Genetic test results dont add much, if anything, to the risk factor predictions about who will develop cardiovascular disease, according to two studies published in this weeks JAMA.

The study results, while far from the final word, may dent further dent the reputation of genetic testing and give ammunition to skeptics who believe its not ready for clinical use. Payers and providers taking on financial risk may have another reason to tap the brakes.

The findings of both these articles lend further support to the lack of meaningful improvement in risk stratification for CAD [coronary artery disease] in different populations of middle-aged individuals of European ancestry when genome-wide risk scores are added to pooled cohort equations, says an accompanying editorial, which acknowledged that the utility of the tests in a younger or more diverse population remains an open question.

One of the studies used a polygenic risk score developed from a case-control study about 16,000 CAD cases with matched controls. The researchers, most of whom are at the Imperial College Londons School of Public Health, then applied it to a 350,000 individuals from the UK Biobank, 6,272 of whom had a heart attack or some other CAD event during a median follow-up period of eight years. When the polygenic risk score for CAD was used, the predicted risk changes by less than 1% for nearly 80% of the participants. At a risk threshold of 7.5%, 526 of the 6,272 (8.4%) were correctly reclassified to the higher risk category but 240 (4%) were incorrectly moved to a lower risk category. Among the 346,388 noncases, more individuals were incorrectly moved up to a high-risk category than correctly moved down to a lower one (6,723 vs. 5,284) when the polygenic risk score was used.

Lead author Joshua Elliott and his colleagues characterized the number of people meaningfully changing risk category as relatively small and noted the worse reclassification among the noncases.

The other study used data from the 4,847 adults in the Atherosclerosis Risk in Communities study and 2,390 people participating in the Multi-Ethnic Study of Atherosclerosis. The research team, led by Jonathan D. Mosley at Vanderbilt, tested how the addition of a polygenic risk affected prediction of CHD events (heart attacks, silent infarctions, revascularization procedures) over a 10-year period. They found that the testing did not significantly improve classification accuracy in either study and, furthermore, among those who developed CHD the reclassification were incorrect about 80% of the time.

Mosley and his colleagues noted that their findings are in keeping with the frequent mismatch between statistical association and predictive performance for risk biomarkers. They noted that the odds ratio associated with being in the top 5% of the polygenic risk score (about 4) is similar to other biomarkers like C-reactive protein and homocysteine that have been shown to have similarly modest predictive utility.

See original here:
JAMA Studies: Genetic Tests for Heart Disease Don't Have Much Predictive Power - Managed Healthcare Executive

Recommendation and review posted by Bethany Smith

The Global Genetic Testing Market is valued at 11.8 billion USD in 2018 and is expected to grow at a CAGR of 11.9% between 2019 and 2025. Rapid industrialization, rising demand for the Genetic Testing, and brisk technological advancements are expected to fuel the market growth during the forecast years.

The global genetic testing market is majorly driven by the importance of early disease diagnosis and prevention, growing need for personalized medicine, increasing application of genetic testing in oncology and increasing awareness on the importance of prognosis and predictive screening. The market is affected by the high costs involved in the genetic testing development and lack of skilled professionals.

Promoting awareness through the government is one of the major factors driving the genetic testing market globally. The government is taking certain initiatives on launching a large number of PGx tests & drugs, controlling the increasing level of genetic disorders, and integrating advanced technologies to meet the needs of patients.

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Download Sample Copy of Research Report:www.marketresearchexplore.com/report/80#enquiry

It also employs diverse analytical tools including Porter's Five Forces Analysis, SWOT Analysis, and Maturity analysis to dig deep into the Genetic Testing market's competitive advantages, various threats, and the existing stage of the market. The report also studies the historical and present events in the Genetic Testing industry in order to provide authentic estimates that will help clients in operating their business accordingly.

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Valuable insights into companies' gross margin, Genetic Testing sales volume, profit margin, revenue, growth rate, serving segments, a pricing structure to facilitate clients to intuit the strengths, weaknesses, and market position of their rivals. It also explores their manufacturing base, production facility, volume, capacity, raw material sources, key raw materials, distribution networks, global presence, value chain, effective technologies, equipment, and import-export practices are also covered in the report that provides insightful acumen to understand how leading players are operating their business.

Obtain Detailed Comprehension of the Global Genetic Testing Market

The global Genetic Testing market has been divided into several crucial market segments such as types, applications, regions, end-users, and technology. The report provides concise delineation of each segment considering current demand, revenue, sales, and growth forecasts.

The analysis drives market players to select appropriate market segments and precisely intuit the actual target market size. It also includes a detailed rundown of major regions including North America, Europe, South America, the Middle East & Africa, and the Asia Pacific.

Genetic Testing Market Segmentation by Type:

Genetic Testing Market Segmentation by Application:

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Global Genetic Testing Market projected to gain maximum revenue and share during the forecast period scrutinized in the new analysis - WhaTech...

Recommendation and review posted by Bethany Smith

The announcement by 23andMe, a company that sells home DNA testing kits, that it has sold the rights to a promising new anti-inflammatory drug to a Spanish pharmaceutical company is cause for celebration. The collected health data of 23andMes millions of customers have potentially produced a medical advance the first of its kind. But a few weeks later the same company announced that it was laying off workers amid a shrinking market that its CEO put down to the publics concerns about privacy.

These two developments are linked, because the most intimate data we can provide about ourselves our genetic make-up is already being harvested for ends we arent aware of and cant always control. Some of them, such as better medicines, are desirable, but some of them should worry us.

Launched in Silicon Valley in 2007, 23andMe offers genetic tests direct-to-consumer (DTC) that is, independently of any healthcare system. The company collects genetic information about people, as well as information about their health, behaviour and much more besides. This allows it to identify links between certain genes and, say, a disease, and then through its therapeutics division to develop drugs that interfere with the action of disease-causing genes.

Companies such as 23andMe have proliferated over the past decade, feeding peoples hunger to know who and where they come from, and what diseases their genes might predispose them to. Over that time, it has gradually become clear that the main source of revenue for at least some of these companies comes from selling the data on to third parties.

Some DTC companies, such as 23andMe, are transparent about the sharing of data. When you sign its contract, you are asked if you consent to your data being used for research, and roughly 80% of 23andMes customers do. Other companies are less forthcoming. A 2016 survey showed that only a third of the 86 companies then offering genetic testing services online explained to customers how their data would be used.

The trouble is, a health tech company is not a doctor. It doesnt take the Hippocratic oath, and the patient or customer is not the person whose wellbeing it is most concerned about. It is not obliged to talk you through its terms and conditions, and it could change these at any time though in some jurisdictions this may void your consent. You can also withdraw your consent at any time, but that withdrawal generally takes time to come into effect, and in the meantime your data may have been passed on after which it is harder to get it back. Erasing it entirely is harder still.

And what rights do the customers have over the product developed from their data? DTC companies are far from the only ones collecting sensitive data about you. National health systems, health insurers and, increasingly, social media providers are too. Its already being used in research designed to improve our health and wellbeing, and there is a legitimate question to be asked about compensation. 23andMe, for example, asks its customers to waive all claims to a share of the profits arising from such research. But given those profits could be substantial as evidenced by the interest of big pharma shouldnt the company be paying us for our data, rather than charging us to be tested? There are echoes of Henrietta Lacks here, the African-American woman whose cells became a workhorse of biomedical research after she underwent a biopsy in 1951, and who was never compensated (nor did she give her consent, but that was allowed under US law at the time).

The larger issue, though, is that with all of these databases there is ambiguity about who has access to them, and for what purposes. Besides pharmaceutical companies, others who might want such access include insurance companies, individuals involved in paternity or inheritance disputes, and law enforcement agencies. 23andMe states that it does not grant access to the police, but other companies such as FamilyTreeDNA boasts that it does. A suspect accused of being Californias notorious Golden State Killer was finally arrested in 2018 after investigators matched a DNA sample from a crime scene to the results of DTC testing uploaded on to a public genealogy site by a relative of his. Government-run biobanks have also granted access to police. This was how a conviction was secured against Swedish foreign minister Anna Lindhs assassin in 2004. And experts speculate that in future, biological data could be used for identifying terrorist suspects, tracking military personnel, and the rationing of treatment in overstretched health systems.

National legislation varies widely across Europe, with respect to DTC genetic testing. France and Germany essentially ban it, unless done under medical supervision and consumers can be fined for ordering tests outside a clinical setting, while Luxembourg and Poland allow it with minimal restrictions though, of course, any restrictions are difficult to police for tests bought online. The UK is somewhere in the middle, allowing the tests but insisting on informed consent. The European Unions General Data Protection Regulation (GDPR), which came into effect in 2018, imposes strict requirements on secondary use of data, and it applies to any company in any jurisdiction that targets EU-based individuals for goods or services. Those individuals strip away their own GDPR protection, however, when they contact foreign companies that dont explicitly target them. The UK recently signalled that it will not remain aligned with the GDPR after the Brexit transition period.

These are the privacy concerns that may be behind layoffs, not only at 23andMe, but also at other DTC companies, and that we need to resolve urgently to avoid the pitfalls of genetic testingwhile realising its undoubted promise. In the meantime, we should all start reading the small print.

Laura Spinney is a science journalist, novelist and author

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Your DNA is a valuable asset, so why give it to ancestry websites for free? - The Guardian

Recommendation and review posted by Bethany Smith

Any way you look at it,Invitae (NYSE:NVTA)is smoking hot right now. The stock soared 46% last year and is up more than 60% so far in 2020.

But Invitae's sizzle fizzled at least somewhat after the medical genetics company announced its fiscal 2019 fourth-quarter and full-year results following the market close on Wednesday. Here are the highlights from Invitae's Q4 update.

Image source: Getty Images.

Invitae's revenue jumped 46% year over year in the fourth quarter to $66.3 million. That's the good news. The bad news is that this result fell short of the average analyst Q4 revenue estimate of $68.14 million.

The company reported a net loss of $76.9 million, or $0.79 per share, based ongenerally accepted accounting principles (GAAP). This trended in the wrong direction from the net loss of $29.8 million, or $0.40 per share, posted in the prior-year period.

Invitae announced an adjusted net loss in Q4 of $61.3 million, or $0.63 per share. While this loss was much wider than the adjusted net loss of $31.4 million, or $0.42 per share, recorded in the same quarter of 2018, it was a little better than the consensus Wall Street estimate of a Q4 net loss of $0.65 per share.

CEO Sean George attributed his company's strong revenue growth to several factors. He noted that Invitae expanded its customer base and saw strong reorder rates among new accounts. George also said that the company "made it easier to access our testing, both through traditional payers and via unique partnership programs."

George had predicted over 500,000accessioned samples for full-year 2019 in his comments during Invitae's Q3 conference call in November. But Invitae reported only 482,000 accessioned samples for the year, with the Q4 total sample count of 148,000 coming in lower than expected.

Accessioned samples are the key metric the company uses. The term refers to DNA samples that have been accepted into Invitae's labs and tracked in its system (as opposed to a sample that is collected at a physician's office but not sent to the lab).

Other key developments in the fourth quarter included Invitae's announcement in November that it plans to acquireClear Genetics, a leading developer of software for providing genetic services. The company also announced an initiative with BioMarin Pharmaceuticalto provide genetic testing at no cost to patients with signs or symptoms of skeletal dysplasias, a group of rare bone and joint disorders.

Invitae expects that more than 725,000 samples will be accessioned in full-year 2020. The company projects revenue of over $330 million for the year, up more than 50% from 2019.

Sean George said: "We enter 2020 with momentum and a unique business model that we believe is well positioned to deliver genetics-informed healthcare to patients. As we continue to scale our business, we are confident our approach and the investments we are making will further strengthen our ability to bring affordable, accessible genetic information to billions of people worldwide."

But Invitae is a growth stock with a market cap that can't be justified on its current revenue. It's still not profitable. As a result, any bump in the road is likely to cause the stock to fall. The Q4 update appears to be just such a bump, with shares sinking around 9% in after-hours trading.

Link:
Why Invitae's Q4 Results Failed to Wow Investors - Motley Fool

Recommendation and review posted by Bethany Smith

SEATTLE Morgen White has always wondered what her biological father would be like. She grew up only knowing him as "Donor #893". That changed last year when the genetic testing site 23 & Me connected them.

"Donor #893" was Spokane's Ryan Johnson and he reached out to Morgen and her mother Liz White. The Ballard teen got to meet Johnson, his wife and 3 children and has spent the last year building a relationship.

