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Heading into 2020, Sickle Cell Community Welcomes Next Generation of Treatment – Morning Consult

December 10th, 2019 5:46 pm

The nascent field of gene therapy, which hit its stride this year, has unlocked an opportunity for tackling sickle cell that was inconceivable just years ago, experts said. While hydroxyurea, the de-facto standard of treatment since its 1998 approval, can meaningfully reduce the frequency of pain crises, potentially curative treatments offer hope of eliminating crises altogether.

Over the weekend, ASH released its highly awaited full set of new clinical guidelines for sickle-cell treatment the most comprehensive slate of recommendations to date with even more nearing completion.

Since the passage of the Orphan Drug Act of 1983 provided financial incentive for pharmaceutical companies to focus on rare diseases, experts have been troubled by a lack of consistency in evaluation of clinical trials. The new guidelines come as drugmakers such as GBT, Novartis and Bluebird establish themselves in this space, offering researchers a uniform, measurable framework for trials to demonstrate the value of their experimental treatments.

All stakeholders agreed that this is only the beginning. Orphan drugs are estimated to comprise one-fifth of global prescription sales by 2024, according to EvaluatePharma, and blood is the leading therapeutic area by sales and market share.

As with any new drugs, uncertainties on cost loom. But experts swiftly rejected the idea that those concerns should dampen the renewed energy around tackling sickle cell, and said attempts to do so may be rooted in prejudice given sickle cells disproportionate impact on black communities.

Therapies for cancers, cystic fibrosis and hemophilia are routinely priced in the hundreds of thousands and even millions, Osunkwo said. The fact that those treatments are widely celebrated as worthwhile endeavors, while the cost of gene therapy for sickle cell is under a microscope before even winning approval, is stigmatizing and rooted in conscious bias, she said.

Both Novartis and GBT said they are actively talking with payers to facilitate coverage for their drugs, both priced around $100,000 per year, and are taking steps to shoulder some of the burden with their own patient support centers.

We should have at least another two drugs, if not more, by next year, Osunkwo said. The sickle cell community is riled up, ready to participate in clinical trials and do what it takes to get more tools in their treatment toolbox. And theyre ready to speak out about how unfair health care and research has been to their cause.

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Orgenesis and Theracell to Launch Point of Care Cell and Gene Therapy Centers within HYGEIA Group’s Hospital Network in Greece – GlobeNewswire

December 10th, 2019 5:46 pm

GERMANTOWN, Md., Dec. 06, 2019 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS)(Orgenesis or the Company), a leading cell and gene therapy enabling company providing centralized CDMO manufacturing and development services through its subsidiary Masthercell Global, Inc., as well as localized point-of-care(POCare) development and processing centers for therapeutic treatments, today announced a strategic partnership agreement (Partnership) between the HYGEIA Group and the TheracellOrgenesis joint venture (JV). Under the Agreement, the JV will implement Orgenesis POCare cell therapy platform for clinical development and commercialization of cell and gene therapies within HYGEIA Groups network of three hospitals in Greece. As previously announced, Orgenesis and TheraCell Advanced Biotechnology formed a JV to advance Orgenesis POCare platform in Greece, Cyprus, the Balkan region and selected Middle Eastern countries.

The POCare platform is designed to collect, process and supply cells within the patient care setting for various therapeutic treatments. The goal of the platform is to reduce the cost and complexity of supplying cell and gene therapies, as well as elevate quality standards by integrating automated processing units and proprietary technologies.

HYGEIA is the first hospital network in this region to implement Orgenesis POCare cell therapy platform. The Partnership is intended to provide HYGEIA Group with resources to advance clinical development and deliver personalized, advanced therapies across its network for a wide range of diseases in oncology, hematology, orthopedics, nephrology, dermatology and diabetes.

This partnership with the HYGEIA Group further validates the significant value proposition of our POCare platform, as it enables the development and delivery of cell and gene therapies onsite at hospitals. We believe this platform has the potential to transform the cell and gene therapy market, by bringing life-saving therapies to market in a much more time and cost-effective manner, said Vered Caplan, CEO of Orgenesis. Theracell has proven to be an ideal partner with extensive experience and capabilities in autologous cell therapy and regenerative medicine, with operations in Greece and strong relationships throughout the region. We are in active discussions to establish PoCare locations and partnerships with hospitals and healthcare networks in other countries and regions across the world.

Andreas Kartapanis, CEO, HYGEIA Group, commented, HYGEIA Group is honored to work with Theracell and Orgenesis to become the first hospital network in Greece to provide advanced cell and gene therapies for both clinical research and patient treatment utilizing the POCare platform. We believe this Partnership will provide us a strong competitive advantage in this rapidly developing field. More importantly, this Partnership will benefit patients that will now have greater access to these important therapies.

About HYGEIA Group

HYGEIA Group operates three hospitals in Greece, with a total capacity of 1,261 beds, 52 operating rooms, 19 delivery rooms and 10 intensive care units. More than 3,100 employees and approximately 3,900 associate physicians offer their services to the HYGEIA Group, which was founded in 1970 by medical doctors, most of which were professors at the University of Athens and have since been active in providing primary and secondary care services. The following hospitals are also part of the HYGEIA Group: MITERA General, Obstetrics - Gynecology & Pediatrics Hospital and LITO Obstetrics, Gynecology & Surgical Center, licensed for 459 and 100 hospital beds, respectively.

About Theracell

TheraCell is a regenerative biotechnology company with operations in Greece, where its laboratories and primary facilities are located. The Company focuses in the areas of autologous cell therapy and regenerative medicine. TheraCell has extensive experience in the isolation, processing and application of adipose derived stem cells (ADSCs), as well as somatic cells and has developed a patented platform for tissue engineering and cell therapies in the areas of Dermatology, Chondral Defects and Chronic Kidney Injury.

About Orgenesis

Orgenesis is a biopharmaceutical company specializing in the development, manufacturing and processing of technologies and services in the cell and gene therapy industry. The Company operates through two platforms: (i) a point-of-care (POCare) cell therapy platform (PT) and (ii) a Contract Development and Manufacturing Organization (CDMO) platform conducted through its subsidiary, Masthercell Global. Through its PT business, the Companys aim is to further the development of Advanced Therapy Medicinal Products (ATMPs) through collaborations and in-licensing with other pre-clinical and clinical-stage biopharmaceutical companies and research and healthcare institutes to bring such ATMPs to patients. The Company out-licenses these ATMPs through regional partners to whom it also provides regulatory, pre-clinical and training services to support their activity in order to reach patients in a point-of-care hospital setting. Through the Companys CDMO platform, it is focused on providing contract manufacturing and development services for biopharmaceutical companies. Additional information is available at: http://www.orgenesis.com.

Notice Regarding Forward-Looking StatementsThis press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, the success of our reorganized CDMO operations, the success of our partnership with Great Point Partners, our ability to achieve and maintain overall profitability, the sufficiency of working capital to realize our business plans, the development of our transdifferentiation technology as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes; our technology not functioning as expected; our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new procedures; our competitors developing better or cheaper alternatives to our products and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended November 30, 2018, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.

Investor contact for Orgenesis:David WaldmanCrescendo Communications, LLCTel: 212-671-1021Orgs@crescendo-ir.com

Media contact for Orgenesis:Image Box CommunicationsNeil Hunter / Michelle BoxallTel +44 20 8943 4685neil@imageboxpr.co.uk/michelle@imageboxpr.co.uk

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Abeona Therapeutics Cleared to Initiate Pivotal Phase 3 Clinical Trial Evaluating EB-101 Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa |…

December 10th, 2019 5:46 pm

DetailsCategory: DNA RNA and CellsPublished on Tuesday, 10 December 2019 11:11Hits: 187

FDA removes clinical hold; Company may proceed with VIITALstudy

Company expects to initiate study in the first quarter of 2020

Primary endpoint confirmed as proportion of wounds with greater than 50% healing at 3 months vs control wounds

Majority of potential subjects have been pre-screened for the study

NEW YORK, NY and CLEVELAND, OH, USA I December 09, 2019 I Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that the U.S. Food and Drug Administration (FDA) has removed its clinical hold and provided clearance to proceed with the VIITALstudy, the Companys pivotal Phase 3 clinical trial evaluating EB-101 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The FDA removed the clinical hold following the Companys submission of additional data points on transport stability of EB-101 to clinical sites. Abeona expects to initiate the VIITALstudy in first quarter of 2020.

The Abeona team has worked diligently to provide a prompt and thorough response to the FDA, enabling us to proceed with our pivotal Phase 3 trial for EB-101, said Joo Siffert, M.D., Chief Executive Officer of Abeona. Recently published long-term follow up data from our Phase 1/2 trial leaves us increasingly confident that EB-101 can provide durable healing for large, chronic wounds that afflict many RDEB patients. We are now focused on initiating the VIITALstudy in the first quarter of 2020. The success in building and qualifying a state-of-the-art GMP manufacturing facility also represents a critical step toward bringing this novel product to patients in dire need of effective treatment.

With two to five years of follow-up, data from a Phase 1/2 clinical trial conducted by Stanford University evaluating EB-101 showed that the gene-corrected cell therapy provided durable wound healing for RDEB patients, including for the largest, most challenging wounds that constitute the majority of wounds in this population.

About The VIITALStudyThe VIITALPhase 3 study will be a multi-center, randomized clinical trial assessing EB-101 in 10 to 15 RDEB patients, with approximately 30 chronic wound sites treated in total. The primary study endpoint will be the proportion of wounds with greater than 50% healing at three months, comparing treated with untreated wound sites on the same patient. Secondary endpoints include the patients global impression of change in pain from baseline as well as other patient reported outcomes assessing pain during dressing changes, pain impact and physical function.

About EB-101 EB-101 is an autologous, gene-corrected cell therapy in late-stage clinical development for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder without an approved therapy. Treatment with EB-101 involves using gene transfer to deliver COL7A1 genes into a patients own skin cells (keratinocytes) and transplanting them back to the patient to enable normal Type VII collagen expression and facilitate wound healing. In the U.S., Abeona holds Regenerative Medicine Advanced Therapy, Breakthrough Therapy, and Rare Pediatric designations for EB-101 and Orphan Drug designation in both the U.S. and EU.

About Recessive Dystrophic Epidermolysis BullosaRecessive dystrophic epidermolysis bullosa (RDEB) is a rare connective tissue disorder characterized by severe skin wounds that cause pain and can lead to systemic complications impacting the length and quality of life. People with RDEB have a defect in the COL7A1 gene, leaving them unable to produce functioning Type VII collagen which is necessary to anchor the dermal and epidermal layers of the skin. There is currently no approved treatment for RDEB.

