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More needs to be done to find and fight COVID-19 variants, says Colorado researcher – FOX 31 Denver

February 14th, 2021 6:58 pm

AURORA, Colo. (KDVR) The novel coronavirus can rapidly mutate inside of compromised patients and give way to new and more dangerous variants, according to new research from a University of Colorado School of Medicine scientist.

David Pollock, a professor of biochemistry and molecular genetics, co-authored the research in the journal Nature.

He studied a patient in his 70s who had COVID-19 and cancer. In just weeks, the virus mutated multiple times and variants that survived were the strongest and most dangerous.

Its allowing for a much more rapid accumulation of mutationsthan if they go on to infect other people, Pollock said.

In the case of the patient Pollock studied, who ultimately died, the variants were not allowed to escape and infect others. But in other cases the variants do. This has most likely led to the more infectious and possibly more harmful variants in the United Kingdom, South Africa and Brazil.

This is like a pandemic in a pandemic, Pollock said. These are spreading amongst the people who are infected.

These variants are also affecting the COVID-19 vaccine. This is most notable with the Johnson & Johnson vaccine, which went through clinical trials later than the vaccines currently approved.

The vaccine was 72% effective in the United States, but just 58% effective in South Africa, where a variant was running rampant.

The worry and the concern is that the vaccines will be less effective, Pollock said. Its much better to take the vaccine. Youre much (more) likely to be better off if youre protected against the old virus.

Pollock said one way to get ahead of the variants is to do more genome sequencing. Hes now pushing the state to do that.

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More needs to be done to find and fight COVID-19 variants, says Colorado researcher - FOX 31 Denver

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Selfish sperm genes ‘poison’ the competition for the win – Big Think

February 14th, 2021 6:58 pm

In the life-or-death scramble to fertilize an egg, not all sperm are alike. A new study of mice by researchers from the Max Planck Institute for Molecular Genetics (MPIMG) in Berlin identifies a genetic factor called "t-haplotype," whose tag-team act with the protein RAC1 helps a spermatozoan speed straight to the prize.

The study is published in PLOS Genetics.

Credit: ibreakstock/Adobe Stock

The researchers conducted experiments with mouse sperm to learn more about the properties of the t-haplotype, a group of genetic alleles that are known to appear on Chromosome 17 of mice.

Comparing the movement of mouse sperm with the t-haplotype against sperm without it, the researchers, led by first author Alexandra Amaral of MPIMG, definitively demonstrated the difference t-haplotype makes. Sperm with the gene factor progressed quickly forward, while "normal" sperm didn't exhibit the same degree of progress.

While most genes operate cooperatively with others, some don't. Among these "selfish" genes are the t-haplotype.

"Genes that violate this rule by unfairly increasing their chance of transmission can gain large fitness advantages at the detriment of those that act fairly. This leads to selection for selfish adaptations and, as a result, counter-adaptations to this selfishness, initiating an arms race between these selfish genetic elements and the rest of the genome." Jan-Niklas Runge, Anna K. Lindholm, 2018

"Sperm with the t-haplotype manage to disable sperm without it," says corresponding study author Bernhard Herrmann, also of MPIMG.

"The trick is that the t-haplotype 'poisons' all sperm," he explains, "but at the same time produces an antidote, which acts only in t-sperm and protects them. Imagine a marathon in which all participants get poisoned drinking water, but some runners also take an antidote."

The t-haplotype distributes a factor that distorts, or "poisons," the integrity of genetic regulatory signals. This goes out to all mouse sperm that carry the t-haplotype in the early stage of spermatogenesis. Chromosomes split as they mature, and half the sperm that retain the t-haplotype produce another factor that reverse the distortion, neutralizing the "poison." These t-sperm hold onto this antidote for themselves.

RAC1

Credit: Emw/Wikimedia

RAC1 acts as a molecular switch outside the sperm cell. It is known to be a protein that guides cells to different places in the body. For example, it directs white blood cells and cancer cells towards other cells that are putting out specific chemical signatures. The study suggests that RAC1 may point sperm toward an egg, helping it "sniff" out its target.

In addition, the presence of RAC1 seems to help the t-sperm carry out their sabotage. The researchers demonstrated this by introducing an RAC1 inhibitor to a mixed population of sperm. Prior to its introduction, the t-sperm in the group were "poisoning" their normal neighbors, causing them to move poorly. When the inhibitor neutralized the populations' RAC1, the t-sperms' dirty trick no longer worked, and the normal sperm began moving progressively.

However important RAC1 may be to t-sperm, too much or too little is problematic. Says Amaral, "The competitiveness of individual sperm seems to depend on an optimal level of active RAC1; both reduced or excessive RAC1 activity interferes with effective forward movement."

When females have two t-haplotypes on Chromosome 17, they are fertile. When sperm have one t-haplotype, their motility may be negatively affected, but when they have two, they are sterile. The researchers discovered the reason: They have much higher levels of RAC1.

At the same time, the study finds that normal sperm who aren't being held back by t-sperm stop moving progressively when RAC1 is inhibited, meaning that too little RAC1 also results in low motility.

Herrmann sums up the insights the study offers:

"Our data highlight the fact that sperm cells are ruthless competitors. Genetic differences can give individual sperm an advantage in the race for life, thus promoting the transmission of particular gene variants to the next generation."

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Selfish sperm genes 'poison' the competition for the win - Big Think

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Some sperm cells swim faster and even poison their competition to climb to the top – ZME Science

February 14th, 2021 6:58 pm

It takes just one sperm to fertilize a womans egg and for each sperm that reaches the egg, there are millions that dont. You probably knew that already, but heres the thing: not all sperm cells are equal. Some have mutations in their DNA sequence that allow them to swim straighter, rather than in circles, and faster on average than their competition. Whats more, sperm cells can even employ gruesome tactics, such as poisoning their neighbors in order to enhance their odds of fertilizing the egg.

The difference between a loser and a winner sperm cell could be down to a protein: RAC1. In a new study, researchers at the Max Planck Institute for Molecular Genetics (MPIMG) in Germany studied mouse sperm cells under the microscope, finding that this protein is responsible for guiding the sperm in the right direction by chemically signaling from the outside and activating other proteins.

The RAC1 protein plays a critical role in controlling the motility of sperm, in particular the average path velocity and linearity. This protein is produced in sperm that carry a particular DNA sequence known as the t-haplotype.

The researchers in Germany knew from previous research that it is thanks to this genetic sequence that some sperm swim in a straighter path and at a faster velocity than sperm lacking the t-haplotype. However, they were shocked to learn that t-haplotype sperm can also poison their competition by injecting them with certain genes that inhibit movement.

Sperm with the t-haplotype manage to disable sperm without it, study co-author Bernhard Herrmann, director at the MPIMG, said in a statement. The trick is that the thaplotype poisons all sperm, but at the same time produces an antidote, which acts only in t-sperm [those with the t-haplotype] and protects them.

In other words, it literally is a race for life (or death) for the millions of sperm cells on a quest to fertilize egg cells and luck seems to play a minor role.

Imagine a marathon, in which all participants get poisoned drinking water, but some runners also take an antidote, said Herrmann, who is also the director of the Institute of Medical Genetics at Charit Universittsmedizin Berlin. Thats the same hospital where Kremlin critic and Russian opposition leader Alexei Navalny was treated after being poisoned, allegedly by the Russian government.

According to experiments, the vast majority of sperm cells that made little progress on their paths were genetically normal, whereas those that moved in a straight and optimal path mostly had the t-haplotype genetic factor. Poisoned cells literally swam in circles until they died. Meanwhile, t-haplotype sperm that had the antidote that inhibited the effects of the poison charge straight ahead.

Our data highlight the fact that sperm cells are ruthless competitors, says Herrmann.Genetic differences can give individual sperm an advantage in the race for life, thus promoting the transmission of particular gene variants to the next generation, says the scientist.

The findings were reported in the journal PLOS Genetics.

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Mutations in frogs point to autism genes’ shared role in neurogenesis – Spectrum

February 14th, 2021 6:58 pm

Mutations in any of 10 autism-linked genes lead to the same overabundance of brain cells that develop into neurons, according to a new study of the mutations in frogs. The sex hormone estrogen lowers this excess, the researchers also found.

Autism is linked to hundreds of genes, but how mutations in this varied pool lead to the same traits remains unknown. The new work sought to pinpoint where the genes effects converge.

Finding shared risk and resilience factors sustains our hope that the field can use the study of individual genes to find treatment targets that work more broadly, says lead investigator Matthew State, professor of psychiatry and behavioral sciences at the University of California, San Francisco.

State and his colleagues used CRISPR to edit genes in a species of frog called Xenopus tropicalis. Although researchers typically model autism in mice, rats and even monkeys, Xenopus offers advantages from day one: Once its first fertilized cell divides into two, each daughter cell and all of its progeny stay on their respective side. As a result, a daughter cell with an edited gene on the left will grow into a tadpole with that mutation in every cell on the left half of its body and only the left half. Researchers can also readily observe stages of brain development in the tadpoles that occur in utero in people and other animals.

The convergence the team observed suggests that all 10 of the genes studied play a role in the early development of neurons, in addition to their other functions, says study investigator Helen Willsey, a postdoctoral researcher at the University of California, San Francisco.

Understanding this role could ultimately lead to better treatments for autism, but that is still a long way off: Premature would be too generous a word, State says.

What we really need right now is a molecular mechanism, Willsey says. In order to get therapeutics, we need to know what these genes are doing, whats in common to them and what are some pathways we could manipulate.

In a day, a pair of Xenopus frogs can produce thousands of embryos, which develop into tadpoles in about a week.

In each frog embryo, the researchers edited one of 10 genes strongly associated with autism: ADNP, ANK2, ARID1B, CHD2, CHD8, DYRK1A, NRXN1, POGZ, SCN2A or SYNGAP1. All 10 are expressed in the frogs cerebrum at stages that line up with prenatal brain development in people, the team found.

Tadpoles with any of the mutations had either unusually large or small cerebrums. And they all had a higher proportion of neural progenitor cells those that eventually become neurons or other brain cells to mature neurons than controls did.

Thats what was so surprising to us, Willsey says. Even for genes that are thought to be primarily at the synapse, we still saw changes in brain size and neural progenitor maturation.

In prenatal human brains, the 10 genes, plus 92 others linked to autism, all encode proteins that interact with proteins in a layer of the cortex where neural differentiation happens, an analysis of a protein-interaction database showed.

The researchers then turned down DYRK1A expression in the tadpoles brains using a chemical inhibitor and tested the effects of 133 cancer drugs designed to suppress cell growth; 17 drugs altered the progenitor cell ratio, including 3 that affect the bodys use of estrogen. Adding estrogen to the tadpoles water restored the cell imbalance. Mutations that altered the function of estrogen receptors led to the same reductions in cerebrum size as the autism genes. The work was published in Neuron in January.