Morgen says she's been connected to at least 9 other half-siblings, all from the same donor, and loves having so many people that care about and support her. She first wrote about meeting Ryan as part of her internship with KUOW Radioactive Youth Media program.

Segment Producer Suzie Wiley. Watch New Day Northwest 11 AM weekdays on KING 5and streaming live on KING5.com.Contact New Day.

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Connected through genetic testing, Ballard teen meets her sperm donor - KING5.com

Recommendation and review posted by Bethany Smith

Are you genetically predisposed to some diseases? Do you carry genetic mutations that can impact the health of your child? A debit card-sized IndiGenome card, recently unveiled by the government, will help you find the answers if your genetic information is captured in a database that India's umbrella research organisation - the Council of Scientific and Industrial Research (CSIR) - is building. Once your genome is sequenced from your blood sample and added to this database, the card can be used to read the information embedded in your genes, just as your debit card is used to generate a financial transaction statement from your bank's database.

Well, the card is not the key. Genome sequencing - or mapping the pattern of the basic building block of every living cell - is. A genome contains all of a living being's genetic material (simply put, the genome is divided into chromosomes, chromosomes contain genes, and genes are made of DNA). Each genome has approximately 3.2 billion DNA base pairs, and the way they are arranged, or variations and mutations in their pattern, can provide clues about the individual's health or ill health, inherited or acquired. Already, 1,008 individuals, chosen to represent India's social, ethnic and geographic diversity, have been issued such cards. Over 280 doctors in 70 institutions have been trained to make sense of such data. A CSIR institute, the Institute of Genomics and Integrative Biology (IGIB) - which is spearheading the Genomics for Public Health in India, also called IndiGen project - is planning to enrol 20,000 Indians for whole genome sequencing in the next couple of years to build a larger database. The data will be important for building the knowhow, baseline data and indigenous capacity in the emerging

area of precision medicine. IndiGen will have applications in a number of areas, including faster and more efficient diagnosis of rare diseases. The other benefits are cost-effective genetic tests, carrier screening applications for expectant couples, enabling efficient diagnosis of heritable cancers and pharmacogenetic tests to prevent adverse drug reactions.

In fact, IGIB leads two other programmes - Genomics for Understanding Rare Diseases India Alliance (GUaRDIAN) Network and Genomics and other Omics tools for Enabling Medical Decision (GOMED), led by Dr Mohammed Faruq, to see that the genome database and genetic screening leads to development of cost effective diagnostic tools and tests that are licensed out to private and public medical institutions.

The world over, fall in cost for genome sequencing (a reason for which is increase in computing power) is leading to path-breaking applications spanning the entire spectrum of healthcare - diagnosis to treatment and drug development to prevention and wellness - and unrelated fields such as agriculture, animal productivity, environment, sports and many more. Consider this: CSIR took six months to sequence the genomes of 1,008 Indians. Seventeen years ago, a global initiative led by the US National Academy of Sciences, had taken 12 years, and spent $3 billion, to complete the sequencing of the first human genome. Today, sequencing a person's genome does not cost more than $1,000. In fact, Sam Santosh, Chairman of MedGenome Labs, a private venture, says he can sequence a complete human genome in his Bengaluru lab for $500-600.

The Industry

The catalyst for the IndiGen project was advent of Next Generation Sequencing (NGS) in the last decade or so. (NGS helps an entire human genome to be sequenced in a day. The previous Sanger sequencing technology used to take over a decade.) The technology is being used by both IGIB and MedGenome for high-throughput sequencing, i.e. sequencing hundreds of thousands of genes in one go.

IndiGen is a good start but there are countries that are much ahead. Genomics England, a public-private partnership between the UK government and world's biggest NGS sequencing machine maker, Illumina, has completed sequencing of 1,00,000 genomes of British citizens comprising a mix of cancer patients, rare disorder patients and healthy people. A new agreement for sequencing of 3,00,000 genomes, with an option to increase it to 5,00,000 over the next five years, was signed by the two partners on January 13. "Countries such as Estonia and Iceland are attempting to sequence every single citizen and link the data with their health schemes. The US has decided to do it for every single rare disorder patient," says Praveen Gupta, Managing Director & Founder, Premas Life Sciences - the authorised partner of US-based Illumina in India.

"The global high-throughput genomics industry will be in the range of $10-12 billion. With an estimated 25-30 per cent annual growth, it is expected to become a $25-30 billion market in the next three-four years," he says. Premas sells tools (reagents, platforms, software, training) to labs that do genetic testing in India. With 90 per cent market share, it drives NGS technology in India, too. "The high-throughput genomics market in India, including reagents, instruments and services, will be about Rs 500 crore. Approximately 50,000 samples must be reaching India's clinical (service) market on an annual basis," says Gupta.

Dr Sridhar Sivasubbu and Dr Vinod Scaria, IGIB scientists at the forefront of the IndiGen programme, say genome sequencing is just one piece of the initiative. IGIB has two other programmes - Genomics for Understanding Rare Diseases India Alliance (GUaRDIAN) Network and Genomics and Other Omics Tools for Enabling Medical Decision (GOMED) - to ensure their genome database and genetic screening lead to development of cost-effective diagnostic tools and tests that can be licensed out to private and public healthcare institutions. "GUaRDIAN focuses on rare diseases. Given that we are a billion-plus people, even the rarest of the rare diseases is found in a few lakh people. So, this programme caters to 70 million people living with some genetic disease. We find technological solutions for these 7,000-odd diseases and partner with a network of 280 clinicians across 70-odd institutions to offer our solutions," says Sivasubbu.

"Patients and their families connect with us through the GUaRDIAN network. We sequence their genes to find the mutation, and once we find it, we go back to their communities with a cost-effective test to identify that mutation. You just have to look for that single mutation in others, and that's cost-effective," says Scaria. Instead of whole genome sequencing, which costs between Rs 50,000 and Rs 1,00,000, a single assay developed by IGIB through these programmes costs Rs 2,000. The team led by Sivasubbu and Scaria has developed 180 tests for 180 genes and transferred the technology to private diagnostic labs. The institute itself has catered to about 10,000 patients and carried about 25,000 tests in the last two years. "We have entered into partnerships with about a dozen companies. The format of the collaboration depends on the business models they follow," says Sivasubbu.

Premas Life Sciences

The authorised partner of US-based Illumina in India provides tools (reagents, platforms, software, training and troubleshooting) to labs engaged in genetic testing in India. With 90 per cent market share, it drives the New Generation Sequencing technology in India

It works in areas other than healthcare, too. For example, Tagtaste, an online platform for food professionals, uses the company's services to understand the genomics of taste. It has customers and partners such as Pepsico, Coca Cola, Nestle and ITC

Dr Lal PathLabs

The company has licensed diagnostic tests for 27 conditions from Institute of Genomics and Integrative Biology (IGIB)

Has a portfolio of more than 200 different types of tests

It is active in fields like rep- roductive health, cancer di- agnosis, pharmacogenomics

Medgenome Labs

The Bengaluru-based player considers itself as the private sector avatar of IGIB. It offers not just genetic tests but also carries out research. It has collaborated with Singapore's Nanyang Technological University to sequence 1,00,000 whole genomes from Asia. The Genome Asia project has already completed sequencing 10,000 whole genomes, of which about 8,000 are from India

MedGenomes research associates recently sequenced and analysed the genome of the Cobra snake. The findings, published in Nature, suggest the possibility of developing a new method of producing anti-venom completely in the lab.

Lifecell International

The company is in the genetic testing space. It has tied up with IGIB and offers tests ranging from basic screening (prenatal screening, newborn screening, etc) to high-end ones based on NGS. It tests more than 50,000 patient samples every month

Mahajan Imaging

The company has set up a new R&D wing to focus on cutting-edge scientific and clinical research and help radiology and genomics companies develop world-class clinically relevant products. The idea is to integrate imaging and genomic data

Trivitron Healthcare

The Chennai-based chain wants to develop tools using genomic data that can work on conventional platforms. It is talking to IGIB and trying to get its knowhow for manufacture of products for sale to pathology labs

The Private Hand

Dr Lal PathLabs, a pathology lab chain with big plans in the genetic testing space, has an entire department for such tests. "We offer tests of all levels - Karyotyping, which looks at the macro level, Microarrays, which offer intermediate resolution, and NGS, used to elucidate the DNA sequence at the micro level. The fields we are active in include prenatal reproductive health, cancer diagnosis and pharmacogenomics (study of how genes affect a person's response to drugs). We have more than 200 tests and conduct around 300 tests per day," says Dr Vandana Lal, Executive Director, Dr Lal PathLabs. The company has licensed tests for 27 conditions from IGIB. "The imported technology is expensive. The idea to partner with CSIR labs is to bring these cutting-edge technologies to Indian masses at a reasonable cost," says Dr Lal.

Lifecell International is another player in the genetic testing space that has tied up IGIB. "We offer tests ranging from basic screening (prenatal screening, newborn screening, etc.) to high-end ones based on NGS. We test more than 50,000 samples a month. PCR-based tests range from Rs 2,000-5,000 whereas tests based on NGS and those involving sequencing of large parts of the genome can cost upwards of Rs 20,000," says Ishaan Khanna, CEO, Biobank & Diagnostics, Lifecell. He believes the IndiGen database will help in development of better analysis and interpretation tools. "Our focus is on developing rapid genome testing for children in NICU (Neonatal ICU) and similar other scenarios where doctors need clear actionable results in the shortest possible time. IndiGen provides the right mix of Indian genome database," he says.

But not every partnership is for access to cost-effective tests. Mahajan Imaging, a medical imaging chain, has set up a Centre for Advanced Research in Imaging, Neuroscience and Genomics to focus on research and helping radiology and genomics companies develop clinically relevant products. The idea is to integrate imaging and genomic data. "We started the project six months ago and are among the first imaging companies to get into genomics. In the next three-five years, it will be possible for an AI algorithm to look at the radiology image and give genomic readings on it," says Vidur Mahajan, Associate Director, Mahajan Imaging.

Chennai-based Trivitron Healthcare sees in IndiGene data an opportunity to develop multiple testing platforms. It wants to develop tools using genomic data that can work on conventional platforms. "There are almost 1,00,000 pathology labs in India. Hardly 500-1,000 must be doing genetic testing. Companies like ours are talking to IGIB and trying to get the knowhow to manufacture products for a larger population," says Jameel Ahmad Khan, Head, R&D, Trivitron. "IGIB will develop the knowhow, provide proof of concept, and we will convert it into a product which pathology labs without highly trained manpower can also run," he says.

Bengaluru-based Medgenome Labs considers itself a private sector avatar of IGIB, perhaps even a couple of years ahead in research and development. The company not only does genetic tests but also carries out research. It has collaborated with Singapore's Nanyang Technological University to sequence 1,00,000 whole genomes from Asia. The Genome Asia project has already completed sequencing of 10,000 whole genomes, of which about 8,000 are from India. On December 4, international journal Nature published the initial findings from the project - genetic variation, population structure, disease associations, etc., from a whole-genome sequencing reference dataset of 1,739 individuals of 219 population groups and 64 countries across Asia. "We sequence a person's genes and other relevant parts of the genome for specific mutations to understand what is causing the disease and specific drugs and dosage the person will respond to. We also help pharmaceutical companies understand genomes and discover new drug targets and biomarkers," says Sam Santosh, Chairman, MedGenome. With about 120 sales people, the company claims it is generating samples from around 10,000 clinicians across the country. "We were the first to enter the market. In that sense, we created the market, and would be having 60-65 per cent market share. The sequencing market must be in the range of $70-75 million," says Santosh. The company expects its diagnostic business to touch $100 million in four years. Interestingly, MedGenome's research associates recently sequenced and analysed the genome of Cobra snake. The findings, published in Nature, suggest the possibility of developing a new method of producing anti-venom completely in the lab.

Other Sectors

Illumina's India partner Premas Life Sciences is not selling its next generation sequencers only to healthcare firms. Gupta says it has more than 200 installations in India alone. "Anything which is living has a DNA nucleic acid and can be sequenced. We have a mass research market and practically every institute has the sequencer. Somebody will be working on cow, somebody on rice, a third institute on some bacteria," says Gupta.

