]]> The updated alliance provides rights for Regeneron to develop products for more in-vivo CRISPR/Cas9-based therapeutic targets. Credit: PublicDomainPictures from Pixabay.

Regeneron Pharmaceuticals has expanded its ongoing partnership with Intellia Therapeutics for the development of therapies for haemophilia A and B.

The updated alliance also provides rights for Regeneron to develop products for more in-vivo CRISPR / Cas9-based therapeutic targets. The company also gains non-exclusive rights to develop and commercialise ex-vivo gene-edited products.

In turn, Intellia will get an upfront payment of $70m, along with an equity investment of $30m from Regeneron.

Regeneron Pharmaceuticals co-founder, president and chief scientific officer George Yancopoulos said: The Regeneron team works hard to push the boundaries of science and technology, and we believe the precise in-vivo gene insertion capabilities jointly developed with Intellia could be a promising therapeutic platform with significant potential in many diseases, including those that have been historically difficult to treat.

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Regeneron and Intellia previously leveraged the latters CRISPR / Cas9 platform for targeted insertion of therapeutic proteins and antibodies.

This expansion is intended to leverage jointly-developed targeted transgene insertion capabilities and advance their discovery and development of therapies, including haemophilia A and B treatments.

The partners tested their first CRISPR / Cas9-mediated targeted transgene insertion in the liver of non-human primates. Following the insertion, the animals could produce normal or higher levels of circulating human Factor IX, a blood-clotting protein missing or defective in patients with haemophilia B.

According to the companies, these findings indicate that transgene insertion could offer a functional Factor 9 gene, which encodes for Factor IX.

Intellia Therapeutics CEO and president John Leonard said: We believe that our CRISPR / Cas9-based technology addresses the limitations of current replacement and gene therapy approaches, and importantly, may provide a durable, potentially life-long solution to these genetic diseases.

Under the expanded deal, the term of the companies alliance comes with an extension until April 2024. Regeneron holds an option to renew the collaboration for an additional two years.

Last month, Regeneron announced the repurchase of around $5bn of its common stock directly from Frances Sanofi.

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Regeneron and Intellia to develop new haemophilia therapies - Pharmaceutical Technology

Recommendation and review posted by Bethany Smith

Despite having more coronavirus cases than any other country, America has a testing rate below several countries that have lower per capita rates of the virus.

The slow rollout of testing has crippled us from making more progress and opening up the economy, says Ryan Demmer of the division of epidemiology and community health at the University of Minnesota.

While testing for active infections has much improved since March, tests are still in short supply in some areas around the country. And where tests are readily attainable, results can still take several days.

Now numerous companies are racing to develop rapid at-home tests. Rather than requiring advanced lab equipment for processing, as current tests do, these new ones would use a sample collected at home and, like a pregnancy test, give you a simple positive or negative in less than an hour. (These tests are distinct from the at-home collection kits also being rolled out that require you to send a sample to a lab for processing.)

If these rapid tests prove to be accurate, affordable, and easy to manufacture, they could allow many more Americans to test themselves, even on a regular basis. This could be a huge asset in the fight against the coronavirus, which continues to spread in the US and take thousands of lives a week.

These tools are urgently needed, says Amanda Castel, a doctor and professor of epidemiology at the Milken Institute School of Public Health at George Washington University.

And for the SARS-CoV-2 virus, which causes Covid-19, testing is particularly important, Demmer says, because a lot of the transmission happens from asymptomatic people or presymptomatic people people who dont have any signs of the virus. (In fact, people seem to be most infectious just before they start to have symptoms.)

But there are many caveats to rolling out large-scale, rapid at-home testing for the coronavirus. For example, the results would need to be shared with public health officials to track cases and trace the contacts of people who test positive, and no ones put in place a way to do that yet. And these tests, some of which will likely have lower accuracy than current PCR tests, are also still probably at least a few months away from being available.

For starters, its painfully clear that we need faster, more frequent, and more widely available testing.

The current testing process in the US typically requires a health care worker wearing personal protective equipment (PPE is still in limited supply in some places) to collect a sample. It then needs a lab to analyze it (which takes hours and expensive machines to amplify the genetic signature of the virus). This resource-intensive process has not proved to be scalable to even approach the 500,000 tests per day that experts say the US should be doing at minimum. And the labs processing these tests continue having major backlogs and supply shortages from nasal swabs to the testing machines further hampering wider rollout.

The long waits for results, which still usually take days, have also caused issues.

Before receiving their results, people are advised to self-quarantine just in case. In addition to people not always complying, this lag can also delay identifying the personal contacts of people who are infected.

As Castel, who has studied testing and tracking for HIV infections, notes, Any time you can get someone tested and provide them with their results right then and there, there is an advantage for public health efforts to stop disease transmission. So far, we havent really been able to do this for Covid-19 at any substantial scale.

At best, there are some coronavirus tests that can provide results within a few hours if the test is done on-site (such as at a health care facility that has a testing lab), but their availability is extremely limited. And the accuracy of another test, made by Abbott, which promised answers in less than an hour, has been called into question.

Having a test that people could do without seeing a health care worker in person would also be helpful, saving strain on medical personnel and personal protective equipment.

At-home tests could make it even safer to test people with symptoms while reducing exposure for health care workers, says Emily Toth Martin, an epidemiologist at the University of Michigan School of Public Health. It might also encourage people who are not sure if they are sick to get tested.

In late April, the US Food and Drug Administration began authorizing some at-home collection kits for coronavirus tests; there are now six such kits that have been authorized. These kits let people collect their sample (whether via a nasal swab or saliva) at home before mailing it to a lab. By avoiding a trip to a medical facility to get tested, they can limit spreading the virus if they are infected and reduce their odds of catching it if they are not.

However, these new test collection methods still require lab processing and take several days to receive results. And many are still only available in limited quantities and are being used primarily for front-line health care workers.

We do have technologies that can detect viral particles more quickly and with far less equipment than the mainstream PCR method. In particular, there are two key techniques researchers are currently pursuing.

One method is known as antigen-based testing. These tests look for virus-specific proteins in mucus from nasal swabs and can produce a quick readout, such as a line on a test strip, if the virus is present. (This is in contrast to PCR tests that rely on multiplying genetic material of the virus with expensive machinery and careful laboratory handling before the virus can be detected.)

Antigen testing is already used for rapid tests for strep throat at doctors offices and as part of at-home HIV tests (which also look for antibodies to the virus). The White House has talked up the potential for wide-scale use of these tests, and the FDA authorized the first one in May.

Antigen tests are, however, considered less accurate than the current PCR tests, with some companies estimating their tests miss one in five people who have Covid-19. This might be in part because, unlike the PCR test, it does not multiply the viral particles and so must rely only on the quantity collected in the sample. So they could be especially prone to missing the infection in people who have early infections or who do not collect the sample properly. So some experts suggest these tests would best serve as a quick initial screening; likely cases would then receive a traditional PCR test for confirmation and diagnosis.

Another approach uses CRISPR, the gene-editing technique. It deploys specially designed molecules to find genetic sequences in the SARS-CoV-2 virus and activate compounds to send a signal again, like a line on a test strip if the virus is present. This could be done in about 20 minutes at home. The two most famous scientists in CRISPR technology, Jennifer Doudna of the University of California Berkeley and Feng Zhang of MIT, are each working to bring tests to market that use this process (with Mammoth Biosciences and Sherlock Biosciences, respectively).

Before the pandemic hit, CRISPR technology was already a potential rapid diagnostic tool for other illnesses such as tuberculosis. Results of early studies like the TB one suggest it might have a relatively high accuracy rate, and an early, non-peer-reviewed paper by the researchers at Sherlock Biosciences reports its lab-based CRISPR Covid-19 test has an accuracy similar to PCR tests.

Like the current viral PCR tests, both of these new test types would only look for current infections, not previous ones. Developing a rapid at-home test for previous infection (by looking for coronavirus antibodies) has been less of a priority so far.

I would choose to test for infection at home over a test for antibodies, because it can change decisions that you make that same day to prevent spreading to others, says Toth Martin. For controlling the pandemic, getting accurate viral tests into the hands of people with symptoms has the potential to stop the transmission through a community. That is incredibly valuable.

But just having these tests widely available would not guarantee a slowing of the coronaviruss surge. It would be a convenient way to broaden the availability of tests; however, it needs to be carefully thought out, Castel says. One potential problem with home-based tests is that you could lose the ability to track the virus: who has it and where it is spreading.

Currently, because Covid-19 tests are being run through approved labs, there is a structure in place to collect information about results positive as well as negative ones. This information gets reported to local and state health departments and, ultimately, the federal government. With this data, officials can learn where the virus is and whether its prevalence is increasing or decreasing in certain locations, and know whom to contact to let people whod been exposed to someone infected know they should self-quarantine and maybe seek testing and care.

But if people were able to get quick results from a paper strip at home, there is a real danger of losing this surveillance that is essential to reducing the spread of the virus across the country.

People who tested positive for the virus would need to self-quarantine, and ideally their contacts would need to be traced and notified to also self-isolate. But if theres no doctor, nurse, or health official involved in the process, that tracing and isolation might not happen. Additionally, it would be important for those who receive a positive test result at home to have access to health care, as needed. Without going through a lab or health care system, these messages and connections could easily get lost.

If people were to do their own testing, ideally a procedure would be in place to ensure that the test results get reported to the local health department, Castel says. What exactly this would look like is still not clear. Mammoth Biosciences, which is working on one of the CRISPR tests, has suggested, for example, possibly somehow integrating the test with an app that would report the results anonymously.

And for the patient side, from Castels work on HIV home-based testing, she notes that having a consumer hotline for people to call with questions about taking the test, interpreting their results, and getting connected to health care would also be crucial.

In the rush to get more tests virus-detection tests as well as antibody tests to more people, the FDA has waved through dozens of brand new diagnostics without subjecting them to in-depth scrutiny. Its done so under the Emergency Use Authorization power, which waives the standard, lengthy approval process. The result is that numerous tests have been deployed with sketchy accuracy rates some estimates suggest even current PCR tests might be missing up to a fifth of coronavirus infections (some of this might be due to the tests themselves and some to imperfect collecting and handling methods).

When talking about scaling up a rapid home-based test to potentially the entire country and giving people a tool that, in essence, told them whether or not they were infected (and could infect other people), Demmer says it is imperative these tests be accurate.

These tests have to be good and valid, and I think were a long way from having those, he says. Antigen tests, for example, tend to perform better when looking for bacteria than viruses. And the CRISPR tests are so new, they are still being studied.

The most important area of accuracy would need to be the false-negative rate. A false negative tells a person they dont have the virus when they really do. And in that instance, the person might have a false sense of reassurance and possibly less adherence to social distancing, resulting in further spread of the disease, Castel says.

Demmer agrees. If its going to scale to millions and millions of people, it has to be very close to perfect, to really remove false negatives, he says. (Occasional false positives for infection-detection tests would be less of a setback in controlling the pandemic.) He notes that to ensure this, government regulation of these tests will be essential.

And people taking the test would also need to understand its limitations. It would be important to have a disclaimer to remind users that the test results only reflect someones status for that particular day and time, Castel says. A negative result one day would not guarantee the person would not become infected and infectious in the coming days.

Current health care worker-administered coronavirus tests run about $50 to $100 each. And tests that allow you to collect a sample at home and mail it to a lab cost around $135 to $150.

So although some companies including Ford, Smithfield Foods, and UnitedHealth are starting to test more of their workers as they return to work, these prices make it unrealistic for many businesses to test everyone regularly for an extended period.