The findings suggest that estrogen plays an important role in the creation of neurons, Willsey says, and that a better understanding of this role could point to treatment targets. Estrogen itself cannot be given as a treatment because of its effects on development, she says.

Estrogen may partially explain the higher rates of autism observed in boys and men, Willsey says, although at least some of the difference in prevalence may be due to underdiagnosis of the condition in girls and women. Estrogen reduces hyperactivity in zebrafish with mutations in the autism-linked gene CNTNAP2, States lab previously showed.

The teams method could be useful for both screening drugs and studying genes whose functions are less well known, says Sarah Elsea, professor of molecular and human genetics at Baylor College of Medicine in Houston, Texas, who was not involved in the work.

The process they laid out is quite nice, she says. Its a template to do additional work.

It could also help researchers identify drugs to alleviate specific difficulties seen in autistic people with different underlying genetics, such as circadian rhythm disruptions that lead to sleep problems, Elsea says.

One of the greatest possible outcomes that we have from something like this is that there might be one medication that [works in] individuals who have [autism] associated with those 10 genes, Elsea says. Maybe there is something that could be identified that would help make their days just a little bit better.

The approach could also be used identify commonalities across genes related to psychiatric conditions such as schizophrenia and bipolar disorder, says Kristen Brennand, a faculty member in the psychiatry department at Yale University, who was not involved in the work.

Its more evidence [that] there needs to be a systematic way of manipulating genes linked to these conditions, Brennand says.

The brain changes observed in the frogs may not relate to autism, because the 10 genes studied are known to be important for neuron and synapse development generally, says David Cutler, professor of human genetics at Emory University in Atlanta, Georgia, who was not involved in the work.

You dont know really what to make of it, Cutler says. The autism phenotype in humans is much more subtle than size of brain. And its much more subtle than number of neurons.

Still, the method could eventually point to a system that will translate to people, he says.

Is it plausible? Yes, Cutler says. Are we there? No.

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Mutations in frogs point to autism genes' shared role in neurogenesis - Spectrum

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We are scientists: U of T researchers reach out to girls and women around the world – News@UofT

February 14th, 2021 6:58 pm

War broke out just as Sanja Fidlers grandmother graduated from medical school and the young doctors experience treating the wounded led her to become one of the first female plastic surgeons in her country.

She was my main source of inspiration, says Fidler, a computer vision expert from Slovenia.

She loved science and she would always inspire me to think about science. She would play board games with me. She loved to hear about me going to math competitions, chess competitions and, later, when I was an adult, the conferences.

When Fidler was working on her PhD, it was her grandmother who encouraged her to go abroad, to experience something new, to see something beyond the environment Id experienced all my life and thats what I did, Fidler says.

I guess Im here because of her.

For Fidler, here is the University of Toronto, where the award-winning researcher is an associate professor of mathematical and computational sciences at U of T Mississauga and a director of AI at NVIDIA.

Shes also one of a number of women at U of T all award-winning researchers in science, technology, engineering and math featured on social media to mark theInternational Day of Women and Girls in Science as part of a campaign aimed at encouraging girls and women to pursue careers in STEM.

The outreach is important because role models and representation matter, says Professor Christine Allen, U of Ts associate vice-president and vice-provost, strategic initiatives.

We know that, globally, women in STEM face lower salaries and higher exit rates than men so its not surprising that fewer than 30 per cent of the worlds researchers in science, technology, engineering and math are women, Allen says. Weve seen what can happen when we work for change when we make concerted efforts to eliminate obstacles, engage and recruit girls and women. Since 2014, for example, women have enrolled in equal or greater numbers than men at the Temerty Faculty of Medicine. But we have a long way to go.

Significant work also remains to be done to overcome the barriers faced by women in STEM with disabilities and/or women in STEM from the BIPOC and LBGTQ+ communities. Issues of racism and discrimination against women in STEM who are from diverse communities must be addressed. It is up to each of us to create an environment in STEM where all girls and women feel welcome and are able to contribute and succeed.

Along with Fidler, the campaign highlights physiologist Patricia Brubaker, cosmologist Rene Hloek, evolutionary biologist Maydianne Andrade, computational medical expert Marzyeh Ghassemi, hepatologist Mamatha Bhat and biomedical engineer Molly Shoichet just a few of the universitys many award-winning women researchers in STEM.

Ghassemi, an assistant professor in the Temerty Faculty of Medicine and Faculty of Arts & Science, counts her mother among her own role models and mentors. She says her mother home-schooled her and instilled a love of science. The late Mildred Dresselhaus, a legendary professor she met while she was a graduate student at MIT, also encouraged her as did Lila Ibrahim, who was Ghassemis boss at Intel when she was just beginning her career.

She always said, you can do that just do it, try it, Ghassemi says. That was really inspirational to me that she believed that anything I chose to focus on I could accomplish, when I was very young, in this new job.

Inspiring young women and girls is the goal of the U of T campaign, says Professor Leah Cowen, chair of the department of molecular genetics in the Temerty Faculty of Medicine and, as of March 1, U of Ts associate vice-president, research.

This reflects the universitys commitment to equity, diversity and inclusion signalled by signing the federal governments Dimensions Charter in 2019. We hope its message reaches young women and girls who may be just beginning to consider STEM as a rewarding career. The world needs their talent, their leadership and their innovation.

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Global Genetic Testing Market Insights, Size Estimation, Research Insights, COVID-19 Impact and Future Trends By 2028 KSU | The Sentinel Newspaper -…

February 14th, 2021 6:58 pm

Global Genetic Testing Market Report Provides Future Development Possibilities By Key Players, Key Drivers, Competitive Analysis, Scope, And Key Challenges Analysis. The Reports Conjointly Elaborate The Expansion Rate Of The Industry Supported The Highest CAGR And Global Analysis. This Report Providing An In Depth And Top To Bottom Analysis By Market Size, Growth Forecast By Applications, Sales, Size, Types And Competitors For The Creating Segment And The Developing Section Among The Global Genetic Testing Market. Market Expansion Worldwide With Top Players Future Business Scope and Investment Analysis Report

Global Genetic Testing Market, By Type (Predictive & Presymptomatic Testing, Carrier Testing, Prenatal & Newborn Testing, Diagnostic Testing, Pharmacogenomic Testing, Others), Technology (Cytogenetic Testing, Biochemical Testing, and Molecular Testing), Application (Cancer Diagnosis, Genetic Disease Diagnosis, Cardiovascular Disease Diagnosis, Others), Disease (Alzheimers Disease, Cancer, Cystic Fibrosis, Sickle Cell Anemia, Duchenne Muscular Dystrophy, Thalassemia, Huntingtons Disease, Rare Diseases, Other Diseases), Product (Equipment, Consumables), Country (U.S., Canada, Mexico, Germany, Italy, U.K., France, Spain, Netherlands, Belgium, Switzerland, Turkey, Russia, Rest of Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia- Pacific, Brazil, Argentina, Rest of South America, South Africa, Saudi Arabia, UAE, Egypt, Israel, Rest of Middle East & Africa) Industry Trends and Forecast to 2028

Genetic testing market is expected to gain market growth in the forecast period of 2021 to 2028. Data Bridge Market Research analyses the market to reach at an estimated value of 585.81 billion and grow at a CAGR of 11.85% in the above-mentioned forecast period. Increase in incidences of genetic disorders and cancer drives the genetic testing market.

Get Sample Report + All Related Graphs & Charts (with COVID 19 Analysis) @ https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-genetic-testing-market

The major players covered in the genetic testing market report are 23andMe, Inc., Abbott., Ambry Genetics., BGI, Biocartis, BIO-HELIX, bioMrieux SA, Blueprint Genetics Oy, Cepheid., deCODE genetics, GeneDx, Inc., Exact Sciences Corp, HTG Molecular Diagnostics, Genomictree., Illumina, Inc, Invitae Corporation, Laboratory Corporation of America Holdings, Luminex Corporation., ICON plc, Myriad Genetics, Inc, Natera, Inc., Pacific Biosciences of California, Inc, Pathway Genomics, QIAGEN, Quest Diagnostics Incorporated, F. Hoffmann-La Roche Ltd and Siemens Healthcare Private Limited among other domestic and global players.

Competitive Landscape and Genetic Testing Market Share Analysis

Genetic testing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies focus related to genetic testing market.

Genetic tests are the type of tests which are defined as medical devices available in the form of kits and panels that are used for testing genetic diseases in humans. The testing is generally performed by collecting samples ofbloodfrom patients and the samples are then run on laboratory machines using test kits. There are numerous types of tests which are used in testing of genetic disorders which includes, predictive and presymptomatic testing, carrier testing, prenatal and newborn testing, diagnostic testing, pharmacogenomic testing among others.

Rise in awareness and acceptance of personalized medicines is the vital factor escalating the market growth, also rising advancements in genetic testing techniques, rising demand for direct-to-consumer genetic testing, rising consumer interest in personalized medicines in Europe, rising application of genetic testing in oncology and genetic diseases in North America and rising physician adoption of genetic tests into clinical care are the major factors among others driving the genetic testing market. Moreover, rising untapped emerging markets in developing countries and rising research and development activities in the machinery used inhealthcarewill further create new opportunities for genetic testing market in the forecasted period of 2021-2028.

However, rising standardization concerns of genetic testing-based diagnostics and rising stringent regulatory requirements for product approvals are the major factors among others which will obstruct the market growth, and will further challenge the growth ofgenetic testing marketin the forecast period mentioned above.

This genetic testing market report provides details of new recent developments, trade regulations, import export analysis, production analysis, value chain optimization, market share, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on genetic testing market contact Data Bridge Market Research for anAnalyst Brief,our team will help you take an informed market decision to achieve market growth.

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Genetic Testing Market Scope and Market Size

Genetic testing market is segmented on the basis of type, technology, application, disease and product. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

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Global Genetic Testing MarketCountry Level Analysis

Genetic testing market is analysed and market size insights and trends are provided by country, type, technology, application, disease and product as referenced above.

The countries covered in the genetic testing market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America dominates the genetic testing market due to rising demand for direct-to-consumer genetic testing and rising consumer interest in personalized medicines. Asia-Pacific is the expected region in terms of growth in genetic testing market due to rise in affordability, increasing surge in healthcare expenditure, and increase in awareness toward early screening of genetic disorders in this region.

The country section of the genetic testing market report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as consumption volumes, production sites and volumes, import export analysis, price trend analysis, cost of raw materials, down-stream and upstream value chain analysis are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Healthcare Infrastructure growth Installed base and New Technology Penetration

Genetic testing market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipments, installed base of different kind of products for genetic testing market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the genetic testing market. The data is available for historic period 2010 to 2019.