IGIB researchers Dr Sridhar Sivasubbu and Dr Vinod Scaria vouch for this. The institute is getting requests, including partnership offers, from non-medical players. Tagtaste, an online platform for food professionals, wants to understand the genomics of taste. "In a lighter vein, you could say that the efficiency of a professional wine taster depends on his genes," says Scaria. With customers and partners such as Pepsico, Coca Cola, Nestle and ITC, and a clientele that includes chefs of global hotel chains, taste is serious business. "The point is, if a person is paying Rs 3,000 for a curry or Rs 5,000 for a soup, you better get the taste right," says Scaria. IGIB also works with Adam's Genetics for R&D and product development in the area of fitness. "One of the companies works in the cricket industry. Each player can be genetically tested for performance and food intake because not all muscles have the same size and some people gain weight, some don't gain muscle mass, while some may be more prone to injury. Genetic tests can find out who is prone to injury, or whether weightlifting is the right exercise for a player or not," says Sivasubbu.

The Future

Indians are 17 per cent of the world's population. But only 0.2 per cent genomic data is from the Indian population. This is one area where India can lead. We have so many diseases, and if we can provide the genetic design, the world can develop diagnostics and therapies. "We can create ideas. We didn't invent computers but we created the IT industry. In the same way, we didn't invent genomic sequences but tomorrow we can create a genome informatics economy," says Premas' Gupta.

There are other possibilities, too. "A lot of pundits say that in the next five-six years, 15 per cent of the world's population will be whole genome sequenced. If I require 100 GB data for a genome sequence, for 1.5 billion people, 25-30 exabytes of data will be needed. The entire data content on YouTube, globally, is 0.8 exabytes. Imagine the kind of data generation and analytics possibilities we are talking about," says Gupta. "We need people to analyse this data. If we can take the lead and train our manpower, we can move the world, we can create a new industry which can lead for the next 20 years just the way the IT industry did," he adds. Incidentally, Gupta claims that TCS has already bought Illumina's sequencing platform. So has WIPRO. It seems IT companies are already sensing an opportunity.

Sivasubbu says it took India 10 years to scale up from sequencing one genome to 1,000 genomes. "In the next decade, it may be a million."

@joecmathew

Continue reading here:
The Gene Business - Business Today

Recommendation and review posted by Bethany Smith

In 2004, Dr. Michael Ackerman got an unexpected phone call.

On the other end of the line was a medical examiner in Kentucky who had recently performed a befuddling autopsy on a 12-year-old Amish girl.

He was perplexed why this seemingly healthy Amish child died suddenly during play, said Ackerman, a genetic cardiologist at Mayo Clinic who studies why some young people die unexpectedly. And he says, I have DNA for you.

Ackerman, who also leads Mayos Windland Smith Rice Sudden Death Genomics Laboratory, pioneered a postmortem test to detect genetic causes behind sudden death. The medical examiner in Kentucky had heard about his work.

That phone call would ignite more than a decade of genetic sleuthing across multiple states to understand why a healthy Amish child had died without an obvious explanation. The mystery of her death and later, the deaths of more than a dozen other Amish children would vex researchers and clinicians for years, until Ackerman and his colleagues finally made a breakthrough in their Mayo lab.

Those findings were recently published in the JAMA Cardiology medical journal. Now, those same researchers are working to find a treatment.

Not long after the medical examiners call in 2004, Ackerman and his team were just beginning their research into the girls DNA when tragedy struck again. Four months after losing their daughter, the family lost her 10-year-old sister under similar circumstances suddenly, while she was outside playing.

Ackerman said his research team had a hunch the siblings deaths involved a gene called RYR2. When there's a single error on the gene, it causes an irregular heart rhythm that often reveals itself in the form of fainting spells while exercising. It can be fatal.

But that was more than 15 years ago, and medical research tools hadnt quite caught up to the teams needs.

Back then, it was painfully slow. It sort of was one gene at a time, Ackerman said.

After extensive testing of the girls' DNA, the Mayo researchers still had no answers.

We basically had a project that was stalled and would stay stalled until we would have evolution of technology, Ackerman said.

Over the next decade, 16 more Amish children died while exercising, without warning. The same family that lost their daughters in 2004 lost two more children under similar circumstances. Amish children in other states died, too.

While Mayos research languished, more than a thousand miles away, doctors at the Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del., encountered a similarly tragic story.

In 2005, a young, apparently healthy Amish child was playing and died suddenly. The autopsy revealed no obvious cause. Several years later, the girls sister experienced cardiac arrest but survived and she is still living, 15 years later.

This started a trend, essentially, in their family, said Kristi Fitzgerald, a genetic counselor at Nemours and an author of the JAMA paper. Its not just a fluke chance, a terrible, tragic event. Now with two girls in one family, the presumption was that this probably was a genetic cause, something to do with a genetic arrhythmia.

But just as in Ackermans lab in Rochester, Minn., genetic testing at Nemours turned up nothing.

Over the years, Nemours staff collaborated with Mayo staff, and in the process learned that the sisters who had died in Kentucky were from the same extended family as the child who had died in Delaware.

Researchers also identified additional relatives in Iowa who have the same genetic defect. To date, no members of Amish communities in Minnesota appear to have the condition.

Clinicians at Mayo and elsewhere are fiercely protective of the families affected, and declined to identify them to maintain their privacy.

In Rochester, Ackerman and his staff continued to collect DNA samples from the children who died in this perplexing way, hoping someday to figure out the cause of their death.

They just needed the technology to catch up. In 2016, it started to.

Ackerman said new testing techniques revealed that the sudden deaths weren't caused by just one error on the RYR2 gene they were caused by 300,000 of them.

What's more, the risk of sudden death came only when the children inherited that faulty gene from both parents.

"We basically did genomic triangulation and figured that all of these sudden deaths and all of these different Amish communities were happening for the exact same reason: a double whammy, a double hit of this exact same duplication, Ackerman said.

Nemours pediatrician Matthew Demczko has made a career working with Amish children who live with an array of genetic abnormalities.

He said the genetic heart defect detected by the Mayo team is likely unique to the Amish community. Thats because researchers think people with the defect are all connected to a small number of people who established a particular Amish community from which the children affected were all descended. Those people are what Demczko calls "founder individuals."

Their genetic information has now become sort of the genetic thumbprint of the entire community, he said.

Demczko said Amish communities tend to be small and insular, and members of the community typically marry and have children with people who are also Amish.

That factor on top of the idea that from a cultural perspective, very few individuals come into the Amish community, there's really no introduction of new genetic material, he said.

Beating heart cells engineered from blood donated by two people living with a condition that has caused the sudden deaths of Amish children are shown on a microscope screen inside of the Mayo Clinic's Windland Smith Rice Sudden Death Genomics Laboratory.

Evan Frost | MPR News

Fitzgerald, Demczkos colleague, is on the front lines of screening members of Amish communities in their region for the defect. She said that Nemours positive reputation in nearby Amish communities helps in her work.

Word of mouth is important, she said. I think that's a great source of referral, to have a patient to say, We had a good experience. This went well.

Fitzgerald said her Amish patients ask the same questions about genetic testing as other families do: What will the test tell them? Why is the test important? What will they do with the information if they test positive?

And she said it's a misconception that Amish people shun medicine.

The families shes worked with, she said, have been open to testing and treatment.

"Parents want what's best for their child. It's about building a relationship, you know, with the family, she said. Most are not at all skeptical."

Fitzgerald said that some parents whose children have tested positive for the condition have opted to get an implantable defibrillator, which is the only available treatment.

But many Amish families dont carry health insurance, so that solution is not only invasive, but can be prohibitively expensive.

Back at Mayo, researcher Dave Tester is trying to better understand the genetic defect he helped discover. Now that theyve pinpointed the cause of the childrens sudden death, theyre trying to find a more affordable and accessible treatment.

"This is sort of phase 2 in this study, said Tester, who also authored the JAMA article.

To do that, the researchers turned to another novel approach: They engineered beating heart cells from blood samples donated by two people living with the condition.

He points to a cluster of heart cells undulating rhythmically under a microscope.

"These cells have the same exact genetic background that our patient does, he said. Here we can understand, at least from this patient's perspective what is the cell doing?"

Beating heart cells from blood samples donated by two people living with a condition that has caused the sudden death of Amish children.

Evan Frost | MPR News

In the coming months, Tester and his staff will perform a battery of tests on these cells, looking for clues that point them toward a better treatment.

But in the meantime, Mayo and Nemours continue to collaborate to understand just how common the condition is and how widespread. Their network has also extended to Iowa, where a genetic counselor is working with nearby Amish communities.

To ease that process, Mayo has made the test free for Amish families who may be affected.

Fitzgerald, the genetic counselor, is hopeful additional screening in Delaware and in other Amish communities will reveal more information about the condition.

And while she may not be able to offer her families a perfect solution today, at least they're starting to get some answers.

We don't want to give false hope, but I think it is important to tell families how far we come, she said. We tell people Hold on, stay tuned.

More:
Amish kids were dying mysteriously. Mayo scientists solved it. But can they treat it? - Minnesota Public Radio News

Recommendation and review posted by Bethany Smith

Senator Thomas J. Umberg (D-Santa Ana) announced today his introduction of legislation that would assure consumers that Direct-to-Consumer (DTC) genetic testing companies will use their genetic data solely for the purposes they consented to.

The fact that the Pentagon just warned all of the countrys military personnel to avoid home DNA tests should raise bright red flags for all consumers, said Senator Umberg. Direct-to-Consumer genetic testing companies have, to date, gone largely unregulated by either state or national governments. This has led to the disclosure of consumers private biological information to third parties.

Although the California Consumer Privacy Act (CCPA) regulates DTC genetic companies by allowing consumers to request information on how their data is being used and to opt out if they so wish, it does not solve the fact that current authorization forms are confusing, and consumers often lack clarity about what they are consenting to. Several media outlets have published stories in recent months of genetic data being improperly used to conduct drug research, discriminate against possible consumers in regard to insurance products, or being stored on hackable private servers.

In December 2019, the Pentagon issued a memo asking service members to not use DTC genetic services due to, the increased concern in the scientific community that outside parties are exploiting the use of genetic materials for questionable purposes, including mass surveillance and the ability to track individuals without their authorization or awareness.

Umbergs measure, Senate Bill 980, creates strict guidelines for authorization forms in a manner that allows consumers to have control over how their DNA will be used. In addition, the measure creates civil penalties for companies that fail to comply with the provisions within it. By passing this act, California would be joining four other states that have made it clear that consumers should control their genetic data without fear of third parties exploiting it. Forcing these companies to clarify their consent forms and requiring them to obtain written authorization for any genetic data disclosure, including de-identified data, will reassure California consumers that their most personal information is safe, noted Senator Umberg.

In support of SB 980, Emily Rusch, Executive Director of the California Public Interest Research Group (CALPIRG) noted that, Consumers deserve to have complete control over the sharing of our genetic data, the most personal, private information about our bodies. We strongly support this proposal to require consumers opt-in consent before genetic data is shared with third parties.

Senate Bill 980 (language attached) will be assigned to, and heard, by Senate policy committees in mid-late March.

Courtesy photo

Originally posted here:
Umberg wants consumers to control of their genetic data - EVENT NEWS

Recommendation and review posted by Bethany Smith

Ive had three miscarriages and one ectopic pregnancy, and every single time I blamed my body, says Danielle Campoamor, 33, a mother of two in New York. My self-hatred became so severe I couldnt look at myself in the mirror. I starved my body as if I was paying a penance. I spent so much of the mourning process asking what was wrong with me. What was wrong with my body.

The shame associated with miscarriage can be overwhelming. As a psychologist specializing in womens reproductive and maternal mental health, I find that counseling patients like Campoamor who blame themselves for their pregnancy losses is as common as loss itself. The women in my office are often riddled with guilt, revisiting every minute detail of their lives in search of the reason behind their miscarriage. In the haze of grief, they point the finger at themselves: Was it something they ate? Did they workout too often? Had they done something catastrophic in the weeks before they even knew they were pregnant?

Having access to concrete answers could change a lot.

At least half of all miscarriages are the result of an abnormal number chromosomes in the embryo, according to the American College of Obstetricians and Gynecologists. Its the most common cause of pregnancy loss. But getting access to the genetic testing of fetal tissue is complicated and costlygenetic testing is rarely offered to anyone whos experienced less than three miscarriages, and it can cost thousands of dollars. A new rapid genetic test, developed by Zev Williams, M.D., Ph.D., director of the Columbia University Fertility Center at New York Presbyterian Hospital, and his team, hopes to change that. The new test would take just hours to complete and could cost less than $200. Williams expects the test to be available within a year, but it will need to be approved by medical regulatory agencies.

