul Greengard, who discovered that the brain communicates with chemical signals, died in April. He was 93.

Paul was an iconic scientist whose extraordinary seven-decade career transformed our understanding of neuroscience, Richard Lifton, president of Rockefeller University, where Greengard had been a faculty member, said in a statement. His discoveries laid out a new paradigm requiring the understanding of the biochemistry of nerve cells rather than simply their electrical activities. This work has had great impact.

Greengards work revealed how the brain uses dopamine and other chemicals to send signals from one nerve cell to another, discoveries that won him a Nobel Prize in Physiology or Medicine in 2000. Greengard used the prize money to establish an award for women doing outstanding biomedical research and named the prize after his birth mother. Drawing attention to the achievements of women working in science, he and Baylor College of Medicine professor Huda Zoghbi wrote in The Scientist in 2014, sets a powerful example for those women still dreaming of their own success.

Public health whistleblower, physician, and researcher, Shuping Wang, died in September at the age of 59.

Wangs career started in China in the 1980s, where she was a doctor and hepatitis researcher. In 1992, she was testing blood serum samples from a plasma collection station where she worked and realized that unsanitary blood collection methods had led to a hepatitis C epidemic among people who donated and received plasma at the clinic. She reported the findings to officials and was fired, the Salt Lake Tribune reported.

She took a job at the Zhoukou Health Bureau and, analyzing the blood samples there, she found 13 percent of donors had HIV and the cross-contamination there was also leading to the spread of the virus. Officials challenged her results and asked her to change the data for a report that would be sent to the provincial Department of Health. Again, she refused.

Her findings lead to the shutdown of her clinic and the establishment of HIV testing for donors. Still, roughly 1 million farmers were infected with HIV from selling their blood plasma at Chinese collection sites during the epidemic, according to The Washington Post.

In September, a few days before Wangs death, a play about her life, The King of Hells Palace, opened at Hampstead Theatre in London.

COURTESY OF RUTGERS UNIVERSITY

The developer of a widely used DNA analysis technique called shotgun sequencing, Joachim Messing, died in September. He was 73.

Jos approach to the development of his DNA sequencing tools was to spread them freely and widelythat is, he did not patent them, Robert Goodman, the executive dean of agriculture and natural resources at Rutgers University, where Messing was a faculty member, told The New York Times. He was an incredibly generous man.

His development of the DNA analysis technique and his use of it made Messing the most-cited scientist of the 1980s, according to the Institute for Scientific Information. He went on to study crop modifications, such as boosting amino acids in corn to make it more nutritious and increasing crops drought resistance.

TUFTS UNIVERSITY SCHOOL OF MEDICINE

Tufts University researcher Stuart Levy died in September at the age of 80.

Levy studied antibiotic resistance and in the 1970s showed that bacteria resistant to the drugs could move from the intestine of farm animals to farm workers, a discovery that had implications for bacterial spread in facilities such as hospitals. After Levy published his findings, other researchers started to study antibiotic resistance in hospitals.

It is hard to overstate his importance in limiting the spread of antibiotic resistance, particularly in hospital settings, Ralph Isberg, a professor of molecular biology & microbiology at Tufts, and his colleague John Leong wrote in a statement sent to The Scientist.

Neuroscientist Rahul Desikan, who developed an MRI-based map of the human cortex and identified genetic risk factors for neurogenerative diseases, died in July from amyotrophic lateral sclerosis. He was 41.

The MRI-based map, which quickly became one of the most widely-used tools in the neuroscience community, has been cited more than 4500 times, Christopher Hess, a colleague of Desikan at University of California, San Francisco, wrote in a memorial. Color figures of the atlas in its various forms still fill the pages of our leading scientific journals.

Desikan and his colleagues had just started, in 2016, what was then the largest study on the genetics of amyotrophic lateral sclerosis (ALS) when he began to experience his first symptoms the disease. He was diagnosed with ALS a few months later.

I went into medicine to take care of patients with brain diseases. Now, I have one of the diseases that I study, Desikan said in a press release earlier this year. Even with the disease, he said, he continued to find neurology fascinating and beautiful.

Ashley Yeager is an associate editor atThe Scientist. Email her at ayeager@the-scientist.com. Follow her on Twitter @AshleyJYeager.

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Those We Lost in 2019 - The Scientist

Amyotrophic lateral sclerosis (ALS), sometimes called Lou Gehrigs disease, is a neurodegenerative disease affecting nerve cells in the brain and spinal cord. Researchers at the University of California San Diego School of Medicine published research describing a new way to deliver a gene-silencing vector to mice with ALS. The therapy resulted in long-term suppression of the disease if the treatment was given before the disease started. It also blocked disease progression in the mice if symptoms already appeared.

The study was published in the journal Nature Medicine.

At present, this therapeutic approach provides the most potent therapy ever demonstrated in mouse models of mutated SOD1 gene-linked ALS, said senior author Martin Marsala, professor in the Department of Anesthesiology at UC San Diego School of Medicine. In addition, effective spinal cord delivery of AAV9 vector in adult animals suggests that the use of this new delivery method will likely be effective in treatment of other hereditary forms of ALS or other spinal neurodegenerative disorders that require spinal parenchymal delivery of therapeutic gene(s) or mutated-gene silencing machinery, such as in C9orf72 gene mutation-linked ALS or in some forms of lysosomal storage disease.

ALS appears in two forms, sporadic and familial. The most common form is sporadic, responsible for 90 to 95% of all cases. Familial ALS makes up 5 to 10% of all cases in the U.S., and as the name suggests, is inherited. Studies have shown that a least 200 mutations of the SOD1 gene are linked to ALS.

In healthy individuals, the SOD1 gene provides instructions for an enzyme called superoxide dismutase. This enzyme is used to break down superoxide radicals, which are toxic oxygen molecules that are a byproduct of normal cellular processes. It is believed that the mutations in the gene cause ineffective removal of superoxide radicals or potentially cause other toxicities resulting in motor neuron cell death.