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An absolute way to forecast what future holds is to comprehend the trend today!Data Bridge set forth itself as an unconventional and neoteric Market research and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best market opportunities and foster efficient information for your business to thrive in the market. Data Bridge endeavors to provide appropriate solutions to the complex business challenges and initiates an effortless decision-making process.

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Acer Therapeutics Announces Topline Results from its Bioequivalence Trial of ACER-001 Compared to BUPHENYL Under Fed Conditions – GlobeNewswire

February 14th, 2021 6:58 pm

NEWTON, Mass., Feb. 11, 2021 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced topline results from its bioequivalence trial in which ACER-001 showed similar relative bioavailability compared to BUPHENYL (sodium phenylbutyrate) under fed conditions. ACER-001 powder is a proprietary, taste-masked, immediate release formulation of sodium phenylbutyrate (NaPB) in development for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD).

The single-center, single-blind, randomized, single-dose crossover trial evaluated bioequivalence (BE) of ACER-001 compared to BUPHENYL when administered under fed conditions in 36 healthy adults. The topline data from this trial showed ACER-001 to have similar pharmacokinetic (PK) profiles for both phenylbutyrate (PBA) and phenylacetate (PAA) compared to BUPHENYL under fed conditions. Acer is initially developing ACER-001 for the treatment of patients with UCDs under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, which provides a potentially streamlined path for sponsors that have developed drug products that rely upon data from drug products previously approved by the FDA.

With topline data now in hand, we are moving forward with our plans to conduct a pre-NDA meeting with the FDA in the second quarter of 2021, assuming successful and timely completion of the ongoing development activities, including evaluation of long-term product stability data, said Chris Schelling, CEO and Founder of Acer. Assuming no additional data is requested by the Agency during our pre-NDA meeting, we will plan to submit an NDA for ACER-001 for the treatment of UCDs in mid-2021. If ACER-001 is approved by the FDA, we believe its unique formulation will provide clinicians with an alternative to existing sodium phenylbutyrate-based treatments.

ACER-001 is an investigational product being studied for the treatment of patients with UCDs and MSUD and has not been approved by FDA for any indication. There can be no assurance that if submitted, a New Drug Application will be accepted by the FDA for filing and review or, if filed, that it will be approved.

About UCDsUCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.1,2

The current treatment of UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medications for UCDs include nitrogen scavengers RAVICTI and BUPHENYL in which the active pharmaceutical ingredients are glycerol phenylbutyrate (GPB) and sodium phenylbutyrate (NaPB), respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications can be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons referenced for non-compliance associated with some available medications include unpleasant taste, the frequency with which medication must be taken, the number of pills, and the high cost of the medication.3

About ACER-001ACER-001 is a powder formulation of sodium phenylbutyrate (NaPB). The proprietary formulation is designed to be both taste-masked and immediate release. ACER-001 is being developed using a microencapsulation process for the treatment of various inborn errors of metabolism, including UCDs and MSUD. ACER-001 microparticles consist of a core center, a layer of active drug, and a taste-masking coating that quickly dissolves in the stomach, allowing taste to be neutralized while still allowing for rapid systemic release. We believe that if ACER-001 is approved, its taste-masked properties will make it a viable alternative to existing NaPB-based treatments, as the unpleasant taste associated with NaPB is cited as a major impediment to patient compliance with those treatments.3 Acer has been granted orphan drug designation by the FDA for the MSUD indication. ACER-001 is under clinical investigation and its safety and efficacy have not been established. There is no guarantee that this product candidate will receive FDA approval or become commercially available for the uses being investigated.

About Acer Therapeutics Inc.Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acers pipeline includes four programs: ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); EDSIVO (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-801 (osanetant) for the treatment of induced Vasomotor Symptoms (iVMS); and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. Each of Acers product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. For more information, visit http://www.acertx.com.

References

Forward-Looking StatementsThis press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund our various product candidate development programs; the adequacy of our capital to support our future operations and our ability to successfully fund, initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on managements current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to fund our various product candidate development programs and to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of managements attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge athttp://www.sec.gov.

Investor Contact:Hans VitzthumLifeSci AdvisorsPh: 617-430-7578hans@lifesciadvisors.com

Jim DeNikeAcer Therapeutics Inc.Ph: 844-902-6100jdenike@acertx.com

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Acer Therapeutics Announces Topline Results from its Bioequivalence Trial of ACER-001 Compared to BUPHENYL Under Fed Conditions - GlobeNewswire

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GeneSight Psychotropic Test’s Combinatorial Approach Proves Better than Single-Gene Testing at Predicting Patient Outcomes and Medication Blood Levels…

February 14th, 2021 6:58 pm

New Analysis Published in Psychiatry Research

SALT LAKE CITY, Feb. 08, 2021 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in genetic testing and precision medicine, announced today the peer-reviewed journal Psychiatry Research has published a new analysis showing the combinatorial approach available in the GeneSight Psychotropic test is better than single-gene testing at predicting patient outcomes and medication blood levels.

Myriads GeneSight test evaluates how variations in multiple genes may influence an individuals outcomes with certain FDA-approved medications commonly prescribed to treat depression, anxiety, and other psychiatric conditions.

Using data from the Genomics Used to Improve DEpression Decisions (GUIDED) randomized-controlled trial, the study evaluated the ability of the combinatorial approach available in the GeneSight Psychotropic test to predict patient outcomes and medication blood levels compared to Clinical Pharmacogenetics Implementation Consortium(CPIC) single-gene recommendations. CPIC recommendations are based on either CYP2C19 and CYP2D6, which are genes that are involved in how the body metabolizes medications commonly used to treat depression and other mental illnesses.

The study included two types of analyses:

Our analysis demonstrated the superior ability of combinatorial pharmacogenetic testing to predict variation in medication blood levels may result in improved patient outcomes, said lead author Anthony J. Rothschild, MD, the Irving S. and Betty Brudnick Endowed Chair and Professor of Psychiatry at the University of Massachusetts Medical School. We believe this study provides compelling evidence of the clinical validity of the combinatorial pharmacogenomic test for patients with major depressive disorder, who have at least one prior medication failure.

This analysis demonstrates that the combinatorial approach of the GeneSight test more accurately predicts blood drug levels and identifies more patients with significant gene-drug interactions who would be missed by single-gene testing, said Dr. Mark Pollack, chief medical officer, Myriad Neuroscience. Combinatorial pharmacogenomics like the GeneSight test should become the standard-of-care to help physicians understand gene-drug interactions that could improve care for people with depression, anxiety and other conditions.

This is the second study evaluating the combinatorial approach of the GeneSight test to be published inPsychiatry Research.The earlier study, published in May 2020, demonstrated the combinatorial approach available in the GeneSight Psychotropic test was better at predicting citalopram and escitalopram blood concentrations when compared to single-gene testing.

The GUIDED study, the largest pharmacogenomic randomized controlled trial in mental health, showed that patients whose doctors received GeneSight results had significantly improved response and remission rates from depression, compared to treatment as usual.

About Myriad NeuroscienceMyriad Neuroscience is a business unit of Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine. Through its GeneSight Psychotropic test, Myriad Neuroscience provides information to healthcare providers about their patients genetic variations, which may impact how they metabolize or respond to certain psychiatric medications. Learn more at genesight.com/about-myriad-neuroscience/

About The GeneSight TestMyriads GeneSight Psychotropic test is the category-leading pharmacogenomic test for depression medications. The GeneSight test can help inform doctors about genes that may impact how patients metabolize or respond to certain psychiatric medications. It has been given to more than one million patients by tens of thousands of clinicians to provide genetic information that is unique to each patient. It supplements other information considered by a doctor as part of a comprehensive medical assessment. Learn more at GeneSight.com.

About Myriad GeneticsMyriad Genetics Inc., is a leading genetic testing and precision medicine company dedicated to transforming patient lives worldwide. Myriad discovers and commercializes genetic tests that determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. For more information on how Myriad is making a difference, please visit the Company's website:www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor StatementThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the Companys strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Assn for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Intl, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2020, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

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GeneSight Psychotropic Test's Combinatorial Approach Proves Better than Single-Gene Testing at Predicting Patient Outcomes and Medication Blood Levels...

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Gu Ailing Eileen: I’ve learned to win for myself, not other people – Olympic Channel

February 14th, 2021 6:58 pm

Shes only 17-years-old, but Gu Ailing Eileen is already one of the worlds most exciting freestyle skiers.

The American-born athlete first gained global attention in 2019 when she won the slopestyle World Cup event at Seiser Alm, before switching allegiances to her mothers birth country, China.

A year later, she lit up the Lausanne 2020 Winter Youth Olympics, with gold medals in the big air and halfpipe events, as well as a silver in slopestyle.

In January 2021, Gu won Chinas first gold at the Winter X Games. In her debut at the Aspen event, she finished with the halfpipe and slopestyle titles as well as big air bronze.

In an Instagram live interview with Olympic Channel, below, the winter sports prodigy reveals her goals for the Beijing 2022 Winter Games, when she'll reveal her secret foodie social media account, her aims for college, a possible future career in government policy, and why her grandma is central to her success!

Olympic Channel: Congratulations for your recent X Games performance. On top of that, youre a Youth Winter Olympic Games champion, you're going to [study at] Stanford [university], you're a pianist, and a model. How do you do all of these things?

Eileen Gu: It's such a surreal thing for me to say out loud that I won the X Games twice! But you know what? When I do something, I focus super wholeheartedly on it. I guess that's the only thing I can say. Growing up, I could only ski on weekends and holidays, so I didn't even think about skiing at all. I was a full-time student. I wanted to get good grades. I wanted to do well in school. I wanted to learn about the things that were exciting to me. I was asking questions about calculus and physics and I wasn't thinking about, How am I supposed to do a double cork? It wasn't really in my head at all. I was thinking the whole time about school.

When I was skiing on the weekends, I would do my homework on the four-hour drive up to Tahoe. On Saturday and Sunday [I was] skiing all the time and I wouldn't think at all about school. And so I think that four-hour drive might be the answer. I did all my homework then, so over the weekend, I would focus on skiing.

I've always thought education was super important. Growing up, my two biggest goals in life were to get into Stanford and to go to the Olympics. So hopefully, fingers crossed, I'll be able to do the second one. I'm really excited just at the thought of it.

Equally at home on the slopes as she is in photo shoots, 16-year-old high s...

OC: What are you going to be studying?

