StemCell Therapy

The increased incidence of chronic illnesses and genetic disorders and increased spending by governments are driving the demand for the market. Market Size USD 3.05 Billion in 2019, Market Growth - CAGR of 9.3%, Market Trends High demand for stem cell technology

This press release was orginally distributed by SBWire

Vancouver, BC -- (SBWIRE) -- 02/11/2021 -- Regenerative medicine can be defined as the category of medicine that delves into the replacement or regeneration of human tissues, cells, and organs for re-establishing the normal functionality of the body.

The treatment of specific indications and chronic conditions is expected to have significant effects on healthcare. Therefore, a high prevalence, combined with increasing global geriatric population and cancer, neurodegenerative, orthopedic and other aging-related disorders drive market growth. In addition, the increasing prevalence of genetic diseases inherited in the field of biotechnology is expected to increase demand.

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Regenerative Medicine Market Drivers

Factors that can be attributed to the growth in the market are a robust product pipeline in clinical trials and government and private funding. Many companies are investing in research and development to enhance their products with the latest technological advancements and comply with the unmet consumer needs.

Leading Key players in the market include Integra LifeSciences Corporation, Astellas Pharma Inc., Corline Biomedical AB, COOK BIOTECH, INC., Bayer BV, Abbott, AstraZeneca, F. Hoffmann-La Roche Ltd, Pfizer Inc., and Merck & Co., Inc., among others.

Companies are developing products for diabetes, neurological diseases, cancers, and cardiovascular disorders due to the rising number of these diseases. Diabetes and obesity may lead to an increase in the complexity of wounds like ulcerations on the legs or foot, infections, and surgical wounds, which require treatments and result in high costs.

For the purpose of this report, Emergen Research has segmented into the global Regenerative Medicine Market on the basis of Product, Therapeutic Category, Application, and region:

Product Outlook (Revenue: USD Billion; Volume: Million Tons; 2017-2027)TherapeuticsToolsBanksServices

Therapeutic Category Outlook (Revenue: USD Billion; Volume: Million Tons; 2017-2027)DermatologyMusculoskeletalImmunology & InflammationOncologyCardiovascularOphthalmologyOthers

Application Outlook (Revenue: USD Billion; Volume: Million Tons; 2017-2027)Musculoskeletal DisordersWound CareOncologyOcular DisordersDiabetes

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North America had the largest share of revenue of regenerative medicines in 2019 and its dominant position is expected to continue in the forthcoming period. A large number of universities and academic organizations are expected to fuel development by exploring various stem cell-based regenerative approaches.

Regional Landscape

On the basis of region, North America held the largest revenue share of the regenerative medicine market owing to the presence of a vast number of key players in the region. Also, the emergence of innovative technologies and the presence of many research institutes are factors responsible for driving the market's growth.

In market segmentation by geographical regions, the report has analysed the following regions-

North America (USA, Canada and Mexico)

Europe (Germany, France, UK, Russia and Italy)

Asia-Pacific (China, Japan, Korea, India and Southeast Asia)

South America (Brazil, Argentina, Columbia etc.)

Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Asia-Pacific region is estimated to register the fastest growth in the near future, which can be attributed to the continuously improving infrastructure for enhancing healthcare research in many countries. Additionally, rapidly changing lifestyles, an increase in the aging population, and rising medical needs are some of the major factors responsible for driving the regenerative medicine market's growth.