The new research involves injecting shRNA, an artificial RNA molecule that can turn off, or silence, a targeted gene. This delivers shRNA to cells by way of a harmless adeno-associated virus (AAV). In the research, they injected the viruses carrying shRNA into two locations in the spinal cord of adult mice expressing an ALS-causing mutation of the SOD1 gene. They were performed just before disease onset or after the laboratory animals started showing symptoms.

The researchers have tested the approach in adult pigs, whose have spinal cord dimensions closer to those in humans. They found that by using an injector developed for adult humans, the procedure could be performed without surgical complications and in a reliable fashion.

The next step will be more safety studies with a large animal model.

While no detectable side effects related to treatment were seen in mice more than one year after treatment, the definition of safety in large animal specimens more similar to humans is a critical step in advancing this treatment approach toward clinical testing, Marsala said.

About 5,000 people are diagnosed with ALS in the U.S. each year, with about 30,000 people living with the disease. There are symptomatic treatments, but no cure. Most patients die from the disease two to five years after diagnosis.

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Experimental Gene Therapy Shows Promise for Preventing and Treating Lou Gehrig's Disease in Mice - BioSpace

Home News Drugs in the Pipeline

BioMarin has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for valoctocogene roxaparvovec (BMN 270) for the treatment of hemophilia A in adults. This is the first marketing application submission for a gene therapy product for any type of hemophilia.

Valoctocogene roxaparvovec is an investigational adeno-associated virus (AAV) gene therapy that is administered as a single infusion to produce clotting factor VIII. The BLA submission is supported by interim analysis of a phase 3 study and 3-year phase 1/2 data. Results from the ongoing phase 1/2 study showed that bleed rate control and reduction in factor VIII usage was maintained for a third year following a single administration of valoctocogene roxaparvovec.

The FDA previously granted Breakthrough Therapy and Orphan Drug designations to valoctocogene roxaparvovec. The Company anticipates the BLA review to commence in February 2020.

We look forward to working with the FDA as we seek marketing authorization for the potential first gene therapy for hemophilia A, said Hank Fuchs, MD, President, Global Research and Development at BioMarin. Our hope is one day very soon to deliver a transformative treatment that has the potential to change the way hemophilia A is treated.

For more information visit biomarin.com.

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BLA Submitted for Gene Therapy to Treat Hemophilia A - Monthly Prescribing Reference

Maximum Life Foundation ("MaxLife"), is rapidly transforming the way we treat aging diseases. MaxLife plans to use a promising gene therapy offered by Integrated Health Systems to give free access to ten (10) early to mid-stage Alzheimer's Disease (AD) patients. David Kekich, MaxLife's CEO, stated "MaxLife will grant 100% of the therapy costs to help bring pioneering gene therapy to cure this disease and make Alzheimer's Disease a thing of the past."

NEWPORT BEACH, Calif. (PRWEB) December 30, 2019

Cure Now Instead of Palliative Care

According to the Alzheimer's Association:

Alzheimer's costs Americans $277 billion a year and rising. Sharp increases in Alzheimer's disease cases, deaths and costs are stressing the U.S. healthcare system and caregivers. About 5.7 million Americans have Alzheimer's disease. To date, no one has survived it.

Improvements of AD symptoms and the recovery of normal brain functions have been demonstrated in-vivo in mouse experiments, and in-vitro in human cell experiments through the rejuvenation of microglia (the brain's first line of defense against infection) and neurons as well as stimulating mitochondrial function using the telomerase reverse transcriptase (TERT) protein.

One human patient received a lower dose therapy in August 2018 with no adverse side effects. To date, the patient's disease has not progressed. MaxLife hopes to see symptom reversals in the next patients.

"If we can prove a benefit to patients that have no other option now, we can potentially treat Alzheimer's Disease in people in early to mid-stage Alzheimer's, finally creating effective medicine at the cellular level," states Kekich. "If successful, this treatment could potentially be used on other diseases such as Parkinson's and ALS."

The unique difference is developing treatments against the cellular degeneration caused by aging as the root cause of most major diseases. Studies have proven aging is the leading risk factor for many life-threatening diseases, including Alzheimer's.

With a world class Scientific Advisory Board, MaxLife is ready to push forward into practical solutions. A gene therapy facilitator, Integrated Health Systems plans to treat other adult aging-related diseases with no previous cure such as Sarcopenia, Atherosclerosis, Chronic Kidney Disease (CKD) and even aging itself with gene therapies.

"This technology could halt many of the big age associated killers in industrialized countries'" states Kekich. "Compassionate care helps patients with no other option to get access to experimental therapies that may benefit both themselves and society as a whole."

MaxLife also seeks grants and donations for human gene therapy studies for atherosclerosis, sarcopenia and chronic kidney disease as well as for human aging. The protocols have already been developed. Please Click Here and scroll to the bottom of the page to see how to donate.

To apply for a free therapy or for more information, see http://www.maxlife.org/alzheimers-disease/ and https://maxlife.org/how-to-register-and-qualify-for-the-alzheimers-human-study/.

For Further Information, Contact: David Kekich, CEO Maximum Life Foundation.

Maximum Life Foundation is a 501(c)(3) Not-For-Profit corporation founded in 1999.

Tax I.D. #31-1656405. David A. Kekich Tel. #949-706-2468. Info@MaxLife.org

For the original version on PRWeb visit: https://www.prweb.com/releases/first_alzheimers_disease_gene_therapy_human_study_provided_by_maximum_life_foundation_offers_10_free_therapies_for_qualifying_patients/prweb16809113.htm

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First Alzheimer's Disease Gene Therapy Human Study Provided by Maximum Life Foundation, Offers 10 Free Therapies for Qualifying Patients - Benzinga

In the summer, a mother in Nashville with a seemingly incurable genetic disorder finally found an end to her suffering -- by editing her genome. Victoria Gray's recovery from sickle cell disease, which had caused her painful seizures, came in a year of breakthroughs in one of the hottest areas of medical research -- gene therapy. "I have hoped for a cure since I was about 11," the 34-year-old told AFP in an email.

