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Viewpoint: Promise of genomics and precision medicine a ‘wave of hype without substance’ – Genetic Literacy Project

March 12th, 2020 8:47 am

An undeclared civil war is breaking out in biomedicine.On one side is precision medicine, with its emphasis on tailoring treatments to ever-narrower groups of patients. On the other side is population health, which emphasizes predominantly preventive interventions that have broad applications across populations.

Which vision will provide the most durable and efficient path to improved health for all?

Disregarding the breakthrough announcements that appear on a regular basis, the question of whether precision medicine will lead to better health for all remains an open one.

We believe that genomics and precision medicine have ridden a wave of hype without substance for far too long. Unless they are able to go well beyond their thin record of empirical success and demonstrate their effectiveness in meeting the actual health needs of populations, they will be marginal players with regard to any lasting impact on the health of the public.

Fortunately, it appears that the tide is beginning to turn toward population health, especially as a more balanced perspective of the value ofpolygenic risk scores one of the most widely advocated innovations of the precision medicine movement is beginning to emerge.

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Modern genetic tools are helping to control the most critical pig diseases – The Pig Site

March 12th, 2020 8:47 am

Modern genetic technology has provided new tools to allow the use of genomic selection for disease resilience. Speaking to Farmscape, Dr John Harding, a Professor with the Western College of Veterinary Medicine, notes scientists have been looking at disease resilience or resistance for the last 20 to 30 years.

"One of the most historic examples that I can remember in my career is the identification of the halothane gene and how we've used it since the early 1990s to eliminate porcine stress syndrome from the pig industry," says Dr Harding.

"There are other examples of single mutations, including the FUT1 gene. It codes for E. coli and has been used to help control post weaning diarrhoea back 15 to 20 years ago.

"We see more recent examples which are really related more to resilience. That is the PRRS WUR SNP which codes for the GBP5 protein which has been used by some of the breeding companies to create animals that are more resilient to PRRS.

"There's a similar gene called synaptogyrin which has been used for PCV2 resilience now.

"We're not seeing that one in the industry quite yet but I'm sure it will come quickly and then we've got the whole aspect of gene editing with the Prather group editing out the CD163 gene, making pigs that are completely resistant to PRRS infection. That's very exciting.

"Whether that comes to market is another big question that the regulators and industry will have to struggle with over the next couple of years.

"More recently, what we're involved with is more general disease resilience and we have set up a project in Quebec to look at resilience to many diseases and that's through a natural challenge model system."

Dr Harding says scientists will continue their work so stay tuned.

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Ultra-Fast Genome Sequencing Could Save the Lives of Newborns – WIRED

March 12th, 2020 8:47 am

Maverick Coltrin seemed like any other newborn when he first came home from the hospital, wearing his beanie cap with bear ears and blue-and-gray onesie and following the typical around-the-clock cycle of sleeping and breastfeeding. But within a couple of days, his parents noticed something was off. At 6 days old, Maverick completely stopped feeding. His arms and legs would stiffen and then release, the spasms punctuated by his cries.

His parents rushed him to Rady Childrens Hospital in San Diego, where EEG monitors recorded that he was having as many as 30 seizures an hour. Doctors scrambled to find the cause. Anti-seizure medicines didnt work, so he was sedated to stop the damage to his brain. His organs started to fail, and his skin turned a dusky blue. His mother, Kara Coltrin, walked into his empty nursery at home and cried.

So when doctors from Radys Institute for Genomic Medicine asked for permission to sequence Mavericks genome as part of a clinical trial of ultra-rapid sequencing for newborns who are critically ill from an unknown cause, Mavericks parents didnt hesitate. The doctors cautioned that they couldnt guarantee that they would pinpoint a genetic disorder or, if they did, that it could be treated. They gave the standard caveat about genetic testingthat identifying a genetic disorder could affect Mavericks eligibility for life insurance someday. But even if the sequencing didnt help him, his participation would contribute to a study that could benefit other babies. Obviously, the pros outweighed the cons manyfold, his mother says. We just wanted his pain to stop.

Within 36 hours, the Coltrins had an answer: Maverick has pyridoxine-dependent epilepsy, caused by a rare mutation of the ALDH7A1 gene, which codes for the enzyme antiquitin. By giving him high doses of vitamin B6 and controlling a couple of amino acids in his diet, doctors stopped the seizures. Maverick, now 2 years old, runs around like a normal, rambunctious toddler. He has hit all his developmental milestones, although they have been somewhat delayed. He hasnt had a seizure since his treatment began. Every once in a while, I think back on him being dusky blue and super skinny and hooked up to all these tubes, says Kara Coltrin. I look at him and its hard to believe that happened to him. People who see him on a normal basis would never know he was ever sick.

The technology that saved Mavericks life stretched the limits of bioinformatics, returning results far sooner than is typical for genetic testing. Rapid sequencing typically takes about seven days for a preliminary diagnosis, while Rady completes ultra-rapid sequencing in three days or less. (In 2018, Rady set a Guinness World Record by sequencing a babys genome in 20 hours and 10 minutes.)

But now ultra-rapid sequencing is moving from an investigational tool to a standard of care. Blue Shield of California is the first insurer to cover rapid and ultra-rapid sequencing of babies and children who have life-threatening and unexplained medical conditions. Since the new policy began in July 2019, 28 babies or children in California have received the testing through Blue Shield, which is just beginning to promote the new coverage.

Blue Shield expects that 250 to 500 newborns will be eligible for the whole genome sequencing each year, which represents about 10 percent of their insured babies treated in neonatal intensive care units in California. Company executive vice president Terry Gilliland said he will encourage other Blue Cross and Blue Shield plans around the country to adopt a similar policy. When you think about all the pain and suffering families go through with sick babies, this is going to be an enormous benefit, he says.

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EDGC goes all out for global supply of COVID-19 test kit – Korea Biomedical Review

March 12th, 2020 8:47 am

EONE-DIAGNOMICS Genome Center (EDGC) said Thursday that its global network would go into full operation to respond to requests for supply contracts and export of its new coronavirus diagnosis test kit.

EDGC is a genetic precision medicine company manufacturing molecular diagnostics kits through its subsidiary, Solgent. The company is negotiating with many countries for the export of several million test kits of COVID-19.

The global demands for diagnostic kit exploded after the World Health Organization declared the current situation as a pandemic, the sixth and highest of an alert level on Wednesday. COVID-19 is WHOs third pandemic, following the Hong Kong flu in 1968, and the swine flu in 2009.

Solgent acquired approval for the urgent of its test kit from the Korea Centers for Disease Control and Prevention on Feb. 27 and won the nod of Conformite Europeen (CE) certification for two of its products the following day. The company is operating an emergent manufacturing system to deal with surging demand

EDGC is negotiating with various countries, including the United States, Australia, Japan, China, Hong Kong, Philippines, Singapore, Vietnam, Malaysia, Bangladesh, the United Arab Emirates, Kuwait, Turkey, Kazakhstan, Germany, the United Kingdom, and Estonia.

Among the four local companies that won urgent use approval from KCDC, Solgent is the only one that makes COVID-19 diagnosis kit with self-developed raw material.

The company said it is producing the test kits by grafting its technology and know-how to its quality management, proven by ISO 9001 and ISO 13485 international certifications as well as Korea Good Manufacturing Practice.

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Veterinary Medical and Biomedical Sciences Professor David Steffen honored with top industry award – Fence Post

March 12th, 2020 8:47 am

Growing up on a farm near the small community in of Fordyce in Northeast Nebraska, David Steffen dreamed of one day becoming a country vet.

His family raised cows, sows and broilers, and he got to know the country veterinarians who tended to the livestock of his family and his neighbors. Their days seemed interesting and varied, Steffen said. Veterinarians helped both animals and the people who cared for them. All of these things appealed to Steffen.

He attended college at the University of Nebraska-Lincoln, where he studied animal science. After graduation, he went on to Iowa State University, where he got his DVM.

For a few years, he did become a country vet. But his wife, whose expertise was in computers, had a difficult time finding a job, and Steffen began looking for a position someplace where she could put her degree to work, too. He and his wife moved to Manhattan, Kan., where he began work on a doctoral degree at Kansas State University. This put him on track for an academic career, with a stop at North Dakota State University before he returned to Nebraska.

Today, he provides leadership in diagnostic pathology and as the quality control section head of the veterinary diagnostic center. And recently, he received the highest honor in the field of veterinary diagnostics the 2019 Dr. Edward P. Pope Memorial Award, presented by the American Association of Veterinary Laboratory Diagnosticians.

The award was a huge honor and came as somewhat of a surprise to Steffen, whose favorite part of the job remains helping people.

On a recent morning in his office in the Veterinary Diagnostic Center, he looked at slides from feeder lambs that were succumbing to a mystery affliction, as well as from a Scottish terrier with a terrible looking liver. Steffen finds it rewarding to figure out a diagnosis for a livestock producer whose livelihood is affected by disease, or for a pet owner who wants to know why their pet is sick.

It is a blessing to work using scientific knowledge to help others, Steffen said in a story about the award in the Journal of Veterinary Diagnostic Investigation. Every day I am provided the opportunity to develop meaningful, productive relationships with clients and scientists as we partner to improve the economic vitality of animal agriculture, the emotional health of pet owners, and the general health of animal populations and all people.

No two days are quite alike, and Steffen enjoys that, too.

You get to see all kinds of weird, interesting stuff, he said. You get to be a detective.

One particularly interesting mystery he encountered was a fatal type of dwarfism that showed up in several different breeds of calves. Steffen was able to pinpoint a genetic cause for the disease, which ultimately allowed for development of a test for breeders. Over his career, Steffen was able to identify seven different genetic disorders all of which led to the development of tests that livestock producers can use to determine whether their animals are afflicted.