Demmer suggests that if new rapid diagnostic tests could approach something closer to $1, they could be deployed virtually everywhere. And many of these rapid tests are looking like they could come in at under $10 each, which would be a vast improvement in making them more accessible.

Demmer acknowledges it might be a pipe dream, but his vision is to have these sorts of rapid tests at every hospital and health clinic and even at the door to every business for employees and customers alike. So if the tests were extremely accurate, a restaurant could conceivably screen everyone and, within several minutes, know whom they could safely allow in. If potential patrons could get screened first, that eliminates the vast majority of your concerns, Demmer says.

Even if rapid tests meet all of these criteria, they are likely still many months away. Of the antigen tests, for example, David Walt, a professor of pathology at Brigham and Womens Hospital, told CNBC that he expects it would probably be four to six months before they would be given FDA authorization.

If and when they do become available, though, he said, I suspect well have pretty good test strips that people will be able to buy like a pack and test themselves every few days or if theyre considering going back to school or work.

As we look ahead to the cold and flu season of the fall and winter, rapid testing could become even more important. I can see these being especially useful in a few months when we might be contending with Covid-19 and other viruses at the same time, Toth Martin says.

And developing rapid at-home tests for these other viruses would be helpful, too, far beyond the pandemic. Id love to see rapid diagnostic tests for all sorts of respiratory viruses, not just SARS-CoV-2, she says. Knowing you have influenza when you thought it might be just a cold could convince you to stay home and not spread it to vulnerable people.

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Covid-19 testing at home: The race to make it easy as a pregnancy test - Vox.com

Recommendation and review posted by Bethany Smith

By: Cristela Hernandez, MD Maternal-Fetal Medicine

Pregnant women commonly ask their doctor, Will my baby be healthy? While the vast majority of babies are born healthy, all pregnancies are at risk for birth defects and genetic diseases. Two to three percent of babies are born with birth defects and 1 in 150 live births involve a chromosomal abnormality. Prenatal care involves screening for chromosomal abnormalities, genetic syndromes, and birth defects. Genetic screening is offered to all women during the first or second trimester of pregnancy. Subsequently, the doctor will review the mothers results to determine, with as much accuracy as possible, whether a specific birth defect or genetic condition is present in her baby. Certain conditions can increase the mothers risk, such as maternal age over 35, or a family history of birth defects and genetic disease. Keep in mind, that although many advances have been made, it is not possible to predict all birth defects or genetic disorders.

Prenatal genetic testing initially focused on the detection of Down Syndrome because it is the most common chromosomal abnormality, but testing has expanded to a broad range of other genetic disorders. Chromosomal abnormalities include extra or missing chromosomes such as Down Syndrome, which arises from an extra chromosome number 21. In addition, chromosomes can have abnormalities such as missing or duplicated fragments, or rearrangements from one chromosome to another. Other genetic disorders are caused by mutations in single genes, such as cystic fibrosis. Lastly, mutations in the mitochondrial DNA can also cause genetic disorders. The field of genetic disorders is complex and genetic counseling is very helpful when these abnormalities are encountered.

Prenatal genetic testing generally begins with a mothers blood test and a fetal ultrasound exam. It is considered a screening test and does not entail any risk to the pregnancy, but is not considered a final diagnosis. Diagnostic invasive testing includes chorionic villus sampling and amniocentesis, and these can provide a definitive diagnosis. Chorionic villous sampling may be performed in the first trimester and an amniocentesis in the second trimester. These procedures can rarely lead to a miscarriage, so benefits and risks should be carefully considered.

Birth defects can be identified with fetal ultrasound exams and newer technology now includes 3- dimensional imaging. If a birth defect is suspected, a detailed fetal ultrasound is recommended. A referral to a Maternal-Fetal Medicine specialist can be helpful to address the multiple issues involved.

All of this information, in response to a concerned mothers simple question, Will my baby be healthy? may seem overwhelming. It is important for every mother to discuss with her doctor the options in prenatal screening and her individual risk of having a genetic disease or birth defect. Prenatal genetic testing provides many benefits, including: reassuring parents when results are normal, identifying conditions which can be treated with fetal therapy before birth, and optimizing care for affected newborns. Such testing may prove very useful for the mother and doctors caring for her baby.

Read more from the original source:
Should I get a prenatal genetic screening test and what can I expect? - Monitor

Recommendation and review posted by Bethany Smith

The genetic mutations that can increase breast cancer risk, including mutations in the BRCA1, BRCA2, and PALB2 genes, are the same for both black and white women, which means that currently available genetic tests are effective for black women, according to a study.

The research was published online on May 19, 2020, by the Journal of the National Cancer Institute. Read the abstract of Contribution of Germline Predisposition Gene Mutations to Breast Cancer Risk in African American Women.

A germline variant is a change, or mutation, in a gene that is inherited from your parents and is in all your DNA.

Three of the most well-known genes that can mutate and raise the risk of breast and/or ovarian cancer are BRCA1, BRCA2, and PALB2. Women who inherit a harmful mutation, or abnormal change, in any of these genes from their mothers or their fathers have a much higher-than-average risk of developing breast cancer and/or ovarian cancer. Men with these mutations have an increased risk of breast cancer, especially if the BRCA2 gene is affected, and possibly of prostate cancer. Many inherited cases of breast cancer have been associated with mutations in these three genes.

The function of the BRCA and PALB2 genes is to keep breast cells growing normally and prevent any cancer cell growth. But when these genes contain mutations that are passed from generation to generation, they do not function normally and breast cancer risk increases. Abnormal BRCA1, BRCA2, and PALB2 genes may account for up to 10% of all breast cancers, or 1 out of every 10 cases.

Earlier studies looking at the genetic mutations linked to a higher risk of breast cancer included mainly white women, so it has been unclear if the same genetic mutations increased breast cancer risk by the same amount in black women.

Earlier research studies looking at genetic mutations linked to breast cancer in black women were very small, so the researchers could only conclude that mutations in the BRCA1 and BRCA2 genes were linked to a higher risk of breast cancer in black women.

So the researchers who did this study were concerned that current genetic tests might not be looking for the correct mutations linked to a higher risk of breast cancer in black women.

The study included 5,054 black women who had been diagnosed with breast cancer and 4,993 black women of the same ages who had not been diagnosed with breast cancer.

All the women had genetic testing that looked for mutations in 23 genes known to be linked to a higher risk of cancer.

Harmful mutations were found in:

Mutations in the BRCA1, BRCA2, and PALB2 genes were linked to a high risk of breast cancer.

Mutations in the RAD51D gene were linked to a high risk of estrogen-receptor-negative breast cancer.

Mutations in the CHEK2, ATM, ERCC3, and FANCC genes were linked to a moderate risk of estrogen-receptor-positive breast cancer.

Mutations in the RECQL gene were linked to a moderate risk of all types of breast cancer.

"This means that the [genetic tests] that are currently available to test women diagnosed with breast cancer or women at high risk due to their family history will be useful for African American women," said lead author Julie Palmer, Karin Grunebaum Professor in Cancer Research at the Boston University School of Medicine.

If you are a black woman who has been diagnosed with breast cancer or who hasnt been diagnosed but you have a strong family history of the disease, this study offers reassurance that current genetic tests will accurately find any mutations linked to a higher risk of breast cancer.

Statistics show that rates of genetic testing are much lower in black women diagnosed with breast cancer than in white women diagnosed with breast cancer.

In February 2019, the American Society of Breast Surgeons issued updated guidelines saying that genetic testing should be made available to everyone who has been diagnosed with breast cancer.

There are a number of reasons why someone diagnosed with breast cancer or who is at high risk because of family history might want to consider genetic testing:

If youve been diagnosed with breast cancer or are at high risk because of family history, you may want to talk to your doctor or a licensed certified genetic counselor about your diagnosis and/or your family history and ask if having a genetic test makes sense for you. A licensed certified genetic counselor or your doctor can help you understand the test and accurately interpret the results.

For more information on genetic testing, including types of genetic tests and how results are reported, visit the Breastcancer.org Genetic Testing pages.

For more information on genes and genetic mutations linked to breast cancer, as well as all the risk-lowering steps you can take if you have a genetic mutation, visit the Breast Cancer Risk Factors: Genetics page in the Breastcancer.org Lower Your Risk section.

To discuss being at high risk for breast cancer with other people, join the Breastcancer.org Discussion Board forum High Risk for Breast Cancer. If you've tested positive for a mutation linked to breast cancer and would like to talk about this with others who have also tested positive, join the forum Positive Genetic Test Results.

Written by: Jamie DePolo, senior editor

Published on June 2, 2020 at 10:18 AM

More:
Genetic Mutations Linked to Higher Breast Cancer Risk Are the Same for Black, White Women - Breastcancer.org

Recommendation and review posted by Bethany Smith

NEW YORK, June 5, 2020 /PRNewswire/ --The Global Preimplantation Genetic Testing Market is expected to grow from USD 418.13 Million in 2018 to USD 946.13 Million by the end of 2025 at a Compound Annual Growth Rate (CAGR) of 12.37%.

Read the full report: https://www.reportlinker.com/p05871267/?utm_source=PRN

The positioning of the Global Preimplantation Genetic Testing Market vendors in FPNV Positioning Matrix are determined by Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) and placed into four quadrants (F: Forefront, P: Pathfinders, N: Niche, and V: Vital).

The report deeply explores the recent significant developments by the leading vendors and innovation profiles in the Global Preimplantation Genetic Testing Market including are ABBott Laboratories, Agilent Technologies, Inc., Oxford Gene Technology, Perkinelmer, Inc., Thermo Fisher Scientific Inc., Beijing Genomics Institute, Combimatrix Corporation, Emerson Electric Co., Invicta Genetics, and Progenesis.

On the basis of Technology, the Global Preimplantation Genetic Testing Market is studied across Comparative Genomic Hybridization, Fluorescence in Situ Hybridization, Next-Generation Sequencing, Polymerase Chain Reaction, and Single-Nucleotide Polymorphism.

On the basis of Offering, the Global Preimplantation Genetic Testing Market is studied across Instruments Services, Reagents and Consumables, and Software and Services.

On the basis of Procedure Type, the Global Preimplantation Genetic Testing Market is studied across Preimplantation Genetic Diagnosis Off-Line Procedure Type and Preimplantation Genetic Screening.

On the basis of Application , the Global Preimplantation Genetic Testing Market is studied across Aneuploidy, Gender Identification, HLA Typing, Single Gene Disorders, Structural Chromosomal Abnormalities, and X-Linked Disorders.

On the basis of End User , the Global Preimplantation Genetic Testing Market is studied across Contract Research and Manufacturing Organizations, Hospitals, Diagnostic Labs, and Service Providers, and Research Laboratories & Academic Institutes.

For the detailed coverage of the study, the market has been geographically divided into the Americas, Asia-Pacific, and Europe, Middle East & Africa. The report provides details of qualitative and quantitative insights about the major countries in the region and taps the major regional developments in detail.

In the report, we have covered two proprietary models, the FPNV Positioning Matrix and Competitive Strategic Window. The FPNV Positioning Matrix analyses the competitive market place for the players in terms of product satisfaction and business strategy they adopt to sustain in the market. The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies. The Competitive Strategic Window helps the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. During a forecast period, it defines the optimal or favorable fit for the vendors to adopt successive merger and acquisitions strategies, geography expansion, research & development, new product introduction strategies to execute further business expansion and growth.

Research Methodology:Our market forecasting is based on a market model derived from market connectivity, dynamics, and identified influential factors around which assumptions about the market are made. These assumptions are enlightened by fact-bases, put by primary and secondary research instruments, regressive analysis and an extensive connect with industry people. Market forecasting derived from in-depth understanding attained from future market spending patterns provides quantified insight to support your decision-making process. The interview is recorded, and the information gathered in put on the drawing board with the information collected through secondary research.