"Since I received the new cells, I have been able to enjoy more time with my family without worrying about pain or an out-of-the-blue emergency." Over several weeks, Gray's blood was drawn so doctors could get to the cause of her illness -- stem cells from her bone marrow that were making deformed red blood cells. The stem cells were sent to a Scottish laboratory, where their DNA was modified using Crispr/Cas9 -- pronounced "Crisper" -- a new tool informally known as molecular "scissors." The genetically edited cells were transfused back into Gray's veins and bone marrow. A month later, she was producing normal blood cells.

Medics warn that caution is necessary but, theoretically, she has been cured. "This is one patient. This is early results. We need to see how it works out in other patients," said her doctor, Haydar Frangoul, at the Sarah Cannon Research Institute in Nashville. "But these results are really exciting." In Germany, a 19-year-old woman was treated with a similar method for a different blood disease, beta thalassemia. She had previously needed 16 blood transfusions per year.

Nine months later, she is completely free of that burden. For decades, the DNA of living organisms such as corn and salmon has been modified. But Crispr, invented in 2012, made gene editing more widely accessible. It is much simpler than preceding technology, cheaper and easy to use in small labs. The technique has given new impetus to the perennial debate over the wisdom of humanity manipulating life itself. "It's all developing very quickly," said French geneticist Emmanuelle Charpentier, one of Crispr's inventors and the cofounder of Crispr Therapeutics, the biotech company conducting the clinical trials involving Gray and the German patient.

Cures

Crispr is the latest breakthrough in a year of great strides in gene therapy, a medical adventure started three decades ago, when the first TV telethons were raising money for children with muscular dystrophy. Scientists practising the technique insert a normal gene into cells containing a defective gene. It does the work the original could not -- such as making normal red blood cells, in Victoria's case, or making tumor-killing super white blood cells for a cancer patient. Crispr goes even further: instead of adding a gene, the tool edits the genome itself.

After decades of research and clinical trials on a genetic fix to genetic disorders, 2019 saw a historic milestone: approval to bring to market the first gene therapies for a neuromuscular disease in the US and a blood disease in the European Union. They join several other gene therapies -- bringing the total to eight -- approved in recent years to treat certain cancers and an inherited blindness. Serge Braun, the scientific director of the French Muscular Dystrophy Association, sees 2019 as a turning point that will lead to a medical revolution. "Twenty-five, 30 years, that's the time it had to take," he told AFP from Paris.

"It took a generation for gene therapy to become a reality. Now, it's only going to go faster." Just outside Washington, at the National Institutes of Health (NIH), researchers are also celebrating a "breakthrough period." "We have hit an inflection point," said Carrie Wolinetz, NIH's associate director for science policy.These therapies are exorbitantly expensive, however, costing up to $2 million -- meaning patients face grueling negotiations with their insurance companies. They also involve a complex regimen of procedures that are only available in wealthy countries.

Gray spent months in hospital getting blood drawn, undergoing chemotherapy, having edited stem cells reintroduced via transfusion -- and fighting a general infection. "You cannot do this in a community hospital close to home," said her doctor. However, the number of approved gene therapies will increase to about 40 by 2022, according to MIT researchers. They will mostly target cancers and diseases that affect muscles, the eyes and the nervous system.

Bioterrorism

Another problem with Crispr is that its relative simplicity has triggered the imaginations of rogue practitioners who don't necessarily share the medical ethics of Western medicine. Last year in China, scientist He Jiankui triggered an international scandal -- and his excommunication from the scientific community -- when he used Crispr to create what he called the first gene-edited humans. The biophysicist said he had altered the DNA of human embryos that became twin girls Lulu and Nana.

His goal was to create a mutation that would prevent the girls from contracting HIV, even though there was no specific reason to put them through the process. "That technology is not safe," said Kiran Musunuru, a genetics professor at the University of Pennsylvania, explaining that the Crispr "scissors" often cut next to the targeted gene, causing unexpected mutations. "It's very easy to do if you don't care about the consequences," Musunuru added. Despite the ethical pitfalls, restraint seems mainly to have prevailed so far.

The community is keeping a close eye on Russia, where biologist Denis Rebrikov has said he wants to use Crispr to help deaf parents have children without the disability. There is also the temptation to genetically edit entire animal species -- malaria-causing mosquitoes in Burkina Faso or mice hosting ticks that carry Lyme disease in the US. The researchers in charge of those projects are advancing carefully, however, fully aware of the unpredictability of chain reactions on the ecosystem.

Charpentier doesn't believe in the more dystopian scenarios predicted for gene therapy, including American "biohackers" injecting themselves with Crispr technology bought online. "Not everyone is a biologist or scientist," she said. And the possibility of military hijacking to create soldier-killing viruses or bacteria that would ravage enemies' crops? Charpentier thinks that technology generally tends to be used for the better. "I'm a bacteriologist -- we've been talking about bioterrorism for years," she said. "Nothing has ever happened."

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Year in Review: Gene Therapy Technology and a Milestone 2019 for Medical Research - News18

Patients with multiple myeloma have a lot to look forward to in the treatment space thanks to precision medicine, but one treatment option alone will not cure the disease.

At the 2019 CURE Educated PatientSummit on Myeloma in Charlotte, North Carolina, Rodriguez, director of the myeloma and plasma cell disorder program at Wake Forest University, had the chance to speak to numerous patients with multiple myeloma on the current treatment landscape of the disease and precision medicines role in it.

This year, Rodriguez also participated in the Multiple Myeloma Research Foundations Moving Mountains for Multiple Myeloma program when he took a 10-day journey through the South American region of Patagonia with other multiple myeloma survivors and specialists. This journey allowed Rodriguez to have intimate contact with patients who have multiple myeloma and talk with them about the future of treatment for the disease.

In an interview with CURE, Rodriguez explained the role of precision medicine in the treatment of patients with multiple myeloma and how he addresses common questions about it from patients.

CURE: How has precision medicine changed the landscape of treatment for patients with multiple myeloma?