About Abeona TherapeuticsAbeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. The Companys clinical programs include EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa, as well as ABO-102 and ABO-101, novel AAV9-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively. The Companys portfolio of AAV9-based gene therapies also features ABO-202 and ABO-201 for CLN1 disease and CLN3 disease, respectively. Its preclinical assets include ABO-401, which uses the novel AIM AAV vector platform to address all mutations of cystic fibrosis. Abeona has received twenty regulatory designations from the FDA and EMA for its pipeline candidates. For more information, visit http://www.abeonatherapeutics.com.

SOURCE: Abeona Therapeutics

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Drug Launch of the Year: Zolgensma – BioPharma Dive

December 10th, 2019 5:46 pm

Up until three years ago, Vamshi Rao didn't have any treatments to offer the families of babies born with a genetic disease that meant they likely wouldn't live past the age of two.

No medicines existed for the degenerative condition called spinal muscular atrophy, or SMA. So Rao, a neurologist at the Lurie Children's Hospital of Chicago, could only help manage expectations and day-to-day care.

His role, and that of other physicians, changed dramatically in 2016, when Biogen's Spinraza became the first drug to win U.S. approval for the condition, and then again this May, when the Food and Drug Administration cleared a gene therapy called Zolgensma.

Rao can now give families options that represent a realistic shot at a longer, better life for babies with SMA.

"We've never been in this situation before," he said in a September interview.

Between May and October, about 100 families facing the diagnosis opted for Zolgensma, just the second gene therapy for an inherited disease to reach commercial markets in the U.S. Unlike Spinraza, Zolgensma is designed to be a one-time treatment and, possibly, a cure.

Several of those infants were treated at Lurie Children's, where Rao is also helping run clinical studies sponsored by Novartis, the Swiss pharmaceutical company that sells Zolgensma. About 50 other U.S. institutions have administered Zolgensma commercially, outside of clinical testing.

Approval was a major accomplishment in a field that had for decades held the potential to develop curative fixes for devastating genetic disorders like SMA.

But its arrival clouded by a scandal over manipulated animal testing data submitted by Novartis made real once theoretical concerns over how patients will receive and pay for expensive, one-time therapies.

Infused via inactivated, hollowed-out viruses, Zolgensma replaces the missing or defective gene that causes SMA to develop. Infants in the Phase 1 study used to win approval could sit up independently, stand and, in two cases, even walk in the months and years after receiving Zolgensma functional milestones that wouldn't have been reached otherwise.

Whether Zolgensma can actually be a cure won't be known definitively for years. But in theory it could be if given to infants early enough, before their affected neurons start to die, says Jerry Mendell of Nationwide Children's Hospital in Ohio, who led the first study of what would become Zolgensma.

The promise of lifelong benefit was central to Novartis' justification for pricing Zolgensma at $2.1 million per patient, more than any other drug before it.

While insurers initially balked at covering such a pricey, one-time treatment, Novartis says coverage is now in place for 90% of eligible patients on commercial plans and 30% of those on Medicaid.

"It's clear that payers are not happy here, but they have largely relented," said Ronny Gal, an analyst at Bernstein, in an interview.

"It's hard to push against a drug that takes a kid who would die and allows him to live. But for products that are less efficacious, I'd expect pushback."

Hoping to ease insurer concerns, Novartis offered to spread Zolgensma's cost over five years, and is working to set up agreements linking reimbursement to patient outcomes. While the latter option has proved popular, none have yet taken up the drugmaker on its pay-over-time proposal, said Dave Lennon, CEO of AveXis, the biotech developer of Zolgensma that Novartis bought for $8.7 billion last year, in an interview.

Also helping the pharma's case to insurers was an estimate from the Institute for Clinical and Economic Review that judged Zolgensma, if given very early, could be cost-effective at a price between $1.2 million and $2.1 million. (A more conservative finding by ICER, however, put Zolgensma's cost-effective price at just under $900,000.)

"Certainly you see now the methodology that ICER is using and the concept of value-based pricing is an extremely important part of the discussions with payers," said Lennon.

Yet early treatment, before symptoms arise, is dependent on genetic screening for SMA. While the federal government has recommended the condition be tested for in newborns since July 2018, only 15 states are currently doing so. Two more, Michigan and Colorado, are expected to soon begin screening.

Nami Sumida/BioPharma Dive

"When states puts these programs in place, we do see much higher utilization in newborns of therapies, at rates that are sometimes three times as high as states that don't have newborn screening," said Lennon.

While Zolgensma's early market success suggests a one-time gene therapy can be commercialized, Novartis has also benefited from both SMA's rarity and the cost of existing treatment in winning over insurers.

In the U.S., only about 500 babies are born each year with SMA, 60% of whom are diagnosed with the most severe form, called Type 1. That's a much smaller population than other rare genetic conditions like hemophilia and sickle-cell disease, the target of other gene therapy programs in Phase 3 trials.

And Spinraza costs $750,000 for the first year of treatment, and $375,000 thereafter potentially making $2.1 million more palatable if Zolgensma truly is a one-and-done treatment.

Novartis' achievement, however, is marred by a damaging data scandal that's put both the drug and company under scrutiny.

When submitting the application for FDA approval, Novartis included testing data from preclinical mice studies that was manipulated, it turned out, by (or at the behest of) top AveXis officials. Novartis management knew of the falsified data in March, but filed Zolgensma anyway.

In a show of its displeasure and a signal to other developers, the FDA warned Novartis of potential civil or criminal penalties, pending an investigation that has yet to complete. Zolgensma, however, could stay on the market, and the FDA affirmed the therapy's positive benefit-risk profile.

Novartis ousted the AveXis executives it says were to blame, and has sped up the integration of the biotech into its own quality control organization.

"Quality, in the grandest scheme, is always a journey," said AveXis' Lennon. "While we've accelerated this, we don't see an end to our commitment to quality improvement."

Months after addressing that controversy, the FDA placed partially on hold a study of Zolgensma due to concerns over toxicity seen in animals, possibly tied to how the therapeutic gene was delivered. The regulatory action revived previously raised warnings about the risk of inflammation in certain neurons exposed to a virally delivered gene.

In both respects, Zolgensma could be a case study in the risks as well as rewards involved for large pharmaceutical companies looking to get into gene therapy.

"This is one of the first gene therapies," said Gal. "We don't have a lot of experience infusing viral particles into the brain."

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Why AI Will Be the Best Tool for Extending Our Longevity – Singularity Hub

December 10th, 2019 5:45 pm

Dmitry Kaminskiy speaks as though he were trying to unload everything he knows about the science and economics of longevityfrom senolytics research that seeks to stop aging cells from spewing inflammatory proteins and other molecules to the trillion-dollar life extension industry that he and his colleagues are trying to fosterin one sitting.

At the heart of the discussion with Singularity Hub is the idea that artificial intelligence will be the engine that drives breakthroughs in how we approach healthcare and healthy aginga concept with little traction even just five years ago.

At that time, it was considered too futuristic that artificial intelligence and data science might be more accurate compared to any hypothesis of human doctors, said Kaminskiy, co-founder and managing partner at Deep Knowledge Ventures, an investment firm that is betting big on AI and longevity.

How times have changed. Artificial intelligence in healthcare is attracting more investments and deals than just about any sector of the economy, according to data research firm CB Insights. In the most recent third quarter, AI healthcare startups raised nearly $1.6 billion, buoyed by a $550 million mega-round from London-based Babylon Health, which uses AI to collect data from patients, analyze the information, find comparable matches, then make recommendations.

Even without the big bump from Babylon Health, AI healthcare startups raised more than $1 billion last quarter, including two companies focused on longevity therapeutics: Juvenescence and Insilico Medicine.

The latter has risen to prominence for its novel use of reinforcement learning and general adversarial networks (GANs) to accelerate the drug discovery process. Insilico Medicine recently published a seminal paper that demonstrated how such an AI system could generate a drug candidate in just 46 days. Co-founder and CEO Alex Zhavoronkov said he believes there is no greater goal in healthcare todayor, really, any venturethan extending the healthy years of the human lifespan.

I dont think that there is anything more important than that, he told Singularity Hub, explaining that an unhealthy society is detrimental to a healthy economy. I think that its very, very important to extend healthy, productive lifespan just to fix the economy.

The surge of interest in longevity is coming at a time when life expectancy in the US is actually dropping, despite the fact that we spend more money on healthcare than any other nation.

A new paper in the Journal of the American Medical Association found that after six decades of gains, life expectancy for Americans has decreased since 2014, particularly among young and middle-aged adults. While some of the causes are societal, such as drug overdoses and suicide, others are health-related.

While average life expectancy in the US is 78, Kaminskiy noted that healthy life expectancy is about ten years less.

To Zhavoronkovs point about the economy (a topic of great interest to Kaminskiy as well), the US spent $1.1 trillion on chronic diseases in 2016, according to a report from the Milken Institute, with diabetes, cardiovascular conditions, and Alzheimers among the most costly expenses to the healthcare system. When the indirect costs of lost economic productivity are included, the total price tag of chronic diseases in the US is $3.7 trillion, nearly 20 percent of GDP.

So this is the major negative feedback on the national economy and creating a lot of negative social [and] financial issues, Kaminskiy said.

That has convinced Kaminskiy that an economy focused on extending healthy human lifespansincluding the financial instruments and institutions required to support a long-lived populationis the best way forward.

He has co-authored a book on the topic with Margaretta Colangelo, another managing partner at Deep Knowledge Ventures, which has launched a specialized investment fund, Longevity.Capital, focused on the longevity industry. Kaminskiy estimates that there are now about 20 such investment funds dedicated to funding life extension companies.

In November at the inaugural AI for Longevity Summit in London, he and his collaborators also introduced the Longevity AI Consortium, an academic-industry initiative at Kings College London. Eventually, the research center will include an AI Longevity Accelerator program to serve as a bridge between startups and UK investors.

Deep Knowledge Ventures has committed about 7 million ($9 million) over the next three years to the accelerator program, as well as establishing similar consortiums in other regions of the world, according to Franco Cortese, a partner at Longevity.Capital and director of the Aging Analytics Agency, which has produced a series of reports on longevity.

One of the most recent is an overview of Biomarkers for Longevity. A biomarker, in the case of longevity, is a measurable component of health that can indicate a disease state or a more general decline in health associated with aging. Examples range from something as simple as BMI as an indicator of obesity, which is associated with a number of chronic diseases, to sophisticated measurements of telomeres, the protective ends of chromosomes that shorten as we age.

While some researchers are working on moonshot therapies to reverse or slow agingwith a few even arguing we could expand human life on the order of centuriesKaminskiy said he believes understanding biomarkers of aging could make more radical interventions unnecessary.

In this vision of healthcare, people would be able to monitor their health 24-7, with sensors attuned to various biomarkers that could indicate the onset of everything from the flu to diabetes. AI would be instrumental in not just ingesting the billions of data points required to develop such a system, but also what therapies, treatments, or micro-doses of a drug or supplement would be required to maintain homeostasis.