The report provides insights on the following pointers:1. Market Penetration: Provides comprehensive information on sulfuric acid offered by the key players in the Global Preimplantation Genetic Testing Market2. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and new product developments in the Global Preimplantation Genetic Testing Market3. Market Development: Provides in-depth information about lucrative emerging markets and analyzes the markets for the Global Preimplantation Genetic Testing Market4. Market Diversification: Provides detailed information about new products launches, untapped geographies, recent developments, and investments in the Global Preimplantation Genetic Testing Market5. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, and manufacturing capabilities of the leading players in the Global Preimplantation Genetic Testing Market

The report answers questions such as:1. What is the market size of Preimplantation Genetic Testing market in the Global?2. What are the factors that affect the growth in the Global Preimplantation Genetic Testing Market over the forecast period?3. What is the competitive position in the Global Preimplantation Genetic Testing Market?4. Which are the best product areas to be invested in over the forecast period in the Global Preimplantation Genetic Testing Market?5. What are the opportunities in the Global Preimplantation Genetic Testing Market?6. What are the modes of entering the Global Preimplantation Genetic Testing Market?

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The Global Preimplantation Genetic Testing Market is expected to grow from USD 418.13 Million in 2018 to USD 946.13 Million by the end of 2025 at a...

Recommendation and review posted by Bethany Smith

The report attempts to offer high-quality and accurate analysis of the global Direct-Access Genetic Testing Market, keeping in view market forecasts, competitive intelligence, and technological risks and advancements, and other important subjects. Its carefully crafted market intelligence allows market participants to understand the most significant developments in the global Direct-Access Genetic Testing market that are impacting their business. Readers can become aware of crucial opportunities available in the global Direct-Access Genetic Testing market as well as key factors driving and arresting market growth. The research study also provides deep geographical analysis of the global Direct-Access Genetic Testing market and sheds light on important applications and products that market players can focus on for achieving strong growth.

Major players profiled in the report:

23andMeMyHeritageLabCorpMyriad GeneticsAncestry.comQuest DiagnosticsGene By GeneDNA Diagnostics CenterInvitaeIntelliGeneticsAmbry GeneticsLiving DNAEasyDNAPathway GenomicsCentrillion TechnologyXcodeColor GenomicsAnglia DNA ServicesAfrican AncestryCanadian DNA ServicesDNA Family CheckAlpha BiolaboratoriesTest Me DNA23 MofangGenetic HealthDNA Services of AmericaShuwen Health SciencesMapmygenomeFull Genomes

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You can thoroughly assess the strengths and weaknesses of your competitors using our competitive analysis. In the report, you also have access to comprehensive production and shipment analysis from point of origin to end user purchase. Furthermore, you are informed about latest industry developments to help you stay ahead of your competitors. Our analysts are always on their toes to continuously track and analyze any changes or developments in the Direct-Access Genetic Testing industry. The report is filled with statistical presentations, market figures related to revenue, volume, CAGR, and share, and global and regional market forecasts.

The report includes a detailed segmentation study of the global Direct-Access Genetic Testing market, where all of the segments are analyzed in terms of market growth, share, growth rate, and other vital factors. It also provides the attractiveness index of segments so that players can be informed about lucrative revenue pockets of the global Direct-Access Genetic Testing market. The extensive evaluation of segments provided in the report will help you to direct your investments, strategies, and teams to focus on the right areas of the global Direct-Access Genetic Testing market.

Segmentation by Type:

Help-Seeking ADReminder ADProduct Claim AD

Segmentation by Application:

OnlineOffline

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Market Overview:Readers are informed about the scope of the global Direct-Access Genetic Testing market and different products offered therein. The section also gives a glimpse of all of the segments studied in the report with their consumption and production growth rate comparisons. In addition, it provides statistics related to market size, revenue, and production.

Production Market Share by Region:Apart from the production share of regional markets analyzed in the report, readers are informed about their gross margin, price, revenue, and production growth rate here.

Company Profiles and Key Figures: In this section, the authors of the report include the company profiling of leading players operating in the global Direct-Access Genetic Testing market. There are various factors considered for assessing the players studied in the report: markets served, production sites, price, gross margin, revenue, production, product application, product specification, and product introduction.

Manufacturing Cost Analysis:Here, readers are provided with detailed manufacturing process analysis, industrial chain analysis, manufacturing cost structure analysis, and raw materials analysis. Under raw materials analysis, the report includes details about key suppliers of raw materials, price trend of raw materials, and important raw materials.

Market Dynamics:The analysts explore critical influence factors, market drivers, challenges, risk factors, opportunities, and market trends in this section.

We follow industry-best practices and primary and secondary research methodologies to prepare our market research publications. Our analysts take references from company websites, government documents, press releases, and financial reports and conduct face-to-face or telephonic interviews with industry experts for collecting information and data. There is one complete section of the report dedicated for authors list, data sources, methodology/research approach, and publishers disclaimer. Then there is another section that includes research findings and conclusion.

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Impact of Corona on Direct-Access Genetic Testing Market : What is the expected revenue for 2026? - Cole of Duty

Recommendation and review posted by Bethany Smith

(STL.News) An Illinois man today admitted his role in a scheme to defraud the Medicare Program in connection with fraudulent orders for genetic tests, U.S. Attorney Craig Carpenito announced.

Kyle D. McLean, 36, of Arlington Heights, Illinois, pleaded guilty by videoconference before U.S. District Judge Brian R. Martinotti to a superseding information charging him with one count of conspiracy to defraud the United States in connection with a scheme to commit health care fraud. McLean and five co-defendants were previously charged by indictment in September 2019 in connection with the conspiracy and a related scheme.

According to documents filed in this case and statements made in court:

McLean and certain of his conspirators operated Privy Health Inc., a company that acquired DNA samples and Medicare information from hundreds of patients through various methods, including offering $75 gift cards to patients, all without the involvement of a treating health care professional. Privy partnered with another company, Ark Laboratory Network LLC, which purported to operate a network of laboratories that facilitated genetic testing. Matthew S. Ellis, a physician based in Gainesville, Florida, and a co-defendant charged in the indictment, served as the ordering physician who authorized genetic testing for hundreds of patients across the country that he never saw, examined, or treated. These included patients from New Jersey and various other states where Ellis was not licensed to practice medicine. Through this process, Ellis, McLean, and others submitted and caused to be submitted fraudulent orders for genetic tests to numerous clinical laboratories. These orders falsely certified that Ellis was the patients treating physician and, in some cases, falsely indicated that a patient had a personal or family history of cancer. In 2018 alone, Medicare paid clinical laboratories at least approximately $4.6 million for genetic tests that Ellis ordered as part of this scheme.

The charge to which McLean pleadedguilty carries a maximum penalty of five years in prison and a fine of $250,000, or twice the gross grain or loss from the offense. Sentencing is scheduled for Oct. 9, 2020.

A co-defendant, Kacey C. Plaisance, of Altamonte Springs, Florida, previously pleaded guilty and is scheduled to be sentenced on September 17, 2020.

U.S. Attorney Carpenito credited the U.S. Department of Health and Human Services, Office of Inspector General, under the direction of Special Agent in Charge Scott Lampert; and special agents of the U.S. Attorneys Office for the District of New Jersey with the investigation leading to todays guilty plea.

The government is represented by Senior Trial Counsel Bernard J. Cooney of the Health Care Fraud Unit of the U.S. Attorneys Office in Newark.

The charge and allegations against the remaining defendants are merely accusations, and they are presumed innocent unless and until proven guilty.

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Illinois Man Kyle D. McLean Admits Role in $4.6 Million Health Care Fraud Related to Genetic Testing - STL.News

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Multinational iron ore mining company Rio Tinto is under fire for blasting through a 46,000-year-old Aboriginal cultural site in Western Australia last monthespecially since the company reportedly knew about the cave dwellings significance as far back as 2014.

On May 24, Rio Tinto, in trying to expand their Brockman 4 iron ore mine in the Pilbara region, destroyed two cave systems, Juukan 1 and 2, that showed evidence of continual human habitation dating back 46,000 years. The sites owners, the indigenous Puutu Kunti Kurrama and Pinikura (PKKP) peoples, reportedly only learned of the demolition on May 15; it was allowed to move ahead as an agreement had already been signed in 2013, one year before an archeological survey to the area was conducted.

What did that survey find? Archeologists reportedly recovered over 7,000 high-quality artifacts, including tools, grinding stones, and 4,000-year-old pleated hair braids that genetic testing linked to still-living Aboriginal peoples. Still, despite the discovery that the Juukan Gorge dwellings were more culturally, historically, and scientifically important than first thought, the demolition was still allowed to proceed under the Aboriginal Heritage Act. In 2013, Rio Tinto secured a permit based on the premise that the caves were of low historic value, and following the provisions set out by the act, were thus free from legal culpability for excavating, destroying, damaging, concealing or in any way altering any Aboriginal site.

Rio Tinto also remains in possession of the items recovered in 2014, and in 2016, even put out a documentary laying out PKKP concerns over the areas preservation, somewhat undermining the companys claim that this was unavoidable. The results of the final archeological report were never made public until summaries were recently provided to the press.

The chief executive of Rio Tinto iron ore, Chris Salisbury, apologized in an interview with Radio National this morning, calling it a misunderstanding, but as ABC News pointed out, the company knew the caves likely had archeological significance as far back as December of 2008.

For their part, the PKKP reportedly tried to stop the destruction but were told by Rio Tinto that the explosives had already been laid and that it was too late.

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Mining company blasts through 46000-year-old cultural site in Australia - The Architect's Newspaper

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Hundreds of published studies over the last decade have claimed it's possible to predict an individuals patterns of thoughts and feelings by scanning their brain in an MRI machine as they perform some mental tasks.

But a new analysis by some of the researchers who have done the most work in this area finds that those measurements are highly suspect when it comes to drawing conclusions about any individual persons brain.

Watching the brain through a functional MRI machine (fMRI) is still great for finding the general brain structures involved in a given task across a group of people, said Ahmad Hariri, a professor of psychology and neuroscience at Duke University who led the reanalysis.

Scanning 50 people is going to accurately reveal what parts of the brain, on average, are more active during a mental task, like counting or remembering names, Hariri said

Functional MRI measures blood flow as a proxy for brain activity. It shows where blood is being sent in the brain, presumably because neurons in that area are more active during a mental task.

The problem is that the level of activity for any given person probably wont be the same twice, and a measure that changes every time it is collected cannot be applied to predict anyones future mental health or behavior.

Hariri and his colleagues reexamined 56 published papers based on fMRI data to gauge their reliability across 90 experiments. Hariri said the researchers recognized that the correlation between one scan and a second is not even fair, its poor.

They also examined data from the brain-scanning Human Connectome Project -- Our fields Bible at the moment, Hariri called it -- and looked at test/retest results for 45 individuals. For six out of seven measures of brain function, the correlation between tests taken about four months apart with the same person was weak. The seventh measure studied, language processing, was only a fair correlation, not good or excellent.

Finally they looked at data they collected through the Dunedin Multidisciplinary Health and Development Study in New Zealand, in which 20 individuals were put through task-based fMRI twice, two or three months apart. Again, they found poor correlation from one test to the next in an individual.

The bottom line is that task-based fMRI in its current form cant tell you what an individuals brain activation will look like from one test to the next, Hariri said. The new analysis, appears June 3 in Psychological Science

This is more relevant to my work than just about anyone elses! Hariri said, his voice rising. This is my fault. Im going to throw myself under the bus. This whole sub-branch of fMRI could go extinct if we cant address this critical limitation.