EG: One thing I'm super excited about is that I actually don't have to declare my major until the end of my sophomore year. So I will be able to try all the classes I want, and figure out what I'm interested in. I have a couple of ideas. I am really interested in molecular genetics. Food connoisseur, I'm actually pretty serious about that for the most part. Perhaps journalism, I think [that course] would be really helpful. I really love writing, so that'll be just fun to take in general. I know that Stanford offers a wine tasting course in your junior year, after you turn twenty-one of course, but they will fly you out to France and they'll teach you how to taste different wines and cheeses. So that sounds right up my alley. Hopefully, I'll be able to do some of that when I get older. And there's just a lot of things that I haven't even tried like computer science, which I know is a really amazing major to take at Stanford. You know, more than anything, I'm just excited to be on campus in a little over a year's time, be living the college life, and meet some new friends.

OC: Chloe Kim knows what its like to be a professional athlete and a student. Have you ever spoken to her about it?

EG: Yes, I have. Chloe is super nice. She's helped mentor me in a lot of ways, but she actually took a year off of snowboarding. So she was a full-time student through her first year. I think she's leaving Princeton for this year to snowboard full time. Plans are always changing, but I think I would want to be able to do both at the same time because you know, this whole time I've been doing school and skiing. I got this far, so we'll see, it really is up in the air. Hopefully, I'll be able to do the weekends and holidays situation that I'm used to.

OC: Where do you think that that drive and that focus comes from?

EG: My grandma lives with us, my mom's mom. And I think she instilled that competitive drive in me when I was three or four years old. She's Chinese and doesn't speak any English, so we would be sitting at the kitchen table and she would be teaching me multiplication tables and three-by-three digit multiplication and division in Chinese. When I went to school, I would show my teachers, and I'm like, Four and four is sixteen. And the teacher is like, No, its eight. So then they eventually figured out that I was talking about multiplication and they would say, That's third grade math when I was in kindergarten!.

My grandma would always want me to be the best in the class if I took a test. It was those little bits of motivation for me that instilled that competitive drive. Shes actually turning 86 in a few days and is going really strong. She actually started running this year because I've always been super into running, and now she runs every day. She always tells me that she wants me to be the president, but is concerned that I cant be the president if I injure my knee skiing! I always push myself to go bigger and better with my jumps. But to be able to stay safe and question, Is this safe? Am I ready for this trick? is a really good thing to ask myself in the long run, in order to stay safe.

OC: Do you want to be president?

EG: You know, I'm really interested in becoming involved somewhere in government policy, perhaps as an ambassador to China, maybe because I have some experience culturally between both countries. Obviously, I'm bilingual. So I think that could be really exciting for me after skiing, and modelling, and all the things I want to do while Im young. I'm only seventeen now, and I have a lot of time to figure it out. I do run a secret food review account, though. I think I'll drop it right before the Olympics, so keep your eyes peeled for it! I only have like nine posts on it right now and I don't follow it on my main account.

OC: Do you have to be quite strict with the diet that you eat, the things you eat?

EG: So as an athlete and model, it's something that I have thought about a lot in the past. And I think it took a while to fully understand what my body needed. I naturally have a really, really fast metabolism. I do have a nutritionist who helps me structure my eating based around my training. I definitely snack, and I brought cookies up to the mountain. Im a huge chocolate fan and my dream job when I grow up is to be a food connoisseur. I think it's all about balance. Last night I had this great chocolate chip cookie bake with ice cream on it. It was mind-blowing. But a little bit of everything just keeps me happy and keeps me focused on skiing and not craving all sorts of food.

OC: I know that you and your grandmother like cooking together. What are you going to do for Chinese New Year?

EG: Oh, so normally growing up, I would always make dumplings with my grandma. And that was our big tradition. It is so cute because she is really good at it, she will roll out the dough for the dumplings and always would teach me to put as much filling as you can, so that the dumpling would obviously be bursting with flavour.

But the problem with me is they would always explode because I would put too much or too little in. And it was just so frustrating because she would do it so effortlessly. She's like, roll up, it'll be perfect and super thin, and then she'd throw like, this gigantic, enormous amount of stuff in there, and you'd be like, "there's no way that will close." And then she'll close it up perfectly. And then I would try it, and [it would] explode every time. So we're still working on it. I've gotten better growing up. I was not very good at it at all. Like I couldn't even make the dumpling. And so I would take the dough and make little shapes with it. So I would make a cat or like skis or try to make like a person skiing. I'm not artistic at all, so it wouldn't look like anything. It looked like a little ball of dough.

But I'd be like, "there's like the little ears," and she's like, "did you put the dumpling inside it as well or were you just playing with the dough?" I was playing with the dough. I was not very good The last couple of years I've actually improved a lot. I have a lot of videos of making dumplings with my grandmother. It's really cute. I've gotten a lot better. They're not as good as hers, but at least they don't explode anymore.

Freestyle skier Gu Ailing Eileen exceeded even her own expectations winning...

OC: Lets talk about Beijing 2022. What are your goals for your first Winter Olympic Games?

EG: I think every athlete entering the Olympics wants to win gold. And I think that gold is on the minds of many, and myself included. It's the biggest contest in the world, I've worked so, so hard and I also have so long to go before then. My biggest goal, honestly, is to enjoy the journey and enjoy the process because I'm so young. Every day in my life I learn something new. Being able to have the Olympics as a long-term goal to drive that passion is something that I'm so grateful for. When I actually get to the Olympics, hopefully through that process, through that zest for life, through that passion for the sport, I will have prepared to the best of my ability so that on the day I can perform the way that I hope to.

OC: How do you think that the Lausanne 2020 Youth Winter Olympics helped prepare you for Beijing?

EG: It was so helpful. It was actually my first big air contest ever, so I was really nervous for that. It was my first time doing all three events at the same contest. The two biggest things were time management and pressure management.

It was such a big production and there were so many cameras and ceremonies that it really felt like a world-class event. Last week at the X Games, I did all three events and podiumed all three. A lot of that I actually attribute to the Youth Olympics, because it taught me how to stand at the start gate three different times within 26 hours and how to be able to manage the pressure and the fatigue and keep the adrenaline high, but also remain safe throughout the whole process.

OC: Are there any athletes that you are interested in meeting?

EG: What's really cool about the ski community is that we're really tight knit. I am one of the younger people and, even though I've competed a lot now, I still think of myself as the underdog. I really look up to people like Gus Kenworthy, obviously Chloe Kim, Shaun (White). But what's crazy is that I see them all the time because we're always in the same training camps. Its really exciting. I definitely think I would love to meet some people from the racing side or the mogul side or the aerial side just because it's so different from what I do.

OC: How do you cope with pressure?

EG: I think that I've learned a lot about it at the Youth Olympics. I used to always think about the crowds at the bottom or the media or sponsors and friends that were there, and that I needed to make them proud, or I needed to do well for them. But I think after the Youth Olympics, and after big air in particular when I messed up my first jump, I think and I had to land both of my later jumps with 100 per cent success rate. That actually taught me that I didn't want to win for other people. I wanted to win for myself, and I wanted to prove how hard I had worked in the past. Nobody really sees behind the scenes. Nobody sees the hours and hours of hard work and mental preparation that I put into the sport. So at the end of the day, I want to be proud of myself and in that work that I've done, and have it show on the day. So I think I've learned to manage pressure and to feel the positive energy from other people who are there. But at the end of the day, when I'm feeling pressure to focus on performing to the best of my ability on that day.

Continued here:
Gu Ailing Eileen: I've learned to win for myself, not other people - Olympic Channel

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Types of leukemia: Prevalence, treatment options, and prognosis – Medical News Today

February 14th, 2021 6:57 pm

Leukemia is a type of cancer that affects the blood and bone marrow, where blood cells are formed. All types of leukemia cause rapid, uncontrolled growth of abnormal bone marrow and blood cells.

The main differences between the types include how fast the disease progresses and the types of cells it affects.

There are four main types of leukemia, which we describe in detail below:

Lymphocytic leukemia affects the lymphocytes, a type of white blood cell. Myeloid leukemia can affect the white blood cells, red blood cells, and platelets.

According to the National Cancer Institute, roughly 1.5% of people in the United States will receive a leukemia diagnosis at some point.

In this article, explore the four main types, their symptoms, the treatment options available, and the outlook.

The full name of this type of cancer is acute lymphocytic leukemia, and acute means that it grows quickly. Lymphocytic means that it forms in underdeveloped white blood cells called lymphocytes.

The disease starts in the bone marrow, which produces stem cells that develop into red and white blood cells and platelets.

In a healthy person, the bone marrow does not release these cells until they are fully developed. In someone with ALL, the bone marrow releases large quantities of underdeveloped white blood cells.

There are several subtypes of ALL, and the subtype may influence the best course of treatment and the prognosis.

One subtype is B-cell ALL. This begins in the B lymphocytes, and it is the most common form of ALL in children.

Another subtype is T-cell ALL. It can cause the thymus, a small organ at the front of the windpipe, to become enlarged, which can lead to breathing difficulties.

Overall, because ALL progresses quickly, swift medical intervention is key.

As research from 2020 acknowledges, healthcare providers still do not know what causes ALL. It may occur due to genetic factors or exposure to:

Although genetic factors may play a role, ALL is not a familial disease.

Learn more about ALL here.

ALL is the most common form of leukemia in children.

The risk of developing it is highest in children under 5 years old. The prevalence slowly rises again in adults over 50.

ALL symptoms can be nonspecific difficult to distinguish from those of other illnesses.

They may include:

In a person with AML, the bone marrow makes abnormal versions of platelets, red blood cells, and white blood cells called myeloblasts.

The full name of this disease is acute myeloid leukemia, and acute refers to the fact that it is fast-growing.

It forms in one of the following types of bone marrow cell:

Doctors classify AML by subtype, depending on:

AML can be difficult to treat and requires prompt medical attention.

Learn more about AML here.

The most common risk factor is myelodysplastic syndrome, a form of blood cancer that keeps the body from producing enough healthy blood cells.

Other factors that increase the risk of developing AML include:

Most people who develop AML are over 45. It is one of the most common types of leukemia in adults, though it is still rare, compared with other cancers.

It is also the second most common form of leukemia in children.

Symptoms of AML can vary and may include:

CLL is the most common form of leukemia among adults in the U.S. and other Western countries.

There are two types. One progresses slowly, and it causes the body to have high levels of characteristic lymphocytes, but only slightly low levels of healthy red blood cells, platelets, and neutrophils.

The other type progresses more quickly and causes a significant reduction in levels of all healthy blood cells.

In someone with CLL, the lymphocytes often look fully formed but are less able to fight infection than healthy white blood cells. The lymphocytes tend to build up very slowly, so a person might have CLL for a long time before experiencing symptoms.

Learn more about CLL here.

Genetic factors are the most likely cause. Others might include:

CLL is rare in children. It typically develops in adults aged 70 or over. However, it can affect people as young as 30.