With genomics now, we can go from recognizing a disease to having a test for it within a year, he said.

Throughout his career, he has dedicated time and expertise to advance animal health and veterinary pathology at state and national levels, serving on the Nebraska Poultry Health Committee, the Nebraska State Lab Response Network, and the Johnes Disease Committee. He has been a member of the American association of Veterinary Laboratory Diagnostics since 1996, over the years serving as both vice president and president. He also served as an associate editor for the Journal of Veterinary Diagnostic Investigation. He has author or co-authored more than 60 peer-reviewed publications on topics including diagnostics, comparative medical sciences and many other issues and received numerous other awards. He also served as an undergraduate adviser for more than a decade, and has kept in contact with many of his old students.

Dave has made many significant contributions to animal health, livestock management and veterinary pathology, said Ron Yoder, associate vice chancellor for the Institute of Agriculture and Natural Resources at the University of Nebraska-Lincoln. We highly value his work here at the university, as do livestock producers across Nebraska and the country.

Steffen didnt imagine that his plan to be a country vet would have led him down the path it did. But the things that drew him into vet medicine in the first place the variety, the opportunity to meet people and to help them have remained central throughout his career. Hes more likely, though, to do so from his office than on a farm like the one where he grew up.

My happy place is here at my microscope, he said.

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The Top 3 Gene-Editing Stocks to Own in 2020 – Investorplace.com

March 12th, 2020 8:47 am

The gene-editing revolution is already here, and these stocks will help you capitalize on the movement.

Gene-editing therapies allow you to remove cells from the body, modify them and reintroduce them. With this technique, theres hope for a cure for cancer, blood disorders, blindness, AIDS, cystic fibrosis, muscular dystrophy, Huntingtons disease and a host of other diseases.

For example, gene-editing has already been used to eliminate HIV in mice.

According to the National Institute on Drug Abuse, HIV-1 could be eliminated in mice using a combination of two antiviral technologies long-acting viral reservoir-targeted antiretroviral therapy and CRISPR/Cas-9 gene editing.

Doctors are even attempting to cure blindness after hacking a patients genes.

A patient recently had the procedure done at the Casey Eye Institute at Oregon Health & Science University for an inherited form of blindness.

We literally have the potential to take people who are essentially blind and make them see, said Charles Albright, chief scientific officer at Editas Medicine. We think it could open up a whole new set of medicines to go in and change your DNA.

If the procedure is found to be a success, doctors plan on testing it on more children and adults. Success for one company could also create a sizable opportunity in the sector for related stocks as well.

Source: Catalin Rusnac/ShutterStock.com

CRISPR Therapeutics (NASDAQ:CRSP) is one of the top names in the gene-editing market with nine drug candidates.

One candidate is CTX001, a drug that targets sickle cell and transfusion-dependent beta-thalassemia (TBT). With both, patients have poorly formed red blood cells that just cant delivery oxygen throughout the body well. In Nov. 2019, CTX001 successfully helped to eliminate symptoms in a patient with TBT, and another with sickle cell.

Overall, while still very early, the results provide the first suggestion of curative potential for this cutting-edge technology in such genetic diseases, and with potential for further safety refinement of Crispr/Cas9 administration, could suggest broad long-term potential of the many early-stage gene editing therapeutic tools VRTX has accumulated, RBC Capital Markets Brian Abrahams wrote.

Other candidates (CTX110, CTX120, CTX130) are also candidates for a cancer treatment known as chimeric antigen receptor T cell (CAR-T) therapy.

Source: vxhal/ShutterStock.com

Editas Medicine (NASDAQ:EDIT) along with Allergan (NYSE:AGN) just treated a blind patient with EDIT-101 as part of a Brilliance phase clinical trial for the treatment of Leber congenital amaurosis (LCA). With this study, its the first time a patients genes are being modified in the body itself, which is known as in vivo treatment.

Editas is also working on a sickle-cell disease and transfusion-dependent beta-thalassemia (TDT) drug, EDIT-301. EDiT-102 is being developed for Usher Syndrome 2a, a genetic condition characterized by hearing loss and vision loss that begins in adolescence or adulthood.

Source: CI Photos/ShutterStock.com

Intellia Therapeutics (NASDAQ:NTLA) is also working on a sickle-cell disease drug. Its also working on NTLA-5001, a drug that could help treat acute myeloid leukemia (AML). This is a rare type of cancer found in the bone marrow, which leads to the production of abnormal red and white blood cells.

In addition, the company is working on NTLA-2001 for transthyretin amyloidosis, a rare condition characterized by buildups of protein deposits called amyloids throughout the body, which can lead to the loss of sensation in extremities, and in internal organs.

Better, according to the company, In 2019, we advanced our full-spectrum strategy, guiding both ourin vivoandex vivo lead programs toward the clinic. We also continued to build on our genome editing and delivery capabilities to enable a rapid succession of candidates, said Intellia President and Chief Executive Officer, John Leonard, M.D., adding:

We are off to a productive start in 2020. We announced the nomination of NTLA-5001, a WT1-directed TCR-T cell therapy for the treatment of AML, and plan to select our third development candidate in the first half of this year, which will be for the treatment of HAE. In addition, in the second half of the year, we expect to begin dosing ATTR patients with NTLA-2001, a potential single-course treatment for ATTR patients. This is anticipated to be the first-ever systemically delivered CRISPR/Cas9-based therapy to enter the clinic, representing an important milestone in our mission to deliver potentially curative therapies from our proprietary modular platform.

Ian Cooper, an InvestorPlace.com contributor, has been analyzing stocks and options for web-based advisories since 1999. As of this writing, Ian Cooper did not hold a position in any of the aforementioned securities.

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Assistant professor says he’s been fired because he dared to talk about human population variation – Inside Higher Ed

March 12th, 2020 8:47 am

An assistant professor of psychology at Marietta College says his contract isnt being renewed because of what hes said and was alleged to have said about differences between ethnic groups.

Many academics believe that race is mere social construct -- that there is no meaning behind being black, white or anything else, beyond what society assigns to it. Others say that that is mere orthodoxy and that race is real; this group often points to research demonstrating group-based differences in complex traits such as intelligence.

Scientists at the cutting edge of studying race and complex traits, meanwhile, say that these traits are always a mix between genetics and environment. And as of now, these experts add, its impossible to tell in any genuine way just what the mix is, because babies cant be raised exactly the same way over two generations, as such experiments would require.

Bo Winegard falls in the middle camp and believes that purposely not talking about race-based differences is disingenuous and dangerous. The "rich, variegated tapestry of humanity" and its evolution have long interested him and ought to be among the truths that academics pursue, he said in a recent interview. Otherwise, he added, "literal racists" will fill the information void.

I do think theres an informational embargo on human population variation and certainly on race and IQ, he said. People have opinions, and they dont want those to get out publicly.

Whatever you think of Winegards ideas, he said in a recent essay in the conservative academic publication Quillette, you should care that hes effectively being fired for them.

If it can happen to me, then it can happen to any academic who challenges the prevailing views of their discipline, he wrote. You may disagree with everything I believe, say, and write, but it is in everyones interests that you support my freedom to believe, say and write it.

Trouble Begins

Winegard, who is in his second year at Marietta and is scheduled to leave at the end of the academic year, says the trouble started in October. That's when he was invited to address the University of Alabamas Evolution Working Group, which is affiliated with the universitys evolution studies program. Both parties agreed that Winegard would talk about population variation, or, in his words, the hypothesis that human biological differences are at least partially produced by different environments selecting for different physical and psychological traits in their populations over time.

The idea was to link the theory with natural selection, in line with a recent article Winegard co-wrote for Personality and Individual Differences. The article, called "Dodging Darwin: Race, Evolution and the Hereditarian Hypothesis," says, "Like most hereditarians (those who believe it likely that genes contribute to differences in psychological traits among human populations), we do not believe there is decisive evidence about the causes of differences in cognitive ability." Yet the "partial genetic hypothesis is most consistent with the Darwinian research tradition."

One class visit with students went well, Winegard recalled in Quillette. Then he received a number of texts from a campus host expressing concern about Winegards entry on the website RationalWiki. The website, like Wikipedia, is edited by volunteers, but is dedicated to debunking what it sees as junk science. And Winegard, according to RationalWiki, is guilty of writing racist bullshit for the right-wing online magazine Quillette.

Winegard told his hosts that he disagreed with the characterization. He has previously argued, for example, that racism isnt wrong because there arent races; it is wrong because it violates basic human decency and modern moral ideals.

This, of course, contradicts a broad literature asserting that race is a social construct, not a biological one, but it doesnt endorse racism. As Winegard said in the same co-written article, In fact, pinning a message of tolerance to the claim that all humans are essentially the same underneath the skin is dangerous. It suggests that if there were real differences, racism would be justified.

Despite the texts, Winegards main talk at Alabama went on as scheduled, followed by what he described as a rowdy question-and-answer period. Someone yelled that he was a racist, and another accused him of promoting phrenology, a discredited pseudoscience having to do with skull shape.

But Winegard said via telephone that that he never spoke about phrenology or on race and IQ at Alabama. The most controversial thing he said was that psychology may someday, in the aggregate, provide some explanation as to why East Asian societies tend toward collectivism, he added.

One of his slides, however, did say that groups may vary on socially significant traits (on average) such as intelligence, agreeableness, athleticism, cooperativeness [and] criminality.

Alabamas student newspaper published an article on the talk, vaguely linking the subject matter to eugenics, or reproduction to promote certain heritable traits. It also published an apology from the group that hosted him.

Winegard said this week that he never mentioned eugenics, and that he finds things such as forced sterilization morally repugnant. He didn't preclude having mentioned embryo selection once or twice on Twitter, he said, but he's never made a sustained argument.

