StemCell Therapy

ASF has been spreading rapidly, threatening pork production and human food security worldwide.

The study from the K-State research team, headed by Megan Niederwerder, assistant professor of diagnostic medicine and pathobiology in the College of Veterinary Medicine, was published in the journal Transboundary and Emerging Diseases.

The team said the paper provides the first evidence that feed additives may be effective tools against the virus, that chemical feed additives may potentially serve as mitigants for reducing the risk of ASFV introduction and transmission through feed.

"Over the last two years, ASF is estimated to be responsible for the death of at least 25% of the world's pig population due to the emergence of the virus within China and subsequent spread to over 10 other Asian countries," Niederwerder said.

"In 2019, we published the first report of African swine fever virus, or ASFV, transmission through the natural consumption of plant-based feed. Our subsequent work has focused on mitigation of ASFV in feed through the use of chemical feed additives and heat treatment, she added.

Niederwerder and her team examined two different classes of liquid feed additives, including a medium-chain fatty acid-based additive and a formaldehyde-based additive, for efficacy against ASF virus in cell culture and in feed ingredients. In general, the scientists observed that both chemical additives demonstrated evidence of reducing the virus infectivity, with data supporting dose-dependent efficacy.

The study lead said there are currently no commercially available vaccines and no effective treatments that can be administered to pigs for ameliorating disease caused by the virus. Thus, control of ASF is focused on biosecurity measures to prevent the introduction of the virus into negative countries or negative farms and regions within a positive country.

The other method of containment would involve large-scale culling of infected or high-risk animals to contain the spread of the virus.

"Our new research reports novel data evaluating the efficacy of feed additives on inactivating ASFV in an in vitro cell culture model and a feed ingredient transoceanic shipment model," Niederwerder said. "This will provide valuable information to the swine industry with regards to mitigating the risk of potential routes for introduction and transmission of ASFV through feed and ingredients."

The K-State study was funded by a grant from the Swine Health Information Center and the State of Kansas National Bio and Agro-defense Facility Fund.

While she said the results of the study are promising, Niederwerder emphasized the need for a multifaceted approach to reducing the risk of ASF virus in feed, including sourcing ingredients from countries without the virus when possible, applying holding times to high-risk ingredients, and implementing consistent biosecurity protocols at the feed mill.

Source:Transboundary and Emerging Diseases

DOI:https://doi.org/10.1111/tbed.13699

Title:Mitigating the risk of African swine fever virus in feed with antiviral chemical additives

Authors:MC. Niederwerder, S. Dee, DG Diel, A MM. Stoian LA Constance, M Olcha, V. Petrovan, G. Patterson, AG CinoOzuna, R RR Rowland

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Certain feed additives may be effective tools against African Swine Fever - FeedNavigator.com

Mike Teavee, played by Paris Themmen, was a bit younger and much rowdier than his other contest-winning peers. The 11-year-old cowboy-loving tween bounced around everyone else until he was "accidentally" trapped in a TV in the TV room of the factory and somehow stretched out to 10 feet tall (completely the Oompa Loompas' fault!).

After his charismatic role in Willy Wonka, Themmen had a brief career on Broadway as a teen in the late '60s and later became a theatre major at New York University. According to an archived version of his official website, he wanted to travel internationally following his graduation.

"I founded 'Access International,' a travel service sending backpackers standby on charter flights to Europe," he wrote. "During this time I visited 36 countries on 6 continents, (I'm up to 40 now!) everything from the Jungles of the Amazon to the Sahara Desert. You name it, I've been there."

His career path took multiple different paths, including real estate, film production, "a stint in Walt Disney Imagineering," retail, and more "entrepreneurial ventures." He honestly added, "As you can tell from my past, there is no telling what I may do next. (Direct?) In any case, I have lived a full and eminently satisfying life."

Themmen added a sentiment that all the living Willy Wonkaactors can likely relate to: "There is life after art."

Read more from the original source:
What the last living stars of Willy Wonka are up to now - Nicki Swift

Mr Cheng has paid tribute to Professor Ian McIntyre with his donation.

Mr Tong Fatt Cheng served in the state Veterinary service in Singapore and then joined the diplomatic service in 1989 as Singapore Ambassador to Japan then to the Peoples Republic of China and as Ambassador-at-Large until his retirement in 2004.