Campoamor says that kind of info would have made all the difference when she was mourning her losses. What I wouldnt have given to have access to a test that wouldve let me know that my body didnt let me down, that there was a problem with the pregnancies from the beginning, she says.

A 2015 national survey published in the Journal of Obstetrics & Gynecology found that 47% of people whove had a miscarriage feel guilty, and 41% felt they had done something wrong to cause the pregnancy loss: 76% of Americans believe pregnancy loss is caused by a stressful event, 64% believe its caused by the pregnant person lifting a heavy object, 28% believe previously using an intrauterine device causes miscarriages, and 22% blame the use of oral contraceptives, according to the survey. I blamed my IUD. I blamed my decision to use birth control at the age of 15. I blamed my job, my work load, a harmless argument with my partner, running at the gym. I looked for any reasonanythingto blame for my losses, Campoamor says. Theres no evidence that any of these things contribute to miscarriage, but the stigma persists. Years later, I still have to work to not blame myself, what I ate, how much water I did or didnt drink. The self-blame just lingers.

After each loss I felt like I was in the dark. Information about why it happened, why my body didnt hold onto those pregnancies, wouldve felt like a lantern.

The same survey found that 78% of the participants reported wanting to know the cause of their miscarriage, even if no intervention could have prevented it from occurring. Thats precisely why this test is poised to be such a game changer. Getting women answers could help dissolve the feelings of shame and failure that so often shroud a miscarriage. A 2019 study found that one in six women experience long-term post-traumatic stress following a miscarriage, and 1 in 10 women meet the criteria for major depression directly following a loss. Bypassing the mystery can potentially lead to a smoother, less complicated emotional journey.

The test wont answer every question about a miscarriage. For starters, it requires tissue from the pregnancy to test, and doctors may not always have the opportunity to gather it. If a test reveals that there were no genetic abnormalities, it could trigger even more questionsand self-blameabout the cause. But even that can be helpful. In the minority of cases where the cause of the loss was not genetics, it allows us to look for the cause soonerbefore waiting for the women to have multiple more losses, says Williams. If a cause is discovered, it can be corrected so the couple can have the best chance for success in the next pregnancy.

As humans, we like to know why. Ive sat across from hundreds of women and heard the desperation in their voices as they search for a reason why they didnt carry a pregnancy to term. This test could help mitigate some of the psychological fallout of pregnancy loss by separating fact from fiction, science from a pervasive cultural misunderstanding that fuels self-blame and self-hatred.

After each loss I felt like I was in the dark, Campoamor says. Like I was just feeling my way through grief, trying to hold onto something, anything, before I floated away. Information about why it happened, why my body didnt hold onto those pregnancies, wouldve felt like a lantern. It wouldnt have assuaged my pain, but it would have lit a path through it.

Jessica Zucker is a Los Angeles-based psychologist specializing in womens reproductive health and the author of the forthcoming book I Had a Miscarriage: A Memoir, a Movement (Feminist Press, 2021).

More:
Women Blame Themselves for Miscarriages. This Test Could Change That - Glamour

Recommendation and review posted by Bethany Smith

Feb. 19, 2020 11:00 UTC

HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)-- Cicero Diagnostics Inc., a womens healthcare diagnostic company, is pleased to announce the awarding of a $1 million Phase II SBIR Fast Track grant from the National Institutes of Health (NIH). The grant, titled "SIRT1 and BCL6: Dual Biomarkers of Endometriosis and Endometrial Receptivity follows completion of Phase I, successfully demonstrating concordance of the protein markers BCL6 and SIRT1 to endometriosis, a leading cause of unexplained infertility. According to the American Society of Reproductive Medicine, endometriosis is associated with 30-50% of all cases of unexplained infertility (over 500,000 cases a year). Cicero Diagnostics on-going commercialization of protein markers to assess uterine receptivity impacted by endometriosis inflammation has proven to be a significant breakthrough in helping women successfully achieve pregnancy.

Cicero Diagnostics currently offers BCL6 as part of their ReceptivaDx test for unexplained infertility, failed implantation and recurrent pregnancy loss. Over 300 fertility centers representing more than 1,000 reproductive endocrinologists across the US and globally are successfully using the test for assessing uterine lining dysfunction typically caused by endometriosis without the cost and invasiveness of surgical laparoscopy. Once identified and treated, outcomes data from both published studies and fertility centers using the test commercially have demonstrated significantly higher success rates in women with IVF failure histories.

Chris Jackson, CEO of Cicero Diagnostics, states, Were proud that ReceptivaDx has helped so many women challenged with infertility. While IVF success rates are now approaching 50-60%, we remain focused on finding answers for the 40-50% of patients where IVF and genetic testing of embryos still doesnt result in pregnancy. This doesnt even begin to address the financial and emotional toll experienced by these women, their partners and their families as a result of those failures. By detecting uterine lining conditions without requiring expensive invasive surgery, we have created a tremendous value proposition for women that have experienced IVF failure and want answers before repeating the IVF process. Phase II of the NIH grant will also let us focus on developing testing for the 85% of women in the US that dont have fertility coverage or the means for seeking advanced fertility help. Expanding the offering to the OB market has been a goal of Cicero Diagnostics from day one and remains a primary goal looking forward.

The Phase II portion of the NIH grant includes a broad range of prestigious universities with significant experience in fertility studies. Patients will be drawn from three main centers and include Wake Forest Health Sciences, University of North Carolina and Stanford University. The NIH grant will continue studies building on published data already in the public domain showing the accuracy of these markers in uncovering and treating women with unexplained infertility. The study is designed to end in late 2021.

Specifically, the new studies will:

Cicero Diagnostics is a medical diagnostic company located in Huntington Beach, California. ReceptivaDx is the companys signature test panel in the area of unexplained infertility. Cicero Diagnostics is the exclusive licensed provider of BCL6 and SIRT1 for the detection of endometriosis. Working with IVF centers across the U.S. and in 15 other countries, Cicero Diagnostics continues to expand their offering globally and is investing in continuing research in the field.

For more information, go to http://www.CiceroDx.com or http://www.ReceptivaDx.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200219005339/en/

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Cicero Diagnostics Awarded $1 Million NIH Grant to Further Research on Markers for Unexplained Infertility, Failed Implantation and Recurrent...

Recommendation and review posted by Bethany Smith

Obit Larry Tesler self-described "primary inventor of modeless editing and cut, copy, paste" has died at the age of 74.

Tesler had a hand in many of the computing concepts taken for granted today. On his website he wrote: "I have been mistakenly identified as 'the father of the graphical user interface for the Macintosh'. I was not. However, a paternity test might expose me as one of its many grandparents."

After a stint at Stanford culminating in AI research in 1973, Tesler became a member of the research staff at Xerox's famed Palo Alto Research Center (PARC).

There, thanks to his intense dislike of operation modes of the era, he conceived and implemented many graphical user interface (GUI) features taken for granted today.

Tesler was very keen on "modeless" software, where a user would not have to, for example, use a keyboard to switch to a command mode before switching back to edit text. Tesler's vision was that a user's action should have a consistent effect there should be no "modes."

It is therefore unsurprising that while at Xerox PARC he laid claim to coming up with the ability to point and click to insert or overwrite text without needing to enter a mode. Entering a mode was also not required for the cut, copy and paste operations.

Apple snapped him up in 1980 and during his time at the firm he rose to vice president and chief scientist. He worked on user interface design and software engineering for the Lisa application API and led development of the first commercial object-orientated frameworks. He was also a voice of support of the spinout of Arm from Acorn (see below) and would go on to serve on Arm's board for 13 years.

Not mentioned on his CV was his involvement in Apple's personal digital assistant (PDA) Newton project, which Tesler took over in 1990 and set in motion events that would see the Arm dominance of today. The low power consumption of the silicon while idle appealed, as did its ability not to hammer the battery of the doomed handheld while running. The Newton, or MessagePad as it was eventually branded, launched in 1993, resplendent in a case designed by a young Jony Ive.

While innovative, the PDA did not set the market on fire and, despite updates, was eventually killed off in 1998, shortly after the return of Steve Jobs to Apple.

By then Tesler had moved on, putting four years into an educational software startup called Stagecast then to Amazon in 2001 and creating the usability group as well as managing data mining and market research to give Bezos' brigade a more effective insight in customers.

Between 2005 and 2008 he was VP of user experience and design at Yahoo! before a year-long stint as a product fellow at genetic testing outfit 23andMe. He rounded out his career as a technology consultant specialising in user experience management, research and design.

While Tesler's name may not have the fame (or infamy) of Jobs (or even Ive) his impact, his work from the earliest free-wheeling days of computing through to projects like the MessagePad continue to be felt today.

Sponsored: Detecting cyber attacks as a small to medium business

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Larry Tesler cut and pasted from this mortal coil: That thing you just did? He probably invented it - The Register

Recommendation and review posted by Bethany Smith

This transcript has been edited for clarity.

I'm Dr Richard Isaacson, director of the Alzheimer's Prevention Clinic at Weill Cornell Medicine and NewYork-Presbyterian.

Hormone replacement therapy (HRT) for Alzheimer's prevention is a loaded topic, around which there are a lot of differing opinions out there. Over the past 5 years, I can tell you that my own comfort level with discussing this topic has definitely evolved exponentially.

Five years ago, I wouldn't have even wanted to talk about a topic like this because the data were all over the place. At that time, I may have been able to state one thing: HRT during the perimenopause transition may have some protective effect on the brain. I couldn't say whether it's protective against dementia, Alzheimer's, or cognitive declinejust that taking HRT for 5-7 years during the menopause transition was okay. But I'd add, "I don't know. I'm just a brain doctor. You should probably go see an ob/gyn."

Today, things are a little bit different. Now when I see a woman with a family history of Alzheimer's disease at our program who wants to try to do anything to reduce her risk for dementia, I spend at least 10-15 minutes in the first hour-and-a-half visit just talking about HRT.

We talk about what her symptoms are. Is she having hot flashes? If so, I explain that hot flashes are not necessarily just an endocrine-related thing; it's really a neurologic manifestation of a hormonal shift in the brain.

I take a pretty comprehensive history of the perimenopausal changes. When was the very first time she started having any symptom whatsoever? Is it night sweats? Is it mood changes? Is it something else?

I also don't ask just about brain symptoms but about other symptoms that maybe neurologists don't focus on too much: Is there vaginal dryness? Is there pain during intercourse? These are really important things to understand, because it helps me fine-tune my understanding of the underlying issues. I can hone in on whether there is a local problem of too little estrogen in the reproductive organs or whether it is just neurologic complaints.

When it comes to HRT, I don't think we know exactly what the right treatment is. However, my general feeling, based on the evidence, being cautious, and wanting to do no harm, is that less is more. For example, is it really necessary to take a pill of estrogen when a very small dose of a cream or even a patch may give a smoother, more continuous delivery over time, which may in fact replicate the body's natural process anyway? Based on my own gut instinct and reviewing the best available evidence on my own and in conversation with many ob/gyns and reproductive endocrinologists, a patch may be sufficient.

Does a person just need estrogen or perhaps progesterone as well? This requires taking a clinical history. Even though we're an Alzheimer's prevention clinic, we now look at hormones, estradiol, progesterone, and all sorts of different things. We obtain these baseline results and follow them over time, just as we track other objective measures. In addition to body composition (eg, fat levels or muscle mass), cognitive function, cholesterol levels, and metabolism, hormones are now one of the important puzzle pieces we consider.

Another aspect of this that we're really just starting to look at is brain function. For example, what if a woman in the perimenopause transition has glucose hypometabolism, meaning reduced glucose activity in specific brain regions that are worrisome for the earliest phases of Alzheimer's disease, even before they exhibit symptoms? Is that someone who I may want to pay more attention to from a hormone replacement perspective? If someone has normal brain metabolism versus impaired brain glucose metabolism, maybe that can give us a clue as to whether they need HRT, and if so, which specific type of treatment.

Although the jury is still out about some of these seminal questions, there has been a big difference in my response to hormone replacement as a potential protective intervention for Alzheimer's prevention.

Now, I understand these idiosyncrasies. I understand that, in the future, whether it's 2 or 10 years away, patients will get an examination, blood test, and perhaps a brain scan, followed by a conversation with their physician to really understand the specific aspects of hormone deficiency that may need to be replaced or balanced in an effort to protect brain function over time.