Hariri has been using fMRI data as part of a long-term study of 1,300 undergraduate Duke students. By combining brain scans, genetic testing and psychological assessments, Hariri is searching for biomarkers of individual differences in the way people process thoughts and emotions, such as why one person comes away from a traumatic event with PTSD or depression and another does not.

We cant continue with the same old hot spot research, Hariri said. We could scan the same 1,300 undergrads again and we wouldnt see the same patterns for each of them.

One possible solution to the reliability problem, using existing technology, would be to collect data for a full hour or longer in the scanner, not just five minutes. Hariri also said developing new tasks from the ground up with the explicit purpose of reliably measuring individual differences in brain activity is another strategy. In the meanwhile, Hariri and his team have shifted their focus to MRI measures of brain structure, which are highly reliable.

Its not as if we havent known these issues of reliability, but this paper brings them together more sharply, said Russell Poldrack, the Albert Ray Lang Professor of Psychology at Stanford University, who had a 15-year-old fMRI paper among those that were reanalyzed.

This is a good wakeup call, and its a marker of Ahmads integrity that hes taking this on, said Poldrack, who was not involved in the meta-analysis but said he has had suspicions about fMRI reliability for a few years now.

Connectivity mapping seeing how areas of the brain are connected to address a task more than just what areas are active is going to be the way forward, Poldrack predicted. Hariri agreed that identifying patterns of activity throughout the brain rather than in one or two areas may improve reliability.

In the meantime, the sociology behind a dramatic debunking of a scientific tool is going to be interesting to watch, Hariri and Poldrack both said.

Theres three things you can do, Poldrack said. You can just up and quit, you can stick your head in the sand (and act as if nothing has changed), or you can dig in and try to solve the problems.

This analysis was supported by the U.S. National Science Foundation. The Dunedin Study is supported by the U.S. National Institute on Aging (R01AG049789, R01AG032282) and the UK Medical Research Council (P005918), the New Zealand Health Research Council and the New Zealand Ministry of Business, Innovation and Employment (MBIE). The Human Connectome Project is supported by 16 centers of the U.S. National Institutes of Health via the Blueprint for Neuroscience Research.

CITATION: What is the Test-Retest Reliability of Common Task-fMRI Measure? New Empirical Evidence and a Meta-Analysis, Maxwell L. Elliott, Annchen R. Knodt, David Ireland, Meriwether L. Morris, Richie Poulton, Sandhya Ramrakha, Maria L. Sison, Terrie E. Moffitt, Avshalom Caspi, Ahmad R. Hariri. Psychological Science, June 3, 2020. DOI: 10.1177/0956797620916786

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Studies of Brain Activity Aren't as Useful as Scientists Thought - Duke Today

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We caught up with Ann L. Steiner, MD, clinical professor of obstetrics and gynecology, who specializes in caring for menopausal women and practices at Penn Health for Women Radnor.

Penn Medicine for Women: When should you have your hormones checked?

Dr. Steiner: First of all, we don't routinely check hormone levels in women. Some women think that because they might be going into menopause, they need to have their hormones checked. Its not appropriate to do this, because we don't treat hormone levels.

The emphasis here is that in menopause, we treat symptoms. And therefore, there's no reason to check sex hormone levels routinely for women who are in the menopause.

Taking a history and hearing someone's story, especially if they have issues related to menopause, is much more important in guiding management than hormone level results. Really, it's the story and history that gives us guidance in joint decision making of care.

For instance, during menopause, a womens estrogen level is dropping and other hormones go up in response. We know what's going on. We treat her symptoms.

You might have one woman who's going into menopause, and she has absolutely no symptoms, she has no hot flashes, she feels great. And if we were to check her hormones, they would be reflective of menopause. We might have another woman who's the exact same age who is not sleeping well, and has terrible hot flashes, and her mood's off, and we check her hormones, and they're exactly the same as the woman who has no symptoms.

PM: Are there other times in a womans life when it would be appropriate to check hormone levels?

Dr. Steiner: Yes. There are other times when we need to check hormone levels.

For instance, if a woman stops getting her period prior to menopause, or has menstrual irregularity, we would check hormone levels to diagnose what is causing the problem, then treat her.

We commonly check thyroid stimulating hormone (TSH), a hormone that regulates metabolism, for women who are having hot flashes, symptoms of having too much thyroid, or not enough thyroid, fatigue, sleep issues or unexplained weight change. Abnormal thyroid levels can be associated with these symptoms, as well as abnormal menstrual changes.

PM: Are women who have reached perimenopause or menopause generally more concerned with hormone levels than those of reproductive age, or does it run the gamut?

Dr. Steiner: That's a tough question, because it's pretty subjective. My practice involves mostly women who are around the age of menopause, but I would just say over the years looking back, I've had women of all ages ask to have their hormones checked when they feel that something is not right or that there are changes.

For instance, if they experience mood changes, weight change, or fatigue, they often will ask to have their hormone levels checked, whether it's an appropriate thing to do or not.

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Ask a Doctor: When Should I Have My Hormones Checked ...

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Prostate cancer specialists are familiar with the role androgens can play in disease because in the prostate, the hormones stimulate an enzyme that boosts cancerous growth. In April, researchers published a paper in the journalCellwhich showed that the enzymeTMPRSS2is also involved in coronavirus infections.

To infect a cell, coronaviruses - including the novel SARS-CoV-2, which causes Covid-19 - use what is called a 'spike' protein that binds to the cell's membrane,a process that is activated by an enzyme. In this case, it appears that TMPRSS2 may be that enzyme.

Scientists do not yet know if the enzyme responds in the same way to androgens in the lungs as it does in the prostate, but other evidence appears to support the potential link.

A study from Veneto, Italy, of 9,280 patients found that men with prostate cancer who were on androgen-deprivation therapy - drugs that cut testosterone levels - were only a quarter as likely to contract Covid-19 as men with the disease who were on other treatments.

Karen Stalbow, Head of Policy at Prostate Cancer UK, said: There have been several recent pieces of research which indicate there may be a link between male hormones and increased risk of Covid-19. This has led some researchers to investigate whether hormone therapies commonly used to treat prostate cancer, such as enzalutamide, could reduce this risk.

However, most of the research so far has been in the lab, and there is conflicting evidence over whether the hormone therapies have the same impact in the lungs as they would in prostate cells. There are now several clinical studies starting which hope to address these issues, but much more evidence is needed before we can know whether these hormone therapies would be an effective treatment for Covid-19.

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Bald men at higher risk of severe case of Covid-19, research finds - Telegraph.co.uk

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Some argue that partnering with Dignity restrict care to LGBTQ+ people, women, others argue more are harmed by not partnering

Unable to agree on a single set of recommendations, a UC task force presented two options on how best to affiliate with health care systems outside of the system to UC President Janet Napolitano in the Working Group on Comprehensive Access (WGCA) Chairs Report of Findings and Recommendations.

The WGCA was formed in August of 2019 after public outcry in the spring when UCSF was revealed to be expanding affiliations with faith-based hospital system Dignity Health. The WGCA was composed of 15 UC officials: a regent, chancellors, deans, faculty, Academic Senate representatives and UC health leadership.

Ten of the 15 WGCA members had already expressed support for the UCSF and Dignity Health partnership before the formation of the WGCA. All three Academic Senate Representatives in the WGCA, as well as UC San Diego Professor Gabriel Haddad, were explicitly not in favor of a UCSF and Dignity Health partnership before the formation of the WGCA.

The group was tasked with creating a list of policy recommendations to ensure the values of the UC are upheld in all affiliations with other health care systems and that UC personnel would be unrestricted in providing medical care.

Unable to agree to one set of recommendations, the WGCA created two options which could be adopted individually or in combination with one another, according to UC Irvine Chancellor and Chair of the WGCA Howard Gillman.

Option 1, supported primarily by UC Health officials allow affiliations with organizations that have non-evidence-based policy restrictions on care if governed by appropriate policies and guidelines, Gillman said in the report. Option 2, supported by those who could not endorse the report was designed to impose a prohibition on such affiliations.

In short, Option 1 encouraged continued affiliation with health care systems that may restrict health care based on religious doctrine if clear guidelines are created to protect UC personnel. Option 2 discouraged continued affiliation with health care systems that have restrictions based on religion.

The two groups formed because the WGCA could not unite in answering two fundamental questions: Whether UC should affiliate at all with organizations whose institutional policies (a) prohibit the use of contraception, abortion, assisted reproductive technology, gender-affirming care for transgender people, and the full range of end-of-life options and (b) permit non-clinicians to make clinical decisions affecting the health and safety of individual patients irrespective of the professional judgment of health care providers and/or the informed decisions of patients.

Though the WGCA was tasked with making policy recommendations that protect the freedoms of UC personnel, enable the appropriate care of patients regardless of which facility they are first examined and encompass respect for a diversity of opinions, the issue comes down to the fact that some Catholic Church-sponsored hospitals restrict care based on religious convictions. These convictions, called Ethical and Religious Directives (ERDs), are determined by the U.S. Conference of Catholic Bishops (USCCB), not doctors.

The ERDs do not allow the prescription of any FDA-approved methods for preventing pregnancy including sterilization, elective abortion; assistive reproductive technology such as in-vetro fertalization (IVF) or the use of a surrogate for pregnancy; gender affirming care such as hormone replacement therapy or surgery or physician-assisted aid in dying.

Women and transgender individuals are those most affected by these policies, and gay couples who need IVF or a surrogate for biological pregnancy are also highly impacted.

Dignity Health, which has agreements with five of six UC medical centers, operates under the ERDs at 17 out of 31 California hospitals. At the other 14, they operate under the Statement of Common Values where they do not perform elective abortions, IVF or physician-assisted death.

Its pretty clear why [these policies are] discriminatory against transgender people, said WGCA member and UCSF Ob/Gyn Vanessa Jacoby. The discrimination against women is trickier to pick out, though, Jacoby argued.

Policies that prohibit women from getting standard of care services are discriminatory against women because the vast majority of our contraception is for women, Jacoby said. Women who are prohibited from getting contraception are the ones that bear the consequences of undesired pregnancy.

Because Jacoby views these policies as so discriminatory towards women and members of LGBTQ community, Jacoby is fundamentally against these partnerships as they conflict with the values of UC.

When Im considering a healthcare decision, if one of the harms is discrimination against any group, but in this case discrimination against women and against LGBT people and against transgender patients [] that, to me, overwhelms any potential benefit, Jacoby said. I dont believe UC should violate our anti-discrimination policies, no matter what the potential benefits are.

UC Davis ASUCD shares this belief and unanimously passed Senate Resolution #18 which calls for the UC to end all plans to expand affiliations with Dignity Health.

Others such as David Lubarsky, vice chancellor of Human Health Sciences and CEO for UC Davis Health, follows a different line of reasoning. Since many of Dignitys facilities are in rural areas, the only healthcare facilities for miles, UC would not have access to these patients if not for partnerships with Dignity Health. Lubarsky said he believes that more harm would be done to these rural communities by not partnering with systems like Dignity Health than could potentially be done by partnering with them.

We agree 100% that we have to do everything we can promote for Reproductive Rights and full access to health care for the LGBTQ community in every way, Lubarsky said in an interview earlier this year with The California Aggies Editorial Board. But that principle cannot trump the real harm that would be done to a large population of individuals who [would no longer be able to] get advanced care at a UC hospital.