Consider it like Tesla with many, many detectors, analyzing the behavior of the car in real time, and a cloud computing system monitoring those signals in real time with high frequency, Kaminskiy explained. So the same shall be applied for humans.

And only sophisticated algorithms, Kaminskiy argued, can make longevity healthcare work on a mass scale but at the individual level. Precision medicine becomes preventive medicine. Healthcare truly becomes a system to support health rather than a way to fight disease.

Image Credit: Photo byh heyerleinonUnsplash

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Reba McEntire Shares Her Secrets on Success, Longevity, and Staying Humble – Thrive Global

December 10th, 2019 5:45 pm

Global star and widely loved country music artist, actress, and humanitarian Reba McEntire celebrates her 16th Grammy Award nomination this year for her album, Stronger Than The Truth, which has resonated deeply within the country music community. One of the greatest selling country artists of all time, McEntire has previously won the Grammy Award for Best Female Country Vocal Performance, Best Country Vocal Collaboration, and Best Roots Gospel Album, and she has also been nominated for a Golden Globe award and more.

We sat down with the reigning Queen of Country Music to talk her Best Country Album nomination, how she turned her passion into a hugely successful career that has spanned over four decades, and advice for other female artists. You can tune into the 62nd Grammy Awards on January 26, 2020.

Where were you when you received the news of your 16th Grammy Award nomination?

I was at home in Nashville and my phone started blowing up around 7:30 a.m., right as the nominations were announced. My entire team texted me to let me know the news! There were a lot of excited emojis!

How does this years Best Country Album nomination compare to the one you received in 1994 for Read My Mind?

Im incredibly proud of both albums. I still love music now just as much as I did then, and I still follow the same formula I did then pick great songs that touch my heart and hopefully theyll touch yours, too.

How does this nomination stand out amongst the other 15 you have previously received?

I wanted to go back to my roots on this album and make a stone-cold country album with great story songs. To be recognized for that some 30 years after my very first nomination is pretty special. Its just icing on the already really wonderful cake.

What about Stronger Than The Truth do you think resonated with the Recording Academy?

Its honest and authentic. Its full of songs that tell stories that I think anyone can relate to.

From your first nomination (and win) in 1986 to now, the 2020 Grammys, how has your outlook on awards and accolades changed?

Im still as competitive as Ive always been, but the pressure is less now. Of course I love to win awards, who doesnt? But now I take pride in knowing that Ive made the best album that I possibly could and that is my reward, whether I take home a trophy or not.

Many of the songs on your album have been on your radar for years. How does it feel to see these songs officially having their moment of recognition?

Im just thrilled to see great songs being recognized, and Im thankful for all the writers letting me be the conduit for their work.

How does it feel to have your music consistently recognized for over three decades?

Well it feels great! I, and my entire team, work very hard to put out music that means something and connects with the listener. Im beyond grateful to still have the platform that I do and I take it very seriously.

Thats why I do this I want the music and the songs to reach out and touch people and make them feel like theyre not alone and that someone else understands.

You most recently took home the award for Best Roots Gospel Album in 2017. How have you incorporated your faith into your country records, and what similarities do you see between the genres?

My faith is part of everything I do. I pray every day that the Lord will use me and guide me in my all my decisions. I may not be singing directly about God and Jesus, but that doesnt mean the ideas arent there. Songs like You Never Gave Up On Me on this record could be about someones relationship with the Lord. Theres always been an overlap between Christian and country, and I think there always will be.

Stronger Than The Truth is your 33rd studio album a tribute to your success and fame. What has allowed you to remain grounded? How do you not let the pressures of success change you?

My family and my friends keep me grounded. No ones going to let my head get too big and they bring me back down to Earth real quick if I get to floating off too far. My sister, Alice, gave me a toilet seat cover one time for Christmas that on the top said, The Twinkle! So Im still working on being that star.

What has been the most unexpected joy you have received from creating this album?

Hearing how the songs have touched peoples hearts. Ive had people tell me they couldnt listen to the entire album through at one time because it was just too emotional for them. Thats why I do this I want the music and the songs to reach out and touch people and make them feel like theyre not alone and that someone else understands.

What things have industry peers shared with you about how they feel about this album that have surprised you? Is there anything that you didnt expect?

Ive had people come to me in tears with how much the songs have impacted them. I was just trying to make a great country record, and if people cry, that means we have touched their hearts. Making that connection is sweet.

What do you think sets you and this album apart from the other nominees?

I think weve all made really great albums, but were all very different and in different stages of our careers. I think its really great to see such diversity represented in the category with all types of country music.

Are there any moments from your past Grammy experiences that stand out to you? If so, what are they?

Winning the Grammy for Sing It Now is something Ill never forget. I made that record as a way to heal my own heart, and to see it connect with so many other people and then be recognized in that way meant the world to me.

What does it mean to you to be nominated for Best Country Album this year?

I dont take it for granted. There are a lot of great artists making incredible music out there every day, and I feel very honored to have my work recognized as standing out among the crowd.

If you could share one piece of advice with female artists getting their start, what would it be?

Stay true to your gut instincts. Ive always felt that is Gods way of directing me. Stay with the type of music you want to be making and what type of artist you want to be. Stand your ground and make music that youre proud of. Everything else will work itself out. Work hard, show up on time, be prepared and have fun!

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MYOS to Introduce its Longevity Business with its Physician Muscle Health Formula at the World Congress on Anti-Aging Medicine in Las Vegas December…

December 10th, 2019 5:45 pm

Product Leverages Fortetropin's Impact on Increasing the Rate of Muscle Protein Synthesis to Increase Muscle Mass and Strength for Improved Longevity

CEDAR KNOLLS, N.J., Dec. 10, 2019 /PRNewswire/ --MYOS RENS Technology, Inc. ("MYOS" or "the Company") (NASDAQ: MYOS), an advanced nutrition company and the owner of Fortetropin, a proprietary bioactive composition made from fertilized egg yolk that helps build lean muscle, announced today that it will launch its longevity business with the introduction of its Physician Muscle Health Formula at the 27thWorld Congress on Anti-Aging Medicine (https://www.a4m.com/las-vegas-december-2019.html) in Las Vegas, Nevada from December 13-15, 2019; MYOS will be in Booth #2090. Considered the largest event in anti-aging medicine, the World Congress is expected to draw approximately 4,000 Medical Professionals and 300 Exhibitors from around the world.

Earlier this year, MYOS announced that in a clinical trial involving 60-75-year-old men and women, subjects who consumed Fortetropin on a daily basis experienced an increase of approximately 15% in the rate of muscle protein synthesis when compared with subjects who received a macronutrient-matched placebo. The results from this clinical trial will be presented by its principal investigator, William J. Evans, Ph.D., Adjunct Professor of Nutrition, University of California, Berkeley at the International Conference on Frailty & Sarcopenia Research on March 11, 2020 in Toulouse, France.

Encouraged by positive results from this clinical study and previous studies showing that Fortetropin increases muscle mass and strength, MYOS decided to formally launch its longevity business by introducing its branded product, Physician Muscle Health Formula. This product will be distributed through medical practices focused on anti-aging medicine across the United States. In addition, the Company will also debut a private labeling service. This service will enable physicians to develop their own Fortetropin-based nutrition products in consultation with the Company's scientists and engineers, leveraging our portfolio of scientific research and clinical trials. Members of MYOS' scientific and business development staff will be at the Company's booth (#2090) to meet with medical professionals and discuss opportunities for collaboration.

"Fortetropin has remarkable potential to improve human longevity and we are pleased to share our advancements on improving muscle health at the upcoming World Congress on Anti-Aging Medicine later this week," commented Joseph Mannello, CEO of MYOS. "Maintaining muscle mass and health plays a vital role in supporting an excellent quality of life as we get older and has been shown in numerous respected publications to be associated with improved longevity. Muscle plays a central role in movement, energy metabolism and bone health. The beauty of MYOS' approach to addressing muscle health is that our products are all-natural nutrition products that capitalize on a patented manufacturing process and are backed by a large body of preclinical and human clinical research," added Mr. Mannello.

About MYOS RENS Technology Inc. MYOS RENS Technology Inc. (MYOS), "The Muscle Company", is a Cedar Knolls, NJ-based advanced nutrition company that develops and markets products that improve muscle health and performance. MYOS is the owner of Fortetropin, a fertilized egg yolk-based product manufactured via a proprietary process to retain and optimize its biological activity. Fortetropin has been clinically shown to increase muscle size, lean body mass and reduce muscle atrophy. MYOS believes Fortetropin has the potential to redefine existing standards of physical health and wellness. For more information, please visit http://www.myosrens.com.

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About Fortetropin Fortetropin works in conjunction with your protein of choice to help your body utilize that protein more efficiently. Fortetropin is made through a patented process that maintains the vital nutrients of fertilized egg yolks to help build more lean muscle and decrease muscle loss. For more information, please visit http://www.myosrens.com.

Forward-Looking Statements Any statements in this release that are not historical facts are forward-looking statements. Actual results may differ materially from those projected or implied in any forward-looking statements. Such statements involve risks and uncertainties, including but not limited to those relating to product and customer demand, market acceptance of our products, the ability to create new products through research and development, the successful results of strategic initiatives, the success of our products, includingQurr, Yolked, MYOS Canine Muscle Formula, Physician Muscle Health Formulaand MYOS Enteral NutritionFormula, the success of our research and development, the results of the clinical evaluation ofFortetropinand its effects, the ability to enter into new partnership opportunities and the success of our existing partnerships, the ability to generate revenue and cash flow from sales of our products, the ability to increase our revenue and gross profit margins, the ability to achieve a sustainable, profitable business, the effect of economic conditions, the ability to protect our intellectual property rights, competition from other providers and products, the continued listing of our securities on the Nasdaq Stock Market, risks in product development, our ability to raise capital to fund continuing operations, and other factors discussed from time to time in our filings with the Securities and Exchange Commission. We undertake no obligation to update or revise any forward-looking statement for events or circumstances after the date on which such statement is made except as required by law.

Investor Relations: Porter LeVay & Rose Matthew Abenante, IRC, SVP Phone: 212-564-4700 Email: MYOS@plrinvest.com

(PRNewsfoto/MYOS RENS Technology)

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Federal Agencies, Nonprofits and Global Companies Connect with Tech Entrepreneurs, Investors at Innovation in Longevity Summit Convened in Nation’s…

December 10th, 2019 5:45 pm

WASHINGTON, Dec. 5, 2019 /PRNewswire/ -- The Washington Innovation in Longevity Summit (WIN) happening here December 9-10 at the National Press Club and produced by Mary Furlong & Associates, is the only conference that brings together a highly curated audience focused on solutions, partnerships, best practices and trends driving the $7.6 trillion U.S. longevity economy. The event is unique in that it selects the top innovators in aging technology backed by leading longevity market investors to share insights, learn from and connect with the federal agencies, private companies,nonprofits and media as well as potential global partners seeking impactful and sustainable innovation to support longer lifespans worldwide.