Also in a few years, when someone goes on HRT, aside from just getting a bone scan and perhaps responding to a questionnaire, they may also get a brain scan. By better understanding this, perhaps we can tell whether whatever variation or specific regimen of HRT the person was put on needs to be changed because cognitive function actually declined.

I truly believe that the perimenopause transition is an exceptional window of opportunity in our fight against Alzheimer's disease. Two out of every three brains affected by Alzheimer's disease is a woman's brain. Five to 10 years ago, I had no idea why. It's not just because women live longer; it's because hormone transition affects brain pathology, brain metabolism, and the person's risk for Alzheimer's disease.

Another key consideration is weighing the risks versus the benefits of HRT so we can get everyone on the same page. For example, if someone has a familial risk for breast cancer, or if the woman has actually had a stroke, a blood clot, or currently smokes, these are all things that increase the potential risks of using HRT. Also, what if a person is using progesterone and she has her uterus? Maybe she will be increasing her risk for uterine cancer. These are really important aspects to consider.

But overall, I would say the gestalt about HRT and its specific impact on women's Alzheimer's risk is that it's an individual decision. One must balance the risks versus benefits, take into account the evolving evidence, and really consider the type, dose, method of delivery, and duration of the HRT. For example, in our practice, 5-7 years of HRT sounds reasonable, but does 10, 12, 15 years, or more? I'm not sure that we really know enough to have a one-size-fits-all approach to this.

In the next several years, I expect much new data to come from our research and from others'. I think, following that, we will have the recipe, algorithm, or at least a general set of recommendations for HRT to reduce Alzheimer's risk.

Thanks so much for listening.

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Originally posted here:
Why a Brain Doctor Asks About Hormone Replacement Therapy - Medscape

Recommendation and review posted by Bethany Smith

TPG Specialty (TSLX) came out with quarterly earnings of $0.51 per share, beating the Zacks Consensus Estimate of $0.47 per share. This compares to earnings of $0.67 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of 8.51%. A quarter ago, it was expected that this business development company would post earnings of $0.48 per share when it actually produced earnings of $0.55, delivering a surprise of 14.58%.

Over the last four quarters, the company has surpassed consensus EPS estimates three times.

TPG, which belongs to the Zacks Financial - Mortgage & Related Services industry, posted revenues of $66.50 million for the quarter ended December 2019, surpassing the Zacks Consensus Estimate by 3.62%. This compares to year-ago revenues of $74.74 million. The company has topped consensus revenue estimates three times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

TPG shares have added about 5.7% since the beginning of the year versus the S&P 500's gain of 4.3%.

What's Next for TPG?

While TPG has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for TPG was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and current fiscal year change in the days ahead. The current consensus EPS estimate is $0.49 on $64.50 million in revenues for the coming quarter and $1.96 on $267.42 million in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Financial - Mortgage & Related Services is currently in the top 8% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

To read this article on Zacks.com click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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TPG Specialty (TSLX) Q4 Earnings and Revenues Top Estimates - Nasdaq

Recommendation and review posted by Bethany Smith

America's Car-Mart (CRMT) came out with quarterly earnings of $1.83 per share, beating the Zacks Consensus Estimate of $1.78 per share. This compares to earnings of $1.55 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of 2.81%. A quarter ago, it was expected that this auto retailer would post earnings of $1.85 per share when it actually produced earnings of $2, delivering a surprise of 8.11%.

Over the last four quarters, the company has surpassed consensus EPS estimates four times.

America's Car-Mart, which belongs to the Zacks Automotive - Retail and Whole Sales industry, posted revenues of $186.73 million for the quarter ended January 2020, surpassing the Zacks Consensus Estimate by 5.51%. This compares to year-ago revenues of $161.05 million. The company has topped consensus revenue estimates two times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

America's Car-Mart shares have added about 10.9% since the beginning of the year versus the S&P 500's gain of 4.3%.

What's Next for America's Car-Mart?

While America's Car-Mart has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for America's Car-Mart was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and current fiscal year change in the days ahead. The current consensus EPS estimate is $2.13 on $189.46 million in revenues for the coming quarter and $8.12 on $728.64 million in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Automotive - Retail and Whole Sales is currently in the top 21% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

To read this article on Zacks.com click here.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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America's Car-Mart (CRMT) Beats Q3 Earnings and Revenue Estimates - Nasdaq

Recommendation and review posted by Bethany Smith

Human development research focused on often overlooked communities

In California, Hispanics have surpassed whites as the largest ethnic group in the state. Although it is often thought that this increase is due to immigration, it is actually caused by individuals already living in the state and building families.

Hispanics increasingly choose to raise families in the U.S., yet little research has gone into understanding their family dynamics and childhood development. Instead, research in human development has historically been focused on white Americans of European descent, resulting in a lack of representative knowledge. Leah Hibel, an associate professor of human development and family studies, is striving to bridge this racial gap in scientific research and learn more about the lives of Hispanics in the U.S.

The California Babies Project began in 2017 with the intention of learning how stress factors impact childhood development in Mexican families in the Yolo County area. The project selected families that had already been studied through the California Families Project, a childhood development study that started at UC Davis in 2006.

The children that are part of the ongoing California Babies Project are the descendants of those who participated in the 2006 California Families Project as children. Hibels study hopes to better understand the daily lives of the families through understanding the main stressors they are facing and the resilience mechanisms they rely on to combat challenges.

The main goals of the project are to understand daily life as its lived, how parents are supporting their infants development and their infants ability to regulate their physiology, emotions and sleep said Andrea C. Bhler-Wassman, a doctoral candidate in human development.

To collect data on the families and children, the study started with children at six months old and plans to follow them until they reach the age of four. A key part of data collection relies on the diaries that the families use to document the many fluctuations in daily life during two-week periods.

What is unique about this project is that we have the families filling out questionnaires each day, so we can see how life is lived each day and how each day is impactful, Hibel said.

Beyond the daily diaries, a quantifiable aspect of the study is the recording of the stress hormone cortisol. To measure cortisol, saliva is collected from both the parents and the children. This physiological measure serves as an objective view of the parents stress levels and as an indicator for the way in which the parents stress is impacting their children. Additionally, sleep patterns are recorded to understand how differing amounts of sleep impact the health of the family members.

Although the study is still primarily in the data collection phase, early analysis has already identified stress factors and resilience methods among the families. Correlations can be found between partner hostility and the amount of sleep mothers receive each night. For mothers sleeping the recommended seven to eight hours a night, less partner conflicts are observed. These are experiences to which many families in the U.S. can relate; however, a specific stressor for the families in this study is the fear of deportation.

The study has seen a significant difference in the depression symptoms for mothers who are worried about deportation compared to mothers with less concerns about deportation. Bhler-Wassman pointed out that it is not just undocumented mothers who are negatively impacted by the fear of deportation. Regardless of citizenship status, these mothers still have fears surrounding deportation from concerns about other family members to racist assumptions that they might be undocumented which may result in symptoms of depression.

In the face of these stress factors, the families have shown strong resilience through familial support. The importance of family and the support members receive from one another helps them fight the challenges they face in the U.S.

We are currently studying how social support affects the families mental health, because when families are living in these stressful environments, the main thing that buffers that stress is familial support, Bhler-Wassman said.

The researchers hope that more evidence-based research on Mexican families in the U.S. will ultimately lead to positive changes and more enjoyable lives for the families they study.

I really want to make this research be reflective of the needs of the community and I hope that this research will be able to help them and give back to them, Bhler-Wassman said.

To help the families, policy and social services need to be catered to their specific needs. It is important for the societal support to be inclusive of all family types. This research will help policy-makers come up with specific solutions that will be most beneficial to the families they hope to serve.

Its important to meet families where they are at and be able to provide families with prevention and intervention, Hibel said. We need to make sure those interventions are culturally appropriate and need them to be able to fit into their day to day lives.

Although there has been widespread objection to policies that are negatively impacting immigrants and their families, Jonathan Mulligan Seplveda, a staff attorney for the UC Davis Immigration Law Clinic, emphasized that such policies have been this way for years.

There does seem to be significant push back that is saying this is extremely inhumane policy, yet it seems like policy has been this way for a long time, Mulligan Seplveda said.

Hibel stressed that it is ultimately a societal limitation to not support all the diverse aspects and people of the U.S.

What is important to recognize is that our country is diverse and our communities are diverse, and that diversity is an asset, Hibel said. If we are not supporting and acknowledging aspects of our society, it holds our society back.

Written by: Alma Meckler-Pacheco science@theaggie.org

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California Babies Project works to better understand lives of Mexican families in Yolo County - The Aggie

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Prosecutors in the trial of Jerry Lynn Burns rested their case Wednesday. Burns is suspected of killing high schooler Michelle Martinko in Cedar Rapids in 1979 and he faces a first degree murder charge.

Eighteen-year-old Martinko was found stabbed to death in her familys Buick parked in the Westdale Mall parking lot early on the morning of December 20, 1979. Her killing upended the lives of her family members and shocked Cedar Rapids residents. The case has stuck in the memories of many for decades.

Thirty-nine years after Martinko was killed, investigators arrested 66-year-old Burns of Manchester, Iowa, after covertly collecting his DNA and testing it. Genetic material retrieved from a straw that Burns used is consistent with DNA found on the dress Martinko was wearing when she died, according to court testimony by forensic genetics experts.

On Wednesday prosecutors argued the scientific evidence in the case is irrefutable and that it links Burns to the scene of the crime.

They also argued the suspect acted with malice aforethought, willfully, deliberately, with premeditation and a specific intent to kill, as is articulated in Iowa Criminal Code.

Investigators and forensic analysts have previously testified that Martinko died after being stabbed repeatedly, and that she suffered defensive wounds, signs that she put up a fight.

There is also evidence that Martinkos assailant wore gloves during the attack, leaving behind prints of the glove material at the crime scene but obscuring their own fingerprints. An investigator testified that based on their analysis, the gloves appeared to be common kitchen gloves, the kind that are often used for dishwashing and are sold at grocery stores.

Prosecutors have argued the use of these gloves is evidence of premeditation.

Prosecutors have not been able to establish that Martinko and Burns knew each other or had any kind of relationship, and have described the killing as a random act of violence committed by a stranger."

Jurors heard more testimony Wednesday from investigator Matt Denlinger of the Cedar Rapids Police Department, one of the many officers who have worked on the case over the years.

It was under Denlingers tenure that the male genetic profile developed from crime scene evidence was shared with private genetic analysis firms and was uploaded to a public family genealogy website and used to develop a family tree. Investigators say these steps were instrumental in leading them to Burns, who has no previous criminal history.

In court on Wednesday, prosecutors played a video recording of Denlinger interviewing Burns, in handcuffs, in the back of a squad car on the way to the Cedar Rapids Police Department. There are long periods where the men sit in silence, but Denlinger also repeatedly asks Burns about what happened the night Martinko was killed.

I wish you could talk me through the issues that night, put me in your shoes if it would help me understand what was going through your mind, Denlinger said.

I dont recollect, Burns replied.

Since Burns was arrested in December of 2018, a criminalist at the Iowa Department of Criminal Investigation laboratory has analyzed DNA from a cheek swab taken from Burns, and has testified that Burns genetic profile is consistent with the genetic profile from the crime scene.

Questioned in court by prosecutor Nick Maybanks, Denlinger testified that during the car ride when he asked if its possible Burns forget what happened that night in 1979, Burns told him it is possible for people to block out their memories.

Besides the comment that Mr. Burns made about blocking out memories, did Mr. Burns offer an explanation as to what happened that night? Maybanks asked.

No, Denlinger replied.

And besides saying that he does not recollect or does not know, to questions about what was going on in his life, did he offer more explanation of his life circumstances? Maybanks asked.

No, Denlinger responded.

In further questioning, Denlinger went on to testify that Burns never told him that he had the wrong guy," and that the suspect never denied killing Martinko.

Where in the action, interaction between you and Mr. Burns in the squad car does he deny killing Michelle Martinko? Maybanks asked.

He never denied it, Maybanks said.

Burns has pleaded not guilty to the charge. If convicted, he could face life in prison.

Judge Fae Hoover Grinde has ruled that there is sufficient evidence for the case to go to the jury, overruling a motion for a judgement of acquittal by the defense. Burns defense team will take up the case Thursday.

More here:
Prosecutors Rest Their Case Against Man Accused Of Killing Martinko - Iowa Public Radio

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What if I told you that you originated from Asia, although, you reside in East Africa? Yes, thats right- its possible.

You see, the world is changing rapidly- especially technologically. Oh, you really wish to explore the innermost subset of your existence- your DNA? With genetic testing, its possible.