Back at Marietta, Winegard was summoned to a meeting with his president and provost to discuss the article. While they werent pleased, Winegard wrote in Quillette, they told [him] to be more strategic in my navigation of such a sensitive topic. I agreed that I would try.

Months later, someone began emailing Winegards department and administration about things hes written and said on Twitter. One tweet, in particular, read, The greatest challenge to affluent societies is dealing openly, honestly, and humanely with biological (genetic) inequality. If we dont meet this challenge, I suspect our countries will be torn apart from the inside like a tree destroyed by parasites.

At a second, consequent meeting with his supervisors, Winegard explained (as he recapped in Quillette) that his tweet was not about groups, but rather about individual genetic differences, and the need to create a humane society for everyone, not just for the cognitive elite and hyper-educated (a theme I discuss often). The simile about parasites was a reference to political conflict and not a reference to some group of humans or another, he also said.

Winegard recalled his bosses expressing disappointment in me and particular dismay about the tweet I had deleted, which they said evoked anti-black and anti-Semitic tropes. He agreed and apologized but said he would continue to pursue potentially controversial research topics.

Termination

Termination never came up, even after Winegard published a co-written article on human population variation -- until two weeks ago.

My boss informed me, without any warning, that the college was not renewing my contract, he wrote in Quillette. I dont know if my paper was the proximate cause of my firing, but in the light of the foregoing weeks tumult, it was plausibly the last straw.

Did Winegard see it coming? I had worried vaguely about such an eventuality, but didnt really think it would happen, he wrote. I naively assumed that the norms of academic freedom would prevail. They did not.

Winegard told Inside Higher Ed that hes had strong teaching evaluations and high research productivity since hes been at Marietta. He sees no apparent reason for his effective termination, apart from the controversy surrounding what he has said and, more to the point, is alleged to have said.

In response to his Quillette article, some have argued that one should wait until tenure to pursue certain topics. But Winegard reiterated that he, perhaps navely, took academic freedom seriously. Beyond that, he said, if academics follow "pragmatic" advice about waiting until tenure to discuss controversial issues, it means waiting 10 or more years, through graduate school and the tenure track.

Im perplexed by the response, he said of Mariettas actions. The best response would have been to come out with a bold, affirmative statement for academic freedom, even if the college distanced itself from Winegards views in doing so.

Otherwise, he said, Youre incentivizing this trollish behavior. Trollish here refers to those Winegard says emailed his institution about him anonymously.

Marietta declined comment, saying Winegards case was a private personnel issue.

Relevant, widely followed American Association of University Professors policy says that even professors on probationary appointments should enjoy the same academic freedom as those with tenure, even if they don't have the same due process protections. Winegard said he's unaware of any paths to appeal, but AAUP policy also holds that a faculty committee should evaluate any concerns about non-reappointment related to a possible violation of academic freedom.

Winegard's department chair did not respond to a request for comment. Marietta's Faculty Council chair also did not respond to questions about the case.

Facts and Feelings

Attempts to link cognition to race have for decades happened mostly in academe's fringes. That's because it's either dog-whistle racist junk science or there is a conspiracy of silence surrounding it, depending on what you believe. In 1994, Richard Herrnstein and Charles Murray's The Bell Curve: Intelligence and Class Structure in American Life was immediately controversial, stirring concerns about lack of peer review and whether it represented mainstream science.

Race-based science debates don't just happen in psychology. In January, for example, Philosophical Psychology faced a boycott for publishing an article in defense of race-based research on intelligence. The gist of that article, written by Nathan Cofnas, a Ph.D. candidate in philosophy at the University of Oxford, was that when advances in science reveal genetic variants underlying individual differences in intelligence, we wont be ready for it.

One of the main criticisms of Cofnas's piece was that it speculated that these breakthroughs are close. They are not. So postulating about them is, in a sense, pseudoscience, critics maintain.

Cofnas said at the time that those "who argue that we should wait for the genetics and neuroscience of intelligence to become more advanced before we attempt to study this issue often claim that, in the meantime, we should accept the environmental explanation for the purpose of policy making" and more. But that is a "political, not a scientific, position."

Journalist Angela Saini, author of the 2019 book Superior: The Return of Race Science (which Winegard has reviewed), said that her research demonstrates there is simply "no conspiracy against talking about race and IQ in academia, largely because this matter was settled 70 years ago -- and reinforced by genetics since -- by the universal understanding that race is a social construct."

It's "impossible to say that any differences in attainment we may see between socially defined groups must be biological in origin," Saini added. "Scientists are overwhelmingly in consensus on this."

That a "few academics like to claim otherwise," she said, "in particular, a small number of social scientists on the margins of respectable academia, does nothing to undermine the scientific facts. The facts, Im afraid, dont care about their feelings."

Intelligence researcher Richard Haier, professor emeritus in the pediatric neurology division at the School of Medicine at the University of California, Irvine, said that the questions Winegard is working on are controversial and emotional -- and well within the bounds of reasonable debate.

What happened at Marietta is, therefore, an apparent violation of academic freedom, Haier said. I dont know all the details, but I do know that it is very hard to defend academic freedom for issues that are not just controversial but also extremely emotional. And a lot of people in academia are happy to say that they support academic freedom but there are many examples of occurrences that appear to violate academic freedom, and the local academic community has not stood up for academic freedom.

Haier added, The hard thing about science is to go where the data take you. Without tenure and even with tenure, its becoming increasingly difficult to address controversial ideas, where some points of view do not acknowledge the legitimacy of other points of view, and therefore shut down discussion. Thats not how science works.

Lee Jussim, distinguished professor of psychology at Rutgers University and co-author of a recent paper on political bias in social science research, said that the topic of race and IQ "is poison." Further, he said, "I see no reason to believe the methods are capable of answering the question of how much race differences in intelligence are genetic versus environmental versus some combination.

That doesn't mean that Winegard or anyone else should be fired for trying to do so, however, Jussim said. Of course he has a right to pursue the line of inquiry.

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Interpace Diagnostics Issues Update Regarding Announced Contract with BCBS of Massachusetts – GlobeNewswire

March 12th, 2020 8:47 am

Parsippany, NJ, March 11, 2020 (GLOBE NEWSWIRE) -- Interpace Diagnostics, a subsidiary of Interpace Biosciences (NASDAQ: IDXG) announced today that it has entered into a contract with Blue Cross Blue Shield of Massachusetts. While terms of this Agreement are not disclosed, Interpace is an in-network lab with Blue Cross Blue Shield of Massachusetts for all product lines.

Interpace continues to expand in-network agreements and medical coverage for its services with leading National and Regional health plans, while maintaining Medicare coverage through Novitas Solutions.

According to Jack Stover, CEO of Interpace, This contract with Blue Cross Blue Shield of Massachusetts continues our trend of establishing improved reimbursement through participation as an in-network provider. Im pleased to announce that this is the first contract secured by our new VP of Managed Care and Payer Relations, Jeff Salzman.

AboutThyroid Nodules, ThyGeNEXT and ThyraMIR Testing

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

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

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

AboutInterpace Biosciences

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

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

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

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

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to the Company's future financial and operating performance. The Company has attempted to identify forward looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from those expressed or implied by any forward-looking statement. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in the Company's filings with the SEC, including without limitation, the Annual Report on Form 10-K and the companys Quarterly Reports filed with the SEC. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

CONTACTS:

Interpace DiagnosticsInvestor Relations:Joe Green(646) 653-7030jgreen@edisongroup.comEdison Group

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Interpace Diagnostics Issues Update Regarding Announced Contract with BCBS of Massachusetts - GlobeNewswire

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Podcast: A family on the frontier of hyper-personalized medicine – MIT Technology Review

March 11th, 2020 12:52 pm

Deep Tech is a new subscriber-only podcast that brings alive the people and ideas in our print magazine. Episodes will be released every two weeks. Were making the first four installments, built around our 10 Breakthrough Technologies issue, available for free.

Three-year-old Ipek Kuzu has an extremely rare genetic mutation that disrupts a protein needed for DNA repair, causing the loss of brain cells. Now shes become only the second person in the world to receive a customized antisense oligonucleotide drug designed to compensate for the DNA mistake by allowing her cells to splice together a functional version of the protein. The drug took Boston-based pediatrician and geneticist Tim Yu only months to create, heralding a new era of individualized genomic medicine. But it cost $2 million to manufacture and testleading to questions about how soon hyper-personalized treatments for rare genetic disorders can be made accessible and affordable. Journalist Erika Check Hayden got to know the Kuzu family, and in this episode she chronicles Ipeks journey, with help from Ipeks father Mehmet and Technology Review biomedicine editor Antonio Regalado.

Show notes and links:

If DNA is like software, can we just fix the code?, from the March/April 2020 print issue, p. 46

Hyper-personalized medicine, from the March/April 2020 print issue, p. 18

Sign up for The Download your daily dose of what's up in emerging technology

Two sick children and a $1.5 million bill: One family's race for a gene therapy cure, from the November/December 2018 print issue, October 23, 2018

Episode Transcript

Audio ID: This is MIT Technology Review.

Mehmet Kuzu: Around five to six months, they said she has something called ataxia telangectasia. And they said this doesnt have any cure. The initial days were very tough. We were crying all the time. So then after a while, we started investigating what can be done.

Wade Roush: Mehmet Kuzus three-year-old daughter, Ipek, has a rare genetic mutation that could end her life by age 25. But now shes getting a so-called antisense drug that her doctors engineered specifically for her. Which makes Ipek one of the first patients being swept up in a new wave of hyperpersonalized medicine. Journalist Erika Check Hayden wrote about the Kuzu family in the latest issue of Technology Review. And today, she helps us understand where this breakthrough came from, and how soon it might be scaled up. Im Wade Roush, and this is Deep Tech.