Lubarsky put bluntly what a complete disengagement with Dignity Health would do: It prevents the poor people [which] Dignity primarily serves from having access to any UC hospital.

Lubarsky said he believes the WGCA did not get to the root of the problem: How can we balance the need of the underserved communities that need access to UC doctors through Dignity with our own values surrounding womens reproductive health care and LGBTQ+ healthcare?

It became an argument over a single issue, which was actually a mistake, Lubarsky said, saying he believes a broader discussion about How do we best serve the human beings were responsible for? would have been more productive.

Dan Loeterman, the director of External Communications for Dignity Health, said he agrees.

Its very clear to us that tens of thousands of Californians depend on [UC and Dignity] programs for their health each year, Loeterman said. We believe that theres a lot more where [UC and Dignity] agree than where we disagree.

Everyone does seem to agree on the fact that the partnership between UC and Dignity Health is highly political, especially because each is a powerhouse of medical care, since half of California doctors are trained at UC, and Dignity Health is the largest hospital chain in California.

UC Health will try to say this isnt about politics this is about one of the most important issues facing this country, said UC Davis Professor and Member of the WGCA Robert May. If Roe v. Wade is overturned, and theres a very good likelihood that that will happen, that will engender a major health crisis in this country. Our getting involved with this is just aiding that.

Lubarsky said he thinks otherwise. By participating in these affiliations, the UC is able to at least have some sway in the conversation regarding the treatment of patients at hospitals that operate under the ERDs.

By disengagement, we lose our voice in that argument, Lubarsky said. We think principled engagement plus support of organizations like Planned Parenthood will be a better tactic than disengagement.

Jacoby, however, did not adhere to this idea.

I really believe that the University of California can find solutions to address our clinical needs, our research needs, our educational needs, that do not compromise our core values and our anti-discrimination policies, Jacoby said. I would love [for leadership in the UC] to propose solutions that dont have this controversy around it and dont discriminate against women or LGBT people.

Written by: Jessica Baggott campus@theaggie.org

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UC task force unable to reach agreement on how to move forward with Dignity Health partnerships, gives two recommendations - The Aggie

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Save your business while saving lives, reads the website of Because Health, a Seattle tech startup selling two types of tests to employers willing to pay $350 a pop to learn whether their workers have been infected with COVID-19.

The Workplace Health plan includes not only nasal swab tests to detect infection, but also blood tests aimed at indicating whether workers have developed antibodies to the virus and, possibly, future protection.

Theres a tremendous consumer demand, said Dr. Lars Boman, the Boston-based medical director for the firm. Can they return to work? Can they return to life?

What the website does not make clear, however, is that public health officials have explicitly warned that antibody tests should not be used to make decisions about workplace staffing.

This is a personal choice of the business, of the consumer, Boman said.

Across America, untold numbers of employers, employees and ordinary citizens are turning to a slew of sometimes pricey new COVID-19 blood tests. Knowing whos already been infected could have important implications for understanding the spread of the disease, scientists say. But serious questions about the accuracy of some of the serology tests and the usefulness of the results they provide have prompted the federal Food and Drug Administration to try to rein in what several infectious disease experts described as the wild, wild West of antibody testing.

It does look as if companies sprang up overnight both importing these tests and distributing them, said Dr. Michael Busch, director of the nonprofit Vitalant Research Institute in San Francisco. Its outrageous that people were trying to make money off of this fear.

More than 200 tests have flooded the market in a matter of weeks, promising to detect antibodies, which are proteins that develop in the blood as part of the bodys immune response to an invading virus. These are different from the molecular tests, typically done with nasal swabs, used to diagnose infection.

As of June 1, only 15 antibody tests had received FDA emergency-use authorizations, which allow tests that havent been fully vetted to be used in a crisis. Even that standard has become a selling point for some large companies, such as LabCorp and Quest Diagnostics, which emphasize that they rely on tests that have received the FDA nod.

In late May, the FDA removed more than 30 serology tests from a list of commercially available kits, saying they should not be distributed for sale. Removal could result from a manufacturer not submitting an emergency-use authorization request within a reasonable period of time, or if the test shows significant problems that cannot be or have not been addressed in a timely manner, the agency said. The manner of enforcement remains unclear.

Last month, the CDC issued new guidelines warning that, given the low prevalence of the virus in the general population, even the most accurate tests could be wrong half of the time.

Serologic test results should not be used to make decisions about grouping persons residing in or being admitted to congregate settings, such as schools, dormitories, or correctional facilities, the guidelines state. Serologic test results should not be used to make decisions about returning persons to the workplace.

Such tests are most useful for understanding the epidemiology of the virus, not for making individual decisions, said Dr. Mary Hayden, director of the division of clinical microbiology at Rush Medical Laboratories in Chicago. Even the best tests cant yet answer the crucial question about whether antibodies confer immunity from future COVID-19 infections, Hayden said.

The best possible scenario is that people get infected and they have protective immunity for a long time, she said. That would be awesome. But we just dont have that right now.

But a plethora of tests being pitched to consumers explicitly promise results aimed at allowing a return to work, school and other social arenas.

The tests offered by Because Health are among hundreds churned out since March, ranging from those offered by commercial labs and academic research centers to small developers seeking a toehold in the lucrative market spurred by a global pandemic. Because Health is using two antibody tests in tandem, one of which received emergency-use authorization on May 29; the other is still pending.

Anders Boman, the son of the medical director and co-founder of Because Health, said that until the COVID-19 crisis occurred, the company, which launched in Seattle last year, was focused on a niche of integrative care and sexual health, including hormone treatments for men and women.

Consumers are not concerned about sexual health right now, Boman said, explaining the change in focus. Theyre concerned about how to get back to work, how to return to normal and are they safe?

The FDA normally follows a stringent approval process for tests to detect diseases, often a costly effort that can take months or years. That typically requires independent validation of the accuracy of the tests. But after being criticized for the fumbled rollout of diagnostic tests during the start of a global pandemic, the FDA swung hard in the other direction, waiving its usual requirements and letting firms rush self-validated tests into the market.

They sort of relaxed all regulatory oversight, Hayden said.

Several experts interviewed by Kaiser Health News said the FDA faced tremendous political pressure to make antibody tests available.

It was really a single pressure and that was the fact that the original inability to get a (diagnostic) test on the market in the U.S. as the outbreak escalated means they were trying to do basically everything they could to get these out, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

The relaxed rules drew concern from Congress, where a subcommittee of the Committee on Oversight and Reform detailed the FDAs failure to police the test market. Groups such as the Association of Public Health Laboratories also raised questions. Scott Becker, the APHLs chief executive, said he spoke to top officials at the U.S. Department of Health and Human Services in early April.

We just let loose and we said, This is a really bad policy, Becker said. Were going to get flooded and were going to lose control of quality. Were not going to know what to do with the results.

Thats exactly what has happened, said Osterholm. The FDA needs to bring much more discipline to this area and they need to articulate it clearly, he said.

A key issue is the accuracy of the tests, which rely on measures known as sensitivity and specificity. A highly sensitive test will capture all true positive results. A highly specific test would identify all true negative results.

In April, researchers at the University of California-San Francisco, led by immunologist Dr. Alexander Marson, analyzed 14 COVID-19 serology tests on the market and found that all but one turned up false-positive results, indicating that someone had antibodies to the coronavirus when they actually did not. False-positive rates reached as high as 16% in the study, which has not yet been peer-reviewed.

Unreliable results worry Dr. Jeff Duchin, the public health officer for Seattle and King County, Washington, where the first surge of COVID-19 cases emerged in the U.S. A person who tests positive for antibodies that dont exist may mistakenly believe he or she is free to ignore guidance about preventing infection, potentially spreading the disease. Regardless of whether you test positive or negative, the workplace still needs to take steps, he said. They shouldnt think a testing program in any way relieves them of that responsibility.

FDA officials said theyre working now with the National Cancer Institute to independently validate serology tests on the market. Until that list is public, users must rely on the relatively few that have received the emergency-use authorizations to date. More than 190 others have asked for that authorization, pending FDA review.

But consumers may have little control, because they are most likely getting tests from their employers or doctors, with little understanding of why those products were chosen.

There isnt a national standard, there isnt a one-stop shop or a Consumer Reports for antibody tests, Becker said. I dont expect a member of the public is going to be able to figure this out.

Even savvy physicians can have trouble. US Acute Care Solutions, a physician-owned medical services group, was trying out a Chinese-made test supplied by Minneapolis-based Premier Biotech, with plans to test its staff of more than 3,500 doctors and employees, said the groups chief medical officer, Dr. Amer Aldeen. That test has been widely used, including in recent controversial serology surveys conducted by Stanford University and the University of Southern California.

When USACS used it, the Premier test failed to detect antibodies in several employees who had been ill and tested positive for the coronavirus on diagnostic tests, Aldeen said. The results could have been caused by faulty instructions rather than flaws in the test itself, he said. Still, the Premier test has not received FDA authorization and the results gave him pause.

It does no good to select a test that isnt FDA-approved, he said.

In a statement, Premier Biotech officials said they anticipate exceeding FDA standards, which call for tests that are at least 90% accurate in identifying positive antibodies in a sample and 95% accurate in identifying samples that contain no antibody.

(EDITORS: STORY CAN END HERE)

Some might ask why the FDA didnt just identify several reliable antibody tests and require their use to avoid the chaos. An FDA official said making that type of choice would be outside the scope of the agencys responsibilities.

FDAs lane is to review these tests and make sure that they are safe and accurate for the American people, said spokesperson Emma Spaulding. It wouldnt be within our lane to say which test must be used.

Although health officials understand the desire for a test that could provide comfort amid the uncertainty of COVID-19, Duchin advised employers and consumers to wait a little longer.

There are costs to testing with unvalidated tests that might outweigh the benefits of satisfying your curiosity, he said.

(Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.)

2020 Kaiser Health News

Visit Kaiser Health News at http://www.khn.org

Distributed by Tribune Content Agency, LLC.

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Hype collides with science as FDA tries to rein in 'wild west' of COVID-19 blood tests - yoursun.com

Recommendation and review posted by Bethany Smith

Jordan is a middle-income country with an estimated total population of 10 million, the majority of them are the younger generation, and only 3.7% are 65years or older [15]. However, given the changing demographics and health care, this group is expanding rapidly.

Age is an important risk factor for breast cancer. However, data on whether patients age at diagnosis is also related to breast cancer treatment outcomes and survival in our region is lacking. Life expectancy for Jordanian females is significantly lower compared to Western societies [16].

Our data presented in this paper shows that chemotherapy and surgery were not aggressively used to treat a significant proportion of our patients, especially those with metastatic disease. Less than two-thirds of those with non-metastatic disease and only 14% of those with metastatic disease received chemotherapy. Similarly, surgical interventions were less aggressive. Less than a third had BCS while sLN biopsy was performed on 38.0% and axillary dissection was performed less often than younger patients [17]. Though breast reconstructive surgery is not commonly performed in our region, less than 5% of our older patients included in this study had it.

Avoidance of both surgery and chemotherapy in this age group was also reported in Western literature [18]. Hormonal therapy use as the sole therapy for breast cancer increases with age. One study at UK hospitals showed an increase from 2.8% in patients aged 6569years to 40.3% among patients aged 70years or older [19]. Furthermore, it has been shown in previous studies that older women are less likely to receive adjuvant radiotherapy [4, 20, 21].