The generous gift by Mr Cheng, who graduated BVMS in 1957 from the University of Glasgow, will be used to establish the McIntyre International Research Fellowships which will foster international collaboration in research on farm animal diseases.

The Fellowships will provide funding for a British veterinary graduate to work overseas for two years and for an overseas veterinary graduate to come to the Glasgow Veterinary School for two years.

By establishing the McIntyre International Research Fellowships, Mr Cheng is paying tribute to Professor Ian McIntyre, the Universitys first Professor of Veterinary Medicine.

Professor McIntyre was an inspirational and innovative teacher, and a strong advocate for international collaboration in veterinary education and research. He was a leading member of the Glasgow team which developed the first antiparasitic vaccine for cattle (Dictol).

In his later career, Professor McIntyre was seconded to the University of East Africa In Nairobi and went on to make further contributions to veterinary medicine In Africa.

Mr Cheng said: I am delighted to commemorate Professor McIntyres name in perpetuity through the creation of these international fellowships.

Professor McIntyre was an inspiring teacher when I was a student at the University of Glasgow Veterinary School and I have always admired his achievements both in Glasgow and internationally.

Originally posted here:
Glasgow University Vet school gifted 1m - The Southern Reporter

The Veterinary Council of Ireland has says 133 new vets and 48 new veterinary nurses have been added to its register so far in 2020.

The statutory body, which is responsible for the regulation and management of the practice of veterinary medicine and veterinary nursing in the state, welcomes its new registrants and believes this influx of talent will benefit animal health and welfare.

The total current number of vets and veterinary nurses on the Veterinary Council register is2,938 and 1,019 respectively.

Four of the new vets and two of the new vet nurses on the register are from county Limerick.

The council predicst that increasing numbers of Irish veterinary students qualifying in universities abroad, as well as increasing numbers of foreign vets registering to practice in Ireland, will help to meet the growing demand for large animal vets in rural areas.

Of the 133 newly registered vets, 50 were awarded their Bachelor of Veterinary Medicine Degree from University College Dublin (UCD).

Twenty-five vets were awarded their qualification from the University of Veterinary Medicine in Budapest, 11 were awarded their qualification from the University of Life Sciences in Warsaw and eight were awarded their qualifications from various universities throughout the United Kingdom.

The remaining vets received their qualifications from other universities abroad.

Of the newly registered veterinary nurses, 35 received their veterinary nursing qualification from UCD, three received their qualification from Letterkenny Institute of Technology; three from Athlone Institute of Technology, two from Saint Johns College Cork, with the remaining five receiving their qualifications overseas.

Vets from throughout Europe are eligible to register with the Veterinary Council of Ireland through the Professional Qualifications Directive, which facilitates the free movement of veterinary practitioners within the EU through the mutual recognition of professional qualifications.

The high number of newly registered vets this year is a positive sign for the profession and shows growth in the veterinary industry," says Veterinary Council of IrelandCEO and registrarNiamh Muldoon.

"It is the councils hope that the influx of new vets will help to meet the demands and recruitment challenges experienced by some under-serviced rural areas, particularly relevant to large animal practices. In order to address the issue of vet shortages, the Veterinary Council is analysing data and plans to conduct further research to inform possible solutions to this issue, she added.

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'Positive sign' as 133 new vets are registered by Veterinary Council of Ireland - Limerick Leader

DALLAS--(BUSINESS WIRE)--Generational Equity, a leading mergers and acquisitions advisor for privately held businesses, is pleased to announce the sale of its client, New Generation Genetics to Swissgenetics International. The acquisition closed July 1, 2020 and details were not disclosed.

New Generation Genetics (NGG), located in Fort Atkinson, Wisconsin, has a primary goal of providing its customers with the best Brown Swiss genetics in the industry. NGG focuses solely on Brown Swiss, giving them the advantage over their competitors. The Company has over 50 years of Brown Swiss A.I. experience combined. They currently offer top bulls for Milk, Type, Net Merit, Sire Conception Rate (SCR), Fat, Protein, and PPR Index. They currently sample only the top genomic bulls and continue to lead the breed by sampling 12 young bulls per year.