[Theme music]

Were right at the beginning of a revolution in individualized genomic medicine. And if you want to know what that revolution sounds like, this is a good place to start.

[Sound of Illumina sequencing machines]

Thats one of the hundreds of high-speed gene sequencing machines at the Broad Institute of MIT and Harvard. Here at the Broads genomics platform in Cambridge there are so many of these machines that the institute can read the equivalent of 30 whole human genomes every 10 minutes.

There arent a lot of research centers with that kind of power. But in many places around the world its now possible to scan a babys full genome for just a few hundred dollars, and locate DNA coding errors that can cause rare conditions like ataxia telangectasia.

Thats how doctors diagnosed Ipek Kuzu when she was just six months old. The mistake in her DNA means her cells cant make a protein called ATM thats essential for DNA repair. Over the long run that causes the loss of brain cells, which means Ipek has some trouble walking and doesnt talk as much as a typical three-year-old.

Today Ipek is receiving an antisense drug made just for her. Its designed to compensate for the DNA mistake and restore production of ATM. Which makes her only the second person in the world to get this kind of treatment. The first was another little girl named Mila Makovec. She has different genetic disorder called Batten disease that causes blindness, seizures, and other neurodegenerative problems. And Mila got her own customized antisense drug starting in 2018.

But to understand how her doctors came up with these two medicines, and why this whole field of hyperpersonalized medicine is so hot that the editors of Technology Review decided to put it on this years list of 10 breakthrough technologies, we first have to jump back a few years, to 2016.

[CNBC Squawk Box news clip]

CNBC male anchor: Ionis Pharmaceuticals, in pre-market trading, is higher. The FDA has approved a drug called Spinraza. Spinraza.

CNBC female anchor: Its not Spine-raza?

CNBC male anchor: Maybe it is. Because its for spinal muscular atrophy. Its the first drug approved to treat the rare and fatal disease.

Wade Roush: Spinal muscular atrophy affects about 1 in 10,000 babies. So its not nearly as rare as Batten Disease or ataxia telangectasia. But Spinraza is literally the key to all of the more recent work to make customized antisense drugs for Mila and Ipek. So lets take a minute to go over how it works.

What made Spinraza a big deal is that it was one of the first successful medicines made using an antisense oligonucleotide. In other words, a customized strand of RNA.

Antonio Regalado: If you can imagine, inside a cell, there's the DNA.

Wade Roush: This is Antonio Regalado, the editor for biomedicine at Technology Review.

Antonio Regalado: And it kind of sends out these messages into the nucleus made of RNA and those are used as the templates to make proteins. And so antisense is a drug that acts at the level of RNA. They're going to stick to that RNA message and they could block it.

Wade Roush: Keep it from being translated.

Antonio Regalado: Keep it from being translated, or modify the translation in some fashion.

Wade Roush: In the cells of healthy people, theres a protein called SMN that helps motor neurons survive and grow. A gene called SMN1 carries the instructions for making that protein, and people with spinal muscular atrophy have a mutation that disables that gene. But it just so happens that human DNA also contains a second copy of the gene, called SMN2. This second copy is typically inactive, thanks to a small error that keeps the RNA message from being spliced together into a proper template. The Spinraza molecule contains a short segment of antisense RNA that prevents the splicing error. And that allows the body to start making the motor neuron protein.

Ionis Pharmaceuticals is the company that makes Spinraza, and they put a lot of work into figuring out how to get their molecule into cells in the brain and the nervous system, where it can do its work.

Antonio Regalado: And they finally mastered it and came up with pretty much kind of a miracle drug for one of these rare brain diseases that affects kids, spinal muscular atrophy. And so from that example, people then said, well, why can't we use antisense for other diseases that are similar?

And what we learned was that there was a doctor in Boston named Timothy Yu, who was an expert in sequencing genomes of sick children. And there was one girl named Mila Makovec. And her parents had come to him. He'd sequenced the genome. And then he just realized, I don't have to stop here. Once I've identified this defect, I don't have to stop. I could potentially make a drug. And so that's exactly what he did.

Wade Roush: It turned out that Milas disease was caused by a splicing error very similar to the one that causes spinal muscular atrophy, except that in Milas case it disrupts a different protein called CLN7. Tim Yus idea was to take the backbone of the Spinraza molecule and attach a customized strand of antisense RNA. With this new business end, so to speak, the drug would enable Milas cells to start making functional copies of the CLN7 protein.

Antonio Regalado: That was probably at that point just the clearest, starkest, most stunning example of this hyper personalized medicine. Because in this case, it was really for one person. So we were very interested in this phenomenon, because it's a reflection of what technology can do. And then in the middle of last year, a pretty prominent journalist, Erika Check Hayden, came to us and she was also interested and wanted to do some work to find the cases, find the families and write more stories about it. And as it developed, we decided, well, let's put this on our list of breakthrough technologies, because it really is. And so Erika ended up writing the piece and she did a lot of work to find the patients. One of the great things she did was to find this Kuzu family, which happens to be right here in Cambridge.

Wade Roush: Erika, could you introduce yourself and tell us a little bit about you?

Erika Check Hayden: Sure. My name is Erika Check Hayden. I'm a journalist based in San Francisco. And I also run the science communication program at the University of California, Santa Cruz.

Wade Roush: When you set out to start reporting this piece, did you feel like it was important to go beyond the first sort of headline-making case of Mila Makovec and look for additional patients who were going through this process to see how broadly applicable the whole idea is?

Erika Check Hayden: I do think that while people have been very impressed by Mila's case and by the drug that Tim Yu made for her, which is called milasen, I think there's also been this question of are we gonna be able to do this for other patients? And if so, you know, who is going to be treatable via this method? And so if I'm going out and finding other families that are hopefully replicating that success, I think is a really important statement about how impactful this approach might eventually be.

Wade Roush: So this is where the Kuzu family comes in. So could you tell us a little bit about them and how you got in touch with them?

Erika Check Hayden: So the Kuzu family, they originally came from Turkey and the father in the family, Mehmet Kuzu, is now a software engineer at Google. And they were living in Silicon Valley when their daughter Ipek was born. And soon after she was born, she was diagnosed with this disease called ataxia telangectasia, which is also called A-T disease. And when that happened, they set about trying to understand if there was anything they could do to treat the disease or slow the disease. And that's what led Mehmet down this path that eventually led him to work with Tim Yu.

Mehmet Kuzu: I sent the genetic report of our daughter. Then he said, oh, there's a potential here, but there are two main problems. He said this might cost around like two million, and the insurance will not cover it. The second problem, it might cause damage because, we have a theoretical idea, but biology is complicated. So at the end of the day, it might be worse than what is expected.

Wade Roush: Right. So for the Kuzu family, while it was obviously bad news that your kid is getting diagnosed with A-T disease, there is this amazing foundation or non-profit led by Brag Margus, the A-T Children's Project, that has all this data and also apparently has some fundraising clout. And they wind up helping to finance a lot of this research and even finance Ipeks treatment.

Erika Check Hayden: Right. And I think that's part of why this particular project was able to move so fast, because Brad Margus and the A-T Children's Project had done a lot of work over the years to fundraise and educate their community about the potential for treating this disease, so that when they found something that he actually thought could work, they were able to raise $1.4 million in a relatively short amount of time to fund the development of this unique drug.

Mehmet Kuzu: I think he understood to the promise of it. And then he agreed to financially support us. But the problem is this money in the pool is coming from many families. So we should have a fair selection. Then they found three kids that young in age, like three, two, two, three, four, with the right mutation type, and they got skin samples from all of them, and tested it. They were able to do it quickly.

Wade Roush: Mehmet can recount all these events pretty calmly. But I think its worth underscoring what a roller coaster the familys been on. The backing of the AT Childrens Project opened a window for Tim Yu to design and manufacture an antisense drug. But the required safety testing is so expensive that only there was only enough money to do that for one patient. There was a two in three chance that Ipek would not be that patient. And even if she did get selected, there was no way to know whether the treatment would be effective. Mila Makovec had been having fewer seizures since she started getting her antisense treatment, but doctors still werent 100 percent sure that it was because of the medicine. On top of all that, there was still the risk of unintended side effects.

Mehmet Kuzu: and then at the end of the day, Ipeks cells responded the best among these three candidates. Now, once we know we are selected, now we concentrate on second issue: do we really want to take this risk of, like, making things worse? And then I thought, like, most probably something good will happen. Of course there is a probability of, a possibility [of failure]. But imagine if that happens: science will learn from this. And her kind of sacrifice, and that would help, too, many other people.

Erika Check Hayden: It's been just incredible over the past few years to meet these families, understand what they're doing, how they're doing it. I've just been really struck by everything they've been able to accomplish. And also the mindset that they bring to this where, you know, you'll talk to, or I will talk to, parents who are doing this for their kids and they've had scientists tell them, 'You've got to be prepared for the possibility that this isn't going to help your kid. You know, you might be doing all of this work on behalf of some other future child. This might not come in time to help your own child.' And they persist and are really driven.

Wade Roush: Ok. So in the same way that Tim Yu helped to create this unique drug called milasen for Mila Makovec, he's created a drug called atipeksen for Ipek. If that drug if that drug works, how will it help Ipek?

Erika Check Hayden: If this drug works, basically what it's going to do is correct the way that Ipek's cells interpret her genetic information so that she will make a functioning copy of the ATM protein. Now, how we will know if this is working is a bit of a tricky question. So, Tim Yu and other doctors are going to try a variety of methods to see if they can tell whether the drug is actually helping her. So, for instance, they will look at things like can they see evidence in Ipek's body that the drug is actually making corrected versions of the protein? They will look for evidence that she isn't declining in the ways that we might expect her to if she wasn't getting treatment to help control her disease. But it might be tricky to tell whether it actually works or not.