CLL typically causes no early symptoms. When symptoms are present, they may include:

Also, 5090% of people with CLL have swollen lymph nodes.

CML is a slow-growing type of leukemia that develops in the bone marrow.

The full name of CML is chronic myeloid leukemia. As the American Cancer Society explain, a genetic change takes place in the early forms of the myeloid cells, and this eventually results in CML cells.

These leukemia cells then grow, divide, and enter the blood.

CML occurs due to a rearrangement of genetic material between the chromosomes 9 and 22.

This rearrangement fuses a part of the ABL1 gene from chromosome 9 with the BCR gene from chromosome 22, called the Philadelphia chromosome. The result of this fusion is called BCR-ABL1.

BCR-ABL1 produces a protein that promotes cell division and stops apoptosis, the process of cell death, which typically removes unneeded or damaged cells.

The cells keep dividing and do not self-destruct, resulting in an overproduction of abnormal cells and a lack of healthy blood cells.

This occurs during the persons lifetime and is not inherited.

CML typically affects adults. People aged 65 and older make up almost half of those who receive a CML diagnosis.

The symptoms of CML are unclear, but they may include:

The symptoms may vary, depending on the type of leukemia. Overall, a person should get in touch with a doctor if they experience:

Learn more about the symptoms of leukemia here.

Treatment for ALL typically involves three basic phases: induction, consolidation, and maintenance. We describe these in detail below.

Treatment for AML involves the first two phases. The induction phase may include treatment with the chemotherapy drugs cytarabine (Cytosar-U) and daunorubicin (Cerubidine) or idarubicin (Idamycin). The doctor may also recommend targeted drugs.

The goal of this phase is to kill the leukemia cells, causing the cancer to go into remission, using chemotherapy.

The doctor may recommend:

People having chemotherapy may need to see their doctors frequently and spend time in the hospital, due to the risk of serious infections and complications.

This phase of the treatment lasts for about 1 month.

Even if the treatment so far has led to remission, cancer cells may be hiding in the body, so more treatment is necessary.

The consolidation phase may involve taking high doses of chemotherapy. A doctor may also recommend targeted drugs or stem cell transplants.

This phase, consisting of ongoing chemotherapy treatments, usually lasts for 2 years.

Since CLL tends to progress slowly, and its treatment can have unpleasant side effects, some people with this condition go through a phase of watchful waiting before starting the treatment.

For a person with CML, the focus is often on providing the right treatment for the phase of the illness. To do this, a doctor considers how quickly the leukemia cells are building up and the extent of the symptoms. Stem cell transplants can be effective, but further treatment is necessary.

Overall, the initial treatment tends to include monoclonal antibodies, targeted drugs, and chemotherapy.

If the only concern is an enlarged spleen or swollen lymph nodes, the person may receive radiation or surgery.

If there are high numbers of CLL cells, the doctor may suggest leukapheresis, a treatment that lowers the persons blood count. This is only effective for a short time, but it allows the chemotherapy to start working.

For people with high-risk disease, doctors may recommend stem cell transplants.

A persons prognosis depends on the type of leukemia.

Learn more about survival rates for people with leukemia here.

About 8090% of adults with ALL experience complete remission for a while during treatment. And with treatment, most children recover from the disease.

Relapses are common in adults, so the overall cure rate is 40%. However, factors specific to each person play a role.

The older a person is when they receive an AML diagnosis, the more difficult it is to treat.

More than 25% of adults who achieve remission live for 3 years or more after treatment for AML.

A person may live for a long time with CLL.

Treatments can help keep the symptoms under control and prevent the disease from spreading. However, there is no cure.

Stem cell transplants can cure CML. However, this treatment is very invasive and is not suitable for most people with CML.

The United Kingdoms National Health Service estimate that 70% of males and 75% of females live for at least 5 years after receiving a CML diagnosis.

The earlier a person receives the diagnosis, the better their outlook.

Leukemia is a type of cancer that affects the blood and bone marrow. It can affect people of all ages.

There are four main types of leukemia. They differ based on how quickly they progress and the types of cells they affect.

Treatments for all types of leukemia continue to improve, helping people live longer and more fully with this condition.

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Types of leukemia: Prevalence, treatment options, and prognosis - Medical News Today

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Roche receives first FDA clearance for urine sample type for BK virus quantitative test to aid in the improvement of care for transplant patients -…

February 14th, 2021 6:57 pm

BKV can cause severe complications in immunocompromised transplant patients. Higher BKV DNA levels can often be present in urine prior to plasma, serving as an early predictor of an impending infection. A urine sample stabilised in cobas PCR Media allows the integrity of urine results to be maintained, making storage and transportation simpler without the need for sample refrigeration.

"Transplant patients face a number of significant challenges, including complications that can arise from viruses like BKV," said Ann Costello, Head Roche Diagnostic Solutions. "With the FDA clearance of this non-invasive and easily collectable sample type, we now offer choices for clinicians using a standardised, automated solution to routinely monitor and manage infection risks. Together with our viral load tests for Cytomegalovirus and Epstein-Barr virus, we are committed to bringing better care to transplant patients."

The cobas BKV Test runs on the widely available, high-throughput cobas 6800/8800 Systems. It is also approved for use in CE markets with EDTA plasma and urine stabilised in cobas PCR Media as sample types.

About the cobas BKV TestThe cobas BKV Test is a real-time polymerase chain reaction (PCR) test with dual-target technology that provides quantitative accuracy and guards against the risk of sequence variations that may be present in the BK virus. The cobas BKV Test has robust coverage with a limit of detection of 21.5 IU/mL and an expanded linear range from 21.5 IU/mL to 1E+08 IU/mL in EDTA plasma. Urine stabilised in cobas PCR Media has a limit of detection of 12.2 IU/mL and a linear range from 200 IU/mL to 1E+08 IU/mL.

The test offers an alternative to lab-developed tests (LDTs) or Analyte Specific Reagent (ASR) combinations, potentially minimising variability and complexity in testing, reducing workload and alleviating risk for laboratories. The test supports the goal of result standardisation across institutions by providing reproducible, high-quality results for clinical decision-making.

The fully automated cobas BKV, cobas CMV and cobas EBV Tests can run on the cobas 6800/8800 Systems simultaneously, providing absolute automation with proven performance and flexibility, leading to time savings and increased efficiency.

About BK polyomavirusBK polyomavirus (BKV) is a member of the polyomavirus family that can cause transplant-associated complications including nephropathy in kidney transplantation and hemorrhagic cystitis in hematopoietic stem cell transplantation. Infection can occur early in life, often with no symptoms. After primary infection, the virus can remain inactive throughout life, only to possibly reactivate in immunocompromised individuals, such as patients who receive solid-organ transplants. For kidney transplant patients, BKV infection is considered the most common viral complication, causing polyomavirus nephropathy (PVN) in up to 10 percent of kidney transplant recipients, and about 50 percent of PVN-affected patients will experience transplant graft failure.2 BKV is also associated with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation.3

About the cobas 6800/8800 SystemsWhen every moment matters, the fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms. With proven performance, absolute automation and unmatched flexibility delivering unparalleled throughput 24/7 cobas 6800/8800 Systems are designed to ensure a lab's long-term sustainability and success now, more than ever. Learn more now: http://www.cobas68008800.com

About RocheRoche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit http://www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References[1] Jha V. Post-transplant infections: An ounce of prevention. Indian J Nephrol. 2010;20(4):171-178.[2] Jamboti, J. S. (2016) BK virus nephropathy in renal transplant recipients. Nephrology, 21: 647 654. doi: 10.1111/nep.12728. [3] Hirsch HH, Randhawa PS; AST Infectious Diseases Community of Practice. BK polyomavirus in solid organ transplantation-Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13528. doi:10.1111/ctr.13528

Media Contact:

Elizabeth BaxterRoche Molecular Solutions Media Relations[emailprotected] 925.523.8812

Mike WeistUS Media RelationsRoche Diagnostics Corporation[emailprotected]317.371.0035

SOURCE Roche

http://www.roche.com

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FDA Approves G1 Therapeutics’ COSELA (trilaciclib): The First and Only Myeloprotection Therapy to Decrease the Incidence of Chemotherapy-Induced…

February 14th, 2021 6:57 pm

- COSELA is the only FDA-approved therapy that helps proactively deliver multilineage myeloprotection to patients with extensive-stage small cell lung cancer being treated with chemotherapy -

- Myeloprotective efficacy of COSELA resulted in reductions in the incidence and duration of severe neutropenia, and impacted anemia and the need for rescue interventions such as growth factors and red blood cell transfusions -

- G1 will host conference call Tuesday, February 16, 2021 at 8:00 a.m. ET -

RESEARCH TRIANGLE PARK, N.C., Feb. 12, 2021 (GLOBE NEWSWIRE) -- G1 Therapeutics Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved COSELA(trilaciclib) for injection to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). It is the first and only therapy designed to help protect bone marrow (myeloprotection) when administered prior to treatment with chemotherapy. COSELA is expected to be commercially available through G1s specialty distributor partner network in early March.

The approval of trilaciclib (COSELA) is an important advance in the treatment of patients with extensive-stage small cell lung cancer receiving chemotherapy, said Dr. Jeffrey Crawford, Geller Professor for Research in Cancer in the Department of Medicine and Duke Cancer Institute. The most serious and life-threatening side effect of chemotherapy is myelosuppression, or damage to the bone marrow, resulting in reduced white blood cells, red blood cells and platelets. Chemotherapy-induced myelosuppression may lead to increased risks of infection, severe anemia, and/or bleeding. These complications impact patients quality of life and may also result in chemotherapy dose reductions and delays.To date, approaches have included the use of growth factor agents to accelerate blood cell recovery after the bone marrow injury has occurred, along with antibiotics and transfusions as needed. By contrast, trilaciclib provides the first proactive approach to myelosuppression through a unique mechanism of action that helps protect the bone marrow from damage by chemotherapy.In clinical trials, the addition of trilaciclib to extensive-stage small cell lung cancer chemotherapy treatment regimens reduced myelosuppression and improved clinical outcomes.The good news is that these benefits of trilaciclib will now be available for our patients in clinical practice.

Chemotherapy is an effective and important weapon against cancer. However, chemotherapy does not differentiate between healthy cells and cancer cells. It kills both, including important hematopoietic stem and progenitor cells (HSPCs) in the bone marrow that produce white blood cells (immune cells that help fight infection), red blood cells (cells that carry oxygen from the lungs to the tissues), and platelets (cells that prevent bleeding from cancer, surgeries, chronic diseases, and injuries). This chemotherapy-induced bone marrow damage, known as myelosuppression, can lead to increased risk of infection, anemia, thrombocytopenia, and other complications. Myeloprotection is a novel approach of protecting HSPCs in the bone marrow from chemotherapy-induced damage. This approach can help reduce some chemotherapy-related toxicity, making chemotherapy safer and more tolerable, while also reducing the need for reactive rescue interventions.