Swissgenetics International is located in Zollikofen, Switzerland. Successful milk and beef producers rely on sustainable breeding strategies and professional production methods. To achieve this, high-performance and healthy animals are needed. The genetics programs from Swissgenetics are aligned consistently to meet and exceed these requirements. Through the testing programs operated in partnership with breeders and breeding organizations, marketable and future-oriented genetics are developed at an international level. Beneficial breeding cooperation assumes mutual trust between genetics providers and breeders. This requires high levels of competence and transparency on both sides. Swissgenetics is a leader in this field.

Generational Equity Executive Managing Director of M&A Central Region, Michael Goss, and his team lead by Managing Director Mergers & Acquisitions, Stephen Dinehart, with support from Managing Director Mergers & Acquisition, Ryan Johnson, successfully closed the deal. Senior Managing Director Joe Van Voorhis established the initial relationship with NGG.

This is a great acquisition for the Brown Swiss producer family combining two of the major players in Brown Swiss Genetics, said Dinehart. It is a win for both the customers and employees of Swissgenetics and NGG.

About Generational Equity

Generational Equity, Generational Capital Markets (member FINRA/SIPC), Generational Wealth Advisors, Generational Consulting Group, and DealForce are part of the Generational Group, which is headquartered in Dallas and is one of the leading M&A advisory firms in North America.

With over 250 professionals located throughout North America, the companies help business owners release the wealth of their business by providing growth consulting, merger, acquisition, and wealth management services. Their six-step approach features strategic and tactical growth consulting, exit planning education, business valuation, value enhancement strategies, M&A transactional services, and wealth management.

The M&A Advisor named the company the 2016, 2017, and 2018 Investment Banking Firm of the Year. For more information, visit https://www.genequityco.com/ or the Generational Equity press room.

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Generational Equity Advises New Generation Genetics in its Sale to Swissgenetics International - Business Wire

Embryonic stem cells. The ethical issues associated with stem cell research could be resolved through the use of induced pluripotent stem cells, which are derived from fully committed and differentiated cells of the adult body

The almost miraculous benefits that stem cells may one day deliver have long been speculated on. Capable of becoming different types of cells, they offer huge promise in terms of transplant and regenerative medicine. It is, however, also a medical field that urges caution one that must constantly battle exaggeration. If stem cells do in fact hold the potential to reverse the ageing process, for example, then such breakthroughs remain many years away.

Recently, though, the field has had cause for excitement. In 2006, Japanese researcher Shinya Yamanaka discovered that mature cells could be reprogrammed to become pluripotent, meaning they can give rise to any cell type of the body. In 2012, the discovery of these induced pluripotent stem cells (iPSCs) saw Yamanaka and British biologist John Gurdon awarded the Nobel Prize in Physiology or Medicine. Since then, there has been much talk regarding the potential iPSCs possess, not only for the world of medicine, but for society more generally, too.

A big stepHistorically, one of the major hurdles preventing further research into stem cells has been an ethical one. Until the discovery of iPSCs, embryonic stem cells (ESCs) represented the predominant area of research, with cells being taken from preimplantation human embryos. This process, however, involves the destruction of the embryo and, therefore, prevents the development of human life. Due to differences in opinion over when life is said to begin during embryonic development, stem cell researchers face an ethical quandary.

The promise of significant health benefits and new revenue streams has led some clinics to offer unproven stem cell treatments to individuals

With iPSCs, though, no such dilemmas exist. IPSCs are almost identical to ESCs but are derived from fully committed and differentiated cells of the adult body, such as a skin cell. Like ESCs, iPSCs are pluripotent and, as they are stem cells, can self-renew and differentiate, remaining indefinitely propagated and retaining the ability to give rise to any human cell type over time.

One important distinction to make is that both ESCs and iPSCs do not exist in nature, Vittorio Sebastiano, Assistant Professor (Research) of Obstetrics and Gynaecology (Reproductive and Stem Cell Biology) at Stanford Universitys Institute for Stem Cell Biology and Regenerative Medicine, told The New Economy. They are both beautiful laboratory artefacts. This means that at any stage of development, you cannot find ESCs or iPSCs in the developing embryo, foetus or even in the postnatal or adult body. Both ESCs and iPSCs can only be established and propagated in the test tube.