Table of Content

Chapter 1. Methodology & Sources

1.1. Market Definition

1.2. Research Scope

1.3. Methodology

1.4. Research Sources

1.4.1. Primary

1.4.2. Secondary

1.4.3. Paid Sources

1.5. Market Estimation Technique

Chapter 2. Executive Summary

2.1. Summary Snapshot, 2019-2027

Chapter 3. Key Insights

Chapter 4. Regenerative Medicine Market Segmentation & Impact Analysis

4.1. Regenerative Medicine Market Material Segmentation Analysis

4.2. Industrial Outlook

4.2.1. Market indicators analysis

4.2.2. Market drivers analysis

4.2.2.1. Presence of strong pipeline portfolio and high number of clinical trials

4.2.2.2. Major milestones & key events in regenerative medicine

4.2.2.3. High economic impact of regenerative medicine

4.2.2.4. Emerging applications of gene therapy in regenerative medicine

4.2.3. Market restraints analysis

4.2.3.1. High cost of treatment

4.2.3.2. Industry Challenges

4.2.3.3. Regulatory issues regenerative medicine

4.3. Technological Insights

4.4. Regulatory Framework

4.5. Porter's Five Forces Analysis

4.6. Competitive Metric Space Analysis

4.7. Price trend Analysis

4.8. Covid-19 Impact Analysis

Chapter 5. Regenerative Medicine Market By Product Insights & Trends, Revenue (USD Billion)

5.1. Product Dynamics & Market Share, 2019 & 2027

5.1.1. Therapeutics

5.1.2. Tools

5.1.3. Banks

5.1.4. Services

Chapter 6. Regenerative Medicine Market By Therapeutic Category Insights & Trends Revenue (USD Billion)

6.1. Therapeutic Category Dynamics & Market Share, 2019 & 2027

6.1.1. Dermatology

6.1.2. Musculoskeletal

6.1.3. Immunology & Inflammation

6.1.4. Oncology

6.1.5. Cardiovascular

6.1.6. Ophthalmology

6.1.7. Others

Chapter 7. Regenerative Medicine Market By - Application Insights & Trends Revenue (USD Billion)

7.1. Application Dynamics & Market Share, 2019 & 2027

7.1.1. Musculoskeletal Disorders

7.1.2. Wound Care

7.1.3. Oncology

7.1.4. Ocular Disorders

7.1.5. Diabetes

Continue!

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Regenerative Medicine Market Revenue, Statistics, Industry Growth and Demand Analysis Research Report by 2027 - Press Release - Digital Journal

TAMPA, Fla. The parents of a Florida boy battling cancer are asking for the publics help in finding a life-saving blood stem cell donor.

Jakobe "Kobe" Washington, 8, was diagnosed with leukemia in August. Hes receiving treatment at All Childrens Hospital in St. Petersburg.

"Its tough to see your kid fighting a fight, and you cant do anything but be there to support him, no control in it at all," said his father Jordan Washington.

With chemotherapy not working, Kobes family says he is now in desperate need of a blood stem cell transplant.

"For Jakobe, his life depends on it," said his mother Imeria Price.

According to Be The Match, the national marrow donor program, Black patients are the least likely to find a matching donor when battling blood cancers like leukemia and lymphoma.

"Finding a matching donor is difficult, and of the 22 million potential donors on the Be The Match Registry, there are no ideal matches for Kobe," said Erica Sevilla. "This is partially because ancestry matters in finding a match and African Americans only make up 4% of the registry. The end result: Less than 1 in 4 Black patients find a match compared to 3 in 4 White patients."

Be The Match held a COVID-safe, drive-thru cheek swabbing event Friday. Dozens of people showed up to see if they may be a match. A second event will be held on Saturday from 9 a.m. to 2 p.m. at WestShore Plaza in Tampa.

Individuals who cannot make the swabbing event can join the registry by texting KOBE to 61474 and a cheek swab kit will be mailed to their home.

"I have a bright future planned ahead of me, Kobe said Thursday from a hospital bed in St. Pete. I just need your help to get through this and Im going to keep fighting."

Be The Match is hoping to find donors between the ages of 18 and 44, which they say has the highest success rate for donations.

Jessie McNeil hopes he can be a match for Kobe, or anyone else on the waiting list. God has given me a blessed life and a fortunate life so I would love for Kobe to be able to experience life as well, he said.