"The longevity economy offers vast domestic and global potential for investors and entrepreneurs but there are challenges for entrants to the space," said Mary Furlong, executive producer of WIN and CEO of Mary Furlong & Associates. "Our summit is carefully curated to help attendees navigate regulatory, privacy and reimbursement issues and remain at the forefront of trends in aging while also helping innovators scale their solutions with the right U.S. and international partners."

Furlong added, "The private companies, federal agencies and nonprofits who attend also benefit by connecting with this curated collection of innovators. Since technology moves fast and so many players enter the space on a daily basis, it is a resource drain for organizations to meet with every start-up company so attending this conference cuts through the clutter to identify best of breed and pursue quicker yet quality partnerships."

Joining the notable keynote speakers Nancy LeaMond of AARP and George Vradenburg of UsAgainstAlzheimer's, will be an impressive line-up of panel speakers from the federal government: James Parker, senior advisor to the Secretary for Health Reform and director of the Office of Health Reform at the U.S. Department of Health & Human Services; Melanie Egorin, deputy health staff director, U.S. House of Representatives Committee on Ways and Means; Todd Haim, chief of the Office of Small Business Research, National Institute on Aging and Vijeth Iyengar, brain health lead and technical advisor to the Deputy Assistant Secretary

for Aging at the Administration for Community Living, U.S. Department of Health and Human

Services. They join lead investors in the longevity market, Dan Hermann, president and CEO, head of Investment Banking forZiegler Link-Age Longevity Fund and Jake Nice, principal,Nationwide Ventures; along with top aging technology entrepreneurs such as CareLinx, Posit Science, Ageless Innovation, PS Salon & Spa and 12 global companies from countries including Japan, Israel and Sweden.

"Through its small business programs, the National Institute on Aging at the National Institutes of Health provided more than $100 million in funding to start up organizations in FY 2019 alone," said Todd Haim, Ph.D., chief, NIA Office of Small Business Research. "For successful applicants, our programs are an excellent source of seed funding for the further development of innovations geared toward older adult health and well-being."

The full agenda and summit details are here. Summit registration is available here. Key sponsors for the Summit include: AARP, Ageless Innovation, CareLinx, Center for Aging + Brain Health Innovation, Sodexo, Thrive Alliance, Posit Science, Audio Cardio, LivPact, CarePredict, Stay Smart Care, LLC., AloeCare, Embodied Labs, Nationwide, It's Never Too Late, VitalTech and Home Instead.

About Mary Furlong & Associates For 17 years, Mary Furlong & Associates (MFA), headquartered in the San Francisco Bay area, has developed strategies for marketing and business development for companies focused on opportunities with the senior and baby boomer markets and the longevity economy. Dr. Furlong is the executive producer of three conferences annually: What's Next Boomer Business Summit, Silicon Valley Boomer Venture Summit, and Washington Innovation in Longevity Summit. She also co-produces What's Next Canada and is scheduled to add a fourth conference in Paris, France, focused on international aging.

Contact Information: Ben Adkins 230490@email4pr.com 502.619.4267

SOURCE Mary Furlong & Associates

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How to live longer: This diet has been proven to help you live longer and stave off cancer – Express

December 10th, 2019 5:45 pm

The age-old secret to a longer life really comes down to a healthy lifestyle including regular exercise, limiting alcohol intake, not smoking and eating a healthy balanced diet. Good nutrition is key to leading a healthy lifestyle. The foods a person eats gives the body information and materials they need to function properly. If a person eats too much food, or food that gives the body the wrong instructions, their risk of potentially life-threatening diseases increases and lifespan shortens. What is the best diet to help a person live a long, healthy life and reduce their risk of deadly diseases?

A study has been published in the JAMA Internal Medicine Journal and reignites debate around increasingly popular vegan diets amid conflicting medical advice and evidence over the impact of ones health.

The study found every three percent in calories form plant protein was found to reduce risk of death by 10 percent.

The figure rises to 12 percent for risk of dying from heart disease. By contrast, raising the share of animal protein in ones diet by 10 percent led to a two percent higher risk of death from all causes.

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Experts recommend eating more plant-based foods, such as fruits, vegetables and whole grains. Lean protein and low-fat dairy products are also recommended.

Numerous research suggests eating at least seven portions of fresh fruits and vegetables per day may lower the risk of dying from cancer by up to 15 percent.

Dr Mingyang Song said: Overall, studies have supported the importance of the sources of dietary protein for long-term health outcomes.

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Around the Bloc – 10 December – Transitions Online

December 10th, 2019 5:45 pm

Todays regional roundup: Turkey in a tizzy over NATO plans; Albania opens probe into deadly earthquake; Kazakhs and China; long-lived Azeris; and the Putin-Zelenskiy summit.10 December 2019

Ankara Threatens to Block NATOs Eastern Defense Plan

Poland will not stand for Turkey walking back its support for NATOs defense plan for Poland and the Baltics, an aide to President Andrzej Duda said yesterday. There is no going back from the decision made at the NATO summit last week, Krzysztof Szczerski told Reuters. After the summit, NATO Secretary General Jens Stoltenberg said Turkey had withdrawn its objections to the plan, although Turkish President Recep Tayyip Erdogan said Turkey expected support from the alliance in its fight against Syrian Kurdish forces it considers to be terrorists. Turkish Foreign Minister Mevlut Cavusoglu then escalated the rhetoric, saying, Ankara will block the plan until it receives a proposal for a defense plan for Turkey, which must be in line with the Turkish viewpoint on YPG, Euractiv quotes him as saying. The Syrian Kurdish YPG force is a main fighting arm of the U.S.-backed Syrian Democratic Forces, Reuters writes. Duda and Baltic defense ministers appeared to be more optimistic for a solution on the matter during the London summit, although Eastern European officials were cautious about the prospects for compromise, Euractiv writes.

Albania Counts the Toll of Deadly November Quake

The earthquake that hit Albania last month totally destroyed at least 261 buildings, Prime Minister Edi Rama said yesterday. Durres, the countrys second city, was worst hit by the 6.4-magnitude quake that struck in the early morning of 26 November. In Durres, 438 buildings are so badly damaged they must be demolished, Rama said. The quake claimed 51 lives, Xinhua reports. Some 500 engineers, along with experts from 11 countries, are inspecting the affected areas, Rama said. Last week, newly appointed Albanian Prosecutor General Olsian Cela said prosecutors in Durres had opened an investigation into who should be held responsible for the damage, Radio Tirana International reported. There are people who have violated the law and many have lost their lives. Responsibility will fall either [on] the builder or [on] the official. There will be no hesitation in any case, Cela said. The minister of state for relations with parliament, Elisa Spiropali, who is also the governments spokeswoman, said new neighborhoods will be built to replace damaged housing, RTI reports today. She also chided the media for spreading the lie that the state has no money for civil emergencies.

Two Ethnic Kazakhs Fight Deportation to China

Two ethnic Kazakhs from Chinas Xinjiang region are facing deportation from Kazakhstan in spite of warnings they could be tortured if returned to China. The men, Murager Alimuly and Qaster Musakhanuly, crossed into Kazakhstan illegally on 1 October and were given asylum seeker status at the end of the month, The Diplomat reported. But as RFE/RL writes, the deputy chief of Kazakhstans National Security Committee said last week that the pair, currently being held in pre-trial detention, will be deported. Three Kazakh opposition activists, Zhanbolat Mamai, Yrysbek Toqtasyn, and Tolegen Zhukeev, told the media yesterday the men will definitely face torture and possible death back in China. China is holding, by some estimates, a million or more Muslims in re-education camps in the predominantly Muslim Xinjiang region. Beijing has long accused the majority Uighur community in Xinjiang of Islamist and separatist tendencies. The few officials who have acknowledged the existence of the camp system say they are aimed at instilling loyalty to the regime, and deny reports that Muslims in the region are subject to persecution. Kazakhs are the second-largest Turkic-speaking community in Xinjiang, RFE writes.

Ukraine Summit Brings Scant Progress

Ukrainian President Volodymyr Zelenskiy rammed home his no-compromise position on autonomy for Russian-backed separatists in the aftermath of yesterdays meeting with the Russian, French, and German leaders. There were no new ideas on resolving the conflict in eastern Ukraine, although Zelenskiy and Russian President Vladimir Putin agreed another ceasefire in the contested Donbas region, the Financial Times writes. They made no progress on the question that has dogged peacemaking efforts throughout the nearly six years of conflict that of a special dispensation for separatist areas in the Donbas. Before elections can be held in those regions, Kyiv must regain control of their borders, Zelenskiy said at a briefing after yesterdays Paris summit, Ukraines broadcaster 112 reports. "For Ukraine, the border is a security issue; for Russia, it is a policy, he said, adding that he and Putin finally agreed on the need to talk further. The four leaders also agreed on removing all minefields, further exchanges of prisoners, and military disengagement from three areas by next March, according to the FT.

Visit Lerik, Where the Living is Easy

Azerbaijani researchers recently conducted a study of the countrys centenarians, hoping to shed light on the legendary longevity of people in some isolated areas. There are certain generations of long-living people, Sevinj Huseynova, lead researcher at the Azerbaijani Institute of Physiologys longevity laboratory, told Trend last spring, as cited by Baku-based Caspian News. If the ecological environment is good, the gene is not lost and is inherited. Inhabitants of three districts in the south, along with Nagorno-Karabakh, are longer-lived than those in and around Baku, the study found. People living in the Talysh Mountains in the southern Lerik district are famous for exceptionally long lives and Lerik town boasts the worlds only Museum of Longevity, according to CNN. This two-room exhibition was built in 1991 and renovated in 2010. Some exhibits claim to document the incredible 168-year life of shepherd Shirali Muslumov. His 95-year-old daughter, Halima Qambarova, said while she might not match his record, she at least hopes to live to the age of 150, like her grandfather, or 130, like her aunt, CNN writes. Lifespans also run long among indigenous groups in Russias North Caucasus republics, where the Ingush often live to 80, Russia Beyond has reported. On the western flank of the region, the Abkhaz are also famed for their healthful diet and long lives.

Compiled by Ky Krauthamer

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Purdue is looking for your dog to participate in a national scientific study. Here’s how. – Journal & Courier

December 10th, 2019 5:45 pm

Purdue is looking for dogs to participate in a national study on the health and wellness of dogs.(Photo: provided by Purdue)

WEST LAFAYETTE, Ind. Purdue is looking for dogs. More specifically, your dog to volunteer as a participant in a national study that will be looking at the general health and wellness of dogs.