Mehmet Kuzu: She had three injections until this point because they are starting with very low dose and escalating itAnd fortunately, we haven't seen any adverse effects in the first three. But like, of course, knowing if this is really working or not, they told us that it will take time. Maybe we need a year to understand if it's really working. But at least we have seen that no bad thing happened. At hospital she's going on the full anesthesia. They're putting on a mask. And after the injection they are taking bloods every four hours, three or four times. These are very stressful for her. She's fighting not to have this mask. She's crying a lot. Uh, but once discharge happens, once we come home, she forgets about everything. She just plays with her toys.

Wade Roush: Right. And this is one of the things you mentioned in your piece. Not only will it be tricky to see whether it's working or not, but we're talking about by definition an n of one study where there's only one patient. So you don't get the kinds of large numbers that help researchers feel more confident that a drug is safe and effective.

Erika Check Hayden: I think what we still don't know very well yet is which diseases are going to be helped most by this approach, or even if any of these individual customized treatments can cure a patient. So if you talk to Mila's mom, Julia Vitarello, she is very convinced that that drug has helped Mila. But I think accumulating that data to the level where we really know that this is a worthwhile approach, you know, that's probably going to take a while.

And to take a step back, I think that's part of the reason why these drugs are only being used right now in patients that have really severe progressive diseases, because you are taking a certain risk by giving a treatment to a patient when you haven't done the kinds of safety testing that we might be used to for a drug that would normally go through an FDA approval process. In fact, there are some people who object to even using the word treatment because we don't necessarily know that these drugs are going to cure the patients.

So in the meantime, I think everybody would like to see far more patients at least be able to try this. And so there's this question as to whether it's only going to be patients who have the resources to raise that money or access that money that are going to benefit. And I don't think anybody wants that to be the case.

Wade Roush: Are there any signs that the drug industry is looking at how to scale up some of these treatments? And, you know, maybe create a pipeline for hyper personalized drugs?

Erika Check Hayden: So we're seeing things like Ionis, their co-founder Stan Crooke has started a foundation called the n-Lorem Foundation that's going to try to develop these treatments for patients. The reason is that developing a drug for one patient that costs millions of dollars and doesn't really have a very large market is not something that's necessarily going to be attractive to a company. But I think people think there is a direction that could evolve where, you know, if the drug industry is better able to manufacture these drug templates or backbones and more easily switch out the part of the drug that's the business end that's doing the targeting of different genetic diseases to where that becomes much more large scale, much more customizable, much cheaper. You know, then you might see a model where this is much more economical, affordable, reimbursed by insurance companies, because right now this is not and obviously that's a major cost barrier.

Wade Roush: Do you think this is a time for patients with rare genetic disorders and families of those patients to feel more hopeful? Or is it just too early realistically for this to affect lots of people who are already suffering from these conditions?

Antonio Regalado: Right. It goes back to the question, should this be a breakthrough technology? Because right now, it's not helping that many people. We're talking about helping one person. Or we're talking about helping two or three very few people. Very few. And that's a strike against the idea, frankly. Like, why? Why should we invest resources into this when it helps so few people? Why should we call it a breakthrough technology? Well, the reason to is, it's sweet. Technically, it's sweet. And it paints a path towards a future where it like you can do a lot more with genetic drugs.

Wade Roush: So you can imagine a future not 100 years away, but maybe 10 years away, where this can be scaled up and broadened out to more patients.

Antonio Regalado: Yeah, absolutely. I mean, will the drugs work? How well will they work? It's kind of an open question. But yeah, we've already gone from one case to five cases next year no doubt it it'll be 10 and then a hundred and then thousands. Most likely. I want to raise something else, which this whole scenario is not fair. Because there's a lot of people with rare diseases and a lot of kids dying of rare disease in every neighborhood and every corner and every precinct of the country, of the world. So who has the opportunity to have this chance?

Wade Roush: Well, who does so far?

Antonio Regalado: Well, it is a very small subset of parents who for whatever reason have the ability to wrap their head around the science, to find where the opportunity is, and to raise quite a lot of money. And this is not bake sale money. This is two million dollars. Three million dollars. You have to really have a way to do that, and it favors people with a big network. That's why we're seeing people, you know, entrepreneurs from Silicon Valley or other people who just for whatever reason, manage to pull it off.

Wade Roush: If this kind of inequity persisted, it would definitely become a huge point of criticism around this whole area of therapy. But maybe you could look at these parents as the pioneers.

Antonio Regalado: Right. Exactly. A lot of the parents will say, well, in addition to trying to help my child, I also want to invest and try and create the process by which everybody else can be helped because they also have a lot of empathy for the next person. The idea is to help everybody. The pathway to doing that is not clear yet.

Wade Roush: All right. Well, whether this is a breakthrough or not, it raises so many interesting and thorny questions that it's perfect fodder for Technology Review.

Antonio: It's definitely a breakthrough, man. It's definitely a breakthrough.

Wade Roush: Okay. Thanks Antonio.

[Theme music]

Thats it for this edition of Deep Tech. This is a podcast were making exclusively for MIT Technology Review subscribers,to help bring alive some of the people and ideas youll find in the pages of our website and our print magazine. But the first four episodes cover our annual 10 breakthrough technologies issue, and were making those episodes free for everyone.

Deep Tech is written and produced by me and edited by Michael Reilly, with editorial help this week from Jennifer Strong. Our theme is by Titlecard Music and Sound in Boston. Special thanks this week to David Cameron, Howard Gelman, Erika Check Hayden, Mehmet Kuzu, Antonio Regalado, and Jane Wilkinson. Im Wade Roush. Thanks for listening, and we hope to see you back here for our next episode in two weeks.

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Podcast: A family on the frontier of hyper-personalized medicine - MIT Technology Review

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Henry Ford Receives $25M Grant to Expand Precision Medicine Program – HealthITAnalytics.com

March 11th, 2020 12:52 pm

March 11, 2020 -Henry Ford Health System has received a $25 million grant to accelerate its precision medicine program, with the ultimate goal of creating a Precision Health Center.

With the donation, Henry Ford will focus on advancing cancer research and treatment, as well as precision therapies for behavioral health, cardiovascular conditions, and metabolic diseases.

Henry Ford received the gift from developer Chris Jeffries and his wife Lisa. The donation is the largest single gift from an individual in the health systems 105-year history.

We are incredibly grateful to Lisa and Chris Jeffries for their generosity, saidWright Lassiter, III, president and CEO of Henry Ford Health System.

We are experiencing a momentous era in medicine, a radical shift from the traditional approach to cancer care. This gift will help us consolidate and advance our collective efforts to create unprecedented access to advanced, highly personalized treatments for our patients and members.

The grant will significantly boost the health systems translational research efforts, which quickly transforms the most innovative discoveries in the lab into new treatments for patients.

Translational research is a significant differentiator of our clinical programs at Henry Ford and is a critical element to help us treat many of the most challenging conditions our patients face, saidAdnan Munkarah, MD, executive vice president and chief clinical officer of Henry Ford Health System.

Translational research is bench-to-bedside, meaning it allows patients to benefit from discoveries in real time. That is an essential part of our history and commitment to medicine and academics not only offering the latest innovations in medicine, but also playing a leading role in their development.

The donation will build on the organizations past work to advance precision medicine and personalized care. In October 2017, Henry Ford Health System launched the Henry Ford Cancer Institute, a facility focused on ambulatory cancer treatment, precision medicine, clinical trials and research, and enhanced support services for cancer patients.

With the grant, researchers will be able to continue to develop individualized therapies for cancer and other conditions.

By analyzing genetic and non-genetic factors, we can gain a better understanding of how a disease forms, progresses and can be treated in a specific patient, saidTom Mikkelsen, MD, medical director of the Precision Medicine Program andClinical Trials Officeat Henry Ford Health System.

As of now, we can check for more than 500 genomic markers, which helps us understand the pattern of changes in a patients tumor cells that influence how cancer grows and spreads. Im confident this gift will lead to advancements that provide hope for patients with even the most complex diagnoses.

The Henry Ford Cancer Institute has one unified team of cancer specialists working to deliver personalized cancer treatments. The Institute includes five hospital locations, six additional outpatient cancer centers, and dozens of aligned doctors offices.

Even a decade ago, our approach to treating brain cancer was Precision Medicine before anyone knew what Precision Medicine was, said Steven Kalkanis, MD, CEO of Henry Ford Medical Group and Henry Fords chief academic officer.

In the time since, weve seen a significant increase in the number of brain cancer patients who are outliving their prognoses, due in large part to clinical innovation. Our relentless pursuit of clinical breakthroughs has more momentum now than at any other point in history.

The new grant will only serve to accelerate precision medicine in care delivery.

The support of our donors is the fuel behind our clinical innovations and the breakthroughs that are improving peoples lives, saidMary Jane Vogt, senior vice president and chief development officer at Henry Ford Health System. It is remarkable to work with donors who believe in a better tomorrow and the power of a unified approach to medicine.

The donation is expected to help drive innovations in treating brain, lung, pancreatic, and colon cancers, as well as other chronic diseases like cystic fibrosis, asthma, and heart disease.

The team at Henry Ford is second to none, said Chris Jeffries. We believe this gift will lead to other families having more time together. Defeating cancer requires a concerted effort from everyone and we hope to make as big an impact on that goal as possible.

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Henry Ford Receives $25M Grant to Expand Precision Medicine Program - HealthITAnalytics.com

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DNA Sequencing Industry Insights and Outlook to 2028 – Analysis of Applications in Healthcare, Oncology and Infections – Benzinga

March 11th, 2020 12:52 pm

Dublin, March 11, 2020 (GLOBE NEWSWIRE) -- The "DNA Sequencing - Technologies, Markets & Companies" report from Jain PharmaBiotech has been added to ResearchAndMarkets.com's offering.