The reason neither ESCs nor iPSCs can be found in the body is that they harbour the potential to be very dangerous. As Sebastiano explained, these cells could spontaneously differentiate into tumorigenic masses because of their intrinsic ability to give rise to any cell type of the body. Over many years of research, scientists have learned how to isolate parts of the embryo (in the case of ESCs) and apply certain culture conditions that can lock cells in their proliferative and stem conditions. The same is true for iPSCs.

To create iPSCs, scientists take adult cells and exogenously provide a cocktail of embryonic factors, known as Yamanaka factors, for a period of two to three weeks. If the expression of such factors is sustained for long enough, they can reset the programme of the adult cells and establish an embryonic-like programme.

Turning back the clockThere is already a significant body of research dedicated to how stem cells can be used to treat disease. For example, mesenchymal stem cells (usually taken from adult bone marrow) have been deployed to treat bone fractures or as treatments for autoimmune diseases. It is hoped that iPSCs could hold the key for many more treatments.

Global stem cell market:25.5%Expected compound annual growth rate (2018-24)$467bnExpected market value (2024)

IPSCs are currently utilised to model diseases in vitro for drug screening and to develop therapies that one day will be implemented in people, Sebastiano explained. Given their ability to differentiate into any cell type, iPSCs can be used to differentiate into, for example, neurons or cardiac cells, and study specific diseases. In addition, once differentiated they can be used to test drugs on the relevant cell type. Some groups and companies are developing platforms for cell therapy, and I am personally involved in two projects that will soon reach the clinical stage.

Perhaps the most exciting prospects draw on iPSCs regenerative properties. Over time, cells age for a variety of reasons namely, increased oxidative stress, inflammation and exposure to pollutants or sunlight, among others. All these inputs lead to an accumulation of epigenetic mistakes those that relate to gene expression rather than an alteration of the genetic code itself in the cells, which, over time, results in the aberrant expression of genes, dysfunctionality at different levels, reduced mitochondrial activity, senescence and more besides. Although the epigenetic changes that occur with time may not be the primary cause of ageing, the epigenetic landscape ultimately affects and controls cell functionality.

What we have shown is that, if instead of being expressed for two weeks we express the reprogramming factors for a very short time, then we see that the cells rejuvenate without changing their identity, Sebastiano said. In other words, if you take a skin cell and express the reprogramming genes for two to four days, what you get is a younger skin cell.

By reprogramming a cell into an iPSC, you end up with an embryonic-like cell the reprogramming erases any epigenetic errors. If expressed long enough, it erases the epigenetic information of cell identity, leaving embryonic-like cells that are also young.

Slow and steadyAs with any scientific advancement, financial matters are key. According to Market Research Engine, the global stem cell market is expected to grow at a compound annual growth rate of 25.5 percent between 2018 and 2024, eventually reaching a market value of $467bn. The emergence of iPSCs has played a significant role in shaping these predictions, with major bioscience players, such as Australias Mesoblast and the US Celgene, working on treatments involving this particular type of stem cell.

The business potential around stem cell research is huge, Sebastiano told The New Economy. [Particularly] when it comes to developing cell banks for which we have detailed genetic information and, for example, studying how different drugs are toxic or not on certain genetic backgrounds, or when specific susceptibility mutations are present.

Unfortunately, even as the business cases for iPSC treatments increase, a certain degree of caution must be maintained. The promise of significant health benefits and new revenue streams has led some clinics to offer unproven stem cell treatments to individuals. There have been numerous reports of complications emerging, including the formation of a tumour following experimental stem cell treatment in one particular patient, as recorded in the Canadian Medical Association Journal last year. Such failures risk setting the field back years.

The challenge for researchers now will be one of balance. The potential of iPSCs is huge both in terms of medical progress and business development but can easily be undermined by misuse. Medical advancements, particularly ones as profound as those associated with iPSCs, simply cannot be rushed.

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Could induced pluripotent stem cells be the breakthrough genetics has been waiting for? - The New Economy

Nature versus nurture: A debate that may only be applicable to women when it comes to a love of affection. A new study found a "latent genetic factor" accounting for up to 48% variance in affection for women with null effects in men.