Variation in the rate of surgery for breast cancer persists even in the same hospital. In one study that utilized data on over 17,000 women aged 70years or more with ER-positive operable breast cancer from two UK regional cancer registries demonstrated considerable variation in rates of surgery. Despite adjusting for case-mix, this variation persisted at the hospital level [10]. Utilizing the Charlsons Index of co-morbidity, Giordano and colleagues reported that among women aged 75years or older treated for breast cancer with clinical stage I-IIIa, the odds of having surgery in accordance with the guidelines were 0.32 (95% confidence interval (CI) 0.20 to 0.51) times lower than those of 5564-year-old [22].

Because treatment decisions for such older patients are based mostly on age rather than health status or potential benefit, objective tools that assess the fitness and functional status of older patients for the planned cancer treatment is highly needed [23, 24]. A study from Sweden that included 4453 women diagnosed with breast cancer in Malm University Hospital between 1961 and 1991 looked at the effect of age on breast cancer-specific mortality. When adjusted for potential confounders, including stage at diagnosis, age was a significant factor only for patients aged 80years or more [25].

Based on women diagnosed with breast cancer between 2008 and 2014, the 5-year OS rate, published by the American Cancer Society, based on SEER (Surveillance, Epidemiology, and End Results)-database, for patients with stage IV disease is 27% [26]. This number had increased from 22% in 2012 [27]. The SEER database, however, does not group cancers by the American Joint Committee on Cancer (AJCC) TNM stages, instead, it groups cancers into localized, regional, and distant stages. The 5-year OS rates for patients with regional disease is 85%. Our survival rates are a little lower. However, the two populations are not comparable. Several of the known poor prognostic pathological features, like positive axillary lymph nodes and high-grade tumors are more prevalent in our patient population compared to what was reported in Western literature. The prevalence of comorbidities among our population, in general, is high enough to explain our lower life expectancy and this obviously affect the aggressiveness of anticancer therapy for this population and may be another factor to explain this difference in OS.

Our study is not without limitations. This is a retrospective study with limited data on potentially important factors like performance status, detailed comorbidities and social support. Though our study is a single-institution one, our center treats over two-thirds of all breast cancer patients in the country.

Original post:
Tumor characteristics and treatment outcomes of older patients with breast cancer in Jordan - BMC Blogs Network

Recommendation and review posted by Bethany Smith

Tomorrow, the first Saturday in June, is National Health and Fitness Day, confirmed by statute, proclaimed by 500 cities, and replete with important implications for all Canadians.

Beyond the current pandemic, were concerned about a different epidemic, one that began decades ago, has continued to spread, and is particularly harmful during self-isolation.

Were talking about the epidemic of sedentary behaviour.

Trends of sedentary behaviour, obesity, cardiovascular disease, and mental illness have worsened, and consequent sickness care costs have steadily climbed.

According to ParticipAction, Canada ranks poorly against other nations: out of 49 countries, were 12th in physical activity, 24th in sedentary behaviour, and 45th in active transportation. Ninety per cent of our children fail to get enough daily physical activity. Over 72 per cent of our children are staring at screens more than two hours daily. Urbanization has made children less active in the outdoors. Since 1979, the percentage of our children who are overweight or obese has tripled to approximately one in three. Canadians are experiencing increasing levels of anxiety and depression. The Public Health Agency of Canada estimates that obesity costs Canadian taxpayers up to $7 billion annually.

Significant evidence demonstrates that physical activity enhances self-confidence, peace of mind, relationships, workplace productivity, academic performance and overall wellbeing. It is proven to prevent and treat mental illness, diabetes, cancer and cardiovascular disease. Being active in nature improves sleep, mental health, blood pressure and stress hormone levels.

If you have COVID-19 symptoms, have in recent days travelled internationally, or have been exposed to someone with COVID-19, follow the health authorities instructions to self-quarantine. Our words here are for Canadians who dont fit in those literally-stay-at-home categories. For people outside those categories, COVID has brought confusion about what levels of exercise are safe. Governments need a unified message that safe physical activity and outdoor recreation are critical to overall health and fitness.

We must exercise to keep up our immune systems, especially during a pandemic. We need exercise for physical, mental, and spiritual health, says Dr. Jack Taunton, one of the founders of sports medicine in Canada and our countrys top physician in the 2010 Olympic and Paralympic Games.

Heightened physical activity routines and increased participation in recreation, sport and fitness activities will increase our quality of life and community health. A more active Canada is a Canada on the journey of transformative cultural change, modelled by our community, political, and corporate leaders and reinforced by government policy.

Tomorrow, National Health and Fitness Day, is an opportunity to re-evaluate our personal activity routines. This June 6, lets exercise active citizenship. Lets size up how to exercise safely, for our health, and the health of our fellow Canadians. And, for good measure, invite a friend to do the same!

Together, as we say at The National Health and Fitness Foundation and the National Health and Fitness Institute, lets make Canada the fittest nation on Earth.

John Weston is the volunteer president of the National Health and Fitness Institute. He practises law at Pan Pacific Law Corporation and served 2008-2015 as a member of parliament; Pierre Lafontaine, former head of Canadas Olympic swim team, is a consultant at Lafontaine Sports Consulting. He is the volunteer president of the National Health and Fitness Foundation.

Originally posted here:
Pierre Lafontaine and John Weston: The case for exercise even during the pandemic - The Province

Recommendation and review posted by Bethany Smith

CARLSBAD, Calif., June 2, 2020 /PRNewswire/ --Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (Qualigen or the Company) announced today that the Company has released a pre-launch supply of its proposed FastPackSARS-CoV-2 IgG Immunoassay diagnostic test kits to the University of Louisville to conduct validation studies with hundreds of patient samples, as well as for use in research on COVID-19. SARS-CoV-2 is the virus that causes COVID-19.

Qualigen's SARS-CoV-2 IgG immunoassay, for use with its new FastPack PRO System point-of-care diagnostic instruments, is a chemiluminescent microparticle test intended for the qualitative detection (i.e., yes/no) of the presence of SARS-CoV-2 IgG antibodies in blood. The FastPack PRO System is an upgraded version of Qualigen's flagship FastPack IP rapid immunoassay diagnostic point-of-care system.

"This is an important step in the evolution of SARS-CoV-2 antibody testing, given the high number of inaccurate tests in the marketplace," said Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen. "Reliable, accurate and rapid testing for the presence of antibodies is critical to understanding who may have been infected with SARS-CoV-2 and who could potentially have an immune response to re-infection."

Mr. Poirier continued, "Since its founding in my basement in Minnesota over 20 years ago, Qualigen has been continuously advancing this sophisticated rapid diagnostic technology, which is now used in physician offices, clinics and small hospital worldwide. I believe Qualigen is well suited to bring to market diagnostic systems that can improve our understanding and tracking of this disease as we strive to open up the U.S. economy."

Kenneth Palmer, PhD, Director of the University of Louisville Center for Predictive Medicine for Biodefense and Emerging Infectious Diseases (CPM), and his research team will be conducting analytical validation studies on the FastPackSARS-CoV-2 IgG Immunoassay to provide Qualigen with validation data to submit to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization. The University of Louisville's CPM is one of only 12 infectious disease biocontainment facilities in the United States and is on the forefront of COVID-19 and infectious disease research.

"The ability to obtain rapid, accurate SARS-CoV-2 antibody data at the point of care for timely assessment of a patient's status is vital to the next phase of this pandemic. We are excited to be working with Qualigen on this important project," added Dr. Palmer.

About the FastPack SystemThe FastPack System is a rapid and highly accurate immunoassay testing system consisting of the FastPack Analyzer and the FastPack test pouch (a single-use, disposable, foil packet that includes the FastPack reagent chemistry). This "Laboratory in a Pouch" is installed in physician offices, clinics and small hospitals around the world, and quickly detects diseases and medical conditions at the point-of-care. Since the conception of the system, the Company has expanded its assay menu to 10 tests including tests for prostate cancer, thyroid function, metabolic disorders and research applications. Over the past 20 years, FastPack has generated more than $100 million in commercial sales. Qualigen's worldwide distributor for FastPack is Sekisui Diagnostics, LLC, a subsidiary of a multibillion-dollar Japanese chemical and technology company.

About Qualigen Therapeutics, Inc.Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack System, which has been used successfully in diagnostics for almost 20 years. The FastPack menu includes tests for cancer, men's health, hormone function and vitamin D status. The Company's cancer therapeutics pipeline includes ALAN (AS1411-GNP), RAS-F3 and STARS. ALAN (AS1411-GNP) is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer with minimal side effects. The foundational aptamer of ALAN, AS1411, is also being studied for use in treating viral-based infectious diseases. RAS-F3 is a small molecule RAS oncogene protein-protein inhibitor for blocking RAS mutations that lead to tumor formation, especially in pancreatic, colorectal and lung cancers. STARS is a DNA/RNA-based treatment device for removal from circulating blood of precisely targeted tumor-produced and viral compounds. Qualigen's facility in Carlsbad, California is FDA and ISO Certified and its FastPack product line is sold worldwide by its commercial partner Sekisui Diagnostics, LLC. For more information on Qualigen Therapeutics, Inc. or to order FastPack diagnostic products, please visit https://www.qualigeninc.com/.

Story continues

Forward-Looking StatementsThis news release contains forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include those related to potential future development, testing and launch of product candidates. Actual events or results may differ from our expectations. For example, there can be no assurance that the validation studies for the proposed FastPackSARS-CoV-2 IgG Immunoassay diagnostic test kits will be timely conducted or will provide favorable validation data; that any request to the FDA for Emergency Use Authorization will be granted; that the Company will be able to manufacture the FastPack Pro System instruments and test kits successfully; that any commercialization of the FastPack Pro System instruments and test kits will be profitable; that the Company will successfully develop any drugs or therapeutic devices; that preclinical or clinical development will be successful; that future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs or therapeutic devices will receive required regulatory approvals or that they will be commercially successful; that we will be able to procure or earn sufficient working capital to complete the development, testing and launch of our prospective therapeutic products; or that we will be able to maintain or expand market demand and/or market share for our diagnostic products. Our stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business (including events beyond the Company's control, such as epidemics and resulting changes) can be found in the Company's prior filings with the Securities and Exchange Commission, available at http://www.sec.gov. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

View original content:http://www.prnewswire.com/news-releases/qualigen-therapeutics-releases-fastpack-sars-cov-2-antibody-diagnostic-test-to-university-of-louisville-to-conduct-validation-studies-301069009.html

SOURCE Qualigen, Inc.

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Qualigen Therapeutics Releases FastPack SARS-CoV-2 Antibody Diagnostic Test to University of Louisville to Conduct Validation Studies - Yahoo Finance

Recommendation and review posted by Bethany Smith

SAN DIEGO, June 05, 2020 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) announced today that Eef Schimmelpennink, President and Chief Executive Officer, will participate in a fire side chat at the William Blair Growth Stock Conference on June 9, 2020. The discussion will be virtual and accessible at http://www.wsw.com/webcast/blair56/pfnx.

Interested parties can access the live audio webcast and archive from the Investors Section of Pfenex's website at http://www.pfenex.com.

About Pfenex Inc.Pfenex is a development and licensing biotechnology company focused on leveraging its Pfenex Expression Technology to develop and improve protein therapies for unmet patient needs. Using the patented Pfenex Expression Technology platform, Pfenex has created an advanced pipeline of potential therapeutic equivalents, and vaccines. Pfenexs lead product candidate is PF708, a therapeutic equivalent candidate to Forteo (teriparatide injection). PF708 has been approved in the U.S. for the treatment of osteoporosis in certain patients at high risk for fracture, and marketing authorization applications are pending in other jurisdictions. In addition, Pfenex is developing hematology/oncology products in collaboration with Jazz Pharmaceuticals, including PF743, a recombinant crisantaspase, and PF745, a recombinant crisantaspase with half-life extension technology. Pfenex also uses its Pfenex Expression Technology platform to produce CRM197, a diphtheria toxoid carrier protein used in prophylactic and therapeutic vaccines.