Probably, youve heard or read so much about this topic, yet, you remain skeptical about its effectiveness- how important is it? How sure am I that I would receive accurate results? questions upon questions, challenging its usefulness and accuracy, speed across your mind as the topic is mentioned.

Companies like 23 and Me offer genetic testing services that could be a great benefit to you. Check out how.

According to Mendel, genes are the units of inheritance. DNA is an integral part of genes, and they are a much smaller subset of chromosomes.

That said, DNA code for proteins that dictate specific traits ranging from your eye color to your diet and physique. This probably explains its complex nature.

The whole essence of modern genetics is to simplify the complexity of DNA and demystify its whole importance in the hereditary process. Although it has been quite hard, weve definitely gone a long way from Mendel Peas experiment.

In 2003, we edged closer to achieving this aim when technology capable of interpreting DNA sequence, in its entirety, was developed. With this came an unprecedented speed in understanding an individuals DNA for frugal costs as well as commercial exploitation.

23 and Me (see in-depth review on MyFamilyDNATest) is one, amongst the many companies that explore the DNA of individuals to reveal the hidden script they have inside of them.

Luckily, through genetic testing, you can get to understand where you are from; your ancestry. If you are interested in your family history, you can learn more than what youve known through what your relatives told you or historical documentation.

Presently, there are three major ways you can undergo ancestry testing.

Y- chromosome DNA tests are used to understand the paternal line of ancestry of an individual. Because Y-chromosomes are only passed from father to sons and are absent in women, this kind of test is carried out only in males. Women who are interested in the result this test provides are required to recruit a male relative.

Mitochondrial DNA tests are used to understand the maternal line of ancestry of an individual. This is because a mitochondrion is a semi-autonomous organelle that has its own DNA. Since it is transferred down to a child by the mother, it can be carried out in both sexes.

Single nucleotide polymorphism tests evaluate a large section of variants of an individual genome and compare it to others of known ethnicity.

Whats more in it for you? DNA mutation is the basis for a faulty protein formation, whose end result is a sprout of genetic-related diseases. Genetic testing helps you recognize these potential diseases, so you can channel your lifestyle in a path that reduces the chances of exhibiting these diseases.

Heres where it gets murky. Test providers use different databases to determine the ancestry or ethnicity of individuals. This means that there might be discrepancies when it comes to the determination of your ancestry.

But then, the term accurate could be quite subjective. This is what I mean: if you use the term accurate to infer that these provide correct results based on their individual databases, then, yeah- they are accurate. On the other hand, comparing two or more genetic testing companies would mean neither of their results is accurate due to different databases.

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How Useful and Accurate is 23 and Me Genetic Testing? - The Union Journal

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Genetics testing conducted by Colorado Parks and Wildlife adds to the growing evidence that a wolf pack has formed in Moffat County.

In a press release, CPW officials said four scat samples collected near a scavenged elk carcass in early January came from wolves, according to lab results. The DNA indicated three females and one male, according to CPW, and that the wolves were likely siblings. This is the first official documentation of a pack of wolves in the state since the 1940s.

The DNA doesnt tell us the age, CPW Species Conservation Program Manager Eric Odell said in a release. We dont know where or when they were born. We cant say. But that there are closely related wolves is a pretty significant finding.

Wolves are a federally endangered species and fall under the jurisdiction of the U.S. Fish and Wildlife Service. According to officials with the agency, killing a wolf can result in federal charges, including a $100,000 fine and a year in prison, per offense.

Anyone who sees or hears wolves, or finds evidence of any wolf activity is urged to contact CPW. A Wolf Sighting Form can be found on the CPW website.

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Genetics tests confirm wolf presence in Colorado - The Grand Junction Daily Sentinel

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Feb. 19, 2020

A Michigan State University scientist is determined to increase the number of women and girls going into STEM fields. Kayla Conner is a doctoral candidate in theDepartment of Microbiology and Molecular Geneticswho says she wouldnt be the student she is today if it werent for her high school chemistry teacher, Ms. Hardin.

Conner is part of MSUsBroadening Experiences in Scientific Training, an experimental program dedicated to empowering graduate student trainees to develop professional skills and experiences. Recently, reporters with WKAR News sat down with some of the BEST students to learn more about their inspiring life stories. Listen to the audio clip to hear Conners story in her own words and those of Hardin.

Conner is currently studying what happens to the placenta when a woman gets an infection during pregnancy and what that could mean for the fetus. Shes researching possible ways to stop some of the negative consequences that happen because of infection.

If a woman gets infected with any sort of ailment during pregnancy, whether it be the cold or the flu, it causes inflammation in the mother, says Conner. And that can lead to downstream effects, whether that is stillbirth, preterm labor, birth defects or even ailments later in life.

Conner was raised in Maynardville, Tennessee, and attended a small high school where she found the atmosphere to be less than encouraging and lacking resources for students who wanted to pursue higher education.

A lot of people have the mentality, Im from here so, therefore, I cant, and its really sad, she says. I really dont want people to have that mentality because even though you are from there you can do wonderful things. I dont think I would have had that drive without Ms. Hardin.

Conner looked up to her chemistry teacher and found encouragement to continue her studies.

She told me how well I was doing even when I felt like I wasnt, says Conner. I thought, Man, you know if she thinks I can do it, then maybe I can.

Hardin says that Conner gives her too much credit.

She has a scientific mind and shes curious, says Hardin. It was obvious to me. She had a natural talent for it. As a teacher, I encourage all my students, especially girls, to not look at science and math as something that boys do. You work at it. You keep plugging away and you can do it too.

For Conner, having women who have helped support her has been extremely important. Ive had women who told me that I can and who have helped me in every way they possibly can, she says. I think its important to give back and be that person for someone else. I go to the Girl Scout troops. I have a little outreach program where I do some hands-on activities and I give a talk. Its a fun time.

Only about 24 percent of the STEM workforce is made up of women. There have been studies that have shown that girls in lower education elementary and middle school show the same interest in STEM courses and enroll in courses at the same rates as their male student counterparts, but once it reaches the level of higher education, women do not seek out STEM courses as frequently as men do.

Conner recognizes the disconnect that is happening and strives to inspire talented women to pursue STEM careers.

Its not a mans game, Conner says. It is absolutely a womans game as well. We can be awesome scientists and be awesome mothers, friends and daughters and be whatever we want to be.

MSU BEST seeks to enhance trainees abilities to develop the confidence and competencies useful in navigating and choosing from diverse career opportunities.Learn more about becoming part of the BEST community.

Photos and video by Alec Gerstenberger.

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Shaping the future: Microbiologist's career inspired by influential teacher - MSUToday

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Feb. 19, 2020 13:12 UTC

BOTHELL, Wash. & TOKYO--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., Astellas) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for PADCEV (enfortumab vedotin-ejfv) in combination with Mercks (known as MSD outside the United States and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.

The FDAs Breakthrough Therapy process is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. Designation is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.

This is an important step in our investigation of PADCEV in combination with pembrolizumab as a first-line therapy for patients with advanced urothelial cancer who are unable to receive cisplatin-based chemotherapy, said Roger Dansey, M.D., Chief Medical Officer, Seattle Genetics. Based on encouraging early clinical activity, we recently initiated a phase 3 trial of this platinum-free combination and look forward to potentially addressing an unmet need for patients.

The FDAs Breakthrough Therapy designation reflects the encouraging preliminary evidence for the combination of PADCEV and pembrolizumab in previously untreated advanced urothelial cancer to benefit patients who are in need of effective treatment options, said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas. We look forward to continuing our work with the FDA as we progress our clinical development program as quickly as possible.

The Breakthrough Therapy designation was granted based on results from the dose-escalation cohort and expansion cohort A of the phase 1b/2 trial EV-103 (NCT03288545), evaluating patients with locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy treated in the first-line setting with PADCEV in combination with pembrolizumab. Initial results from the trial were presented at the European Society of Medical Oncology (ESMO) 2019 Congress, and updated findings at the 2020 Genitourinary Cancers Symposium. EV-103 is an ongoing, multi-cohort, open-label, multicenter phase 1b/2 trial of PADCEV alone or in combination, evaluating safety, tolerability and efficacy in muscle invasive, locally advanced and first- and second-line metastatic urothelial cancer.

About Bladder and Urothelial Cancer

It is estimated that approximately 81,000 people in the U.S. will be diagnosed with bladder cancer in 2020.1 Urothelial cancer accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter and urethra.2

Globally, approximately 549,000 people were diagnosed with bladder cancer in 2018, and there were approximately 200,000 deaths worldwide.3

The recommended first-line treatment for patients with advanced urothelial cancer is a cisplatin-based chemotherapy. For patients who are unable to receive cisplatin, such as people with kidney impairment, a carboplatin-based regimen is recommended. However, fewer than half of patients respond to carboplatin-based regimens and outcomes are typically poorer compared to cisplatin-based regimens.4

About PADCEV

PADCEV (enfortumab vedotin-ejfv) was approved by the U.S. Food and Drug Administration (FDA) in December 2019 and is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. PADCEV was approved under the FDAs Accelerated Approval Program based on tumor response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.5

PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.5,6 Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).5 PADCEV is co-developed by Astellas and Seattle Genetics.

Important Safety Information

Warnings and Precautions

Adverse Reactions

Serious adverse reactions occurred in 46% of patients treated with PADCEV. The most common serious adverse reactions (3%) were urinary tract infection (6%), cellulitis (5%), febrile neutropenia (4%), diarrhea (4%), sepsis (3%), acute kidney injury (3%), dyspnea (3%), and rash (3%). Fatal adverse reactions occurred in 3.2% of patients, including acute respiratory failure, aspiration pneumonia, cardiac disorder, and sepsis (each 0.8%).

Adverse reactions leading to discontinuation occurred in 16% of patients; the most common adverse reaction leading to discontinuation was peripheral neuropathy (6%). Adverse reactions leading to dose interruption occurred in 64% of patients; the most common adverse reactions leading to dose interruption were peripheral neuropathy (18%), rash (9%) and fatigue (6%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common adverse reactions leading to dose reduction were peripheral neuropathy (12%), rash (6%) and fatigue (4%).

The most common adverse reactions (20%) were fatigue (56%), peripheral neuropathy (56%), decreased appetite (52%), rash (52%), alopecia (50%), nausea (45%), dysgeusia (42%), diarrhea (42%), dry eye (40%), pruritus (26%) and dry skin (26%). The most common Grade 3 adverse reactions (5%) were rash (13%), diarrhea (6%) and fatigue (6%).

Lab Abnormalities

In one clinical trial, Grade 3-4 laboratory abnormalities reported in 5% were: lymphocytes decreased, hemoglobin decreased, phosphate decreased, lipase increased, sodium decreased, glucose increased, urate increased, neutrophils decreased.

Drug Interactions

Specific Populations

For more information, please see the full Prescribing Information for PADCEV here.

About Seattle Genetics

Seattle Genetics, Inc. is a global biotechnology company that discovers, develops and commercializes transformative medicines targeting cancer to make a meaningful difference in peoples lives. The company is headquartered in Bothell, Washington, and has offices in California, Switzerland and the European Union. For more information on our robust pipeline, visit http://www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

About Astellas

Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit our website at https://www.astellas.com/en.

About the Seattle Genetics and Astellas Collaboration

Seattle Genetics and Astellas are co-developing PADCEV (enfortumab vedotin-ejfv) under a collaboration that was entered into in 2007 and expanded in 2009. Under the collaboration, the companies are sharing costs and profits on a 50:50 basis worldwide.

About the Seattle Genetics, Astellas and Merck Collaboration

Seattle Genetics and Astellas entered a clinical collaboration agreement with Merck to evaluate the combination of Seattle Genetics and Astellas PADCEV (enfortumab vedotin-ejfv) and Mercks KEYTRUDA (pembrolizumab), in patients with previously untreated metastatic urothelial cancer. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Seattle Genetics Forward Looking Statements

Certain statements made in this press release are forward looking, such as those, among others, relating to the development of PADCEV in combination with pembrolizumab as a first-line therapy for patients with advanced urothelial cancer who are unable to receive cisplatin-based chemotherapy, and the therapeutic potential of PADCEV including its efficacy, safety and therapeutic uses. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the possibility that ongoing and subsequent clinical trials may fail to establish sufficient efficacy, that adverse events or safety signals may occur and that adverse regulatory actions may occur. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors included in the companys Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Astellas Cautionary Notes

In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on managements current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice.