Rodriguez: Precision medicine has changed the way we treat myeloma in many ways, and that not only means that we are finding new therapy that can target specific areas of the cancer cells, (allowing us) to have more effective therapy with less side effects, but it also means that we can actually tailor therapy to an individual patient.

It's not just that we're developing new drugs that are homing in on the cancer cells, but it also is that we're taking some time to individualize the care based on each patient's needs, each patient's requirements, and the cancer that each patient has. We do know that multiple myeloma is not a one-stop, everybody-has-the-same-type disease; everybody has different variants, and within a person, there's different subgroups of myeloma cells that needs to be targeted in a different way.

What are some of the questions about precision medicine that patients might have for you, and how do you address them?

One of the questions that normally arises whenever precision medicine, or personalized medicine, or targeted therapy all of these words are used interchangeably in clinic (comes up) is: Will a new treatment that targets a specific mutation cure my disease, if I have that mutation? And that's a very valid question, because you would think that if we've designed a therapy that can target a particular mutation that your cancer has, that we would eradicate the cancer.

Yet, the reality is, I don't think that targeting one particular mutation is going to be the solution to our problems. Myeloma is composed of many subgroups of myeloma cells within one patient.

So, combining precision medicine with a therapy that we already have and targeted immunotherapy that might give us a broader aspect of how we can target the cancer and have better control of it. Hopefully, by combining different targeted therapies with standard therapy, we might be able to eradicate the cancer. But the precision medicine or a single agent on its own is probably not going to be the solution for it.

What are some of the unique challenges from the use of precision medicine to treat patients with multiple myeloma?

One of the challenges of precision medicine in myeloma in particular is that myeloma tends to evolve as time goes by, and it's developing new mutations. And these new mutations can cause resistance to therapy. Even if we're using precision medicine that can target a particular mutation, if that cancer cell continues to evolve and mutate, maybe that particular mutation, or that target, might change as well, and then the therapy stops working.

That's a big challenge that we still have with precision medicine, that we need to figure out how we can factor that in whenever we're treating patients. So, resistance to therapy, despite (the use) of precision medicine, is something that we can potentially see.

What is the difference between DNA and RNA testing for patients with multiple myeloma?

The difference between DNA and RNA when it comes to cancer is a little bit different. We're using genes now to understand how cancer behaves. That's given us a lot of information about how we can potentially treat myeloma and how it normally behaves. A lot of doctors might say, Oh, I'm checking your DNA, or I'm checking your RNA to see what information we can get from it.

The main difference is, DNA is all the genes that we have in our body, and all the genes that are going to be in a cell and particular in a cancer cell. RNA are the genes that are actually used and expressed in those cancer cells. So not all the DNA is used. It's just the RNA portion that's going to be telling us what sections of the DNA are actually active and which ones are not.

Can you discuss some of the highlights from your keynote lecture at the 2019 CURE Educated Patient Summit on Multiple Myeloma?

The focus of the talk was on a few factors. One is that we've realized that treating myeloma patients it's not the same if I treat somebody here or if I treat somebody in a different state or in a different country. Humans are not all the same. We all are very unique. We all have very different characteristics and features, medical problems, social issues, environmental differences and walks of life. We cannot use one same treatment for all of us, because it's not going to be effective for all of us.

So, tailoring it for our different characteristics is one part of precision medicine. And then the other factor in my talk was the cancer itself. Myeloma is not just one cell type, where all the people who have myeloma are going to have the same characteristics. It's very variable, and within patients, there's variability, and there are different clones of myeloma cells in that same patient, and then each patient is very different in terms of how their myeloma is.

We've learned so much about cancer, and myeloma in particular, that we've now been able to identify different subgroups of myeloma cells within a patient, or between patients, that we can target and be more specific in how we treat. So, the goal of the talk was to let everybody see that whenever we are treating myeloma, we have to individualize the care to that particular patient.

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Precision Medicine Paves the Way for Exciting Treatment Combinations for Patients with Multiple Myeloma - Curetoday.com

As 2019 comes to a close, this is the perfect time to consider what lies ahead in the new year. As a physician working in digital health, my sense is that the pace of change in medicine is accelerating in ways that we havent seen before.

Here are my picks for the top healthcare trends to watch in 2020:

1. Tech giants will build more tools to support doctors.Apple, Amazon and other tech giants have been increasing their focus on consumer healthcare products for several years now, from the Apple Watch to Alexas voice-enabled prescription refills. In 2020, expect to see these companies increase their attention on the physician community.

Top health industry issues of 2020: Will digital start to show an ROI?

Each year, PwC's Health Research Institute (HRI) names the top issues for the health industry in the coming year. What made the list for 2020? Join HRI for a discussion of the most important trends for providers, insurers, pharma/life sciences and employers.

Google is determined to fix the mediocre choices among existing electronic health records (EHRs) with its own integrated charting system. They plan to leverage their dominance in Search to make it easier for doctors to find data across multiple systems with a single login. In addition, their smart compose technology will help clinicians enter information accurately, with typos becoming a thing of the past. Users will also be able to search scanned documents, such as faxes, handwritten and typed notes.

The optimist in me hopes that all EHR companieswill see Googles entry as a nudge to be more physician- and patient-friendly, enabling doctors to spend less time staring at computer screens and more time making eye contact with patients.

2. Personalized medicine will become even more precise.The past decade showed us that a one-size-fits-all approach to medicine is under attack. While customized medical therapies are not yet available on a wide-scale, we are on the path to making substantial life-saving strides soon. The capability to leverage a person's distinct genetic make-up to provide them with tailored therapies will continue to be refined in 2020 and beyond. This should give physicians more treatment options and possibly help patients diagnosed with serious conditions to live longer, fuller lives.

3. Telemedicine will continue its growth streak.Research reveals that patient demand for telehealth is growing fast. According to a study published inJAMA, telemedicine visits grew 261% between 2015 and 2017.And physicians are enthusiastically supporting this trend.