Bekin Burkinshaw also got his cheeks swapped to see if he could help. Theres 22 million people in the database and not a single match for Kobe which is kind of an unbelievable statistic to think is real, so I think its important to try to give him that one person who could help him out and save his life, added.

See the rest here:
Florida boy battling cancer in need of blood stem cell donor - ABC Action News

(Feb 2021) The latest report published by Polaris Market Research, titled Global Regenerative Medicine Market by Company, Region, Type and Application, Forecast for 2026provides key information about the current status and prospects of the market. The report focuses on market size, share, growth, emerging trends and market area analysis. The research also includes a comprehensive analysis of various market factors, including market drivers, restrictions, trends, risks, and opportunities that are common in the market.

The report provides an in-depth analysis of the global Regenerative Medicine market, which can help market participants design strategies and improve the profitability of their businesses. The study also outlines the major companies that exist in the market and their market shares, growth rates and product launches. The report covers the rapidly changing market scenario and covers the initial and future assessment of the impact

Ask for Sample copy: https://www.polarismarketresearch.com/industry-analysis/regenerative-medicine-market/request-for-sample

The report produced by Polaris Market Research is widely known for its accuracy, because it is composed of precise charts, tables and graphs that clearly depict the development of past products and their market performance and predict future trends. It uses statistical surveys for SWOT analysis, PESTLE analysis, predictive analysis and real-time analysis.

Manufacturers covered in this report are:

Regenerative Medicine market include Organogenesis Inc., Vericel Corporation, Osiris Therapeutics, Inc., Stryker Corporation, and NuVasive, Inc., Medtronic Plc., Acelity, Cook Biotech Inc., Integra LifeSciences, C.R. Bard

*Note: Additional companies can be included on request

The study is a source of reliable data on:

Research methodology

In order to infer the market size, the report considered various aspects on the basis of secondary research. In addition, data points such as product segmentation and market segmentation are also divided by end use. It also combines the qualitative opinions of the main interviewees to arrive at an appropriate market estimate. The forecast provided in the report assesses the total revenue generated by the Regenerative Medicine market and the expected revenue contribution.

When formulating market forecasts, the report will determine the size of the current market, which is the basis for predicting how the market will form in the near future. Market Insights triangulates data through different analysis based on supply side, demand side and other dynamics. The report not only provides CAGR forecasts, but also analyzes the market based on key parameters such as year-on-year (Y-o-Y) growth to understand the predictability of the market and identify the right opportunities.

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The regional analysis covers:

Regenerative Medicine Market Segmentation:

Regenerative Medicine Market Size and Forecast by Therapy Type, 2015-2026

Regenerative Medicine Market Size and Forecast by Product Type, 2015-2026

Regenerative Medicine Market Size and Forecast by Application Type, 2015-2026

Highlights of the report:

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Regenerative Medicine Market Report Provides An In-Depth Insight Of Demand And Trends Forecast To 2026 | Regenerative Medicine market include...

Sperm are simple cells with a straightforward job: swim until they reach an egg, then fertilize it. But in mice, some sperm resort to divisive tactics in order to gain the advantage.

A study published on February 4 in the journal PLOS Genetics shows that a genetic variation in mouse sperm, called the t-type, can give a swimmer the upper hand. These t-type sperm are able to spread a protein called RAC1 that essentially poisons other sperm. T-type sperm plant the seeds of destruction early in their development, then fortify themselves against RAC-1, Brandon Specktor reports for Live Science. When it comes time to race for the egg, the t-type sperm can swim in a straight line while poisoned sperm swim in hapless circles until they die.

We found out that the level of this protein can be more or less active, depending on whether the sperm have the gene to make it, and whether that gene is flipped on like a light switch, says biologist Alexandra Amaral of the Max Planck Institute for Molecular Genetics to Kassidy Vavra at Inverse. The level of protein that is on has to be quite well regulated. If it is too much, sperm don't move well. And if its too low, it also doesnt move well theyre kind of in circles.