The Dog Aging Project is a collaboration between more than 40 scientists and researchers across the U.S. and will be looking at dogs of all breeds, mixes and ages. At Purdue, Audrey Ruple, an assistant professor of One Health Epidemiology in the College of Health and Human Sciences, is one the researchers leading the study and is hoping to recruit dogs from across Indiana.

Ruple, who is a veterinary epidemiologist specializing in dogs as a model of human health, said the goal of the study is to examine factors that maximize the health and longevity of dogs, which can be linked to the health and longevity of humans.

Humans and dogs have more in common than we might think sharing 650 million base pairs of genetic information with the canines which Ruple said makes the animals useful to study human disease processes. Dogs also have a sophisticated health care system, comparable to the human health care system.

Dogs are unique because they share our environment, Ruple said. They live in our homes, drink our water and sometimes eat our human food. We both have similarities, and we see a lot of similar diseases and health issues.

The Dog Aging Project will follow participating dogs to watch how different environmental and biological factors can affect longevity for the next 10 years, although the schedule could extend beyond that time. The research hopes to look at specifics that could affect longevity, including an individuals genome, proteome, microbiome, demographics and environmental factors.

Owners who nominate their dogs to participate in the study will complete a 200-question health and lifestyle survey as well as submit electronic medial records, likely through the dogs veterinarian. The study isnt limiting the types of dogs participating eitherdogs of all breeds, mixes and sizes are encouraged to participate.

Neither the dogs nor owners will be compensated for the research, butthere is no cost to participate. Researchers will be working closely with the primary care veterinarians of the dogs, who will be expected to visit for their regular annual examination.

Ruple said the study is a citizen scientist project, meaning the owners of participating dogs are considered to be research partners in the study.

The study is funded by a five-year grant from the National Institute of Aging, which is part of the National Institute of Health, as well as private donations.

The Dog Aging Project hopes to enroll tens of thousands of dogs to research by the end of 2020.

People can take a part in the scientific process, whether its for human health or dog health, Ruple said. Through this study, we can learn to not only be better stewards of their existence, but also for our own.

TO APPLY:For more information on the Dog Aging Project or to nominate your dog, visithttps://dogagingproject.org/

Emily DeLetter is a news reporter for the Journal & Courier. Contact her at (765) 420-5205 or via email at edeletter@jconline.com. Follow her on Twitter at @EmilyDeLetter.

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How to live longer: This activity has been proven to boost life expectancy – Express

December 10th, 2019 5:45 pm

Longer life expectancy is found among those who do a certain activity. Scientists say it not only boosts life expectancy but reduces the risk of obesity, high blood pressure, high cholesterol, disability, type 2 diabetes, heart disease and cancer. It also improves aerobic endurance, heart function, balance and metabolism. Best of all it requires no equipment, free of charge and promises some stunning scenery along the way.

Numerous studies have proven that running has a lot of health benefits. In fact, running once a week could help a person live longer, according to a November 2019 study published in the British Journal of Sports Medicine.

The study examined and analysed available data about the health benefits of running and found that running, even just 50 minutes per week, was associated with a 27 percent lower risk of death from all causes, a 30 percent reduced risk of death from heart disease and a 23 percent lower risk of death from cancer.

READ MORE: How to live longer: Following this diet once a month could increase your life expectancy

Researchers of the study noted: Increased rates of participation in running, regardless of its dose, would probably lead to substantial improvements in population health and longevity.

Fourteen studies were analysed with more than 232,000 people whose health was tracked between 5.5 and 35 years.

The collective data showed that any amount of running was associated with a reduce risk of death from heart disease or cancer.

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The reason behind how running helps reduce risk of deadly diseases and premature death is unclear and the study doesnt establish cause and effect.

Even so, the study proves that any amount of running has major benefits to the body and overall health.

Previous studies have found that fast walking also has a myriad of physical and cognitive health benefits.

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‘Biologically younger’ people who defy their real age often have 5 things in common – INSIDER

December 10th, 2019 5:45 pm

Dan Buettner, the man who popularized the idea that there are five "Blue Zones" around the world where people live some of the longest, healthiest, happiest lives, says that people living in those zones all share five common traits.

"It is this interconnected web of characteristics that keep people doing the right things for long enough, and avoiding the wrong things," Buettner said.

Blue Zone residents, whether they're home in Loma Linda, California; Ikaria, Greece; Okinawa, Japan; Sardinia, Italy; or Nicoya, Costa Rica, all eat very little meat. Instead, they subsist on a largely plant-based diet filled with beans, nuts, and cruciferous vegetables, which Buettner has written about in a new cookbook.

But that diet is only, at best, about 50% of the Blue Zones longevity equation.

"It's the scaffolding, this collagen," Buettner told Insider. "That keeps people eating the right way for long enough."

Here are the other four core principles that sustain life in the Blue Zones.

Dan Buettner pioneered the idea that the world includes five "Blue Zones." Crystal Cox/Business Insider

Going to the gym is not a Blue Zones tradition.

"They don't exercise," Buettner said. Instead, people in Blue Zones are "nudged" into movement in little bursts throughout the day, by force of habit and, also, necessity.

"They're walking, or they're in their garden, or they're doing things by hand," he said.

In Buettner's home state of Minnesota, he credits shoveling the walks in winter, digging, weeding, and watering a garden in the summer with keeping him spry.

"I don't have a garage door opener, I open it by hand," he said. "To the extent that I can, I use hand-operated tools."

He's turned the inside of his house into a little mini Blue Zone, too, where he's getting up and moving all year round.

"I put the TV room on the third floor," Buettner told me, "So every time if I want a snack, I'd go up and down stairs."

The technique is one he's honed by studying life in the Blue Zones.

"It's being mindful of how to engineer little bursts of physical activity," he said.

Research has shown that such little energetic busts throughout the day can do a lot for overall fitness. One study published in January showed that even 20 second-long, vigorous stair-climbing exercise "snacks" spread out over the course of a day can improve fitness.

"It's a reminder to people that small bouts of activity can be effective," lead study author Martin Gibala told Insider when his team's research came out. "They add up over time."

Gallo Pinto ("spotted rooster") is a traditional breakfast meal in Costa Rica, made from leftover rice cooked with beans. Beans and rice are a complete protein. Kevin Schafer / Getty Images

In Japan they call it "ikigai," and in Costa Rica it's a "plan de vida." The words literally translate to "reason to live," and "life plan," respectively, and both concepts help residents of the Blue Zones feel there's a reason to get up and do what needs to get done each morning.

Studies also suggestthat a sense of purpose in life is associated with fewer strokes and less frequent heart attacks among people with heart disease, as well as more use of preventive care.

One 2017 investigation from researchers at Harvard concluded that a sense of purpose in life is associated with better "physical function among older adults," including better grip strength and faster walking.

Good health and happiness can be contagious, and obesity can too.

In Japan's Blue Zone, people form social groups called "moai" to help them get through life.

"Parents cluster their children in groups of five, and send them through life together," as Buettner explained in a recent video. "They support each other, and share life's fortunes and woes."

The trend is not unique to the Japanese. In Loma Linda, California, Blue Zoners (many of whom are Seventh-day Adventists) are more likely to share vegetarian potluck meals than meet each other over a Chipotle burrito or McDonald's fries.

Buettner has created Blue Zones "Projects" across the US, where cities and towns enact policies that change the entire environment that people live in.

"We're genetically hardwired to crave sugar, crave fat, crave salt, take rest whenever we can," Buettner said. "We've just engineered this environment where you don't have to move. You're constantly cooled down or heated up ... and you cannot escape chips and sodas and pizzas and burgers and fries."

In cities from Minnesota to Texas, he's helped create healthier communities where policies favor fruits and vegetables over junk food, people form walking groups to move around town and shed pounds together, and many quit smoking, too.

All of this, he said, adds up to troupes of "biologically younger" people, who not only weigh less, but suffer fewer health issues as they age.

"At every decade, you have more energy," he said.

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A Genetic Dating App Is a Horrifying Thing That Shouldnt Exist – Free

December 10th, 2019 5:44 pm

For marginalized people, the tech worlds constant barrage of innovations is getting exhausting. It seems like every week, science and tech pioneers are revealing new projects that pose a clear threat to anyone not white, cisgender, or malewhether its porn deepfakes or algorithms that judge womens boobs.

Enter Harvard Medical School, where researchers are creating a new dating app that matches people based on their DNA. The goal is to create a system that screens out matches that would result in a child with an inherited disease, according to a report aired Sunday night on 60 Minutes.

In other words, its a dating app for eugenicsthe disturbing ideological practice of systematically discriminating against people based on genetic qualities judged to be undesirable or inferior.

The app is being developed by a team of geneticists led by George Church, who, in the same interview, defended accepting money for his lab donated by convicted pedophile Jeffrey Epstein. Churchs lab is most famous for its work on the gene-editing technology CRISPR/Cas9, and its researchers are looking at ways to make humans immune to viruses, reverse the effects of aging, and de-extinct animals. Its 7,000 diseases, its about 5 percent of the population, [and] about $1 trillion a year worldwide in medical expenses, Church told 60 Minutes.

But for anyone not white, cis, able-bodied, or male, its obvious where all this is going.

Eugenics has long been a fascination of Nazis and white supremacists, who dream of creating a white and genetically pure master race. Dystopian sci-fi tales like Gattaca have also warned of the horrifying dangers of organizing society based on the perceived desirability (or undesirability) of peoples genetic code.

For people who exist outside mainstream gender norms, these dangers are very real. Last week, Newsweek reported on a team of researchers at the University of Michigan who are attempting to identify regions of the brain associated with gender dysphoriathe discomfort which occurs when a persons gender does not match the sex they were assigned at birth.

Many, but not all transgender people experience gender dysphoria, and it has been used to establish a system of medical gatekeeping that pathologizes trans people and controls access to treatments like hormone replacement therapy and gender-affirming surgeries. But even if scientists identified some hypothetical trait that causes people to be trans, choosing to edit out those traits would be an attempt to effectively erase trans people from existence.

Meanwhile, research into trans medical treatments remains severely underfunded. The federal government is also trying to make it legal for medical providers to refuse to treat trans patientswhether for gender dysphoria or a broken arm.

In other words, these cis researchers, funders, and policymakers seem more interested in curing or erasing trans people than finding better and cheaper ways of treating themor anyone else labeled as falling outside the norm of biologic desirability. Churchs lab, for example, recently received over $100 million for its work on gene-editing.

Church says he is being careful, and claims his lab has appointed a full-time ethicist on its staff to work toward the goal of genetic equitywhere all people have access to genetic technology, regardless of race or economic status.

But for marginalized people suffering under deeply unequal and discriminatory systems of power, that mission seems dangerously naive. If the people who risk being most harmed by these innovations arent intimately involved in their development, maybe its better toyou knownot make them at all?