Pfenex investors and others should note that Pfenex announces material information to the public about Pfenex through a variety of means, including its website (http://www.pfenex.com/), its investor relations website (http://pfenex.investorroom.com/), press releases, SEC filings, public conference calls, corporate Twitter account (https://twitter.com/pfenex), Facebook page (https://www.facebook.com/Pfenex-Inc-105908276167776/timeline/), and LinkedIn page (https://www.linkedin.com/company/pfenex-inc) in order to achieve broad, non-exclusionary distribution of information to the public and to comply with its disclosure obligations under Regulation FD. Pfenex encourages its investors and others to monitor and review the information Pfenex makes public in these locations as such information could be deemed to be material information. Please note that this list may be updated from time to time.

Company Contact:investorrelations@pfenex.com

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Pfenex to Participate in the William Blair Growth Stock Conference - GlobeNewswire

Recommendation and review posted by Bethany Smith

Enel Green Power has announced that it has been awarded 68 MW of new renewable capacity for two wind projects and 38.3 MW of nominal capacity deriving from the repowering of already-operational hydro plants in the second renewable auction launched by the state-owned energy service company GSE (Gestore Servizi Energetici) in Italy.

Specifically, the company participated in the 500 MW tender for new wind and solar projects and the 98.5 MW tender for renovations of renewable plants with a capacity exceeding 1 MW.

Regarding the new capacity, the two wind farms are located in Campania and Basilicata. The upgrading and useful life extension concern the three hydro plants already operating in the municipalities of Castiglione dei Pepoli (Bologna), Civitella in Val di Chiana (Arezzo) and Montecreto (Modena).

With this second award we confirm the commitment to invest in new renewable capacity in Italy, contributing to the challenging decarbonisation objectives of the Enel Group and the country,saidAntonio Cammisecra, CEO of Enel Green Power and Head of the Global Power Generation business line. Thanks to our development strategy, in 2019 the Groups installed capacity from renewables exceeded that from thermal sources globally, marking a further step forward towards the progressive replacement of fossil fuels with zero-emission ones.

The firm has stated that the construction of new capacity and the upgrading of existing plants in Italy are part of the wider commitment of the Enel Group to the growth of renewables and to decarbonisation which in our country foresees, in the 2020-2022 period, the development of new renewable capacity for around 700 MW and for which EGP has developed a pipeline of approximately 1.3 GW of opportunities that can start operating in the same period.

In the second auction conducted by GSE, wind won 406 MW of the 425 MW awarded in an undersubscribed auction 500 MW was on offer.

The primary reason for the undersubscription is Italys cumbersome and lengthy permitting process, stated WindEurope. Besides the challenges with permitting, the auction was also undersubscribed because repowering projects were not allowed to bid. This is significant. Italy has huge repowering potential: almost half of Italys installed wind fleet (10 GW) will reach the end of its operational life by 2030. The fact that repowering projects could not bid in the auction makes no sense.

Onshore wind accounted for the entire 406 MW of the 425 MW awarded in the most recent auction. The price range was from EUR 56/MWh to EUR 68.4/MWh. The weighted average was EUR 64.6/MWh.

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Enel Awarded 106.3 MW in Italy in GSE's Second Auction - Saurenergy

Recommendation and review posted by Bethany Smith

The Cracow Gold Mine is on track to produce 82,500 87,500 ounces of gold in the 2020 financial year and generate net mine cash flow of $84 to $89 million.

() has entered into a binding agreement with () to acquire the Cracow Gold Mine in Queensland.

Cracow is an established, high grade, low-cost underground gold mining operation and processing facility operating continuously since 2004, producing more than 1.4 million ounces over its life, with a consistent track record of profitability and reserve replacement.

The mine is on track to produce 82,500 87,500 ounces of gold in the 2020 financial year and generate net mine cash flow of $84 to $89 million.

Aeris has agreed to pay Evolution $60 million in cash upon closing of the transaction, a deferred payment of $15 million on June 30, 2022 plus a 10% net value royalty from July 1, 2022 to June 30, 2027, capped at $50 million.

Completion of the transaction is expected to occur on June 30, 2020.

Aeris executive chairman Andre Labuschagne said: This is a truly transformational transaction for Aeris and will be immediately accretive in value.

The acquisition provides us with asset and commodity diversity, strong cashflow generation and high value synergies.

Cracow will be a perfect fit for the unique skill set of our management team, who have a track record of extracting value and life extensions, as demonstrated at the Tritton mine, and previously with Norton Gold Fields at the Paddington gold mine. Our immediate focus will be on transitioning Cracow into the Aeris culture and aggressively investing in the mine life extension opportunities we have identified.

Labuschagne added: Aeris inherits a well-run, proven operation which has been a consistent performer for Evolution.

Importantly for us, there is a strong operating team in place that has a culture of continuous improvement.

We are confident that Cracow management and the workforce will fit well with Aeris own culture and the renewed focus to reinvesting in mine life extensions which Aeris will bring.

Aeris intends to fund the transaction through a fully underwritten $40 million equity raising and a $30 million acquisition bridge debt facility.

A new $15 million guarantee facility has also been secured to provide for the replacement of financial assurances relating to the mine and will be provided by SPOV (Special Portfolio Opportunity V), a subsidiary of a fund managed by PAG.

The equity raising will be conducted via a fully underwritten institutional placement and an underwritten 2.02 for 1 pro-rata accelerated renounceable entitlement offer.

Aeris has already secured commitments from its three largest shareholders, representing about 60% of the register to commit to participating in the equity raising, subject to a maximum holding of 19.99% at completion.

The Cracow Gold Mine is about 500 kilometres north-west of Brisbane in a highly endowed goldfield with gold mineralisation hosted in steeply dipping structurally controlled low sulphidation epithermal veins.

The underground mine is accessed through a single surface decline with ore primarily mined via open stoping through a modified Avoca mining sequence.

Cracow has a strong track record of reserve and resource replacement and Aeris plans to aggressively invest in brownfield and greenfield exploration with the aim of growing the resource base to extend mine life.

Multiple near term opportunities for resource conversion have been identified with about $13 million budgeted over the next two years for exploration, with key priorities including both underground near-mine extensions (e.g. Killarney) as well as nearby open-pit deposits (e.g. the Golden Plateau and Roses Pride).

Extracting value through integration efficiencies will also be a key driver of Aeris immediate plan with about $4 million of targeted annual cost synergies as well as the potential for utilising Aeris existing carried forward tax losses ($256 million at June 30, 2019).

Over the two year period to June 30, 2022, Aeris expects Cracow to generate more than $100 million of net mine cash flows at the current gold price, with pro forma Aeris group EBITDA of $272 million to $282 million and pro forma group net mine cash flows of $137 million to $155 million.

This significant cashflow will provide for both investment in life of mine extension projects at Cracow and Tritton as well as to also continue deleveraging Aeris balance sheet.

To protect the very significant near term positive cashflows from Cracow, Aeris intends to enter a prudent gold hedging program, with an initial focus on the first 12 months.

See more here:
Aeris Resources to acquire producing gold mine from Evolution in transformational move - Proactive Investors Australia

Recommendation and review posted by Bethany Smith

A new study by researchers at Tulane University, located in the city of New Orleans, United States, revealed the discovery of the gene behind the most aggressive form of breast cancer, as well as how to disable it to curb tumor growth and cancer spread.

We also recommend: High-performance cancer vaccine developed in China

The report published in the Scientific Report of the journal Nature, explains that the research focused on triple negative breast cancer (TNBC), the most aggressive form of this type of cancer. It is a difficult disease to treat and where the chances of survival are lower than in other types of this cancer.

The researchers looked at the role two specific genes play in TNBC called Rab27a and TRAF31P2. Subsequently, they suppressed these two genes causing them to stop working and found positive impacts in the fight against breast cancer.

Doctor Reza Izadpanah, team leader, explains:

Our findings show that both genes play a role in the growth and metastasis of breast cancer. Although the Rab27a target slows the progression of tumor growth, it does not affect the spread of small numbers of cancer cells or micrometastases. Conversely, attacking TRAF3IP2 suppresses tumor growth and spread, and interfering with it reduces preformed tumors and prevents further spread. This exciting discovery has revealed that TRAF3IP2 may play a role as a novel therapeutic target in the treatment of breast cancer.

And it is that the scientists of the University of Tulane discovered that when they turned off the TRAF3IP2 gene, the metastasis of the cancer, that is, its spread, did not take place for a full year after treatment. Furthermore, deletion of this gene was also related to stagnant tumor growth and shrinking the tumor to undetectable levels.

So far, these positive effects have been seen in animals, meaning that gene deletion therapy has yet to be tested in humans. However, Izadpanah and his team are quite positive about it and have already turned to the FDA. to speed up the path and be able to carry out clinical trials.

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They discover how to stop tumor growth in breast cancer - Explica

Recommendation and review posted by Bethany Smith

Human chorionic gonadotropin (hCG) hails from the group of gonadotropin hormones and is normally created by the placenta. hCG hormone plays a vital job after the development of the incipient organism, and thus has increased huge footing throughout the years for the treatment of fruitlessness in men and women.

Sample Link Here: https://www.globalinforeports.com/request-sample/1070128

Ascend in the incidence of male hypogonadism among the aged populace is the key factor driving the market development. Likewise, increment in footing picked up by hCG among social insurance experts and patients would enhance the market development. Nonetheless, alerts and admonitions gave by the FDA relating to the symptoms of hCG treatment is anticipated to hamper the market development.

North America was the significant revenue generator in 2017 and is foreseen to keep up its predominance all through the conjecture time frame. This is ascribed to noteworthy increment in occurrence of infertility related issues both in females and male.

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Rising infertility related issues are boosting the growth of the Human Chorionic Gonadotropin (HCG) Market - Day Web Chronicle

Recommendation and review posted by Bethany Smith

Global 3D Cardiac Mapping Systems Market: Overview

Cardiac mapping is a special type of technique which helps in gathering and displaying the information from cardiac electrograms. Such technique is mainly used in the diagnosis of heart rhythms. Therefore, cardiac mapping technique has gained immense popularity in case of arrhythmia. The cardiac mapping procedure involves the percutaneous insertion of catheter into the heart chamber and recording the cardiac electrograms sequentially. Such procedure helps in correlating the cardiac anatomy with the electrograms. The latest 3D cardiac mapping systems provide the three dimensional model of hearts chamber, which further helps in tracking the exact location of the catheter. Such advantages are majorly driving the global 3D cardiac mapping systems market.

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From the perspective of technology, the global 3D cardiac mapping systems market is segmented into basket catheter mapping, electroanatomical mapping, and real-time positional management (Cardiac pathways) EP system. Among these segments, electroanatomical mapping segment accounts for the maximum share in the global 3D cardiac mapping systems market. This mapping are extensively used in several healthcare industry due to its potential in increasing the safety, accuracy, and efficiency of catheter. A research report by TMR Research (TMR) thoroughly explains the new growth opportunities in the global 3D cardiac mapping systems market. Additionally, the report also provides a comprehensive analysis of the markets competitive landscape.

Global 3D Cardiac Mapping Systems Market: Notable Developments

Some of the recent developments are contouring the shape of the global 3D cardiac mapping systems market in a big way:

Key players operating in the global 3D cardiac mapping systems market include BioScience Webster, Boston Scientific Corporation, and Abbott.