Genes play a really important role in how affectionate women become as adults, said Kory Floyd, a professor of communication at the University of Arizona, specializing in the study of affection. It appears to play virtually no role in how affectionate men become we still are trying to figure out why.

According to Floyd, the original goal of the study was to answer the broad question of why many people are more affectionate than others. He described that throughout life, it is easy to observe levels of affection among people; some are very affectionate, some are somewhere between and some are just not comfortable with a lot of affection.

Even though the team assumed that environmental factors such as affectionate or non-affectionate households would play a big role, they also wanted to see how much of this trait is genetic.

The question wasnt which one is it is it nature or is it nurture we assumed that it would be a combination of both of those things, Floyd said.

To gather this information, Floyd worked with two other professors to find answers to their questions. The first professor Colter Ray was a former Ph.D. student of his who is now an interpersonal communication professor at San Diego State University. The second Chance York was an interpersonal professor at Kent State University specializing in behavioral genetics.

The three set off to find answers to their questions on the genetics of affection through surveying 464 pairs of twins, all ages 19 to 84, according to UANews.

Some of the pairs were identical twins, meaning that they inherited 100% of the same genes and some were fraternal twins, meaning that they inherited about 50% of the same genes.

The team assumed that if affection has a strong genetic component to it, then identical twins would likely show more similar levels of affection than fraternal twins.

What we expect to find is that the scores of twins who are identical are more similar to each other than the scores of twins who are fraternal because they are more closely related genetically, Floyd said.

In the survey sent out, every participant was able to report on their levels of affection using a measurement system that would assess it. Essentially, Floyd and the team wanted to find how similar scores would be within pairs.

Through the survey, it was found that for the female participants alone, around 48% of affection levels could be attributed to genetics and 52% could be attributed to environmental factors. In the males, genetic components played absolutely no role.

Floyd explained that this study brings the discipline of communication into a new realm.

In my field, we have a very strong assumption that differences between people in terms of their social behavior are almost entirely environmental, Floyd said. Unlike fields like psychology, for example, we dont have a history of looking at biology or genetics or heritability as explanations for social behavior.

He believes that this study could lead people to question the assumption in the communication discipline that most social behaviors are purely products of an environment.

Recently, Floyd has also participated in research on the concept of skin hunger. According to Psychology Today, skin hunger is a deep longing and aching desire for physical contact with another person.

During the times of COVID-19, the concept of skin hunger could not be more relevant.

I think a lot of people right now are really feeling like, I miss getting hugs, I miss holding hands or kissing or putting my arm around somebody, Floyd described. Its really the one thing that social media and Skype and Zoom dont allow us to do.

In research on deprivation of touch in the past, Floyd has found that it can definitely increase negative feelings like loneliness, anxiety, sleep issues and even a depressed immune system.

Though Floyd has not found any solutions to this issue, he believes that there are many ways to cope with the deprivation of physical attention. A major coping mechanism that Floyd suggests for those struggling with such a type of deprivation is to be around animals.

Petting a dog, petting a cat, petting a horse can have some of the same benefits in terms of calming us, in terms of anxiety reduction, in terms of stress reduction, Floyd said.

So, regardless of sex and your level of genetic cravings for affection, a reliable coping mechanism for the skin hunger you may be facing during these times could be to invest in a dog or cat.

Follow Quinn McVeigh on Twitter

Originally posted here:
New study finds love of affection heavily attributed to genetics in women - Arizona Daily Wildcat

In a case of first impression at the circuit level, the Sixth Circuit Court of Appeals reversed dismissal of a disability discrimination complaint because the plaintiff had plausibly alleged a condition covered by the Americans with Disabilities Act (ADA) based on a genetic mutation causing abnormal cell development.

Disability for purposes of the ADA is broadly defined as a physical or mental impairment that substantially limits a major life activity. The ADA instructs that the definition of disability shall be construed in favor of broad coverage of individuals to the maximum extent permitted by the terms of the ADA.