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Harvard geneticist George Church’s goal: to protect humans from viruses, genetic diseases, and aging – 60 Minutes – CBS News

December 10th, 2019 5:44 pm

Our lives have been transformed by the information age. But what's coming next is likely to be more profound, call it the genetic information age. We have mapped the human genome and in just the last few years we have learned to read and write DNA like software. And you're about to see a few breakthroughs-in-waiting that would transform human health. For a preview of this revolution in evolution we met George Church, a world leading geneticist, whose own DNA harbors many eccentricities and a few genes for genius.

We found George Church in here.

Cory Smith: Most of these are frozen George. Little bits of George that we have edited all in different tubes.

Church threw himself into his work, literally. His DNA is in many of the experiments in his lab at Harvard Medical School. The fully assembled George Church is 6'5" and 65. He helped pioneer mapping the human genome and editing DNA. Today, his lab is working to make humans immune to all viruses, eliminate genetic diseases, and reverse the effects of time.

Scott Pelley: One of the things your lab is working on is reversing aging.

George Church: That's right.

Scott Pelley: How is that possible?

George Church: Reversing aging is one of these things that is easy to dismiss to say either we don't need it or is impossible or both.

Scott Pelley: Oh, we need it.

George Church: Okay. We need it. That's good. We can agree on that. Well, aging reversal is something that's been proven about eight different ways in animals where you can get, you know, faster reaction times or, you know, cognitive or repair of damaged tissues.

Scott Pelley: Proven eight different ways. Why isn't this available?

George Church: It is available to mice.

In lucky mice, Church's lab added multiple genes that improved heart and kidney function and levels of blood sugar. Now he's trying it in spaniels.

Scott Pelley: So is this gene editing to achieve age reversal?

George Church: This is adding genes. So, it's not really editing genes. It's, the gene function is going down, and so we're boosting it back up by putting in extra copies of the genes.

Scott Pelley: What's the time horizon on age reversal in humans?

George Church: That's in clinical trials right now in dogs. And so, that veterinary product might be a couple years away and then that takes another ten years to get through the human clinical trials.

Human trials of a personal kind made George Church an unlikely candidate to alter human evolution. Growing up in Florida, Church was dyslexic, with attention deficit, and frequently knocked out by narcolepsy.

Scott Pelley: What was it that made you imagine that you could be a scientist?

George Church: The thing that got me hooked was probably the New York World's Fair in 1964. I thought this is the way we should all be living. When I went back to Florida, I said, "I've been robbed," you know? "Where is it all?" So, I said, "Well, if they're not going to provide it, then I'm gonna provide it for myself."

With work and repetition, he beat his disabilities and developed a genius for crystallography, a daunting technique that renders 3D images of molecules through X-rays and math. But in graduate school at Duke, at the age of 20, his mania for the basic structures of life didn't leave time for the basic structure of life.

Scott Pelley: You were homeless for a time.

George Church: Yeah. Briefly.

Scott Pelley: Six months.

George Church: Six months.

Scott Pelley: And where were you sleeping when you were homeless?

George Church: Well, yeah. I wasn't sleeping that much. I was mostly working. I'm narcoleptic. So, I fall asleep sitting up anyway.

His devotion to crystallography was his undoing at Duke.

George Church: I was extremely excited about the research I was doing. And so, I would put in 100-plus hours a week on research and then pretty much didn't do anything else.

Scott Pelley: Not go to class.

George Church: I wouldn't go to class. Yeah.

Duke kicked him out with this letter wishing him well in a field other than biology. But, it turned out, Harvard needed a crystallographer. George Church has been here nearly 40 years. He employs around 100 scientists, about half-and-half men and women.

Scott Pelley: Who do you hire?

George Church: I hire people that are self-selecting, they see our beacon from a distance away. There are a lot of people that are a little, you know, might be considered a little odd. "Neuroatypicals," some of us are called.

Scott Pelley: "Neuroatypical?"

George Church: Right.

Scott Pelley: Unusual brains?

George Church: Right, yeah.

Parastoo Khoshakhlagh: One thing about George that is very significant is that he sees what you can't even see in yourself.

Parastoo Khoshakhlagh and Alex Ng are among the "neuroatypicals." They're engineering human organ tissue.

Cory Smith: I think he tries to promote no fear of failure. The only fear is not to try at all.

Cory Smith's project sped up DNA editing from altering three genes at a time to 13,000 at a time. Eriona Hysolli went to Siberia with Church to extract DNA from the bones of wooly mammoths. She's editing the genes into elephant DNA to bring the mammoth back from extinction.

Eriona Hysolli: We are laying the foundations, perhaps, of de-extinction projects to come.

Scott Pelley: De-extinction.

Eriona Hysolli: Yes.

Scott Pelley: I'm not sure that's a word in the dictionary yet.

Eriona Hysolli: Well, if it isn't, it should be.

Scott Pelley: You know there are people watching this interview who think that is playing God.

George Church: Well, it's playing engineer. I mean, humans have been playing engineer since the dawn of time.

Scott Pelley: The point is, some people believe that you're mucking about in things that shouldn't be disturbed.

George Church: I completely agree that we need to be very cautious. And the more powerful, or the more rapidly-moving the technology, the more cautious we need to be, the bigger the conversation involving lots of different disciplines, religion, ethics, government, art, and so forth. And to see what it's unintended consequences might be.

Church anticipates consequences with a full time ethicist in the lab and he spends a good deal of time thinking about genetic equity. Believing that genetic technology must be available to all, not just those who can afford it.

We saw one of those technologies in the hands of Alex Ng and Parastoo Khoshakhlagh. They showed us what they call "mini-brains," tiny dots with millions of cells each. They've proven that cells from a patient can be grown into any organ tissue, in a matter of days, so drugs can be tested on that patient's unique genome.

Scott Pelley: You said that you got these cells from George's skin? How does that work?

Alex Ng: We have a way to reprogram essentially, skin cells, back into a stem cell state. And we have technologies where now we can differentiate them into tissue such as brain tissue.

Scott Pelley: So you went from George's skin cells, turned those into stem cells, and turned those into brain cells.

Alex Ng: Exactly. Exactly.

Scott Pelley: Simple as that.

Organs grown from a patient's own cells would eliminate the problem of rejection. Their goal is to prove the concept by growing full sized organs from Church's DNA.

George Church: It's considered more ethical for students to do experiments on their boss than vice versa and it's good to do it on me rather than some stranger because I'm as up to speed as you can be on the on the risks and the benefits. I'm properly consented. And I'm unlikely to change my mind.

Alex Ng: We have a joke in the lab, I mean, at some point, soon probably, we're going to have more of his cells outside of his body than he has himself.

Church's DNA is also used in experiments designed to make humans immune to all viruses.

George Church: We have a strategy by which we can make any cell or any organism resistant to all viruses by changing the genetic code. So if you change that code enough you now get something that is resistant to all viruses including viruses you never characterized before.

Scott Pelley: Because the viruses don't recognize it anymore?

George Church: They expect a certain code provided by the host that they replicate in. the virus would have to change so many parts of its DNA or RNA so that it can't change them all at once. So, it's not only dead. But it can't mutate to a new place where it could survive in a new host.

Yes, he's talking about the cure for the common cold and the end of waiting for organ transplants. It's long been known that pig organs could function in humans. Pig heart valves are routinely transplanted already. But pig viruses have kept surgeons from transplanting whole organs. Church's lab altered pig DNA and knocked out 62 pig viruses.

Scott Pelley: What organs might be transplanted from a pig to a human?

George Church: Heart, lung, kidney, liver, intestines, various parts of the eye, skin. All these things.

Scott Pelley: What's the time horizon on transplanting pig organs into human beings?

George Church: you know, two to five years to get into clinical trials. And then again it could take ten years to get through the clinical trials.

Church is a role model for the next generation. He has co-founded more than 35 startups. Recently, investors put $100 million into the pig organ work. Another Church startup is a dating app that compares DNA and screens out matches that would result in a child with an inherited disease.

George Church: You wouldn't find out who you're not compatible with. You'll just find out who you are compatible with.

Scott Pelley: You're suggesting that if everyone has their genome sequenced and the correct matches are made, that all of these diseases could be eliminated?

George Church: Right. It's 7,000 diseases. It's about 5% of the population. It's about a trillion dollars a year, worldwide.

Church sees one of his own genetic differences as an advantage. Narcolepsy lulls him several times a day. But he wakes, still in the conversation, often, discovering inspiration in his twilight zone.

Scott Pelley: If somebody had sequenced your genome some years ago, you might not have made the grade in some way.

George Church: I mean, that's true. I would hope that society sees the benefit of diversity not just ancestral diversity, but in our abilities. There's no perfect person.

Despite imperfection, Church has co-authored 527 scientific papers and holds more than 50 patents. Proof that great minds do not think alike.

The best science can tell, it was about 4 billion years ago that self-replicating molecules set off the spark of biology. Now, humans hold the tools of evolution, but George Church remains in awe of the original mystery: how chemistry became life.

Scott Pelley: Is the most amazing thing about life, then, that it happened at all?

George Church: It is amazing in our current state of ignorance. We don't even know if it ever happened ever in the rest of the universe. it's awe-inspiring to know that it either happened billions of times, or it never happened. Both of those are mind boggling. It's amazing that you can have such complex structures that make copies of themselves. But it's very hard to do that with machines that we've built. So, we're engineers. But we're rather poor engineers compared to the pseudo engineering that is biological evolution.

Produced by Henry Schuster. Associate producer, Rachael Morehouse. Broadcast associate, Ian Flickinger.

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Harvard geneticist George Church's goal: to protect humans from viruses, genetic diseases, and aging - 60 Minutes - CBS News

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$125 million for Inscripta may usher in the next wave of genetic engineering – TechCrunch

December 10th, 2019 5:44 pm

In these waning days of the second decade of the twenty-first century, technologists and investors are beginning to lay the foundations for new, truly transformational technologies that have the potential to reshape entire industries and rewrite the rules of human understanding.

It may sound lofty, but new achievements from businesses and research institutions in areas like machine learning, quantum computing and genetic engineering mean that the futures imagined in science fiction are simply becoming science.

And among the technologies that could potentially have the biggest effect on the way we live, nothing looms larger than genetic engineering.

Investors and entrepreneurs are deploying hundreds of millions of dollars to create the tools that researchers, scientists and industry will use to re-engineer the building blocks of life to perform different functions in agriculture, manufacturing and medicine.

One of these companies, 10X Genomics, which gives users hardware and software to determine the functionality of different genetic code, has already proven how lucrative this early market can be. The company, which had its initial public offering earlier this year, is now worth $6 billion.

Another, the still-private company Inscripta, is helmed by a former 10X Genomics executive. The Boulder, Colo.-based startup is commercializing a machine that can let researchers design and manufacture small quantities of new organisms. If 10X Genomics is giving scientists and businesses a better way to read and understand the genome, then Inscripta is giving those same users a new way to write their own genetic code and make their own organisms.