Chemotherapy is the most effective and widely used approach to treating people diagnosed with extensive-stage small cell lung cancer; however, standard of care chemotherapy regimens are highly myelosuppressive and can lead to costly hospitalizations and rescue interventions, said Jack Bailey, Chief Executive Officer at G1 Therapeutics. COSELA will help change the chemotherapy experience for people who are battling ES-SCLC. G1 is proud to deliver COSELA to patients and their families as the first and only therapy to help protect against chemotherapy-induced myelosuppression.

COSELA is administered intravenously as a 30-minute infusion within four hours prior to the start of chemotherapy and is the first FDA-approved therapy that helps provide proactive, multilineage protection from chemotherapy-induced myelosuppression. The approval of COSELA is based on data from three randomized, placebo-controlled trials that showed patients receiving COSELA prior to the start of chemotherapy had clinically meaningful and statistically significant reduction in the duration and severity of neutropenia. Data also showed a positive impact on red blood cell transfusions and other myeloprotective measures. The trials evaluated COSELA in combination with carboplatin/etoposide (+/- the immunotherapy atezolizumab) and topotecan chemotherapy regimens. Approximately 90% of all patients with ES-SCLC will receive at least one of these regimens during the course of their treatment.

The majority of adverse reactions reported with COSELA were mild to moderate in severity.The most common adverse reactions (10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia. Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis. Grade 3/4 hematological adverse reactions occurring in patients treated with COSELA and placebo included neutropenia (32% and 69%), febrile neutropenia (3% and 9%), anemia (16% and 34%), thrombocytopenia (18% and 33%), and leukopenia (4% and 17%), respectively.

Quite often, people diagnosed with extensive-stage small cell lung cancerrely on chemotherapy to not only extend their lives, but also to acutely alleviate their symptoms, said Bonnie J. Addario, lung cancer survivor, co-founder and board chair of the Go2 Foundation for Lung Cancer. Unfortunately, the vast majority will experience chemotherapy-induced side effects, resulting in dose delays and reductions, and increased utilization of healthcare services. G1 shares our organizations goal to improve the quality of life of those diagnosed with lung cancer and to transform survivorship among people living with this insidious disease. We are thrilled to see new advancements that can help improve the lives of those living with small cell lung cancer.

Approximately 30,000 small cell lung cancer patients are treated in the United States annually. G1 is committed to helping patients with extensive-stage small cell lung cancer in the U.S. gain access to treatment with COSELA. For more information on access and affordability programs, patients and providers should call the G1toOne support center at 833-G1toONE (833-418-6663) from 8:00 a.m. to 8:00 p.m. Eastern time.

G1 received Breakthrough Therapy Designation from the FDA in 2019 based on positive data in small cell lung cancer patients from three randomized Phase 2 clinical trials. As is common with breakthrough-designated products that receive priority review, G1 will conduct certain post-marketing activities, including in vitro drug-drug interaction and metabolism studies, and a clinical trial to assess impact of trilaciclib on disease progression or survival in patients with ES-SCLC with chemotherapy-induced myelosuppression treated with a platinum/etoposide-containing or topotecan-containing regimen with at least a two year follow up. G1 intends to initiate the post-approval clinical trial in 2022.

Webcast and Conference Call The management team will host a webcast and conference call at 8:00 a.m. ET on Tuesday, February 16, 2021 to discuss the FDA approval of COSELA (trilaciclib). The live call may be accessed by dialing 866-763-6020 (domestic) or (210) 874-7713 (international) and entering the conference code: 6195528. A live and archived webcast will be available on theEvents & Presentationspage of the companys website: http://www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

COSELA (trilaciclib) Co-Promotion Agreement with Boehringer Ingelheim

InJune 2020, G1 announced a three-year co-promotion agreement withBoehringer Ingelheimfor COSELA in small cell lung cancer in theU.S.andPuerto Rico. G1 will lead marketing, market access and medical engagement initiatives for COSELA. The Boehringer Ingelheim oncology commercial team, well-established in lung cancer, will lead sales force engagement initiatives.G1 will book revenue and retain development and commercialization rights to COSELA and payBoehringer Ingelheima promotional fee based on net sales. The three-year agreement does not extend to additional indications that G1 is evaluating for trilaciclib. Press release details of the G1/Boehringer Ingelheimagreement can be foundhere.

About Small CellLung Cancer

In the United States, approximately 30,000 small cell lung cancer patients are treated annually. SCLC, one of the two main types of lung cancer, accounts for about 10% to 15% of all lung cancers. SCLC is an aggressive disease and tends to grow and spread faster than NSCLC. It is usually asymptomatic; once symptoms do appear, it often indicates that the cancer has spread to other parts of the body. About 70% of people with SCLC will have cancer that has metastasized at the time they are diagnosed. The severity of symptoms usually increases with increased cancer growth and spread. From the time of diagnosis, the general 5-year survival rate for people with SCLC is 6%. The five-year survival rates for limited-stage (the cancer is confined to one side of the chest) SCLC is 12% to 15%, and for extensive stage (cancer has spread to the other lung and beyond), survival rates are less than 2%. Chemotherapy is the most common treatment for ES-SCLC.

COSELA(trilaciclib) for InjectionINDICATIONCOSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

WARNINGS AND PRECAUTIONS

Injection-Site Reactions, Including Phlebitis and Thrombophlebitis

Acute Drug Hypersensitivity Reactions

Interstitial Lung Disease/Pneumonitis

Embryo-Fetal Toxicity

ADVERSE REACTIONS

DRUG INTERACTIONS

To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Please see full Prescribing Information here

For more information about COSELA, please call 1-800-790-G1TX (1-800-790-4189)

About G1 TherapeuticsG1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the discovery, development and delivery of next generation therapies that improve the lives of those affected by cancer, including the Companys first commercially available product COSELA (trilaciclib), a first-in-class therapy approved by the U.S. Food and Drug Administration to help protect against chemotherapy-induced myelosuppression in patients with extensive-stage small cell lung cancer being treated with chemotherapy. Trilaciclib is also being evaluated in other solid tumors, including colorectal, breast and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit http://www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

Tecentriq (atezolizumab) is a registered trademark of Genentech.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, those relating to the therapeutic potential of COSELA (trilaciclib), and COSELAs (trilaciclib) possibility to improve patient outcomes, are based on the companys expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the companys actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the companys filings with theU.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the companys ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the companys initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contacts:Will RobertsG1 Therapeutics, Inc.Vice President, Investor Relations and Corporate Communications(919) 907-1944wroberts@g1therapeutics.com

Christine RogersG1 Therapeutics, Inc.Associate Director, Corporate Communications(984) 365-2819crogers@g1therapeutics.com

A PDF accompanying this announcement is available athttp://ml.globenewswire.com/Resource/Download/fb9c3593-c36f-4769-9c66-c1ca2e1f78f7

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/25e03769-0cd1-482e-9a70-8b3c81bc46c3

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Energy drinks may damage the heart, researchers warnshould the FDA get involved? – Cardiovascular Business

February 14th, 2021 6:57 pm

Drinking certain energy drinks may cause significant damage to the heart, according to new findings published in Food and Chemical Toxicology.

Because the consumption of these beverages is not regulated and they are widely accessible over the counter to all age groups, the potential for adverse health effects of these products is a subject of concern and needed research, lead researcher Ivan Rusyn, MD, PhD, a professor at Texas A&M University in College Station, said in a prepared statement.

Rusyn et al. assessed a total of 17 popular energy drinks, studying their chemical profiles and looking for any associations with potential cardiac complications. Energy drinks sold by Adrenaline, Shoc, Bang Star, C4, CELSIUS, HEAT, EBOOST, Game Fuel, GURU, Kill Cliff, Kickstart, Monster Energy, Red Bull, Reign, Rockstar, RUNA, UPTIME, Venom Energy and Xyience Energy were all part of the teams analysis.

Overall, the authors found that stem cell-derived cardiomyocyteshuman heart cells grown in a laboratoryshowed signs of an increased beat rate after being exposed to some energy drinks. Also, theophylline, adenine and azelate were all ingredients the team associated with potentially contributing to QT prolongation in cardiomyocytes.

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Easter Ross mum of blood cancer tot urges would-be stem cell donors to show the love this Valentine’s Day; Alness lass Adeline Davidson’s plight…

February 14th, 2021 6:57 pm

Adeline Davidson and dad Jordan.Picture: Callum Mackay

THE Easter Ross mum of a little girl with an extremely rare form of blood cancer has urged life-saving donors to step up to help others.

Steph Davidson made the appeal as blood cancer charity DKMS asked people to show the love this Valentine's Day by signing up for a worldwide register of potential blood stem cell donors.

Her daughter Adeline (3) is awaiting a blood stem cell donation from a stranger and has endured many "false starts" and complications as a result of the coronavirus crisis.

Ms Davidson, who lives in Alness, is backing the DKMS campaign at a time when UK-wide registrations have slumped by 28 per cent.

Big-hearted Highlanders have bucked that trend with an increase in registrations during the pandemic.

With no match within her family, a blood stem cell donation from a complete stranger is Adelines best chance of survival.

The brave little girl, who has missed out on her first year at nursery and valiantly gone through painful and invasive treatment over the last year, has finally got a date for her lifesaving transplant.

With one donor pulling out at the last minute, and her transplant date pushed back several times due to the pandemic, her family have their heart set on finally having their healthy and happy little girl back home and able to play with her friends and family.

Her mum said: Shes such a sweet and friendly little girl, so confident and the best big sister to her little brother and sister. Its just felt like the world has been against us this past year with so many treatments, needles and false starts.

"We are so incredibly grateful to this stranger, who could be anywhere in the world. I want to give them the biggest hug in the world. I cant begin to imagine how awful it is for other families who have a loved one in need of a lifesaving transplant where no match has been found.

"As a parent it makes you feel so powerless being unable to protect your child. Anyone who is healthy and able to register, please, please do. Its such a small commitment for you and could give someone a second chance at life Adelines not even had a chance to start hers and we were so close to it being taken away from her.

The Valentines Day campaign by DKMS is asking people to celebrate with their loved one by taking five minutes to sign up to the stem cell donor register to potentially save the love of someone elses life.

Every 20 minutes, someone in the UK is diagnosed with blood cancer. Around 2000 people each year are dealt the shocking news that they need a blood stem cell transplant.

For these people the perfect match doesnt necessarily have a compatible Zodiac sign or share the same taste in films they need to have a genetically similar make up to give them the best shot at a second chance of life.

With two in three of those people not finding a perfect match within their family, they must turn to the worldwide donor registry and rely on a stranger to save their lives. By signing up to the register you could one day be a match for someone who needs you to help save their life.