The value of DNA sequencer market in 2018 is described with estimates for 2023 and 2028. Various methods and factors on which market estimates depend are described briefly. Markets are tabulated according to geographical areas as well as applications. Small sequencers form the basis of SWOT (strengths, weaknesses, opportunities, threats) analysis. Several marketing strategies have been outlined. The report includes profiles of 147 companies involved in sequencing and their 173 collaborations.

The report briefly reviews basics of human genome variations, development of sequencing technologies, and their applications. Current large and small sequencers are described as well as companies developing them. Various applications of sequencing are described including those for genetics, medical diagnostics, drug discovery and cancer.

Next generation sequencing technologies, both second and third generations, are reviewed. Companies developing software for analysis of sequencing data are also included. Selected academic institutes conducting research in sequencing are also listed.

Current market is mostly for research applications and future markets will be other applications related to healthcare.

Key Topics Covered

Executive Summary 1. Introduction2. DNA Sequencing Technologies3. Role of Bioinformatics in Sequencing4. Comparative Analysis of Sequencing Technologies5. Sequencing for Research6. Applications of Sequencing in Healthcare7. Applications of Sequencing in Oncology8. Sequencing in Genetic Disorders9. Sequencing in Neurological and Psychiatric Disorders10. Applications of Sequencing in Infections11. Role of Sequencing in Personalized Medicine12. Current Status and Future Prospects13. Markets for Sequencers14. Companies Involved in Sequencing15. References

For more information about this report visit https://www.researchandmarkets.com/r/8bubjr

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Continued here:
DNA Sequencing Industry Insights and Outlook to 2028 - Analysis of Applications in Healthcare, Oncology and Infections - Benzinga

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Ethos Therapy Continues Global Expansion – PRNewswire

March 11th, 2020 12:52 pm

PALO ALTO, Calif., March 10, 2020 /PRNewswire/ -- Varian (NYSE: VAR) today announced Medisch Spectrum Twente Hospital in The Netherlands, and Icon Cancer Centre Wahroonga and Royal North Shore Hospital (RNSH) in Australia treated their first patients with Ethos therapy. Thisartificial intelligence (AI)-driven holistic adaptive therapy solution is designed to deliver an entire adapted treatment in a typical 15-minute timeslot.

Adaptive therapy provides the ability to personalize the patient's treatment based on their anatomy and position at the time of treatment. The goal is to better target the tumor, reduce dose to healthy tissue, and potentially improve overall outcomes.

At Medisch Spectrum Twente Hospital, the first two patients treated were for prostate cancer, at RNSH the first treatment was for head and neck cancer and at Icon Cancer Centre Wahroonga, the first treatment was for prostate cancer. Additionally, since delivering the first Ethos therapy in the world in September 2019, Herlev and Gentofte Hospitalin Denmark has already delivered 100 adaptive fractions for bladder cancer patients.

"Since the launch of Ethos therapy, the response from clinicians globally has been very strong," said Chris Toth, president Varian Oncology Systems. "Ethos therapy was designed to launch a new era of personalized adaptive radiation therapy and we are very pleased to see patients in Australia and The Netherlands now have access to these adaptive treatments. With Ethos therapy recently receiving 510(k) clearance, the first installation in the US is in process and will be treating patients soon."

Clinician Experience

"The future is adaptive," said Erik Van Dieren, head of Medical Physics, Medisch Spectrum Twente Hospital."With Ethos we know adaptive radiotherapy on a daily basis is achievable for a large number of patients due to high accuracy and excellent sparing of the healthy tissue in about 15 minutes treatment time."

"Early Ethos therapy experience from Icon is showing promising results," said Amy Teh, MD, radiation oncologist at Icon Cancer Centre, Wahroonga."In a prostate patient, where the target volume is highly dependent on bladder and rectal positioning, we have used the AI-driven online adaptive workflow on the Ethos platform to effectively and efficiently adapt to the new position of the bladder and rectum each day. This has allowed superior coverage of the true target. This technology marks another step forward in the advancement of radiation therapy taking personalized medicine to another level allowing us to ensure more dose to the tumor target, and less dose to surrounding healthy organs."

"RNSH is very pleased to enter the world of Ethos therapy after recently treating our first patient," said Jeremy Booth, head of Medical Physics, Northern Sydney Cancer Centre, RNSH. "The patient treatment for head and neck cancer was an exceptional experience, uniting our expert team of radiation therapists, medical physicists and radiation oncologists at the console to ensure we safely delivered the best treatment."

"We've found that, with bladder cancer patients, we are seeing the most impact using online adaptation," said Poul Geertsen, MD, PhD, head of Radiotherapy, Department of Oncology at Herlev and Gentofte Hospital. "With Ethos therapy, we are seeing treatment margin reductions of up to 50 percent, which is impressive."

The streamlined workflow of Ethos therapy is enabled by its AI-driven planning and contouring capabilities. Physicians define their clinical intent from pre-defined templates and the initial treatment plan is generated based on the physician's pre-defined clinical objectives. The treatment is adapted in response to changes in the patient's anatomy and the tumor's shape and position, at the time of treatment. The ability of Ethos to enable on-couch adaptive treatment puts the patient at the center of care.

Ethos therapy offers the use of multimodality images (MR, PET, CT) registered with daily iterative CBCT images at the console. By providing an up-to-date view of the patient's anatomy in multiple imaging modality views, Ethos therapy provides clinicians the confidence to make more informed adaptive treatment decisions. The solution is built on Varian's latest treatment delivery technology andprovides fast imaging and treatment delivery without compromising quality.

For more information on Ethos, visit http://www.varian.com/ethos.

About Varian

At Varian, we envision a world without fear of cancer. For more than 70 years, we have developed, built and delivered innovative cancer care technologies and solutions for our clinical partners around the globe to help them treat millions of patients each year. With an Intelligent Cancer Care approach, we are harnessing advanced technologies like artificial intelligence, machine learning and data analytics to enhance cancer treatment and expand access to care. Our 10,000 employees across 70 locations keep the patient and our clinical partners at the center of our thinking as we power new victories in cancer care. Because, for cancer patients everywhere, their fight is our fight. For more information, visit http://www.varian.comand follow @VarianMedSys on Twitter.

Customers were not paid for their testimonials. Individual results may vary

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Global Therapeutic Drug Monitoring Industry Insights, 2018-2028: Unmet Needs and Strategies for Development – MENAFN.COM

March 11th, 2020 12:52 pm

(MENAFN - GlobeNewsWire - Nasdaq) Dublin, March 11, 2020 (GLOBE NEWSWIRE) -- The "Therapeutic Drug Monitoring (TDM) Technologies, Markets & Companies to 2028" report from Jain PharmaBiotech has been added to ResearchAndMarkets.com's offering.

This report deals with therapeutic drug monitoring, a multi-disciplinary clinical specialty, aimed at improving patient care by monitoring drug levels in the blood to individually adjust the dose of drugs for improving outcome. TDM is viewed as a component of personalized medicine that interacts with several other disciplines including pharmacokinetics and pharmacogenetics. One chapter is devoted to the monitoring of drugs of abuse (DoA). Various technologies used for well-known DoA are described. A section on drug abuse describes methods of detection of performance-enhancing drugs.

TDM market is analyzed from 2018 to 2028 according to technologies as well as geographical distribution. The global market for DoA testing was also analyzed from 2018 to 2028 and divided according to the area of application. Unmet needs and strategies for development of markets for TDM are discussed. The report contains profiles of 35 companies involved in developing tests and equipment for drug monitoring along with their collaborations. The text is supplemented with 21 tables, 9 figures and 210 selected references from the literature.

Benefits of the Report

The report contains information on the following:

Key Topics Covered Executive Summary

1. Introduction

2. Technologies for TDM

3. Drug Monitoring Instruments

4. Applications of TDM

5. Drugs Requiring Monitoring

6. Monitoring of Biological Therapies

7. Monitoring of Drug Abuse

8. Markets for TDM

9. Companies

10. References

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

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

MENAFN1103202000703653ID1099832888

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Scientists developed the worlds most sophisticated lab model of the human body – Tech Explorist

March 11th, 2020 12:52 pm

Current practices in drug development have led to therapeutic compounds being approved for widespread use in humans, only to be later withdrawn due to unanticipated toxicity. These occurrences are mostly the result of erroneous data generated by in vivo and in vitro preclinical models that do not accurately recapitulate human physiology.

To speed up new drugs to market and reduce animal testing, scientists from the Wake Forest Institute for Regenerative Medicine (WFIRM) have come up with a mindblowing solution. They have developed the worlds most sophisticated laboratory model of the human body, a system of miniaturized organs that can be used to detect harmful and adverse effects of drugs before they are prescribed to patients.

Scientists developed this system from many human cell types that are combined into human tissues representing a majority of the organs in the human body, such as the heart, liver, and lungs. Each of these miniature organs is tiny 3D tissue-like structures about one-millionth the size of an adult human organ.

Anthony Atala, MD, of the Wake Forest Institute for Regenerative Medicine and the studys senior author said,The most important capability of the human organ tissue system is the ability to determine whether or not a drug is toxic to humans very early in development and its potential use in personalized medicine. Weeding out problematic drugs early in the development or therapy process can save billions of dollars and potentially save lives.

During the experiment, this new model shows the potential of quantifying toxicity measure toxicity in many drugs approved for human use. Although toxicity from the recalled drugs was not found initially using standard 2D cell culture systems and animal testing models, and adverse effects were not detected throughout three levels of human clinical trials, this new system can readily detect toxicity, replicating the damage seen in humans.