Its a technology that investors are falling over themselves to finance. The company, which closed on $105 million in financing earlier in the year (through several tranches, which began in late 2018), has just raised another $125 million on the heels of launching its first commercial product. Investors in the round include new and previous investors like Paladin Capital Group, JS Capital Management, Oak HC/FT and Venrock.

Biology has unlimited potential to positively change this world, says Kevin Ness, the chief executive of Inscripta . Its one of the most important new technology forces that will be a major player in the global economy.

Ness sees Inscripta as breaking down one of the biggest barriers to the commercialization of genetic engineering, which is access to the technology.

While genome centers and biology foundries can manufacture massive quantities of new biological material for industrial uses, its too costly and centralized for most researchers. We can put the biofoundry capabilities into a box that can be pushed to a global researcher, says Ness.

Earlier this year, the company announced that it was taking orders for its first bio-manufacturing product; the new capital is designed to pay for expanding its manufacturing capabilities.

That wasnt the only barrier that Inscripta felt that it needed to break down. The company also developed a proprietary biochemistry for gene editing, hoping to avoid having to pay fees to one of the two laboratories that were engaged in a pitched legal battle over who owned the CRISPR technology (the Broad Institute and the University of California both had claims to the technology).

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Veritas Genetics, the start-up that can sequence a human genome for less than $600, ceases US operations and is in talks with potential buyers – CNBC

December 10th, 2019 5:44 pm

Veritas Genetics had big plans to lower the price of sequencing the human genome, making it on par with the price of buying an Apple Watch or a fancy dinner.

The company, which was the first in the world to map out a person's DNA for less than $1,000 back in 2016, just shared with customers via email that it is ceasing operations in the U.S.

"Due to an unexpected adverse financing situation, we are being forced to suspend our operations in the U.S. for the time being," the email, which was viewed by CNBC, reads. "We are currently assessing all paths forward, including strategic options."

The company also laid off the bulk of its employees based in the U.S., about 50 people, earlier this week, according to a source familiar with the company. The source asked not to be named because they were not authorized to speak for Veritas Genetics.

"I can clarify this temporarily affects U.S. operations only," a spokesperson for the company said. "All of the customers outside of the U.S. will continue to be served by Veritas Europe and Latin America."

Veritas, which made this year's CNBC Disruptor 50 list, hoped to expand to millions more consumers in the coming years by bringing down the price of whole genome sequencing to just a few hundred dollars. It raised more than $50 million in financing since it got its start in 2015.

But the company's investors, including Simcere Pharmaceutical and Lilly Asia Ventures, are based in China, at a time when the Trump administration is cracking down on Chinese firms making investments in U.S. companies. Earlier this year, the Committee on Foreign Investment in the United States,or CFIUS, forced a health-tech company called PatientsLikeMe to find a buyer after ordering its Chinese owner to divest its stake. PatientsLikeMe eventually sold to UnitedHealth.

For Veritas, it meant that new investors who were interested in the business got skittish because of the potential for oversight from CFIUS, according to the person familiar with the company. As a result, Veritas has also been in talks with potential acquirers in recent months, said the person.

If Veritas is able to figure out a path forward, it hopes to be competitive with companies such as Ancestry and 23andMe by offering more information for about the same price. 23andMe has dabbled with offering sequencing to its customers, but currently provides only genotyping services, meaning it looks at specific parts of the genome which are known to be associated with a certain condition or trait.

While 23andMe and Ancestry primarily sell tests for people interested in their ancestral composition and wellness traits, Veritas has long stressed that it's different because it provides potentially actionable insights into its users' health.

Veritas' decision to stop selling its tests in the U.S. comes as other consumer-facing DNA testing companies report that sales have slowed. One potential factor is that people have grown more concerned about protecting their privacy, especially in the wake of high-profile news events such as the Golden State Killer case. That stoked fears about whether individuals could be found and convicted for past crimes based on distant relatives' DNA.

But for Veritas, which bills itself as more of a medical company, sales of its tests have been increasing since it dropped its price in July, according to the person familiar.

Veritas in November experienced a security breach that included some customer information, the start-up confirmed to Bloomberg. The company stressed that only a handful of people were affected.

Follow @CNBCtech on Twitter for the latest tech industry news.

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Does the ‘genetics revolution’ unsettle you? Here is a guide, and reasons to be hopeful – Genetic Literacy Project

December 10th, 2019 5:44 pm

Its that time of year again an avalanche of ads urging us to drool into tubes so companies can spit back verdicts on our pasts, presents, and futures. Judging from my emails, those unceasing ads have inspired many questions about genetics in general.

Among the emails that pinged in recently:

So I started a list of my e-mails, with apologies to Hillary, and extracted three recurring themes: transgender identity, when a human life begins, and by far the largest group: interpreting DNA test results, either consumer or clinical.

What do you think about a new studythat found 20 genetic markers of transgender identity? asked a reporter from The Times of London In March 2018. Id suggested just such a study a year earlier, which hed found here.

Impressed with the study, I agreed to comment. But the reporter forgot to distinguish me from the researcher, and so throughout Europe, I was suddenly an expert on transgender genes. And that inspired some telling emails.

The first, from a trans woman born in 1948, shared her 70-page story:

As far back as I can remember I thought nothing of going into my mothers closet, pulling down her nightgowns, and putting them on. They were soft, they smelled of her, and they felt so perfect. This was me. Everything feminine fascinated me. Anything male repelled me. I wanted to emerge myself in the female world. But no matter what I did, I just couldnt look like Mommy.

Another transgender woman wrote:

I would love to have that degree of certainty that a genetic study would show. Parents would be able to perhaps work with their children instead of ignoring it either intentionally or out of ignorance.

A recent email from 58-year-old Edith brought up nature v nurture:

Two of my nine nieces and nephews are transitioning. My family has an overall fluid concept of gender identity, which we discussed with each other before either child made it known they were trans. I find myself wondering if this is true in other families.

Me too.

I repost 17 timepoints whenever womens reproductive rights are threatened, or I read or hear a comment that indicates ignorance of biology. The idea of the list came to me when considering that an embryos genome turns on at day 5, but it cant possibly exist at that point outside of a womans body.

One woman asked about fetal rights. Her ex had given her an herbal abortion tea without her knowledge when she was pregnant. Her baby so far is healthy, but she wants a court to recognize the tea-poisoning as child abuse. At what point in utero does a fetus have rights? It seems to vary state to state, she wrote.

Celia Collias, a statistics major at the University of North Carolina, offered a compelling perspective: distinguishing two types of viability. Natural ability to be physiologically independent for a human fetus is around 24 weeks. Technologically assisted viability for a human fetus is 21 weeks.

If we dont use natural viability as the cut off for reproductive rights, Ms. Collias argues, then those rights will erode as technology sets back the age of assisted viability:

Technologically assisted viability is not free. If we allow that to be the benchmark, its going to cost society a lot to care for all those fetuses where would that money come from?

Good question.

Is he really my brother? asked the woman who sent me scanned columns of genetic markers. I circled 16 of 38 that they share and sent it back: Yes.

I dont have mutations in BRCA1 or 2, so Im ok, right? I do have a mutation in ATM (or p53 or CHEK2 or PTEN or RAD51 or a few dozenothers). Inherited mutations for cancer risk go beyond the most common ones in the BRCA pair, and altogether they account for only 5 percent of cases. Yes, shes at high risk.

BRCA brings up the limited variant problem. Consumer DNA tests, for cancer or single-gene diseases, are likely to check for only the most common variants, such as a handful of mutations in the CFTR gene behind cystic fibrosis, which has more than 1,700. These health reports may provide a false sense of reassurance and should not be used for making any health decisions without confirmation testing, said Edward Esplin, MD, of Invitae, a clinical testing company, at the American Society of Human Genetics conference in October, catalyzing a flood of headlines.

I had a prenatal screen for 125 genes and one is a variant of uncertain significance. What the heck is a VUS? Do I have a mutation or not?

A VUS is a gene variant that isnt common, but hasnt shown up in someone with a disease and reported in the medical literature. Yet. I explain here.

My ethnicity estimate changed overnight. Huh? When an ancestry company adds a new group to its database of reference populations, the sections of those pie charts can shift, or a new one appear.

Im 20 weeks pregnant. The fetus has a microduplication of chromosome 18. Is that a problem? The healthy dad-to-be also had the tiny extra bit of DNA. So, no.

I just found out that I have an extra Y chromosome. Ive had severe acne since my early teens, and today Im 62 and weigh 295 pounds. Im a biker, football player, and served time for selling pot. Did my extra chromosome get me arrested?

Probably not. Being in the wrong place at the wrong time, before decriminalization, was more likely at fault.

Because most of my email brings up medical matters, heres a short guide to getting help in making sense of DNA test results related to health. (For interpreting ancestry findings, the International Society of Genetic Genealogy is an excellent resource.)

Its important to distinguish consumer DNA tests, which anyone can take by purchasing a kit and spitting or swizzling a cheekbrush, from clinical DNA tests, which a health care provider orders and the FDAs Clinical Laboratory Improvement Amendments (CLIA) regulate.

Like mushrooms materializing after a warm rain, articles, websites, books and companies are springing up to help consumers navigate test-taking and interpretation.

Finding an expert specifically trained at the graduate level in genetics a genetic counselor, PhD geneticist, or MD with genetics/genomics training is challenging because their priorities are in clinical testing, not the entertainment/education space that the consumer companies so ceaselessly promote. Other scientists may be helpful molecular biologists, biochemists but genetics as a discipline transcends DNA, including developmental, transmission, and population and evolutionary genetics too. Ancestry testing in particular melds these levels of genetics.

Assuming a sit-down with an expert to intrepret consumer DNA data isnt happening easily, here are some places to turn.

A longstanding helpful website is Genetics Home Reference, from the NIH.

A newer resource is this report from ConsumersAdvocate.org. Their researchers recently sent DNA anonymously to 9 leading consumer DNA testing companies, interpreted the data, and then wrote a detailed, clear analysis that compares the services, privacy/security measures, online resources, and cost of tests.

Consumer DNA testing is a fast-growing industry with over 26 million users worldwide. That number is expected to grow to 100 million by 2021, Sam Klau, Community Outreach at the organization, told me.

An excellent new book is DNA Nation: How the Internet of Genes is Changing Your Life, by PhD molecular biologist Sergio Pistoi. And my human genetics textbook will be out in a new edition in September. Ive added a chapter called The Genetics of Identity, inspired by having my past rewritten recently thanks to ancestry testing.

The testing company websites, like that of 23andme, provide clear and well-written info on interpreting test results. But without any prior knowledge of genetics, misinterpretation and misplaced angst can arise.

Does the average person know the difference in significance between revealing a pattern of genome-wide single-base variations (SNPs) associated with elevated risk of a trait or illness, and detecting a well-studied mutation in a single gene?