At Doximity, we saw the number of doctors that self-reported practicing telemedicinedouble in just three years between 2015 and 2018.At the same time, the government is recognizing the benefits of telemedicine.AnExecutive Ordersigned this year outlined Medicare reform intended to help speed telemedicine adoption.Additionally, theU.S. Department of Veterans Affairswill focus efforts on telemedicine to benefit veterans in need of care.

Technological advancements, an aging population, and personalized medicine will all have an impact on the future of healthcare. The next decade will certainly introduce the healthcare industry to new challengesand from those challenges solutions for providers and patients will emerge.

Peter Alperin, M.D., is vice president at Doximity, an online networking service for medical professionals.

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Industry VoicesA doctor's perspective on the top 3 healthcare trends to watch in 2020 - FierceHealthcare

A breast cancer drug that can provide a last resort option to patients who have run out of treatments has been granted accelerated approval from the Food and Drug Administration, a move that could provide a new standard of care for hundreds of thousands of women with the disease.

The drug, called Enhertu, was recently granted approval for patients who have received two or more prior treatments for inoperable or metastatic HER2-positive breast cancer, a type of cancer that learns to resist the drugs designed to attack it.

The drug is given intravenously and will be available by prescription in the United States in the coming weeks. The drug can offer less severe side effects than chemotherapy for some patients.

Its always really hard to know the options are getting thinner. Theres a lot we can do for HER2-positive breast cancer, though we do reach a time where there is little else we have to offer and I think having a drug like this provides a lot of hope, said Dr. Eric Winer, director of the breast cancer program at Dana-Farber Cancer Institute.

Cheryl Osimo, executive director of the Massachusetts Breast Cancer Coalition, was diagnosed with stage two HER2-positive breast cancer in 1991 and was given a poor prognosis.

It was a life-changing experience for me in more ways than one, Osimo said. Her cancer did not resist treatment, and six months of chemotherapy along with six weeks of radiation proved successful in beating the deadly disease.

Im one of the lucky ones, there are many women who are not so lucky, so those who have to move on to try other treatments, to learn there are options where there are less painful side effects is good news, said Osimo.

About one in five breast cancers are HER2-positive. The drug works by attaching chemotherapy to antibodies that offer a targeted attack on the cancer cells.

Dr. Michael Misialek, associate chair of pathology at Newton-Wellesley Hospital, said Enhertu offers a new standard of care for patients running out of alternatives.

It gives patients another option, it gives oncologists another arrow in their tool kit to fight the cancer and the big picture here is that treatment of breast cancer is following the pathway more and more of personalized medicine, said Misialek, who is also the medical adviser to the Massachusetts Breast Cancer Coalition.

Winer also noted a shift in cancer care with the approval of groundbreaking drugs like Enhertu, saying, I can imagine a time when we wont be giving standard chemotherapy.

Winer said new treatments are giving patients hope, This is an example of the fact that if they just hang in there and manage to do well for however long they can with the drug they have, there may be something else coming around the corner.

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FDA approval of new breast cancer drug offers hope to patients with few options - Boston Herald

AGOURA HILLS, Calif., Dec. 27, 2019 (GLOBE NEWSWIRE) -- Mateon Therapeutics, Inc. (OTCQB:MATN) today announced the publication of a peer-reviewed research article co-authored by Fatih Uckun MD. PhD, the Chief Medical Officer for Mateon, Vuong Trieu, PhD, the Chief Executive Officer and President for Mateon and four hematology/oncology professors from academic US institutions in the prestigious oncology journal Cancers (Basel).

The article describes in detail the data obtained in the recently completed multi-institutional OXI1222 study that was aimed to evaluate the clinical potential of Mateons lead anti-leukemia drug Combretastatin A1 (also known as OXi4503) in adult patients with previously treated relapsed acute myeloid leukemia (AML). This clinical study was registered at http://www.clinicaltrials.gov as NCT02576301. Patients were treated by participating leukemia experts affiliated with the University of Florida, University of Kansas Cancer Center, David Geffen School of Medicine at UCLA, and University of Miami Sylvester Comprehensive Cancer Center, Miami who co-authored the published article. The primary purpose of this Phase 1B study was to define the maximum tolerated dose and safety profile of OXi4503 and cytarabine administered in combination (OXA) in patients with relapsed/refractory AML. The study was completed in August 2019 and met its primary endpoint. The study showed that adding OXi4503 to the standard chemotherapy drug cytarabine was generally well tolerated by AML patients and a maximum tolerated dose level of OXi4503 was identified as the recommended dose for further clinical development of this novel two-drug combination. In 26 evaluable AML patients, there were 4 complete remissions (CR/CRi) and one partial remission (PR). The CR responses were associated with >1-year overall survival times. The combination therapy exhibited a manageable toxicity and a promising benefit to risk profile in older adults with relapsed AML who are in urgent need for effective new therapies. The safety, feasibility, and early clinical activity of this new treatment in relapsed/refractory AML deserves further clinical validation in a randomized registration study.

This work emphasizes our commitment to find effective new therapies for difficult-to-treat cancers,stated Dr. Vuong Trieu, Chairman and Chief Executive Officer of Mateon Therapeutics.

OXi4503 has received orphan drug designation for AML in both the US and the European Union. Further, the US FDA has granted fast-track designation to OXi4503 for the treatment of relapsed/refractory AML.

AML is the most common form of adult acute leukemia with >20,000 estimated new cases and >10,000 deaths in the United States (US) for 2019. Despite recent advances in therapy, the five-year overall survival remains < 30% and prognosis is grim in patients who experience a recurrence of their disease after first-line induction therapy, with <10% surviving five years after relapse.The greatest challenge in AML is relapsed or refractory disease. For relapsed or refractory AML, there is no consensus on a single re-induction regimen.By combining OXi4503 with the standard chemotherapy drug cytarabine, we hope to develop an innovative approach that improves outcomes for patients with relapsed AML, especially those who are older and have a dismal prognosis, explained Fatih Uckun, MD, PhD, Chief Medical Officer of Mateon Therapeutics.