In Darby v. Childvine, Inc., et al., No. 1:18-cv-0669, Plaintiff Sherryl Darby alleged that she underwent a double-mastectomy after genetic testing resulted in a positive match for the BRCA1 gene. Although her employer, Childvine Inc., approved her request to use vacation and sick time to cover her absence for surgery, when Darby returned to work, her supervisor told her she had been terminated. Darby alleged that the stated reasons for her termination an unpleasant attitude, dress code violations and by being unable to work were pretexual. Childvine moved to dismiss the complaint. While the motion was pending, discovery revealed that Darby was never diagnosed with cancer, but had a family history of cancer and the genetic mutation BRCA1. The parties stipulated to certain admissions, including that [t]he BRCA1 gene is an impairment that substantially limits normal cell growth. And that, because of her genetic match, Darbys doctors urged her to have a double mastectomy. In dismissing Darbys complaint, the district court concluded that Darby had offered no statutory, regulatory, or caselaw support for her [argument] that the BRCA1 gene, like cancer itself, is a physical impairment that substantially limits normal cell growth.

The Sixth Circuit reversed and remanded. After reviewing the definition of disability in the ADA and the federal regulations, the court posed the following question: Has Darby plausibly alleged that her impairment substantially limits her normal cell growth as compared to the general population due to both a genetic mutation (BRCA1) that limits her normal cell growth and a medical diagnosis of abnormal epithelial cell growth serious enough to warrant a double mastectomy? The answer is yes.

In reaching this conclusion, the court specifically noted that the 2008 amendments to the ADA included normal cell growth in the definition of a major life activity. The court also pointed out that the ADAs implementing regulations cite cancer as a condition that at a minimum will qualify as an impairment that substantially limits a major life activity. Because this language suggests a floor rather than a ceiling, Darbys gene mutation and abnormal cell growth qualify as a disability under the ADA despite not being cancerous. However, the court did not go so far as to say that a genetic mutation that merely predisposes an individual to other conditions, such as cancer, is itself a disability under the ADA. The terms of the Act do not reach that far.

The court emphasized the narrowness of both the issue before the court and its holding. Specifically, the court did not decide whether Darbys condition in fact falls under the ADAs definition of a disability.

Alternatively, the court essentially found that the Darbys condition could be considered a disability under the ADA if certain conditions were met, such as: that her pre-cancerous cells constitute a substantial limitation on her normal cell growth and that her genetic mutation caused those pre-cancerous cells. Those issues require consideration beyond the four corners of Darbys complaint, and may require an expert to prove. Thus, although Darbys factual allegations were sufficient to survive a motion to dismiss, more would be required to survive summary judgment. The court reversed and remanded with instructions for the lower court to consider the claim under Ohio law as well as the ADA.

Despite the narrowness of the Sixth Circuits holding, it provides important direction as to what may constitute a disability under the ADA in cases of genetic mutation and the attendant medical conditions. And, though the court did not resolve whether Darby had adequately pleaded her failure to accommodate claim in this case, generally employers should engage in an interactive process with employees when presented with a medically-documented request for accommodation and provide a reasonable accommodation when possible.

Link:
Sixth Circuit: A Genetic Mutation That Interferes With Normal Cell Growth May Qualify as a Disability Under the ADA - JD Supra

SAN DIEGO, July 08, 2020 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) announced today that two top cytogeneticists from leading institutions in The Netherlands and France presented their research data as part of a multicentric, international effort to compare data generated with Bionanos Saphyr system against gold standard cytogenetic methods consisting of karyotyping, FISH, and/or chromosomal microarray in patients with a variety of constitutional or inherited genetic disorders and in patients with leukemias. In back-to-back online presentations, each showed 100% concordance between Saphyr and standard cytogenetics along with other discoveries that extend the capabilities of the current standard of care.

Summary of data presentations:

In a webinar originally hosted by LabRoots on Friday, June 22, Dr. Laila El Khattabi from the Cochin Hospital in Paris, France discussed how Saphyr improved structural variant detection for constitutional chromosomal aberrations in her research. The data originate from an international multi-center effort between the hospitals of Paris-Cochin, Lyon and Clermont-Ferrand and the Radboud University Medical Center in the Netherlands, as part of the first international consortium to validate Saphyr for constitutional cytogenetic analysis. The consortium compared the performance of Saphyr against the combination of karyotyping, FISH and array-based methods in 85 samples with a variety of constitutional aberrations including deletions, duplications, balanced and unbalanced translocations, inversions, ring chromosomes and aneuploidies in patients with intellectual disabilities and recurrent miscarriages. Saphyr showed 100% concordance with gold standard methods in these 85 samples. Dr. El Khattabi expressed the consortiums confidence in Saphyrs potential to largely replace standard cytogenetic testing methods in the future. A manuscript describing the study results will be submitted for publication in the coming weeks.