The pandemic has had a destructive impact on the lives of people with blood cancer. Not only has it led to a huge drop in the number of people registering as donors, it has meant fewer people are visiting the GP with cancer symptoms, and resulted in hospital appointments and treatments being postponed or cancelled. Due to this, DKMS expects to see a surge in blood cancer diagnoses and increased demand for blood stem cell donors when we are back to normal, making it all the more important that people register now.

Jonathan Pearce, chief executive of DKMS UK, said: At DKMS, we are dedicated to the fight against blood cancer and are proud to have registered over 780,000 blood stem cell donors. Hearing the stories of people like Adeline shows why people registering as blood stem cell donors is so important.

"With the shocking drop in registrations over the last 10 months we are calling on Scots to save the love of someone elses life this Valentines Day. We want every worried family to get the reassuring call that a match for their loved on has been found. If youre inspired by Adelines story, please register as a stem cell donor to give the ultimate gift this Valentines Day by saving a life.

How to sign up

Signing up to save the life of someone like Adeline is easy to do. Register as a potential lifesaver online at dkms.org.uk to receive your home swab kit. It takes a few moments to swab. When you return your swab kit you go on standby to help save someones life.

Taking the first steps to register as a potential blood stem cell donor can be done within a few minutes from the comfort of your own home. If you are aged between 17-55 and in general good health you can sign up for a home swab kit online. Your swabs can then be returned with the enclosed pre-paid envelope to DKMS in order to ensure that your details are added to the UKs aligned stem cell registry.

Related: Alness parents make heartfelt plea after coronavirus-related donor blow

Waiting game as stem cell donor found in United States

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Global Induced Pluripotent Market Positive Outlook, Revenue Generation & Leading Manufacturers, Forecast 2026||CELGENE CORPORATION; Astellas…

February 14th, 2021 6:57 pm

A consistent statistical surveying report like this Induced Pluripotent report stretches out your reach to the achievement in your business. All the information and measurement remembered for the report is supported up by notable investigation devices which incorporate SWOT examination and Porters Five Forces investigation. Statistical surveying contemplates did in this report are chivalrous which help organizations to take better choices and create predominant methodologies about creation, advertising, deals and advancement. Market definition, market division, key improvements in the market, serious investigation and examination approach are the significant section of this Induced Pluripotent market report which are again explained accurately and explicitly.

Induced Pluripotent statistical surveying report has been formed with most up-to-date insight and examination to give greatest advantages to the healthcare business. The Induced Pluripotent market report features the worldwide key makers to characterize, depict and break down the market rivalry scene through SWOT investigation. A variety of goals of the showcasing research has been considered to produce this best statistical surveying report. The market information introduced in the report assists with perceiving diverse market openings present globally. Serious investigation acted in this Induced Pluripotent report makes you mindful about the moves of the vital participants in the market, for example, new item dispatches, extensions, arrangements, joint ventures, associations, and acquisitions.

Few of the major competitors currently working in the induced pluripotent market areBristol-Myers Squibb Company; CELGENE CORPORATION; Astellas Pharma Inc.; Thermo Fisher Scientific; Cell Applications, Inc.; Axol Bioscience Ltd.; Organogenesis Holdings; Merck KGaA; FUJIFILM Holdings Corporation; Fate Therapeutics; KCI Licensing, Inc.; Japan Tissue Engineering Co., Ltd.; Vericel; ViaCyte, Inc.; STEMCELL Technologies Inc.; Horizon Discovery Group plc; Lonza; Takara Bio Inc.; Promega Corporation and QIAGEN.

Objective of the Report

Market Drivers

Market Restraints

Get Full Table Of content @ https://www.databridgemarketresearch.com/toc/?dbmr=global-induced-pluripotent-market

Key Developments in the Market:

Segmentation: Global Induced Pluripotent Market

By Product Category

By Cell Type

By Application

By End-User

By Geography

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AboutData Bridge Market Research

An absolute way to forecast what future holds is to comprehend the trend today!

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

Data bridge is an aftermath of sheer wisdom and experience which was formulated and framed in the year 2015 in Pune. We ponder into the heterogeneous markets in accord with our clients needs and scoop out the best possible solutions and detailed information about the market trends. Data Bridge delve into the markets across Asia, North America, South America, Africa to name few.

Data Bridge adepts in creating satisfied clients who reckon upon our services and rely on our hard work with certitude. We are content with our glorious 99.9 % client satisfying rate.

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EyeSight Max Supplement Reviews [UPDATED] – The Best Eye Supplement? Effective Ingredients? – L.A. Weekly

February 14th, 2021 6:55 pm

Richards EyeSight Max Pills Reviews Can it protect your eyesight effectively? User exposed the truth! Must read before buy.

Official Website: Click Here

What is EyeSight Max?

EyeSight Max is one of the biggest dietary supplements that have been formulated to help thousands of people to help fix their eyesight.

EyeSight Max is for all those people who have lost their vision and are willing to get it back in the most natural and effective manner.

If you are someone who hates the idea of surgeries or living your entire life with the help of spectacles, then, EyeSight Max product is the best thing that can ever happen to you.

The formula not only helps you cure eye problems but it will make sure that you never suffer from them once again.

The formula has been made with the best herbs and ingredients that have been carefully chosen to help you have an effective living.

Eye Sight Max has undergone several tests and researches before it got launched to ensure safety.

Each bottle of Eye Sight Max has been made right here in the USA in an FDA registered and Goods Manufacturing Practices certified facility.

EyeSight Max is made under strict, sterile, and precise standards that ensure the highest quality.

Thousands of people have used the solution and have received the best results in a very short period of time which is quite impressive in comparison with other products.

Which are the ingredients used to formulate the EyeSight Max formula?

As I mentioned above, the formula has been made using the best herbs and ingredients so that it works effectively for all.

EyeSight Max solution is made with 3 potent nutrients that are sourced from the highest and cleanest places on the earth.

These ingredients have been combined together in their best qualities and are added in proper proportions and quantities which ensure the safety and effectiveness of each and every ingredient.

The best part about these superfoods is that they have been tested and proven scientifically and clinically to be highly potent.

Let us know these superfoods below:

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How does EyeSight Max work so well?

EyeSight Max is made effectively in order to help you have an enhanced vision. The formula is simply based on an ancient formula by the Navajo tribe.

Thus, the solution is backed by all scientifically proven all-natural ingredients that have the ability to help detoxify your body.

The food we consume is highly filled with toxicants that are extremely harmful to our bodies.

Thus, EyeSight Max is made with a natural antioxidant that will help your body flush out the PM 2.5 chemicals that can cause fatal disease to take place and will also cause the ocular system dysfunctional.

Thus, the first step the ingredients will do is to get absorbed immediately and then reverse the damage caused by these toxins.

Through this, you will have an enhanced vision for life

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What are the pros and cons of consuming EyeSight Max every day?

EyeSight Max has both pros and cons.

But the pros will leave you happy to the core! Because the formula will improve your overall life and will protect your overall health while providing some of the best health benefits daily such as:

These were the amazing pros, now, let us take a look at the cons of the Eye Sight Max formula:

How much of EyeSight Max is to be taken daily?

As I already mentioned above, it is highly crucial to consume the formula every day without fail.

Regular consumption helps you have fast results that are accurate. So, you are supposed to consume the formula daily.

All you have to do is consume 2 pills of EyeSight Max solution every day after lunch and dinner with a big glass of water.

Once you continue consuming the formula every day, you will be able to get the results in just a few days.

Most people have been able to experience the results within just 3 weeks only. Although the results may vary on the basis of time.

This happens because our bodies have different capacities and ability to adapt to certain things that can cause a bit of delay in results.

But it will be worth the wait!

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How much does the EyeSight Max solution cost?

EyeSight Max has been made available at the cheapest and highly discounted prices. You can choose from the offers below:

Does the EyeSight Max formula have a refund policy?

It is completely fine to be confused. It is okay! After all, you have earned all that money from working really hard daily.

I am sure you must be thinking about what happens when you are not happy with the product!

Thus, to ensure that every consumer of Eye Sight Max is happy and satisfied, the manufactures of the Eye Sight Max formula have come up with an amazing refund policy!

This refund policy is a full 60 days of 100% money-back guarantee.

So, you can now try and test this solution for one or two months and see how it works for you.

If the results make you unhappy and if you are not completely satisfied with it, you can simply contact the makers and ask them for a complete refund without any hesitation.

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Overall review of the Eye Sight Max solution:

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EyeSight Max Supplement Reviews [UPDATED] - The Best Eye Supplement? Effective Ingredients? - L.A. Weekly

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Americans Show New Interest In Virtual Eye Care Options, Finds 2nd Annual Vision Wellness Study – PRNewswire

February 14th, 2021 6:55 pm

BALTIMORE, Feb. 11, 2021 /PRNewswire/ --Today,Versant Health, released the results of the 2nd annual Vision Wellness Study, which found Americans, in particular young adults under 40, are showing a new interest in the use of virtual technology and telemedicine for eye care.

The Vision Wellness Study surveyed consumers and health plan executives on their perceptions of eye care in a pandemic environment, including the value they place on eye care services and their beliefs about the impact of eye care on overall health.

Almost three quarters (74%) of respondents under 40 say having access to technology and tools for virtual visits would make them more likely to schedule a routine eye exam, compared to 67% of all respondents. More than one third (38%) of people under 40 say that being able to communicate remotely with eye doctors would have a high impact on seeing an eye doctor more often, compared to 34% of people ages 40-59 and just 15% of people ages 60 and over. Health plan executives also see the value of telemedicine76% of those surveyed believe members' use of alternatives to face-to-face contact with eye doctors will increase substantially or somewhat as a result of the pandemic.

"With COVID-19 as the backdrop, patients are showing an increased desire for convenient and easily-accessible eye care using remote technology," said Dr. Mark Ruchman, Chief Medical Officer at Versant Health. "As we look to the future of eye care, ocular telemedicine will play an important role in improving access to care, as patients are provided more ways to address their eye health on their own terms."

Perceptions of Eye Care Value vs. Costs

Overall, Americans are increasingly recognizing the importance of eye care, with 81% of respondents receiving an eye exam in the past two years, compared to 77% who said the same in the inaugural study. For all respondents, including those who have not seen an eye doctor in the past two years, the ability to identify eye diseases and the ability to identify other serious health conditions, such as diabetes, ranked as the top two services that would make them more likely to schedule an eye doctor appointment, supporting the role of eye health as a window into overall health.

Of people who have not received an eye exam in the past two years, 37% say it's due to cost and affordability, pointing to a need to dispel misconceptions about the costs of eye care.