T-type sperm produce the RAC1 protein at full throttle.

If all of the sperm in a group are t-type, and theyre all making RAC1, they will all struggle because there is so much of the poisonous protein going around, Sara Rigby reports for Science Focus magazine. On the other hand, if there are no t-type sperm present, then all the other sperm remain relatively healthy and swim well because theres no overabundance of RAC1. However, if a cohort has a mix of t-type and normal sperm, then t-type will have the advantage.

"The trick is that the t-haplotype 'poisons' all sperm, but at the same time produces an antidote, which acts only in t-sperm and protects them," says Bernhard Herrmann, director of the Max Planck Institute for Molecular Genetics, in a statement. "Imagine a marathon, in which all participants get poisoned drinking water, but some runners also take an antidote."

The t-type sperm do the equivalent of poisoning the drinking water early in sperm development, affecting both themselves and their non-variant peers. All of the sperm inherit genes that make it difficult to interpret the chemical signals around them. But in the final cell division of sperm development, when half of a cells genes go to one sperm and the other half to another, only the sperm that inherit the t-type variation have an extra set of genes that reverses the poisons effect, per Live Science.

The poisoned sperm end up swimming in circles, unable to advance in their quest. But the impervious t-type sperm swim ahead. In this case, theres a 99 percent chance that the sperm that fertilizes the egg first will have the t-type variation. The research shows the importance of small genetic variations in sperms success, Amaral tells Inverse.

The study was conducted in about 100 mouse sperm cells, but not all species sperm behave the same way, University of California, Berkeley, cell biologist Polina Lishko tells Inverse. The study is preliminary, but future research could illuminate the specific molecular mechanism behind RAC1 that makes it damaging to sperm at high levels.

An earlier study showed a similar effect of RAC1 on bull sperm, which is more similar to human sperm than a mouses is. Amaral says that the team plans to conduct future research with human sperm, to see if RAC1 might be involved with some cases of male infertility.

Original post:
Mice Sperm Sabotage Other Swimmers With Poison | Smart News - Smithsonian Magazine

Newswise Considered the most lethal form of DNA damage, double-strand breaks must be repaired to prevent cell death. In developing therapies for hard-to-treat breast and ovarian cancers in patients with BRCA gene mutations, scientists aim to identify ways to keep cancer cells from using DNA break repair pathways. New findings demonstrate a previously-unknown capability for polymerase theta (pol theta) a key enzyme in this repair function that shows promise as a new avenue for treatment development.

The study results are published in Molecular Cell.

Researchers at the University of Vermont (UVM), The University of Texas MD Anderson Cancer Center (MD Anderson), and Yale University discovered that pol theta, previously known to extend DNA in the repair process, is also able to behave like a nuclease and trim DNA.

Because these cancer cells rely on the pol theta pathway to survive and repair double-strand breaks, researchers have been focused on pol theta and trying to find out how to inhibit this pathway.

Pol theta is a hot enzyme right now, says senior author and self-described polymerase geek Sylvie Doubli, Ph.D., professor of microbiology and molecular genetics at the UVM Larner College of Medicine and the UVM Cancer Center. This is a new activity for pol theta; its an elegant way of solving the problem you only need one enzyme.

For patients with hard-to-treat cancers, this finding could lead to the development of new therapeutic options, like the Poly-ADP-ribose polymerase (PARP) inhibitors class of drugs that have been used to treat breast and ovarian cancer over the past decade.

The cell has to decide which function needs to be applied and this trimming activity is a point of vulnerability for pol theta, says Doubli. One aim of the research is to create conditions where one reaction can be encouraged over the other.

A potential role for such an inhibitor would be to improve ionizing radiation therapy in cancer patients with BRCA1 or BRCA2 mutations.