Dr. Alexander Hoischen from Radboud University Medical Center described how Bionano genome imaging identified likely pathogenic variants in 25% of unsolved rare disease cases analyzed with Saphyr. Dr. Hoischen presented two of these research cases, which involved families with undiagnosed genetic disorders. The first case involved a rare and aggressive childhood tumor named Atypical Teratoid Rhabdoid Tumor (ATRT) in which Saphyr detected an insertion in the SMARCB1 gene in a family affected by ATRT, while MLPA and next generation sequencing were unable to identify this variant. In a family affected by intellectual disability, Saphyr identified a single de novo deletion affecting the NSF gene, undetected by chromosomal microarray, whole exome and whole genome sequencing and long read sequencing. This deletion was confirmed to be de novo in the child through PCR validation. Finally, Dr. Hoischen provided an update on his retrospective comparative study on leukemias, which he presented at ESHG 2020 and is expected to be submitted for peer-review publication in the near future. The study showed 100% concordance between Bionanos Saphyr system and standard cytogenetics in 48 leukemia patients. Additionally, Saphyr identified novel events previously undetected by traditional cytogenetic methods, many of them being rare inter-chromosomal translocations causing gene fusions never described before, opening potential new avenues of research in precision medicine and drug development. Dr. Hoischen concluded that Saphyr has value in solving unanswered rare disease cases and has the potential to replace classical cytogenetics methods.

At the ESHG 2020 conference, Dr. Uwe Heinrich, representing MVZ Martinsried, Germany presented that Bionano was able to confirm all known large rearrangements in a cohort of patients with intellectual disability, developmental disorders and chromosomal aberrations. Drs. Hoischen and Heinrich announced that their respective teams are planning to seek accreditation for the Saphyr system, to start offering Bionanos genome imaging as part of a stepwise diagnosis, and to subsequently replace chromosomal microarray with Saphyr altogether later on.

Erik Holmlin, Ph.D., CEO of Bionano Genomics commented: We previously demonstrated the notable performance of Saphyr in leukemia studies across the globe, but the international study presented by Dr. El Khattabi demonstrates that Saphyr performs equally well in genetic diseases such as intellectual disabilities and subfertility. Saphyr showed 100% concordance with traditional cytogenetic methods and made additional discoveries in both leukemia patients and in those with constitutional disorders. We believe that Saphyr is capable of replacing traditional cytogenetic methods and consolidating these outdated methods into a single digital platform that is faster, less expensive and has lower manual labor needs, while providing greater accuracy than these methods.

A recording of the presentation by Drs. El Khattabi and Hoischen can be viewed at https://bionanogenomics.com/library/webinars/

About Bionano GenomicsBionano is a genome analysis company providing tools and services based on its Saphyr system to scientists and clinicians conducting genetic research and patient testing. Bionanos Saphyr system is a platform for ultra-sensitive and ultra-specific structural variation detection that enables researchers and clinicians to accelerate the search for new diagnostics and therapeutic targets and to streamline the study of changes in chromosomes, which is known as cytogenetics. The Saphyr system is comprised of an instrument, chip consumables, reagents and a suite of data analysis tools, and genome analysis services to provide access to data generated by the Saphyr system for researchers who prefer not to adopt the Saphyr system in their labs. For more information, visitwww.bionanogenomics.com.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as may, will, expect, plan, anticipate, estimate, intend and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our intentions, beliefs, projections, outlook, analyses or current expectations concerning the Saphyr System; the intended use of Saphyr by the institutions identified in this press release; expectations regarding the rate and extent of adoption of Saphyr in research and clinical settings; and the general effectiveness and utility of Saphyr, including its ability to replace traditional cytogenetic methods and enable discoveries that can contribute to treatment of disease. Each of these forward-looking statements involves risks and uncertainties. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks and uncertainties associated with: the impact of the COVID-19 pandemic on our business and the global economy; general market conditions; changes in the competitive landscape and the introduction of competitive products; changes in our strategic and commercial plans; our ability to obtain sufficient financing to fund our strategic plans and commercialization efforts; the loss of key members of management and our commercial team; and the risks and uncertainties associated withour business and financial condition in general, including the risks and uncertainties described in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2019 and in other filings subsequently made by us with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