The research article "A Phase 1B Clinical Study of Combretastatin A1 Diphosphate (OXi4503) and Cytarabine (ARA-C) in Combination(OXA) for Patients with Relapsed or Refractory Acute Myeloid Leukemia" hasbeen published in Cancers (Basel) as part of the Special Issue Personalized Medicine:Recent Progress in Cancer Therapy and is available online:

Abstract:https://www.mdpi.com/2072-6694/12/1/74PDF Version:https://www.mdpi.com/2072-6694/12/1/74/pdfSpecial Issue:https://www.mdpi.com/journal/cancers/special_issues/PM_Cancers

About Mateon TherapeuticsMateon was created by the recent reverse merger with Oncotelic which became a wholly owned subsidiary of Mateon Therapeutics Inc. (OTCQB:MATN) creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics as well as small molecule drugs against cancer. The founding team members of Oncotelic were responsible for the development of Celgenes Abraxane as a chemotherapeutic agent for breast, lung, melanoma, and pancreatic cancer. Abraxane was approved in 2005 and has more than $1B in sales annually. The same team was also responsible for the development of Cynviloq, a next generation Abraxane, which was acquired by NantPharma for $1.3B. Mateon/Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on pediatric cancer patients. For more information, please visit http://www.oncotelic.com and http://www.mateon.com.

The Chief Executive Officer of Mateon, Dr. Vuong Trieu, PhD is a very experienced biotech executive and a KOL in the field of immunotherapy. He is best known for his seminal contributions to the development of Abraxane (https://www.linkedin.com/in/vuong-trieu-3a64aa3b).

The Chief Medical Officer of Mateon, Dr. Fatih Uckun MD, PhD, is an internationally renowned KOL in cancer research and treatment (https://www.linkedin.com/in/fatihuckun). Dr. Uckun is an elected Member of the American Society for Clinical Investigation (ASCI), an honor society for physician-scientists, and an active member of several professional organizations. He received numerous national and international awards for his work on biologics and small molecule targeted therapeutics for difficult-to-treat cancers. He is a former recipient of the Stohlman Memorial Award from the Leukemia & Lymphoma Society, the highest honor given to a Clinical Leukemia Scholar.

Mateon's Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as may, expect, anticipate hope, vision, optimism, design, exciting, innovative, promising, will, conviction, "estimate," "intend," "believe", quest for a cure of cancer, innovation-driven, paradigm-shift, high scientific merit, impact potential and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the companys product candidates and the potential use of the companys product candidates to treat various cancer indications. Each of these forward-looking statements involves risks and uncertainties and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the companys annual report on Form 10-K filed with the SEC on April 10, 2019 and in the companys other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information future events, or otherwise.

Contact Information:For Mateon Therapeutics, Inc.:Amit ShahEmail: ashah@oncotelic.com

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Mateon Therapeutics Team Publishes a New Peer-Reviewed Oncology Article on the Positive Clinical Study Results for Its Lead Anti-Leukemia Drug...

As we close out this decade, our biggest medtech stories of the past year have all looked toward whats coming nextwhether its new treatments or renewed companies, the common thread running through our most popular reads is that people are eager to see these advancements realize their promise.

Our top 10plus some honorable mentionsinclude research and breakthroughs in diabetes, Alzheimers disease, cancer testing and vision care, with some products tantalizingly close to that FDA green light and getting into the hands of doctors and patients.

It also covers large devicemakers and big pharmas aiming to remake themselves by embracing new technology or potentially new acquisitions.

How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDC

CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management.

Up first is our report on a closed-loop artificial pancreas system being developed by Tandem Diabetes Care and Dexcom that promises to automatically deliver insulin based on continuous glucose data and eliminate the need for frequent fingerstick draws or daily injections for people who have Type 1 diabetes.

A six-month trial supported by the National Institutes of Health followed participants as young as 14 as they used the system over their daily lives and found it helped keep blood sugar in a healthy range for longer. More importantly, users saw fewer spikes and drops over a 24-hour periodimportant news for children and adults who would prefer to sleep than manage their diabetes. The Control-IQ system recently picked up its FDA approval.

In an interesting twist, another of our most read stories also featured an artificial pancreas system, though it first debuted in 2016. Making its viral return this year was our piece on the FDAs approval of Medtronics MiniMed 670G, designed to regulate insulin with little personal input.

Our second story of 2019 comes from the annual meeting of the American Society of Clinical Oncology, where blood testing upstart Grail delivered early study results for its cancer-seeking diagnostic. Its liquid biopsy was able to identify 12 early-stage cancers and their locations in the body by searching for small, tainted pieces of tumor DNA floating in the bloodstream.

In third place is Novartis new, expansive partnership with Microsoft, which aims to put artificial intelligence tools in the hands of each of the big pharmas research associates. The five-year project includes plans for joint AI labs and clinical research supportand is paired with our tenth most popular story of the year, on the drugmakers separate team-up with Amazon to help revamp its supply chain and personalized medicine manufacturing.

Next, we have startup Sigrid Therapeutics, developer of an edible medical device to help ward off the progression of Type 2 diabetes. Technically a therapeutic material, Sigrid has been working on a superfine silica powder that mechanically separates stomach enzymes from food to slow down digestive processes.

In fifth is Strykers $4 billion acquisition of Wright Medical, which looks to give the company a stronger foothold in fast-growing orthopedic markets focused on the upper and lower extremitiesincluding joint replacements, bone grafts and fixation systems for shoulders, elbows, wrists, ankles and toes.

Elsewhere, Apple, Eli Lilly and Evidation presented their first results from a collaboration that hopes to develop digital warning signs for Alzheimer's by sifting through the data and patterns created in our day-to-day lives. Their work, on trying to spot the nearly imperceptible symptoms and changes that could belie cognitive decline, was featured in our list of the top lighthouse projects in AI and biopharma to keep an eye on in the future.