Doublis former doctoral student Karl Zahn, Ph.D., now a postdoctoral fellow at Yale, saw evidence of this dual function in pol theta several years ago while working in Doublis lab. He carried out the experiments described in the paper after engaging the expertise of Richard Wood, Ph.D., professor of epigenetics and molecular carcinogenesis at MD Anderson. Wood and Doubli have had a long-term collaboration, funded by a Program Project grant from the National Cancer Institute.

Conducting the experiments, controls, and reproducing the findings took the research team several years but was critical to confirming this discovery.

It was an unexpected finding, and the biochemistry makes sense, suggesting a way to inhibit the DNA repair process orchestrated by pol theta, says Wood.

The trimming reaction is rapid, and many people missed it, says Doubli, adding that the research teams patience and work paid off. Chance favors only the prepared mind, she says, quoting the late French scientist Louis Pasteur.

Excerpt from:
Study Identifies Never-Before-Seen Dual Function in Enzyme Critical for Cancer Growth - Newswise

Some sperm cells are ruthless manipulators that will literally poison their competition in the race to fertilize an egg, new research shows.

In a study published Feb. 4 in the journal PLOS Genetics, researchers from the Max Planck Institute for Molecular Genetics (MPIMG) in Berlin studied mouse sperm cells under the microscope to better understand the effects of a particular DNA sequence known as the t-haplotype. The team knew from previous research that sperm cells carrying this sequence tend to swim straighter (rather than in circles of death) and faster on average than competing sperm without it.

Now, they've found that those highly-effective sperms' tactics are a little less than sportsmanly.

Related: The 7 biggest mysteries of the human body

"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."

The result, Herrmann said, is sort of like a marathon "in which all the participants get poisoned drinking water," but only some of the runners have access to the antidote.

The t-haplotype is a series of linked genes occupying chromosome 17 in house mice all over the world. (Unlike humans, who have 23 pairs of chromosomes, mice have only 20). Herrmann and other researchers have called it a "selfish" gene genetic material with a single mission: to make copies of itself. Because of the t-haplotype's ruthless effectiveness at passing from one generation to the next, according to the researchers, male mice carrying one copy of the t-haplotype will transmit it to up to 99% of their offspring.

After studying more than 100 mouse sperm cells, Herrmann and his colleagues learned more about the selfish haplotype's devious tactics. They found that the t-haplotype "poisons" all sperm cells during the early phases of sperm production, injecting every cell with certain genes that inhibit their ability to regulate movement.

It's not until a later phase, when each cell divides in half, that the "antidote" comes into play. After dividing, half of the sperm cells inherit the t-haplotype genes on chromosome 17. For those lucky sperm, the t-haplotype provides new genetic variants that reverse the inhibiting effects of the "poison" that every cell consumed during the previous phase of development.

For the other half of sperm cells, which don't carry the t-haplotype or its genetic "antidote," life becomes a lot harder. These poisoned cells have a lot more trouble moving in a straight line (an important skill for a cell whose only job is to race full-speed-ahead to an unfertilized egg). In their study, the researchers saw that many sperm without the antidote literally swam in circles until they died, while their t-haplotype competitors charged straight ahead.

"Our data highlight the fact that sperm cells are ruthless competitors," Herrmann said. "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."

Originally published on Live Science.

Continued here:
Devious sperm 'poison' their rivals, forcing them to swim in circles until they die - Livescience.com

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.

See the original post:
More needs to be done to find and fight COVID-19 variants, says Colorado researcher - FOX 31 Denver

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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Related Articles Around the Web

Read the original here:
Selfish sperm genes 'poison' the competition for the win - Big Think

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.

See more here:
Some sperm cells swim faster and even poison their competition to climb to the top - ZME Science

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.

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

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

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

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

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.

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

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

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.

Read more from the original source:
Types of leukemia: Prevalence, treatment options, and prognosis - Medical News Today

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

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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 -...

- 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

COSELA (trilaciclib) image

COSELA (trilaciclib) image

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

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

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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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...