The raw data dump from consumer DNA testing can be overwhelming, and to paraphrase Elizabeth Warren: Theres a company for that. A consumer can pay to avoid bushwhacking through dense SNP forests.

Strategene, for example, is a genetic reporting tool that uses 23andMe data to identify SNPs in a few dozen well-studied, health-related genes, and not every SNP under the sun. The $45 is a sound investment; it would take hours to sort through Google Scholar to DIY. But the client needs to know about the limited variant issue of checking only for common SNPs.

(I was briefly fooled into confusing the company with 1980s biotech giant Stratagene, but its off by one letter and one capitalization. The only person named on the company website is a naturopath referred to many times as Dr., which wouldnt necessarily denote a genetics expert.)

Im curious to see how soon the medical profession catches up. Right now, genetic counselors in the US number only about 5,000. But professional organizations are stepping in. The American College of Medical Genetics and Genomics, for example, offers online continuing medical education, ACMG Genetics 101 for Healthcare Providers.

But doctors Ive encountered recently still go deer-in-the-headlights when I ask a genetics question, just to be obnoxious. And so a company like ActXmakes sense in helping medical professionals keep pace with the growing tide of patients coming in waving consumer DNA test results. The company helps physicians and patients apply 23andMe raw data to select drugs, order clinical tests to help diagnose specific conditions, and to confirm carrier status for single-gene diseases.

When I started my career as a Drosophila geneticist, mutating flies to grow legs out of their heads, I never imagined at-home DNA testing. When I started my career as a science writer and textbook author, I still couldnt have predicted at-home DNA testing. Now that its here, Im thrilled that DNA science has become so much more tangible and practical. Yet we must use the information in our strings of A, C, T, and G wisely.

Ricki Lewis is the GLPs senior contributing writer focusing on gene therapy and gene editing. She has a PhD in genetics and is a genetic counselor, science writer and author of The Forever Fix: Gene Therapy and the Boy Who Saved It, the only popular book about gene therapy. BIO. Follow her at her website or Twitter @rickilewis

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New Data from Ambry Genetics Showed Concurrent RNA and DNA Testing Identified More Patients with Hereditary Breast Cancer than DNA Testing Alone -…

December 10th, 2019 5:44 pm

ALISO VIEJO, Calif., Dec. 10, 2019 /PRNewswire/ --Researchers atAmbry Genetics(Ambry), a leading clinical genetic testing lab, will announce new data showing that conducting RNA and DNA tests for hereditary cancer risk at the same time identifies more patients with mutations that increase cancer risk than DNA testing alone. To be presented at the San Antonio Breast Cancer Symposium (SABCS) this week, the data come from a study of 746 patients with breast cancer that received +RNAinsight, paired RNA and DNA genetic testing for hereditary cancer risk.

Standard DNA testing for hereditary cancer risk excludes large portions of DNA, thereby missing some mutations. In addition, DNA testing can produce inconclusive results and fail to determine that an error in our DNA increases cancer risk. These limitations impact patients and their families because doctors may not have the information needed to recommend appropriate preventive, early detection, or therapeutic steps. Additionally, relatives may not be referred for genetic testing and obtain the care they would otherwise have gotten if they had learned they had mutations.

Adding RNA to DNA testing overcomes these limitations for a substantial number of patients as it provides considerably more evidence than DNA testing alone about whether our DNA has mutations.

The data showed that adding RNA genetic testing to DNA testing increased the diagnostic yield the number of people found to have a mutation that increases cancer risk across 16 hereditary breast and/or ovarian cancer genes. As a result of +RNAinsight, five breast cancer patients were identified to have mutations in clinically-actionable genes that would have otherwise been missed completely or the patient would have received inconclusive results if they had received DNA testing only. These findings included three women with mutations in BRCA1/2, one woman with a mutation in ATM, and one woman with a mutation in PMS2. Additionally, paired RNA and DNA genetic testing decreased the number of inconclusive results, giving patients more definitive answers about whether their breast cancers were hereditary. Additional results will be presented on an expanded breast cancer cohort at the meeting on Saturday, December 14th.

"These data further prove that paired RNA and DNA genetic testing for hereditary cancer should be the industry standard," said Holly LaDuca, MS, CGC, senior manager of Ambry's clinical affairs research. "Our research has consistently shown that +RNAinsight provides clinicians with more accurate results, better informing patient care."

Researchers from Ambry will also present at SABCS new data from a pre-and post-test clinician survey that assessed how genetic testing for hereditary cancer impacted medical management, such as screening recommendations. The survey found that positive genetic testing results frequently lead to changes in management recommendations in both high risk (e.g. BRCA1) and moderate risk (e.g. ATM) genes. Changes to mammogram, breast MRI, and/or preventive surgery options were reported in 77.3% of positive individuals. Moreover, medical management changes largely adhered to published guidelines, indicating that cliniciansare applying recommendations appropriately based on test results.

"With this survey data, clinicians are showing us that they truly do use genetic testing results to implement personalized recommendations, which can be life-saving for a patient," said Carrie Horton, MS, CGC, senior researcher in Ambry's clinical affairs team. "These data provide further evidence that genetic testing is essential to comprehensive cancer care. Continued study in this area will aid clinicians, laboratories, health plans, and ultimately patients."

Below are summaries of each of the four studies that Ambry will present at SABCS 2019.

Friday, December 13, 5:00- 7:00 PM CST

P5-07-06,Black M, et. al., Performance of Polygenic Risk Score Combined with Clinical Assessment for Breast Cancer Risk

Saturday, December 14, 7:00 9:00 AM CST

P6-08-35,Horton C, et. al., Impact of Multigene Panel Testing on Medical Management: Preliminary Results of a Pre- and Post- Test Clinician Survey

P6-08-08,LaDuca H, et. al., Concurrent DNA and RNA Genetic Testing Identifies More Patients with Hereditary Breast Cancer than DNA Testing Alone

P6-08-04,Yadav S, et. al., Germline Mutations in Cancer Predisposition Genes in Patients with Invasive Lobular Carcinoma of the Breast

ABOUT AMBRY GENETICS

Ambry Genetics, as part of Konica Minolta Precision Medicine, excels at translating scientific research into clinically actionable test results based upon a deep understanding of the human genome and the biology behind genetic disease. Our unparalleled track record of discoveries over 20 years, and growing database that continues to expand in collaboration with academic, corporate and pharmaceutical partners, means we are first to market with innovative products and comprehensive analysis that enable clinicians to confidently inform patient health decisions. We care about what happens to real people, their families, and the people they love, and remain dedicated to providing them and their clinicians with deeper knowledge and fresh insights, so together they can make informed, potentially life-altering healthcare decisions. For more information, please visitambrygen.com.

For more information on risk factors for hereditary cancer, please visit cancer.gov's fact sheet on hereditary cancer and genetic testing.

ABOUT +RNAINSIGHT

+RNAinsight, paired with Ambry Genetics' hereditary cancer DNA tests, uses next-generation sequencing to concurrently analyze a patient's DNA and RNA, another layer of genetic information. +RNAinsight identifies more patients who have mutations that increase their cancer risks than through standard DNA-only testing by overcoming limitations of DNA testing. +RNAinsight enables more accurate identification of patients with increased genetic risks for cancer, finds actionable results that may otherwise be missed, and decreases the frequency of inconclusive results. +RNAinsight is now available through doctors and genetic counselors around the country. For more information on +RNAinsight, please go toambrygen.com/RNAinsight.

Press Contact:Liz Squirepress@ambrygen.com (202) 617-4662

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Caris Life Sciences, Ambry Genetics Team on New Hereditary Cancer Panel – Clinical OMICs News

December 10th, 2019 5:44 pm

Caris Life Sciences has announced it will begin offering Ambry Genetics 67- gene CancerNext Expanded panel to evaluate hereditary risks for cancer. That test will now be available combined with Caris somatic (tumor) tests that analyze a cancers detailed molecular makeup. In a release, Caris says this will be: The most comprehensive, clinically relevant molecular and genetic offering on the market today to guide treatment and management of cancer. The combined Caris and Ambry testing is already available nationwide.

We are committed to providing clinicians with high-quality information they can use to inform treatment decisions, said David D. Halbert, Caris Life Sciences Chairman, CEO and founder. By partnering with Ambry Genetics to better inform patient care, we are able to provide clinicians a greater ability to learn about a cancers molecular composition.

According to the National Cancer Institute, about 10% of cancers are hereditary. Inherited cancers often occur at a relativelyearly age and involve pathogenic variants in one or more genes. The most common hereditary cancer syndromes in women include hereditary breast and ovarian cancer syndrome, Lynch syndrome, LiFraumeni syndrome, Cowden syndrome, PeutzJeghers syndrome, and hereditary diffuse gastric cancer. A hereditary cancer risk assessment identifies patients and families who may be at increased risk of developing certain types of cancer.

Caris currently offers clinicians Caris Molecular Intelligence, a proprietary, comprehensive tumor profiling approach that assesses DNA, RNA, and proteins that are unique to an individuals cancer, among other products. The Molecular Intelligence test reveals a molecular blueprint aimed to guide more precise and individualized treatment decisions.

Through the partnership, Caris will now also offer Ambrys CancerNext-Expandedhereditary cancer panel, which analyzes 67 genes associated with an increased hereditary risk of cancer, including brain, breast, colon, ovarian, pancreatic, prostate, renal, uterine, and many other cancers. This test identifies inherited risks for cancer in order for clinicians to accurately diagnose, treat, and manage cancer risks for each patients needs.

To best diagnose and treat cancer, clinicians must understand whether patients have mutations in genes associated with an increased risk for hereditary cancer, said Aaron Elliott, Chief Executive Officer of Ambry. Caris molecular tests combined with Ambrys germline genetic testing, give clinicians the most comprehensive, clinically relevant molecular profile on the market to guide treatment and management.

Being able to simultaneously conduct comprehensive tumor genomic testing and multi-gene germline sequencing is invaluable, especially for sick patients at the beginning of their cancer journey, said Michael J. Hall, M.D., and chair, Department of Clinical Genetics at Fox Chase Cancer Center. This is information I can immediately begin using for my patients to more accurately diagnose them and to better individualize their treatments.

In further news from Caris, the National Comprehensive Cancer Network (NCCN) updated their treatment guidelines for Non-Small Cell Lung Cancer (NSCLC), which stress the importance ofRNA profilingand noteDNA-based next-generation sequencing may under-detectNTRK1andNTRK3fusions.Caris offers a suite of molecular profiling offerings, including whole transcriptome sequencing with MI Transcriptome which they say provides themost comprehensive and unique RNA analysis available and covers all 22,000 genes.

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Caris Life Sciences, Ambry Genetics Team on New Hereditary Cancer Panel - Clinical OMICs News

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