____________________________1 American Cancer Society. Cancer Facts & Figures 2020. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf. Accessed 01-23-2020.2 American Society of Clinical Oncology. Bladder cancer: introduction (10-2017). https://www.cancer.net/cancer-types/bladder-cancer/introduction. Accessed 05-09-2019.3 International Agency for Research on Cancer. Cancer Tomorrow: Bladder. http://gco.iarc.fr/tomorrow 4 National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Bladder Cancer. Version 4; July 10, 2019. https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf.5 PADCEV [package insert]. Northbrook, IL: Astellas, Inc.6 Challita-Eid P, Satpayev D, Yang P, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res 2016;76(10):3003-13.

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Seattle Genetics and Astellas Receive FDA Breakthrough Therapy Designation for PADCEV (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in...

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Ever since Charles Darwin began investigating the early evolution of humans, scientists have worked to understand just how far back our species goes, where man first lived, and how his DNA traveled out of Africa and into the world at large.

Ancient humanoids have been found in large portions of Africa, which led to scientific understandings of how man both on and off that continent evolved. What was less understood until recently is how man evolved in areas of Eurasia, and who ancient species bred with to create what researchers are calling a ghost species.

Modern Eurasian species have been easier for scientists to investigate because cold temperatures preserved DNA samples so much better than those in Africa, where hot temperatures caused DNA to deteriorate. That made learning about how man evolved within Africa a challenge to scientists.

Broken Hill Skull from Kabwe, Zambia of Homo rhodesiensis, renamed as Homo erectus, also sometimes named Homo heidelbergensis or archaic Homo sapiens. Photo by Gerbil CC by 3.0

But a study done in 2017 by more than a dozen scholars and published in Cell, an online scientific journal, shed new light on these matters that had challenged researchers for years. In the study, sample genomes were examined from people who lived in southern Africa 10,000 years ago. This revealed that the history of these populations is far more complicated than researchers once believed.

RESTORATION BY A. FORESTIER OF THE RHODESIAN MAN WHOSE SKULL WAS DISCOVERED IN 1921

The samples were taken from Cameroon, which has the earliest and best preserved archaeological site in Africa. Now, a new study confirms the theories put forth in the 2017 paper, and asserts that, in fact, humanoids from Africa left the continent, bred with Neanderthals, and returned to Africa at some point, thereby creating a whole new ghost species, as the new study refers to it.

Anatomical comparison of skulls of Homo sapiens (left) and Homo neanderthalensis (right)

The study, entitled Identifying and Interpreting Apparent Neanderthal Ancestry In African Individuals, was also published in the journal Cell. In the study, 16 sample genomes were examined from people who lived in South Africa during the past 10,000 years. This examination revealed that the history of these populations is far more complicated than once believed. When these folks left Africa about 100,000 years ago, there wasnt, in fact, just one kind of humanoid there.

Model of the head and shoulders of an adult male Homo heidelbergensis [H. rhodesiensis] on display in the Hall of Human Origins in the Smithsonian Museum of Natural History in Washington, D.C. Photo by Tim Evanson CC by 2.0

The study goes on to examine gene flow into the ancient ancestors of modern South Africans, and concludes that there may be links between archaic hominims and present day Africans. In fact, research suggests as many as seven percent of present day Africans may have genomes from a population that scientists have yet to identify right now, it has no known genome, hence the term ghost population. Scientists theorize this group lived somewhere between 360,000 years ago and more than one million years ago, long before the gene flow started in West Africa, about 43,000 years ago.

The new research postulates that this ghost species of early humans resembled Neanderthals, and was in Africa about 100,000 years ago. Or, scientists suggest, the archaic species was present somewhere outside of Africa, but co-mingled by interbreeding, and then returned to Africa. This theory contravenes prior scientific research, that believed that there was simply one expansion out of Africa, and man developed and evolved from there.

The scientists behind the study, five authors, have stated conclusively that they believe more research needs to be done into the genetics of early humans, both within Africa and those species from outside the continent.

Related Article: Missing Link Skeletons Finally Deciphered Show New Path of Human Evolution

They assert that the DNA of modern and early humans must be studied further if we are to finally develop a full understanding of who we are, how we evolved, and our ancestors who once travelled both inside and outside Africa. Both studies are available for viewing online at: (https://www.cell.com/cell/fulltext).

The rest is here:
Study Finds Early Humans Bred with Mysterious Extinct Species in Africa - The Vintage News

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Sometimes I think there is this perception that you have to be really tough in order to be successful. I have worked with some women, that appeared to think that in order to compete with male counterparts, they have to have a hard exterior. I dont think thats true. I think you can still be yourself, even in a male-dominated field, and succeed in the industry.

I had the pleasure to interview Lesa Nelson. Lesa has worked in the field of human genetic research for the past 27 years, with the last 20+ years being in senior management positions. She directs all operational activities ofPredictive Laboratoriesand serves as the laboratory technical supervisor.

Thank you so much for doing this with us! Can you tell us a story about what brought you to this specific career path?

Iwas a biology major, and as an undergraduate student, I started working in a molecular genetics lab where I worked on projects with physicians who wanted to look at the genetics of human disease. By doing this, I gained a desire to work in applied human genetics. I was interested in doing the research, but was also interested in how it applied to actual patients. I began working with Dr. Kenneth Ward, M.D., who is currently the laboratory director atPredictive Laboratories, and we established a clinical molecular genetics laboratory at the University of Utah. We conducted research and clinical testing for patients, and together we became more entrepreneurial, which led me to move away from the university and to start working in the private sector.

Can you share the most interesting story that happened to you since you began at your company?

The most interesting thing that Ive experienced since my start at Predictive Laboratories was having the opportunity to launch genetic tests aimed to help women with infertility and endometriosis. I have been working on this research for years, so seeing it all come to fruition with the official launch of our productsARTguideandFertilityDX, this past October, has been incredibly rewarding. ARTguide identifies genetic causes of female infertility, including the risk for endometriosis and FertilityDx will provide guidance to couples struggling with infertility by identifying genetics risks to conception, pregnancy and the newborn. It has been fascinating to work on a product that can be a full solution, by leveraging everything possible in todays genetic world, across the disciplines of reproductive endocrinology and even pediatrics. Overall, its just an exciting service we are able to offer those in need!

Can you share a story about the funniest mistake you made when you were first starting? Can you tell us what lesson you learned from that?

One of the funniest mistakes that I first made in my career actually had to do with the weather! I was supposed to meet someone on a Saturday at the laboratory, and we started a job on Friday that needed to be done by Sunday. There was a 20-inch snowstorm in Salt Lake City that Saturday and I was the only one who could walk to the lab. I had to complete the job, despite never doing the procedure before, on my own while receiving guidance from another technician over the phone, while also trying to learn at the same time. Looking back, I laugh at how you can plan for everything on paper, but the weather has a mind of its own.

What do you think makes your company stand out? Can you share a story?

I think what makes Predictive Laboratories stand out is our belief in identifying a problem and applying what we know in terms of genetic diagnosis to then develop a solution with technology. I have been lucky enough to work on projects where there is an actual discovery, and we try to find ways to turn it into something that is practical and usable. I myself was an infertility patient and I know what its like to go through that process, so I am extremely empathetic with the patients that were trying to reach and help through our diagnostic tests.

There was a recent case where a couple was going through infertility problems, a niece of theirs had developmental delay and other issues, and naturally, they wanted to know if their prospective children would be at risk and the childs parents wanted to find out what was going on. We call these situations diagnostic odysseys. The child turned 1-year-old and still no one knew what was wrong. We checked the entire coding region of the childs genome and were able to identify the mutation that ultimately caused the symptoms. It turns out it was a rare disease that only 30 people in the world had ever been diagnosed with. While there is no treatment for the disease, we were able to tell the parents the reason why this was happening. This means a lot to families.

Are you working on any exciting new projects now? How do you think that will help people?

Right now, Im excited about our focus on FertilityDX and the service it will provide to help couples navigate everything from conception to the delivery of a healthy baby. Through this service, were also able to train physicians in using genetics, so we can teach them to have a more personal approach to helping each of their patients.

Were also in the middle of an exciting time where were able to leverage all of the genetic technology out there. I would really like to see us facilitating the transfer of that genetic knowledge to different specialists and making it comprehensive. We have the ability for personalized medicine, so we need to stop thinking about a population statistic and start thinking how we can leverage technology to diagnose each individual based on their genetics.

Ok super. Thank you for all that. Lets now shift to the main focus of our interview. Are you currently satisfied with the status quo regarding women in STEM? What specific changes do you think are needed to change the status quo?

There are a lot of women in the STEM field, but you still see it kind of segregated by role. Ive noticed in my experience that most of the laboratory technicians end up being women, because the men wind up leaving for higher positions. I think it is almost historical, but I hope its changing.

A while ago, my colleagues and I interviewed third graders about what they wanted to be when they grew up. The boys who responded shared a wide variety of aspirations, while the girls mainly responded that they wanted to be teachers, actresses, nurses and moms, which are all admirable roles, but the responses did not range among the girls like they did with the boys.

I think that there is a lack of exposure to science at a young age, which is why I was involved in a local elementary school where we introduced a program to offer students the chance to do science experiments. I hope there are more and more programs that are introduced like this because I believe this is what will change the status quo. The University of Utah, for example, offers a program that takes high achieving college freshmen girls in science and provides them with a two year mentorship where they are placed in a laboratory. These women have the opportunity to spend their entire summer, prior to the start of their freshman year, exploring science with different people. I think things like this can also help get women in STEM leadership areas.

In your opinion, what are the biggest challenges faced by women in STEM or Tech that arent typically faced by their male counterparts? What would you suggest to address this?

I think we are still in a society where one of the biggest challenges that women are facing is managing work and family life. It can be challenging to work and still have a family. I think there is more pressure on women to do both and do both well. I always felt lucky because even though I worked really hard, I still had the flexibility to make time for family. Flexibility in the workplace helps and it is much easier to work remotely in the modern day, thanks to technology. Hopefully this will eventually resolve some of those issues for women who are trying to balance both.

What are the myths that you would like to dispel about being a woman in STEM or Tech. Can you explain what you mean?

Sometimes I think there is this perception that you have to be really tough in order to be successful. I have worked with some women, that appeared to think that in order to compete with male counterparts, they have to have a hard exterior. I dont think thats true. I think you can still be yourself, even in a male-dominated field, and succeed in the industry.

What are your 5 Leadership Lessons I Learned From My Experience as a Woman in STEM or Tech and why. (Please share a story or example for each.)

None of us are able to achieve success without some help along the way. Is there a particular person who you are grateful towards who helped get you to where you are? Can you share a story about that?

I am most grateful for the guidance by Dr. Ken Ward, who had worked with me almost from the start of my career in molecular genetics, as mentioned earlier. We first met when he was doing a fellowship and we immediately hit it off and worked well together.

Despite not having a doctorate of philosophy (Ph.D) like most of the other professionals in my industry, Ken was always willing to work with me. He always saw what I was capable of and there were never any limitations of what I could do in the laboratory.

I have been working with Ken for nearly 30 years, and I came from a laboratory where as a technician, you werent going to scientific conferences or rarely were an author on a paper. At a laboratory, I worked very hard on a project and my name wasnt on the paper because I did not have my Ph.D. Since working with Ken, not having a Ph.D has never held me back, and that is super important to me. He has let me do what I wanted to on both the research and clinical side. He was always super supportive of me becoming exactly what I wanted to be. I think we are on the same wavelength and it has made me feel confident in my career and role at Predictive Laboratories. Like Ken, I too just want people to succeed. I like hearing about peoples aspirations, and I try to pass that forward as well.

How have you used your success to bring goodness to the world?

It is mostly what I said earlier, but were bringing goodness to the world and to patients by taking our research and applying it to something that affects individuals. I do not care what it is you do in the laboratory, you can always be learning from it. The ability to take something and then apply it to change someones life has been the most satisfying part of my job. What makes my heart beat the fastest is when we figure something out or help somebody with genetic testing.

You are a person of enormous influence. If you could inspire a movement that would bring the most amount of good to the most amount of people, what would that be? You never know what your idea can trigger.

I would really love to see the healthcare system be able to provide more without being governed by cost. For example, rare diseases do not get looked at because they dont generate enough revenue and Medicare doesnt want to pay for something that would cost too much. I think we could offer so much more without financial barriers. I dont mean that companies and providers of services should not have a profit, but I feel like a lot of healthcare gets caught up in the dollars. Much of it isnt driven from a patient centric point, but from a monetary one.