In seventh and eighth place we have two pieces exploring the latest in contact lens technology. A new silicone hydrogel material from Alcon contains 51% water and holds a permanent layer of moisture on the surface of the daily disposable. A second lens, developed by CooperVision, is designed to help slow the progression of nearsightedness in children by splitting off incoming light and reducing a potential driver of myopia.

Number nine delves into the future of the $8 billion diagnostics maker Qiagen as it considers being acquired by one of several potential suitors. That includes fellow diagnostics maker Thermo Fisher Scientific, which has begun early talks, according to reports. The news comes just a month after Qiagen announced its long-time CEO plans to step down amid a reorganization of the company around a 15-year partnership with Illumina.

Finally, we have our annual class of the FierceMedTech Fierce 15, the private companies we think will best move the needle when it comes to patient outcomes and technological advancement in the field.

And on a broader note, wed like to thank you all for helping to make 2019 FierceMedTechs best year yetreadership has grown by leaps and bounds over the past 12 months, and by at least 1 million views over 2018s total. But that wouldnt be possible if we didnt cover a dynamic industry with a surplus of interesting stories to tell.

Though were taking a short publication break for the holidays, we, like you, are still looking forward to 2020 and the decade ahead. Check in for any breaking news, and feel free to share your tips, thoughts and stories with us. We will return Jan. 2. Conor Hale

Read your top 10 stories here:

1) Closed-loop artificial pancreas from Tandem, Dexcom aces Type 1 diabetes study

2) ASCO: In early study results, Grail's blood test identifies 12 cancers before they spread

3) Novartis to put AI on every employee's desk through Microsoft partnership

4) Sigrid Therapeutics aims to ward off Type 2 diabetes with an edible, powdered medical device

5) Stryker to buy orthopedic device maker Wright Medical for $4B

6) Apple, Eli Lilly and Evidation present first results from digital Alzheimer's study

7) Alcon to launch new water-containing silicone hydrogel contact lenses in the U.S.

8) FDA approves first contact lens to slow childhood nearsightedness

9) Thermo Fisher looks to buy fellow diagnostics maker Qiagen: Bloomberg

10) Novartis' digital transformation continues apace with Amazon supply chain tie-up

Link:
FierceMedTech's top 10 stories of 2019: Looking toward a new decade on the cutting edge - FierceBiotech

All too often, software patents stop more innovation than they promote. Patents are legal instruments that can be used to sue people and companies for creating, selling, or using software. Very often, the entities wielding software patents are patent trollscompanies that make money off suing and threatening to sue others instead of building or doing anything of their own.

Weve been advocating against problematic patents, particularly in software, for many years. In the past few years, its fair to say that patent trolls have been downbut not out. Two big changes that happened several years ago have made it realistic, finally, to get bad patents kicked out of the system. The first is the creation of the inter partes review system, in 2012; and next, the Supreme Courts Alice v. CLS Bank decision, in 2014.

Unfortunately, 2019 has shown us that we need to keep working to protect the patent system. Congress and the U.S. Patent Office have been working remarkably hard to roll back these positive changes, and make life easier for patent trolls. At the same time, the Federal Circuit has been eroding the effect of Alice in decisions like last years in HP v. Berkheimer and this years Garmin v. Cellspin.

At the beginning of the year, USPTO Director Andre Iancu promulgated new guidance for patent examiners that essentially allows them to blow off the clear guidelines of the Alice decision. What that meant, in practice, is that examiners are being told to issue more of the worst type of software patentsones that simply take abstract ideas, and make them sound like an invention by adding generic computer language. That means more patents coming out that will be fodder for patent trolls.

At EFF, we encouraged people to let the Patent Office know that the new guidelines were a bad idea. While we werent able to stop the new guidelines from taking effect, our supporters sent more than 1,500 comments to the Patent Officesending a strong message that everyday users of technology are finally watching a government office that, all too often, is left in a state of total industry capture.

In the U.S. Senate, leaders of a newly reconstituted IP Subcommittee have pushed forward two ideas that threaten to bring back the bad old days of peak patent trolling. The first attempt to empower patent trolls is a year-long effort to undermine Section 101 of the patent laws. Thats the section that bans patents on abstract ideas, natural phenomenon, and laws of nature. Its the area of law that the Supreme Court properly interpreted in the Alice case, and in recent years, has allowed courts to throw hundreds of junk patents out of the system.

Senators Thom Tillis (R-N.C.) and Chris Coons (D-Del.) have insisted that Section 101 has stopped good inventions from getting patents. Thats not true. Many of the parties asking Congress to alter Section 101 are flat-out patent trolling entities, who dont invent any technology themselvestheyre simply good at manipulating the patent system and threatening lawsuits. Others are large incumbent companies with massive patent portfolios, like GlaxoSmithKline, Qualcomm, and IBM. These companies simply want more monopolies on areas of emerging technology, like artificial intelligence and personalized medicine.

At EFF, we spoke out against this misguided effort, and EFF Staff Attorney Alex Moss testified in front of Congress. In the end, no bill to damage Section 101 has yet been introduced. Thats a testament to the advocacy of EFF and our many allies on this issue. But well have to stay vigilant on this front, since theres no doubt the same groups, seeking to wring more money from the patent system, will be back again in 2020. Fortunately, were able to work together with a huge range of alliesnot just tech companies that want a balanced patent system, but also health care providers, labor unions, and consumer organizations.

Another perennial bad idea that returned in 2019 was the Stronger Patents Act, which would do a great job of strengthening patent trolls but offers nothing to true innovators. The Stronger Patents Act would have essentially wrecked inter partes review, or IPR, which is one of the most effective ways of challenging patents. Were glad to report this bill went nowhere, and hope we dont see it again.

Patent trolls continue to seek unjustified payments from companies of all sorts, many of them small firms that cant afford the million-dollar legal bills that would come with a patent trial. Just one example: a patent troll called Inventergy sued a family-owned GPS tracking company, along with several other GPS firms. Inventergy backed off once we sent a letter explaining the problems with its patent, and EasyTracGPS has become one of the firms that was Saved by Alice.