To create the model, scientists isolated tiny samples of human tissue cells and engineered them into miniature versions of the human organ. These tissue cells can contain blood vessel cells, immune system cells, and even fibroblasts.

Each of these organs, also known as organ tissue equivalents, performs the same functions that they do in the human body. For example, the heart beats about 60 times each minute, the lung breaths the air from the surrounding environment, and the liver breaks down toxic compounds into harmless waste products.

Co-author Aleks Skardal, Ph.D., formerly of WFIRM and now at Ohio State University, said,We knew very early on that we needed to include all of the major cell types that were present in the original organ. To model the bodys different responses to toxic compounds, we needed to include all of the cell types that produce these responses.

Another exciting thing about the model that each system contains media, a substance containing nutrients and oxygen that is circulated among all the organ types, delivering oxygen, and removing waste. The small blood system n these devices use a technology called microfluidics to recirculate test compounds through the organ system and remove the drug breakdown products that each organ is producing.

Co-author Thomas Shupe, Ph.D., of WFIRM, said,Creating little human organs for drug testing was a logical extension of the work we have accomplished in building human-scale organs. Many of the same technologies we have developed at the human-scale level, like including a very natural environment for the cells to live in, also produced excellent results when brought down to the microscopic level.

Additional co-authors include Julio Aleman, Steven Forsythe, Shiny Rajan, Sean Murphy, Mahesh Devarasetty, Nima Pourhabibi Zarandi, Goodwell Nzou, Robert Wicks, Hooman Sadri-Ardekani, Colin Bishop, Shay Soker, and Adam Hall.

Authors Skardal, Shupe, Soker, Murphy, Bishop, and Atala are inventors on patent rights related to this work owned by Wake Forest University Health Sciences. The patents, whose value may be affected by publication, have the potential to generate royalty income in which the inventors would share.

The study is published in the journal Biofabrication.

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3 steps to add annual Medicare wellness visits in your practice – American Medical Association

March 11th, 2020 12:52 pm

Medicare now recognizes the important work that primary care physicians do when it comes to preventive screenings in older patients. So instead of only paying doctors for sick visits, the program will pay physicians to perform a preventive annual Medicare wellness visit (AWV).

But physicians should make some adjustments to their practices to ensure they adapt to what is the first of several Medicare changes intended to promote preventive care and improve care coordination and chronic disease management for Medicare patients.

The AMA STEPS Forward module Medicare Annual Wellness Visit (AWV): Streamline Workflow to Perform a Thorough AWV helps physicians understand the AWV, communicate with patients to set expectations about the visit and map out an AWV workflow.

TheAMAsSTEPS Forward open-access modules offerinnovative strategies that allow physicians and their staff to thrive in the new health care environment. These courses can help you prevent physician burnout, create the organizational foundation for joy in medicine and improvepractice efficiency.

The AWV is a primary care visit that involves preventive care, advanced care planning and depression and dementia screening. It gives physicians a chance to focus on safety issues, such as falls, and social needs, such as food insecurity and transportation. Physicians and their teams can update information in a patients chart, such as a medication list, or they can create and maintain a personalized screening and prevention plan.

The Centers for Medicare and Medicaid Services (CMS) is recognizing that these visits help enhance a patients quality of life and that they are different from traditional sick visits. Identifying mental health concerns, cognitive impairments and other factors often involves in-depth conversations and non-face-to-face work. And physician offices can set up a system where all members of the care team contribute to the effort, maximizing patient benefit, practice pay and time savings.

Here are three steps to optimize annual wellness visits in your practice.

An annual wellness visit is different from the initial preventive physical examination, known as the IPPE. AWVs are offered to patients 12 months after they enroll in Medicare Part B and they are then covered once every 12 months.

Numerous components are part of the initial AWV, including screening for cognitive impairment and reviewing functional ability and level of safety. Nonphysician members of the care team can perform most of the components; the physicians role is to synthesize the findings and provide recommendations. During subsequent visits, the information is reviewed and updated.

Make clear this visit is not the same as an annual physical and doesnt include a physical exam. Medicare covers the AWV 100%, but any evaluation and management (E/M) work done during the visit is subject to copays, deductibles and coinsurance.

An AWV is covered only once every 12 months, so if a patient has had one elsewhere in that timeframe, they are not eligible for another one from your office.

First, physician offices will need to decide whether to combine AWV and problem-based visits. The STEPS Forward module then offers a sample process map as guidance on how to map out each step of the visit.

For example, if an office chooses to combine an AWV with E&M, the module outlines how to conduct and document the visit using both AWV and E&M templates.

TheCMEmodule, Medicare Annual Wellness Visit (AWV) Streamline Workflow to Perform a Thorough AWV,is enduringmaterial and designated by the AMA for a maximum of0.5AMA PRA Category 1 Credit.

The module is part of theAMA EdHub,anonline platformwith top-quality CME and education that supports the professional development needs of physicians and other health professionals. With topics relevant to you, it also offers an easy, streamlined way to find, take, track and report educational activities.

Learn more aboutAMA CME accreditation.

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Podcast: Treating blindness with CRISPR; customized cancer drugs; Beyond Meat takes on critics; and saving bananas from extinction – Genetic Literacy…

March 11th, 2020 12:51 pm

For the first time ever, CRISPR has been used to edit DNA inside a living human being. Scientists have also tapped the gene-editing tool to accelerate DNA sequencing in hopes of customizing cancer treatments. Plant-based burger startup Beyond Meat blasts critics who claim its products are ultra-processed. Genetic engineering may save the worlds favorite banana from extinction. But how does the public feel about all this genetic tinkering?

On this episode of Science Facts & Fallacies, plant geneticist Kevin Folta and GLP editor Cameron English go beyond the headlines to break down the latest developments from the world of genetics and biotechnology.

Podcast: Play in new window | Download

Subscribe: Apple Podcasts | Android |

Can CRISPR gene editing save the Cavendish banana from extinction?

The Cavendish bananathat delicious, yellow tropical fruit currently populating the produce sections of our grocery storesmay not be available for much longer. A fungal disease known as Tropical Race 4 (TR-4) is wreaking havoc on banana plantations across South America, threatening to wipe out the Cavendish for good. TR-4 spreads rapidly and isnt easily controlled with pesticide applications. Thats why scientists are working feverishly to immunize the banana by cutting a segment of DNA out of its genome that makes it susceptible to TR-4.

More precise cancer treatments may be possible by pairing CRISPR with genetic sequencing

Researchers at Johns Hopkins School of Medicine have used CRISPR to rapidly sequence particular genes involved in the development of breast cancer, eliminating the DNA replication process usually required for genome sequencing. The development could enable the selection of customized cancer drugs that treat the disease based on the genetic makeup of individual patients.

Beyond Meat goes on the offensive, blasting critics who claim plant-based burgers are ultra-processed

Plant-based burgers have been a hit with consumers so far, achieving nearly a $1 billion in sales in 2019. This development has made the meat industry nervous, and theyve launched expensive marketing campaigns to dissuade the public from chowing down on the beef-free alternatives. The industrys biggest criticism: plant-based meats are ultra-processed, and presumably less nutritious than traditional burgers.

Beyond Meat, maker of the wildly popular Beyond Burger, is having none of this. The company announced in early March it was going on the offensive to counter the marketing assault on its products, arguing that plant-based foods may actually be healthier than meat in some cases.

Targeting blindness with CRISPR: Doctors attempt first editing of genes inside a human body

Gene editing has yielded dozens of important medical treatments for deadly diseases, including cancers like leukemia and lymphoma. Typically, doctors extract immune cells from a patient, edit their DNA, then infuse them back into the persons body to attack the disease. Scientists have now taken this approach a step further by injecting a virus carrying the instructions to produce CRISPR-Cas9 directly into a patients eye, where it is expected to edit out a mutation involved in Leber congenital amaurosis, a genetic condition that causes blindness. Will this groundbreaking procedure work? Is it safe?

Infographic: What the US public thinks about tinkering with human genetics

As all this genetic engineering work begins reshaping intimate aspects of our lives, scientists and policy makers are eager to find out how consumers feel about the technology. Is the public on board, or do they fear a loss of human control? Both.

A majority of people surveyed by Pew (60%) said genetic engineering should be used to prevent serious diseases and produce organs for people who need them (57%), but they were also concerned about using the technology to enhance human performance. 69 percent, for example, said implanting brain chips to improve memory and information processing would be a step too far.

Kevin M. Folta is a professor in the Horticultural Sciences Department at the University of Florida. Follow Professor Folta on Twitter @kevinfolta

Cameron J. English is the GLPs senior agricultural genetics and special projects editor. BIO. Follow him on Twitter @camjenglish

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Podcast: Treating blindness with CRISPR; customized cancer drugs; Beyond Meat takes on critics; and saving bananas from extinction - Genetic Literacy...

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Genetic Engineering Co. Says Its COVID-19 Vaccine Could Be Approved By End of the Year – American Greatness

March 11th, 2020 12:51 pm

A Texas-based genetic engineering company claims to have created a vaccine to prevent the coronavirus (COVID-19) and is hoping to have the drug approved and available to the public by the end of the year.

John Price, the CEO of Greffex, told Fox News Monday that he was completely confident in his companys new vaccine.

Were confident in the vaccine, the quality of the vaccine completely. The end result will be what the government wants to do in terms of testing, Price said.

The company had previously created a vaccine to combat MERS and that research helped them develop the new vaccine. MERS has a tremendous number of similarities to the coronavirus, Price explained.

The vaccine is still in the testing stage, and if approved, could be available to the public by years end, he said.

When asked whether there was a way to fast track the approval process, Price answered that it would be a policy decision for the government.