Can you please give us your favorite Life Lesson Quote? Can you share how that was relevant to you in your life?

I have two that I think sum up my approach to life.

One of them is that high achievement always takes place in the framework of high expectation, which was said by Charles F. Kettering, and the other is from Steve Jobs when he said, technology is nothing, what is important is that you have faith in people, that they are basically good and smart, and if you give them the tools, they will do wonderful things.

These sentiments are applicable to everything whether that be STEM or life.

Read more:
It is a myth that you have to be really tough in order to be successful with Penny Bauder & Lesa Nelson - Thrive Global

Recommendation and review posted by Bethany Smith

In order to contain a virus, its important to know exactly what youre dealing with and the COVID-19 coronavirus is no different.

One of the key tools to try to contain or limit transmission of infectious diseases is case identification, saysSamira Mubareka, a virologist in the University of Torontos Faculty of Medicine and at Sunnybrook Health Sciences Centre.

If you identify cases, then you can contain them. If you miss them, then you dont.

Mubareka and her colleagueRobert Kozak, both in U of Ts department of laboratory medicine and pathobiology, are part of a local working group of scientists who are researching the novel coronavirus outbreak and are developing a suite of tools to control it.

One of their current projects involves using the latest in whole-genome sequencing technology to help hospitals characterize the virus more quickly. Their work may help to track the viruss evolution and trace its spread.

If the viruss genome was a book, were going to figure out its entire story, Kozak says.

Mubareka and Kozak collected specimens of the coronavirus from the first confirmed case in Canada, an adult male who was treated and eventually discharged from Sunnybrook after returning from Wuhan, China the epicentre of the outbreak. Two more cases in Ontario have since been confirmed: the original patients wife, who accompanied him to China, and a woman in her 20s in London, Ont. who had also traveled to Wuhan.

Worldwide, there are more than 73,300 confirmed cases ofCOVID-19 as of Feb. 18. More than 1,800 have died.

Robert Kozak, pictured here in the lab, andSamira Mubareka say their teams work will enable front-line hospital staff to run a test on-site, helping to identify and triage patients more efficiently (photo by Nick Iwanyshyn)

In Canada, where there are so far seven confirmed cases, health authorities say the risk remains low. But Mubareka and Kozak are preparing for any possible scenario.

You put a smoke alarm in your house even if you hope theres no fire, says Kozak, who previously worked at the National Microbiology Laboratory in Winnipeg on Ebola and Zika.

Part of the teams work involves developing a test that will speed up the characterization of the virus. Currently, patient samples in Ontario are sent from local hospitals by courier to the Public Health Ontario lab in downtown Toronto for testing, and to the national lab in Winnipeg for confirmation.

The process can take a few days, depending on the hospitals distance from the labs and test volumes.

Mubareka and Kozak say their teams work in collaboration with McMaster University and infectious disease expert Allison McGeer of U of Ts Dalla Lana School of Public Health, Faculty of Medicine and Mount Sinai Hospital will enable front-line hospital staff to run a test on-site, helping to identify and triage patients more efficiently. The test involves using swabs from a patients nose and throat to do genomic testing to sequence the virus.

If theyre negative, you can take them [the patients] out of precautions and maybe even send them home, Kozak says. If theyre positive, then you can again take the appropriate precautions to isolate them and do everything else that needs to be done.

The researchers hope they can adapt the approach for mini-sequencers the size of a cell phone, so it can be used more widely.

Vivek Goel,U of Ts vice-president, research and innovation, and strategic initiatives,says the university worked quickly to mobilize support for the project.

With its cross-disciplinary expertise and close relationships with area hospitals, the university recognizes that its uniquely positioned to play a leadership role when it comes to these sorts of global health issues, Goel says.

We also have the benefit of having experienced the SARS outbreak in Toronto in 2003, so we know first-hand how important this sort of research can be.

The genomic testing being performed by the U of T-led group could also help researchers get a fuller picture of the mysterious illness.

Although genomic sequences of the virus were published and shared in public databases, many were deposited soon after the first cases were identified in Chinas Hubei province, according to Mubareka.

The problem is that was early on before it started going from person to person-to-person, she says, noting that viruses mutate.

There are only about 50 sequenced genomes of the virus, adds Kozak for about 48,000 confirmed cases.

Youre not getting a great snapshot, he says. Its tough to really understand a lot about the virus.

Among the nagging questions about COVID-19 that U of T and Sunnybrook researchers hope to answer are how long patients remain contagious and if the amount of the virus present in respiratory secretions is proportional to its severity.

Their work may help others understand how the virus spreads from point A to point B, and if its changing in ways that make it more dangerous.

The research team includes U of T students likeNatalie Bell, a second-year masters student in laboratory medicine and pathobiology who is also working with Mubareka on a project related to influenza from swine.

Its really interesting to see science happen in real time, especially being part of Sams lab [and] to see her involvement and the movement from lab to policy work, and how it impacts public health, Bell says.

Mubareka and Kozak plan to upload the sequencing data to public servers and share it with the world to help with epidemiological studies and vaccine design.

We will build global capacity any way that we can, Kozak says.

Mubareka and Kozak say their work was made possible thanks in part to the McLaughlin Centre, which provided emergency funding for the project. We have no shortage of ideas of things we can do to hopefully make a difference, Kozak says, but you always need someone to provide the resources to do it.

Stephen Scherer, the director of the McLaughlin Centre at U of T and a University Professor in the department of molecular genetics, says the centre wanted to make sure the researchers had the necessary funds to do their work in time.

Nobody is busier right now than this group, so we wanted to make the process as easy as possible for them, Scherer says. We also wanted these researchers to know the rest of us value their efforts to keep us safe.

Go here to read the rest:
U of T and Sunnybrook virologists work on tools to combat coronavirus outbreak - News@UofT

Recommendation and review posted by Bethany Smith

MedicalResearch.com Interview with:

Robert E. Dudley, Ph.D.Chairman, Chief Executive Officer and PresidentClarus Therapeutics

Dr. Dudley discusses the recent announcement that Clarus Therapeutics, Inc. has launched JATENZO (testosterone undecanoate) capsules for the treatment of appropriate men with testosterone deficiency (hypogonadism):

MedicalResearch.com: What is the background for this announcement?

Response: JATENZOis the first and only oral softgel testosterone undecanoate and the first oral testosterone product approved by the U.S. FDA in more than 60 years.JATENZO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

The launch of JATENZO means that physicians and men living with testosterone deficiency due to genetic or structural abnormalities finally have a safe and effective oral testosterone replacement therapy. We are proud to commercially launch this unique oral formulation to healthcare providers and the appropriate patients who they treat. JATENZO is now available at pharmacies across the country.

MedicalResearch.com: What are the main findings of the underlying studies?

Response: JATENZO was evaluated in a Phase 3 pivotal trial among 166 adult, hypogonadal men in a 4-month, open-label study with a topical testosterone comparator arm. The starting dose was 237 mg twice daily (BID) with meals. Dose adjustments (minimum 158 mg BID; maximum 396 mg BID) were made roughly 3 and 7 weeks after initiation of JATENZO based on average circulating testosterone concentration levels. 87% of JATENZO patients reached testosterone levels within the normal eugonadal range at the end of the study; peak testosterone levels were in close alignment with FDA targets.

Across all Phase 2 and Phase 3 trials combined, the safety of JATENZO has been evaluated in 569 patients who were treated with JATENZO for up to two (2) years. Liver toxicity was not observed with JATENZO in clinical trials.

Mild gastrointestinal adverse events observed with JATENZO were transient, manageable and did not lead to discontinuation.Decreased HDL cholesterol and increased hematocrit were associated with JATENZO use but did not lead to discontinuation of JATENZO. Only three of the 166 patients (1.8%) in the 4-month study experienced adverse reactions that led to premature discontinuation from the study, including rash (n=1) and headache (n=2). JATENZO was associated with an increase in systolic blood pressure. A boxed warning about the potential risks associated with elevated blood pressure appears on JATENZO labeling. Patients on JATENZO should have their blood pressure monitored.

Among the 569 patients who received JATENZO in all Phase 2 and 3 trials combined, the following adverse reactions were reported in >2% of patients: polycythemia, diarrhea, dyspepsia, eructation (i.e., burping), peripheral edema, nausea, increased hematocrit, headache, prostatomegaly (i.e., enlarged prostate), and hypertension.

MedicalResearch.com: How doesJATENZO differ from other treatments for testosterone deficiency?

Response: The launch of JATENZO is an important step forward in testosterone replacement therapy. The only other oral testosterone replacement therapy product ever approved by the FDA is methyltestosterone (an alkylated androgen) that has been associated with serious liver toxicity and is rarely, if ever, used today. Because JATENZO is formulated as a lipophilic prodrug, it bypasses the first-pass hepatic metabolism. No liver toxicity-related events were observed in clinical studies of JATENZO including in patients who took JATENZO at higher doses than recommended in current product labeling for two (2) years.

We believe JATENZO addresses a long-standing need for a safe and effective oral testosterone replacement product that meets current day FDA safety and efficacy standards. JATENZO enters a market where the vast majority of hypogonadal men are treated with injectable or topical testosterone products. JATENZO avoids administration challenges seen with these non-oral treatments it presents no injection site pain, no transfer risk, no mess, no skin irritation and no surgical procedure. Therefore, we believe a significant number of hypogonadal men will prefer JATENZO as an alternative to other forms of testosterone therapy.

MedicalResearch.com: How are men tested to determine ifJATENZO therapy is appropriate for them?

Response: According to the American Urological Association and Endocrine Society clinical guidelines, diagnosis of hypogonadism is determined by both the identification of symptoms and/or signs consistent with hypogonadism and blood test measurement of low morning total serum testosterone concentration (defined as <300 ng/dL, on two separate days). Healthcare providers should assess each patient individually for the appropriateness of JATENZO to treat their clinical hypogonadism.

MedicalResearch.com: What else should readers take away from your report?

Response: Clinical hypogonadism can be more complex than most people realize and left untreated, can have a profound negative impact for the individual. Men with the symptoms of hypogonadism have a real medical need that deserves appropriate diagnosis and treatment.

Any disclosures?

Pleaseclick herefor full Prescribing Information, including BOXED WARNING on increases in blood pressure.

Citation:

CLARUS THERAPEUTICS ANNOUNCES COMMERCIAL LAUNCH AND AVAILABILITY OF JATENZO (TESTOSTERONE UNDECANOATE) CAPSULES, CIII FOR THE TREATMENT OF HYPOGONADISM

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Feb 19, 2020 @ 12:05 pm

The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

The rest is here:
Clarus Therapeutics Lauches JATENZO - Oral Testosterone Replacement Therapy - MedicalResearch.com

Recommendation and review posted by Bethany Smith

One of the more underrated horror-thrillers is Warner Bros./Dark Castles 2009 Orphan, directed by Jaume Collet-Serra and starring a young Isabelle Fuhrman as Esther, an adopted9-year-old girl who is not nearly as innocent as she claims to be.

As its revealed, Esther is actually a 33-year-old woman named Leena Klammer. She has hypopituitarism, a rare hormonal disorder that stunted her physical growth and caused proportional dwarfism, and has spent most of her life posing as a little girl. (Wiki)

In an interesting turn, Sierra/Affinity is launching sales at the EFM in Berlin on Esther, a prequel to Orphan that will be directed by William Brent Bell (The Devil Inside, The Boy, Brahms: The Boy II), reports Deadline.

In it, Lena Klammer orchestrates a brilliant escape from a Russian psychiatric facility and travels to America by impersonating the missing daughter of a wealthy family. But Lenas new life as Esther comes with an unexpected wrinkle and pits her against a mother who will protect her family at any cost.

Orphans big selling point was the shocking twist that changed the way you viewed the intense and immensely uncomfortable events of the film. It will be interesting to see if the prequel can conjure up the same kind of suspense with the audience already being in on the Esthers secret. Its unclear if Fuhrman will return, although its extremely unlikely.

The prequel, expected to start in the third quarter, is written by David Coggeshall.

Dark Castle Entertainments Alex Mace, Hal Sadoff and Ethan Erwin will produce with James Tomlinson. David Leslie Johnson will serve as an executive producer and Jen Gorton and Josie Liang will oversee for eOne.

Here is the original post:
'Orphan' Prequel to Tell the Origins of 'Esther' - Bloody Disgusting

Recommendation and review posted by Bethany Smith