Another great example is Ruth Taylor, who was sued over her website that organized online photography contests. We helped Ruth win her patent case back in 2015. This year, we published a video interview with Ruth talking about her experience, facing down a patent trolls demand for $50,000 over her hobby website.

EFF scored a big win for transparency in the patent system when we intervened in a lawsuit filed by Uniloc, one of the most litigious patent trolls of all time, in court. Uniloc has sued dozens of technology companies, but at the same time has kept much of its most important pleadings redacted. But when Uniloc sued Apple, documents emerged that seemed to indicate Uniloc may not have rights to the patent it was asserting, because it had split the rights with a murky patent investment fund. EFF intervened to demand that the redacted documents be published, so that the public can understand the nature of Unilocs far-ranging allegations.

In May, Uniloc definitively lost this attempt to hide its machinations and shell games from the public. Uniloc has chosen to appeal this case to the Federal Circuit, where well defend the publics First Amendment right of access to the courts.

Finally, 2019 saw a major win for patents and free speech. In New Hampshire, a patent troll called Automated Transactions, LLC sued more than a dozen people and a trade group claiming it was defamedsimply because these groups had described it as a patent troll. EFF filed an amicus brief arguing this term cant be defamatory. The New Hampshire Supreme Court agreed, finding that calling someone a patent troll is a statement of protected opinion, not fact.

In 2020, with our supporters help, well continue to litigate, and advocate, for a fairer and more balanced patent system. And, when we need to, well call a troll a trolland you can, too.

This article is part of our Year in Review series. Read other articles about the fight for digital rights in 2019.

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Time to Save Alice: 2019 Year in Review - EFF

The United States is the top food exporter in the world, and scientists are constantly studying ways to protect the ag sector from the field and into the storage bins that hold crops, according to the University of Arkansas System Division of Agriculture.

Mycotoxins, a family of toxins generated by fungi attacking grains, nuts and other foods and commodities, impact public health and international trade. Researchers at the UA are leading some of the worlds most cutting-edge efforts to stop the prevalent toxins.

Burt Bluhm, associate professor of plant pathology for the University of Arkansas, is primary investigator and director of the Mycotoxin and Seed Borne Disease Research Lab. After operating out of the Rosen Alternative Pest Control Center on the UA Fayetteville main campus, the lab relocated in 2018 to the newly-constructed Don Tyson Center for Agricultural Sciences, several miles north.

Bluhm said that mycotoxins, while pervasive, are still relatively unstudied, compared to other dangers faced by producers.

Mycotoxins in particular have been overlooked in some corners of the research world, Bluhm said. There are a lot of reasons for that. In some ways, especially in corn, and in the United States, its historically been perceived as a Southern problem. Mycotoxins havent been as common in the big corn-producing states through the Midwest.

Countries worldwide try to minimize an influx of foods that have these fungi. The European Union has stringent intolerances for the presence of mycotoxins in any grain shipment, especially imports, leading to the rejection of exports that would otherwise meet or exceed safety standards at the point of origin. In other areas of the world dealing with elevated food scarcity, mycotoxins are sometimes tied to severe illness.

For the E.U., its primarily a trade issue, Bluhm said. But in developing nations in Asia and Africa, mycotoxins are a more serious problem. Where food security is an issue, where people have to eat whatevers available, if the food is contaminated with mycotoxins, youll see outbreaks of extreme illness and death.

Mycotoxins are a family of toxins created when fungi feed on grain, either during the growing season, or when grain has been improperly stored. The fungi feed off the available carbohydrates, then secrete toxins into the colonized grain. In addition to corn, mycotoxins are found in other grains, tree nuts and cotton. There is a concern, Bluhm said, about possible mycotoxins in rice.

There are really two issues at play, Bluhm said. One is that a little bit of mycotoxin goes a long way, so to speak. So even if you have a low percentage of infected kernels, the mycotoxin-per-kernel can be very high. So at the level of a truckload, when that grain is eventually homogenized, even a relatively low incidence of infection can lead to serious problems.

Mycotoxins are relatively stable, and can easily survive the food making process, according to the World Health Organization. These fungi can cause liver damage, several types of cancers, kidney damage, can compromise a consumers immune system, and ingestion in some cases can lead to death, the World Health Organization reported. The fungi can be visible to the naked eye in the form of mold, but often it goes undetected.

Bluhm received his training in pathology, and mycotoxins specifically, at Purdue University in Indiana. When he arrived in Arkansas, he said, it was clear that the problem was more widespread in the states (and the regions) corn crops that he had realized.

Over the past decade, Bluhms lab has worked to map the genetic layout of the 20-30 fungi involved in creating mycotoxins around the world, searching for specific weaknesses to attack. The lab is also working to develop biological control agents to combat mycotoxins.

In some cases, if you apply a non-toxigenic strain of a species like you would a fungicide or insecticide, you overwhelm the fungus with that nontoxic cousin of whats naturally out there, Bluhm said. It can be very effective.

In October, the Division of Agriculture hosted the annual conference of the Council for Agricultural Science and Technology, commonly known as CAST. More than 70 representatives of academic, legal, governmental and other institutions attended the 2019 Annual Fall Board Meeting, touring facilities and projects chosen to highlight the universitys efforts and contributions to modern agriculture.

Dr. Mark Cochran, vice president for agriculture for the University of Arkansas System, said he selected Bluhms lab for conference attendees to tour because, in addition to the lab being fundamentally important to international food safety, it also speaks to CASTs concerns regarding the advancement of science and technology within the world of agriculture.

We tried to match our expertise with some of the issues CAST is addressing, Cochran said. CAST is organized into animal, plant and food working groups. A lot of the more complex issues are going to transcend all three of those areas.

Cochran also noted that Bluhm has been broadly recognized for his work as a molecular pathologist with particular expertise in mycotoxins of grain, Cercospora diseases of corn and soybeans, and the development of novel approaches for disease control.

His approaches have included molecular genetics, gene editing and the use of RNA interference, Cochran said. His research has been supported by several nationally competitive grants.

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