Thats always the $100 million question. The earliest that we think would be the end of the year. The latest would be 18 months. But we think that we could depending on the approval process of the government get something in 2020, he said.

Yesterday was the first time I heard people say its a pandemic, Price added. If its truly a pandemic, then you can pretty much do whatever you want. The process is roughly four weeks for the first animal testing and then you go into human trials. And thats the part that will be determined by the government.

National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci and his team, meanwhile, are working on a separate vaccine which could take up to 18 months to prove safety and effectiveness. The FDA has granted approval for the National Institutes of Health to begin the first stage of clinical testing in that vaccine.

Media-driven panic about the virus has contributed to a jittery and unnerved stock market in recent days. The Dow Jones Industrial Average plunged 1,500 points in early trading, Monday.

As of Monday morning, there were approximately 600 confirmed cases of COVID-19 in the United States and 22 deaths. There are now 111,362 cases worldwide, according to the John Hopkins tracking map.

By comparison, the CDC estimates that 35.5 million people got sick with seasonal influenza in the United States during the 20182019 season, with an estimated 16.5 million people going to a health care provider for their illness. According to the CDC, there have been 490,600 hospitalizations, and 34,200 deaths from influenza, this season.

Unfortunately, the global death rate for COVID-19 is 3.4 percent, which is much higher than the common flu, according to the World Health Organization.

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Genetic Engineering Co. Says Its COVID-19 Vaccine Could Be Approved By End of the Year - American Greatness

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US agencies launch initiative to boost understanding of GMOs – World Grain

March 11th, 2020 12:51 pm

WASHINGTON, DC, US The US Food and Drug Administration, the Environmental Protection Agency and the US Department of Agriculture launched a $7.5 million consumer education initiative focused on highlighting the science behind genetically modified organisms.

The goal of the effort, called Feed Your Mind, is to answer the most common questions consumers have about GMOs, including how they are regulated and whether they are safe and healthy.

Less than a dozen genetically modified crops are grown in the United States, but they often make up an overwhelming majority of the crop grown. More than 90% of soybeans, corn and sugar beets planted in 2018 were genetically modified.

Genetic engineering has created new plants that are resistant to insects and diseases, led to products with improved nutritional profiles, as well as certain produce that dont brown or bruise as easily, said Stephen M. Hahn, MD, commissioner of the FDA.

One educational video from the FDA points out that genetically modified soybeans have healthier oils that may be used to replace oils that contain trans fats. Other materials highlight how reduced bruising and browning may help combat food waste.

Consumers, however, remain uncertain. Concerns that GMOs are unhealthy and harmful are widespread. The number of shoppers avoiding GMOs tripled over the past decade, according to The Hartman Group. Close to half of consumers surveyed last year said they avoid bioengineered ingredients, compared to 15% in 2007.

A study published last year in Nature Human Behavior found more than 90% of participants had some level of opposition to GMO foods. It also found that consumers with the strongest opposition to GMO foods thought they were more knowledgeable about the topic than other participants, despite scoring lower on an actual knowledge test.

While foods from genetically engineered plants have been available to consumers since the early 1990s and are a common part of todays food supply, there are a lot of misconceptions about them, Hahn said. This initiative is intended to help people better understand what these products are and how they are made.

The Feed Your Mind initiative will launch in phases. Materials already released include a new website, fact sheets, infographics and videos. Supplementary science curriculum for high schools, resources for health professionals and additional consumer materials will be released later this year and in 2021.

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How children can learn to balance science and religion – The Conversation UK

March 11th, 2020 12:51 pm

It sometimes feels like society is permanently at loggerheads, divided over any number of issues, from genetic engineering and vaccines to euthanasia and religion, and unable to engage in productive exchanges across ideological divides.

Consequently, if education is to develop the next generation, it must nurture children as future citizens with the capacity to have productive conversations across these barriers of opinion and discipline.

We are often faced with big questions. But beyond the eternal questions concerning how life came into being and its purpose, there are more immediate concerns about which there will need to be decisions from citizens and leaders both now and in the future. How should we respond to climate change? Should government be allowed to quarantine people to prevent the spread of disease? Should euthanasia of terminally ill children be allowed?

Responses to questions such as these can be informed by science, as well as by ethics, philosophy and religion. But how can we generate a well reasoned argument using a range of diverse and often contradictory sources? And how can we develop childrens ability to do so, too? Children, after all, are the future.

First, children need to explore what an argument is, and what a good argument looks like within the subject they are studying. Put simply, an argument is a claim or set of claims supported by evidence and reasons, while a good argument is one justified by strong reasons and evidence that are relevant to the claim. But how do these arguments differ when it comes to the study of science and religious education (RE) in school?

The teaching and learning of arguments in science subjects has been extensively researched over the past 20 years. Academic textbooks and practical resources for teaching have been produced to support it.

But while RE curriculum documents often cite the need for students to produce well reasoned arguments, there has been far less research on and fewer resources for the teaching and learning of arguments within the subject.

One distinguishing feature between arguments in different subject areas is what is considered to be an acceptable reason. In the case of arguments in RE, what counts as a reason can be less defined and evidence-based than in the sciences, particularly when the focus may be on providing a safe space for expressing beliefs and respecting diversity, rather than on constructing persuasive arguments.

So what can be done about this and how can we ensure that children studying the two subject areas can better argue with one another? The Oxford Argumentation in Religion and Science (OARS) project brings the expertise of working science and RE teachers together, in collaboration with academic researchers. The project is exploring potential approaches for cross-curricular work across these disciplines, producing resources to support the teaching and learning of argument and reasoning in schools.

Our project team suggests that there are at least three good reasons to engage in cross-curricular teaching of argument and reasoning.

First, the subject groups can learn useful lessons from each other. Science teachers can draw on the skills of RE teachers for whom discussion, debate and dialogue are core features of their curriculum and daily work. RE teachers, on the other hand, could benefit by drawing on the well established resources and structure for teaching scientific arguments. They may also draw upon science teachers expertise when exploring scientific ideas and worldviews in RE.

Second, for the range of issues that might draw on both scientific and religious arguments for example, abortion, end-of-life decisions, evolution cross-curricular teaching could help develop a students capacity to discern the difference between those based on scientific evidence and those based more on faith and belief. It could also further their ability to accept and learn from other worldviews.

Finally, this work could extend across the whole school curriculum and bring greater coherence between school subjects. Learning about arguments in different subjects can make clear what is distinctive about each subject area (for example, highlighting the features of scientific arguments that make them distinctly scientific, as compared to other subjects). It can also highlight what features of arguments are common across specialities, showing how different subjects across the curriculum are related.

There is no single way that this cross-curricular collaboration could be rolled out in schools. Indeed, our participating teachers are innovative in finding approaches that work within the bounds of their busy, and often different, school lives.

In one example, an RE teacher and a science teacher are exploring the same question in their separate subject lessons: Why should we act on climate change? Students are asked to construct arguments using information that they have been learning in each subject, before combining these separate arguments from religion and science to present a convincing and coherent answer that draws on both disciplines.

We do not have all the answers and our work is ongoing. But we are convinced of the importance of learning how to argue and how to engage with others arguments for the sake of better scientific literacy, better religious literacy, and to create better citizens. Ultimately, it is about having productive discussions about what often appear to be unbridgeable divides and unanswerable dilemmas and to bring people together in the process.

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How children can learn to balance science and religion - The Conversation UK

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FDA, EPA and USDA launch GMO education initiative – New Food

March 11th, 2020 12:51 pm

The initiative aims to educate consumers about GMOs, including their production processes, their health information and other safety-related questions.

The US Food and Drug Administration (FDA), in collaboration with the US Environmental Protection Agency (EPA) and the US Department of Agriculture (USDA), have launched a new initiative to help consumers better understand foods created through genetic engineering, commonly called GMOs or genetically modified organisms.

The initiative, Feed Your Mind, aims to answer the most common questions that consumers have about GMOs, including what GMOs are, how and why they are made, how they are regulated and to address health and safety questions that consumers may have about these products.

While foods from genetically engineered plants have been available to consumers since the early 1990s and are a common part of todays food supply, there are a lot of misconceptions about them, said FDA Commissioner, Stephen M. Hahn, M.D. This initiative is intended to help people better understand what these products are and how they are made. Genetic engineering has created new plants that are resistant to insects and diseases, led to products with improved nutritional profiles, as well as certain produce that dont brown or bruise as easily.

Farmers and ranchers are committed to producing foods in ways that meet or exceed consumer expectations for freshness, nutritional content, safety, sustainability and more. I look forward to partnering with FDA and EPA to ensure that consumers understand the value of tools like genetic engineering in meeting those expectations, said Greg Ibach, Under Secretary for Marketing and Regulatory Programs at USDA.

As EPA celebrates its 50th anniversary, we are proud to partner with FDA and USDA to push agricultural innovation forward so that Americans can continue to enjoy a protected environment and a safe, abundant and affordable food supply, said EPA Office of Chemical Safety and Pollution Prevention Assistant Administrator, Alexandra Dapolito Dunn.

The Feed Your Mind GMO initiative is launching in phases. The current materials released include a new website, as well as a selection of fact sheets, infographics and videos. Additional materials including a supplementary science curriculum for schools, resources for health professionals and additional consumer materials will be released later in 2020 and 2021.

To guide development of the Feed Your Mind initiative, the three government agencies formed a steering committee and several working groups consisting of agency leaders and subject matter experts; sought input from stakeholders through two public meetings; opened a docket to receive public comments; examined the latest science and research related to consumer understanding of genetically engineered foods; and conducted extensive formative research. Funding for Feed Your Mind was provided by Congress in the Consolidated Appropriations Act of 2017 as the Agricultural Biotechnology Education and Outreach Initiative.

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