"Members are realizing that comprehensive eye exams can provide a clearer picture of their overall health," said Elizabeth Klunk, RN, BSN, CCM-R, Senior Vice President of Medical Management at Versant Health. "In fact, eye exams are one of the lowest cost and least invasive methods at looking at whole body health for early disease detection."

The Social Determinants of Eye Health

Despite the low cost of eye care, barriers to access persist, particularly for people in lower income households81% of all respondents say they have received an eye exam in the past two years, but only 68% of people in households with incomes under $35,000 say the same. When it comes to insurance, 69% of respondents say someone in their household has vision insurance, and that drops to 61% for people with incomes under $35,000.

While 43% of people with incomes under $35,000 say affordability is the reason why they don't go to the eye doctor as often as they'd like, health plan executives say transporation is the key obstacle for members' access to eye care services (88%), highlighting a disconnect. Where health plan executives are concerned about physically getting members to eye doctors' offices, members are more concerned with the costs of care.

"The future of eye care requires us to implement tools that can increase access to care for all patient populations, especially those who are more likely to face systemic barriers. During this pandemic, the rapid advancement of technology has helped us to better meet the needs of vulnerable populations, and we are committed to continuing to explore how it makes healthy sight more accessible," said Klunk.

MethodologyVersant Health's 2nd annual Vision Wellness Study, conducted between October 30 and November 17, 2020, included two distinct surveys fielded by Market Measurement, a custom market research firm. The consumer survey comprises 525 responses from consumers 18 and older. The healthcare plan executive survey comprised 17 responses from health plan executives across the U.S. The survey covered their opinions on routine eye care, access to eye exams, preventative health measures, care costs and other topics related to managed vision care.

About Versant HealthVersant Health, a wholly-owned subsidiary of MetLife, is one of the nation's leading managed vision care companies serving more than 35 million members nationwide. Through our Davis Vision plans and Superior Vision plans, we help members enjoy the wonders of sight through healthy eyes and vision. Providing vision and eye health solutions that range from routine vision benefits to medical management, Versant Health has a unique visibility and scale across the total eye health value chain.As a result, members enjoy a seamless experience with access to one of the broadest provider networks in the industry and an exclusive frame collection.Commercial groups, individuals, third parties, and health plans that serve government-sponsored programs such as Medicaid and Medicare are among our valued customers.

For more information visitversanthealth.com.

SOURCE Versant Health

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His vision suddenly vanished in his left eye. The diagnosis was startlingand life-threatening. – The Daily Briefing

February 14th, 2021 6:55 pm

When the vision of his left eye suddenly clouded over, a 57-year-old man was launched into a maze of hospital testing, imaging, and examinations untildays lateran in-depth eye exam revealed the startling and life-threatening cause of his partial blindness, Lisa Sanders writes for the New York Times Magazine.

In September 2020, the patient realized while washing his face that he could no longer see correctlywhile his right eye seemed fine, an "impenetrable gray cloud" hovered over the upper half of everything he could see from his left eye, Sanders writes.

The patient's wife immediately took him to Bridgeport Hospital, where a physician took down all his symptoms: blurry eyesight, a throbbing headache, and pain on the left side of his chest.

Immediately, the doctor ordered an EKG and a blood test in case of heart attack, but the tests came back normal. So did a round of additional testsan CT scan, an MRI, and more blood teststhat the doctor ordered to rule out a potential stroke, tumor, or temporal arteritis, a disease that can destroy arteries in the brain and eye.

The doctor hypothesized the blindness could stem from a migraine, but even after the patient's headache finally cleared up, his partial blindness lingered.

The hospital had ruled out potential causes of blindness stemming from the brain or the area between the brain and eyebut it didn't have the technology to do an in-depth exam of the eye itself. For that procedure, the patient was sent to Jay Wang, a retinal specialist at Yale New Haven Hospital.

After several hours of testing and imaging, Wang identified the problem: While the vessels in the patient's right eye were "perfect," the vessels of the left eye were irregular. Some were brightly spotted in the imaging and others nearly invisibleincluding the artery that supplies blood to the fovea, a section of the retina that is integral to clear vision.

As Wang explained, the imaging indicated that the man had suffered a stroke, with tiny clots of blood travelling through his bloodstream before lodging in his eye, where they had irreparably damaged his vision.

But the man's medical mystery was by no means solved, Wang cautioned: They had to find out where those clots had originated from, or else it could happen again.

Wang sent the patient to Yale New Haven's ED for an echocardiogram. While there, a fourth-year medical student shadowing the case, Joshua Hyman, asked the patient if he could do an initial scan before the official echocardiogram just as a learning exercise. The patient agreed.

But when Hyman placed the ultrasound probe between the patient's third and fourth rib, he didn't see what he should have seen: "the light gray muscles of the two chambers on the left side of the heart squeezing around a dark center of black that is the blood," Sanders writes. Rather, Hyman saw a kiwi-sized "bright ball zooming back and forth across the screen with every heartbeat."

Hyman immediately shared the results with his attending physician, Karen Jubanyik, who confirmed his suspicions: The patient had a myxoma, a rare type of slow-growing tumor, often found in the heart. The tumor had likely been developing for 20 years or so, and the tumor's rough surface provided a haven where blood could pool and eventually form clotsclots that could be launched any time tumor lurched side-to-side.

According to Hyman and Jubanyik, the patient was lucky. Tumors like these, they explained, often presented in cases of stroke or heart attack, but sometimes can grow large enough to block the blood's ability to flow out from the heart, causing sudden death. So far, the patient had only lost some of his vision, they explained, but he needed immediate surgery to excise the tumor before further damage could be done.

Three days later, the patient underwent a successful surgery, and today, he says he feels healthy enough to exercise. While his vision isn't perfect, the patient added, it seems better than it was when the symptoms first hit.

Wang, who had followed his patient's journey, said he was amazed by what the providers in the ED had discovered and grateful the operation went well. "As an ophthalmologist," he said, "I'm used to saving vision. It's not every day you get to save a life" (Sanders, New York Times, 2/4).

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His vision suddenly vanished in his left eye. The diagnosis was startlingand life-threatening. - The Daily Briefing

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Long holidays can be a strain on the eyes, doctor says –

February 14th, 2021 6:55 pm

By Chiu Shu-yu and Jonathan Chin / Staff reporter, with staff writer

Intense eye use during long vacations could endanger the eye health of children and adults, a New Taipei City-based ophthalmologist said.

Chu Hsueh-yen (), a doctor at Composite Municipal Hospital in Tucheng (), said that eyestrain from intense use of electronic devices while on vacation could damage vision and lead to myopia in children.

Children with normal eyesight had been observed to have myopia readings of minus-2 diopters following a summer or winter break, Chu said, adding that a myopia reading of minus-5 diopters or higher is linked to increased risks of glaucoma, cataracts and retinal detachment.

Photo courtesy of Taipei Tzu Chi Hospital

Excessive eye use could also lead to dry eyes, a condition increasingly recognized as a disease of civilization. Its symptoms include oversensitivity to light, swelling, blurred vision and tears, he said.

People with dry eyes have suppressed their blink reflex and the normal secretions of the tear duct, he said, adding that untreated dry eyes could lead to corneal injury or vision-affecting corneal ulcers.

When using devices in poorly lit conditions, the pupils dilate and allow more blue light to reach the retina, which could lead to macular degeneration, a serious condition that causes missing spots in the field vision and distortions of shapes, he said.

People should take a rest and put on a warm compress as soon as they feel eye soreness or discomfort, he said, adding that they should see a doctor if the sensations do not go away.

Reading, studying, playing with blocks and using electronic devices are activities that could tax a childs eyes and potentially cause myopia, so parents should make the child rest for five minutes for every 30 minutes of activity, he said.

Children using atropine eye drops a prescription used to control myopia progression should always wear sunglasses when engaging in outdoor activities, or risk greater harm to the eyes from direct sunlight, he said.

Styes are another common post-Lunar New Year affliction which usually stem from a combination of festive comfort foods and lack of sleep, he said.

People can use a warm, clean towel as a compress to treat the condition, but should consult a doctor if the symptom does not improve, he said.

Eating less greasy or sweet food and maintaining good personal hygiene can help prevent such problems, he added.

Comments will be moderated. Keep comments relevant to the article. Remarks containing abusive and obscene language, personal attacks of any kind or promotion will be removed and the user banned. Final decision will be at the discretion of the Taipei Times.

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Dr. Julie Steinhauer in Glen Carbon Reveals Treatment Procedure For Vision Compromised By Hypertension and Stroke – RiverBender.com

February 14th, 2021 6:55 pm

GLEN CARBON Dr. Julie Steinhauer, OD, FCOVD, owner of Vision For Life, and one of a select group of functional vision doctors in the nation, says those with hypertension, known as high blood pressure, may often suffer from undiagnosed vision issues. Left unchecked hypertension can cause blurriness, double vision or a complete loss in one part of the visual field.

Severe hypertension can restrict blood and oxygen to the brain causing an artery to either be blocked or burst. It can induce a stroke, lead to heart and kidney issues, and potentially eye disease.

Those who suffer from hypertension, and their families, should be aware of symptoms of a stroke. According to the National Institute of Health (NIH) website these can include sudden numbness or weakness of the face; weakness in the arm or leg especially on one side of the body; confusion and trouble speaking or understanding speech; issues with walking, dizziness, loss of balance and coordination; and problems seeing in one or both eyes.

Dr. Steinhauer, in her YouTube video How Hypertension Or Stroke Affect Vision, said a stroke will often damage a visual pathway causing a loss in the vision field. Eyesight becomes altered. Some may have significant loss of vision, blurriness or a blind spot. In many cases the individual doesnt even realize they have suffered a vision loss after the stroke has occurred.

According to Steinhauer, family members should be aware of these symptoms if they see a loved one acting differently, especially following a stroke diagnosis. They may have blurred vision while watching TV, or what we call visual neglect where the individual ignores stimuli on either the left or right side. Other symptoms include problems when reading, and bumping into objects while walking.

A thorough diagnosis can reveal any eye damage that has occurred as a result of a stroke and best course of treatment. In many cases the eye-brain connection can be retrained using a light therapy called Syntonics. This helps ignite the neurons in the brain that were turned off as a result of the stroke. The patient can gain back some of the normal visual field. An eye doctor can properly evaluate and diagnose vision loss, no matter the age of the patient.

Dr. Steinhauer said functional vision therapy helps to regain 30% to 80% of a stroke patients vision loss. Timing is important because the quicker therapy begins post stroke the better the chances for more visual recovery.

The goal is to let people know that they can regain their vision due to severe hypertension or after a stroke. Utilizing proper therapy we can help improve their ability to read, write, and work, and enjoy life to its fullest.

For additional information visit https://visionforlifeworks.com.

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