Global 3D Cardiac Mapping Systems Market: Key Growth Drivers

Rising Number of Patients with Cardiac Disorders and Arrhythmia Fillips Market

The global 3D cardiac mapping systems market has grown steadily over the years, owing to the convenience it provides to the patients with heart problem. Growing number of people with cardiovascular diseases and rising cases of arrhythmia are the major factors fueling growth in the global 3D cardiac mapping systems market. Along with this, increasing pressure for reducing diagnosis errors and rapidly rising healthcare expenditure are also responsible for boosting the global 3D cardiac mapping systems market. However, above all such factors, the global 3D cardiac mapping systems market is majorly fueled by the accuracy and patient safety provided through real-time monitoring. Such 3D cardiac mapping systems are mainly designed to improve the resolution. This system also helps in gaining prompt of cardiac activation maps. All such advantages are also providing impetus to the growth of the global 3D cardiac mapping systems market.

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Furthermore, rising ageing population who are prone to heart-attack and several chronic heart disorders and increasing diagnosis rate of cardiac illness are the factors stoking demand in the global 3D cardiac mapping systems market. Moreover, this 3D cardiac mapping helps in reducing the diagnosis time. Such factor is also contributing to the growth of the global 3D cardiac mapping systems market.

Global 3D Cardiac Mapping Systems Market: Regional Outlook

On the regional front, North America is leading the global 3D cardiac mapping systems market as the region has seen rapid growth in healthcare industry. Along with this, increasing prevalence of heart attacks, rising healthcare expenditure, and burgeoning population is also responsible for fueling growth in the 3D cardiac mapping systems market in this region.

About TMR Research:

TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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3D Cardiac Mapping Systems Market Segmentation Analysis and Global Industry Trends Forecast 2028 - Cole of Duty

Recommendation and review posted by Bethany Smith

An inflammatory environment can turn astrocytes, key supportive cells for neurons, into their killers, fostering the progression of neurodegenerative diseases like multiple sclerosis (MS), a new study shows.

This work, led by researchers at the New York Stem Cell Foundation(NYSCF), created for a first time astrocytes derived from human induced pluripotent stem cells (hIPSCs). The group then placed these cells in an inflammatory environment, and observed what happened.

Now that we can create this critical brain cell type from any individuals stem cells and capture its errant behaviors, we can better understand its role in diseases like multiple sclerosis, Parkinsons, and Alzheimers, Susan L. Solomon, the CEO of theNYSCF, said in a press release.

This will shed new light on the devastating process of neurodegeneration, pointing us towards effective treatments for this growing group of patients, Solomon added.

The study CD49f Is a Novel Marker of Functional and Reactive Human iPSC-Derived Astrocytes was published in the journal Neuron.

Astrocytes compose more than half of the cells of the central nervous system (brain and spinal cord), and work as support cells. They help to maintain brain homeostasis (stable equilibrium), provide neurons with metabolic support, enhance the connectivity of neural circuits, and control the brains blood flow.

Yet, these cells are also thought to be key players in the onset and progression of neurodegenerative diseases such as MS.

Knowledge on astrocyte biology has mostly come from animal models, namely rodents, since scientists struggle to obtain astrocytes from people.

NYSCF researchers developed a method to generate functional astrocytes that are derived from human IPSCs. (IPSCs themselves arederived from either skin or blood cells that have been reprogrammed back into a stem cell-like state, which allows for the development of an unlimited source of almost any type of human cell.)

They based their work on a previous protocol, which they developed to produce oligodendrocytes one type of cell capable of producing myelin, the protective layer covering nerve fibers and whose loss triggers MS.

Here, the researchers generated a mix of astrocytes and neurons.

They then conducted a screen to identify a surface protein that could be used to specifically purify astrocytes.

The marker CD49f was found to distinguish astrocytes from neuronal progenitors and neurons. At the genetic level, cells isolated using this marker showed activity of genes characteristic of both mature and immature astrocytes. However, when researchers looked at individual cells, they saw that CD49f was more enriched in mature astrocytes.

The hIPSCs-derived astrocytes expressing CD49f helped in neuronal growth, neural communication, provided metabolism support including glutamate uptake, and secreted molecules (called cytokines) in response to inflammation triggers.

We were excited to see that our stem-cell-derived astrocytes isolated with CD49f behaved the way typical astrocytes do: they take up glutamate, respond to inflammation, engage in phagocytosis which is like cell eating and encourage mature firing patterns and connections in neurons, said Valentina Fossati, PhD,the studys lead author.

CD49f expression was found to be specific for astrocytes in samples from both healthy and diseased human brains.

We looked at human brain tissue samples from both a healthy donor and a patient with Alzheimers disease and found that these astrocytes also expressed CD49f suggesting that this protein is a reliable indicator of astrocyte identity in both health and disease, Fossati added.

Researchers next focused on addressing the question of how astrocytes misbehave in disease.

They stimulated hIPSCs-derived cells with interleukin (IL)-1b and TNF-a, two molecules known to trigger the transition of astrocytes into a neurotoxic state (called A1 reactive astrocytes) in animal models. Cells reacted by secreting pro-inflammatory cytokines, including IL-6, IL-1 alpha, and ICAM-1.

Theseastrocytes lost their capacity to uptake (absorb) glutamate, a metabolite that is toxic to neurons. They also changed their morphology, becoming constricted instead of spreading out with long arms.

To assess whether reactive A1 astrocytes would damage neurons, the team grew neurons with stimulated and unstimulated astrocytes, or treated neurons with molecules produced by astrocytes.

Astrocytes in a reactive state were seen to decrease the electric activity of neurons and to increase their apoptosis a programmed process of cell death thats a form of suicide.

These findingsdemonstrate the specific neurotoxicity of A1 hiPSC-derivedastrocytes, the researchers wrote.

They also confirmprevious work in mice, where researchers observed that inflammation turns astrocytes neurotoxic. This work was led by Shane Liddelow, PhD, an assistant professor at the NYU Grossman School of Medicine and an author of the current study.

We observed in mice that astrocytes in inflammatory environments take on a reactive state, actually attacking neurons rather than supporting them, Liddelow said.

The latest work, the researchers concluded, showed that CD49f is a reactivity-independent,astrocyte-specific cell surface antigen that is present at allstages of astrocyte development in hiPSC-derived cultures.

Astrocytes isolated with this marker recapitulatein vitrocriticalphysiological functions, they continued, and following inflammatory stimulationbecome reactive, dysfunctional, and toxic, triggering neuronaldeath all of which opens a window for the study of their role in neurodegenerative disorders.

What we saw in the dish confirmed what Dr. Liddelow saw in mice: the neurons began to die, Fossati said. Observing this rogue astrocyte phenomenon in a human model of disease suggests that it could be happening in actual patients.

She and the others now look forward to using our new system to further explore the intricacies of astrocyte function in Alzheimers, multiple sclerosis, Parkinsons, and other diseases, in the hope it will point us toward new treatment opportunities that might slowor prevent neurodegeneration.

Patricia holds her Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She also served as a PhD student research assistant in the Laboratory of Doctor David A. Fidock, Department of Microbiology & Immunology, Columbia University, New York.

Total Posts: 1,053

Patrcia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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Ability to 'Create' Astrocytes Supports Their Damaging Role in MS... - Multiple Sclerosis News Today

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MedicalResearch.com Interview with:

Charles-de-SM.D., Ph.D.Rio de Janeiro, Brazil

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

Response: Our clinical trial was based on our clinical skin observations in areas submitted to a lipotransfer previously, an ordinary practice in plastic surgery. These clinical observations lead us to investigate what will be the key element played in these findings. Our scientific support investigation addressed the Dardick1and Zuk, P2 studies, that demonstrated fibroblastic-like cells in adipose tissue with regenerative ability. Our clinical trial proposal is to investigate the adipose-derived stem cell (ADSC) role in the photoaged skin. The direct endpoint of the study was to assess the histological benefits provided by the subdermal ADSC injection. Mesenchymal stem cells were obtained from lipoaspirates, expanded in vitro, and introduced into the facial skin of 20 patients submitted after three to four months to a face-lifting surgery. In the retrieved skin, immunocytochemical and ultrastructural analysis quantified elastic matrix components, cathepsin-K, metalloprotease MMP-12, and the macrophage M2 markers: CD68, CD206 and heme-oxygenase-1.An overview of the trial steps is described in the infographic.

MedicalResearch.com: What are the main findings?

Response:A full de novo formation of oxytalan and elaunin fibers was observed in the subepidermal region, with a reconstitution of the papillary structure of the dermal-epidermal junction. Elastotic deposits in the deep dermis were substituted by a normal elastin fiber network. The coordinated removal of the pathologic deposits of old elastic fibers and their substitution by the normal ones was concomitant with activation of cathepsin-K and MPP12, and with expansion of the M2 macrophage infiltration.

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

Response: This study has demonstrated ADSC to remodeling the skin extra cellular matrix, mainly in the elastic system.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Based on these findings, the future of thisresearch line aims to create new possibilities in regenerative cell therapy not only in skin diseases, but also in other clinical applicability in the case of organs and tissues with reduction and / or alteration in the elastic system (ex: aneurysms, cardiac valve disease and others), with a better understanding of the mechanisms involved and the control of these processes.

MedicalResearch.com: Is there anything else you would like to add? Any disclosures?

Response: It is interesting to be able, in future studies, to evaluate other mechanisms involved and the duration of effects regenerative effects on skin treated with ADSC. Another question could be considered: optimized ADSC (quantity) / area with the tissue effect found. We have not any to disclosure. This study was developed by federal university of Rio de Janeiro-Brasil and Verona University-Italy

Citation:

Charles-de-S, Luiz M.D., Ph.D.; Gontijo-de-Amorim, Natale Ferreira M.D., Ph.D.; Rigotti, Gino M.D., Ph.D.; Sbarbati, Andrea M.D., Ph.D.; Bernardi, Paolo Ph.D.; Benati, Donatella Ph.D.; Bizon Vieira Carias, Rosana Ph.D.; Maeda Takiya, Christina M.D., Ph.D.; Borojevic, Radovan Ph.D. Photoaged Skin Therapy with Adipose-Derived Stem Cells, Plastic and Reconstructive Surgery: June 2020 Volume 145 Issue 6 p 1037e-1049e doi: 10.1097/PRS.0000000000006867

References:

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Photoaged Skin Therapy with Adipose-Derived Stem Cells - MedicalResearch.com

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For Australias balding community, letting your hair down is just an idiom.

But soon, it may be a reality.

In a breakthrough in the battle against baldness, researchers from the University of Pennsylvania have managed to grow skin that develops distinct layers, including hair follicles,from stem cells.

Scientists were already able to grow skin cells, but recreating the complex, multi-layered skin structure has been a major challenge.

As the largest human organ, the skin has multiple functions including temperature regulation and bodily fluid retention to the sensing of touch and pain that increases the difficulty of synthesising it, researchers say.

But over a four-to-five month period, researchers succeeded in growing complex skin cells and hair follicles, which were grafted onto mice.

More than half of the mice sprouted hair from the process.

Its a development that may also affect those with genetic skin disorders and cancers, as well as those with burns or wounds.

But those who are a little thin on the top shouldnt get excited too fast.

There are several major questions that remain before this approach can become a reality, researchers Leo Wang and George Cotsarelis say.

Several other aspects of the authors approach will also need to be optimised before it can move to the clinic.

The hairs that grew in the current study were small; in future, furtheroptimisation of culture conditions will be needed to form large scalp hairs.

However, the authors conclude: The work holds great promise of clinical translation we are confident that research will eventually see this promise realised.

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Eradicating balding a step closer with new procedure in the cross hairs - The New Daily

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