ContactsCompany Contact:Erik Holmlin, CEOBionano Genomics, Inc.+1 (858) 888-7610eholmlin@bionanogenomics.com

Investor Relations Contact:Ashley R. RobinsonLifeSci Advisors, LLC+1 (617) 430-7577arr@lifesciadvisors.com

Media Contact:Kirsten ThomasThe Ruth Group+1 (508) 280-6592kthomas@theruthgroup.com

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First Extensive Validation Study of Saphyr for Constitutional Genetic Disorders by European Consortium Shows 100% Concordance to Standard Cytogenetics...

Predictive Genetic Testing and Consumer/Wellness Genomics Market: Snapshot

Genetic testing comprises examination of ones DNA. The term DNA refers to the chemical database that is responsible for conveying the instructions for functions that need to be performed by the body. Genetic testing is capable of revealing changes or mutations in the genes of living beings, which might result in any kind of disease or illness in the body.

Get Exclusive PDF Sample Copy Of This Report:https://www.tmrresearch.com/sample/sample?flag=B&rep_id=1274

Predictive genetic testingrefers to the utilization of genetic testing methods in an asymptomatic individual to make a prediction about risk of contacting particular disease in future. These tests are regarded as representation of emerging class of medical tests, which differ in fundamental ways from the usual diagnostic tests.

The global predictive genetic testing and consumer/wellness genomics marketis likely to gather momentum owing to the benefits offered by predictive genetic testing.

The benefits of predictive genetic testing are

The global predictive genetic testing and consumer/wellness genomics marketis influenced by reducing cost of genetic sequencing and technological advancement in the field of genetics. North America is expected to emerge as a prominent region for the global predictive genetic testing and consumer/wellness genomics market in years to come due to high adoption rates of latest technologies in all fields.

Over centauries human DNA has undergone tremendous alteration due to evolutionary and lifestyle changes. They have led to both, advantages and disadvantages over the years. Some have given the mankind a deserving edge over other creatures while the others have led to disorders and diseases. Predictive genetic testing and consumer/wellness genomics market thrives on the growing demand for understanding the lineage of a certain gene pool to identify disorders that could manifest in the later or early stage of a human life. The surging demand for understanding the family history or studying the nature of certain diseases has given the global market for predictive genetic testing and consumer/wellness genomics market adequate fodder for growth in the past few years.

This new class of medical tests are aimed at reducing the risk of morbidity and mortality amongst consumers. The thorough surveillance and screening of a certain gene pool can allow an individual to avoid conditions that disrupt normal existence through preventive measures. The clinical utility of these tests remains unassessed. Therefore, increasing research and development by pharmaceutical companies to develop new drugs by understanding diseases and disorders is expected to favor market growth.

Unlike conventional diagnostic testing, predictive genetic testing identifies the risk associated with potential conditions. In certain cases it is also capable of stating when the disease may appear and the how severe will it be. Thus, this form of testing is expected to allow consumers to take up wellness measurements well in time to lead a life of normalcy, characterized by good health.

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Global Predictive Genetic Testing and Consumer/Wellness Genomics Market: Overview

Predictive genetic testing are used to identify gene mutations pertaining to the disorders that surface at a considerably later stage in life after birth. These tests are particularly beneficial for people from a family with a history of genetic disorder, although they themselves show no symptoms of the disorder at the time of testing. Genetic testing promises to revolutionize the healthcare sector, providing crucial diagnostic details related to diverse verticals such as heart disease, autism, and cancer. As the healthcare sector touches new peaks, the global predictive genetic testing and consumer/wellness genomics market is projected to expand at a healthy growth rate during the forecast period of 2017 to 2025.

This report on the global market for predictive genetic testing and consumer/wellness genomics analyzes all the important factors that may influence the demand in the near future and forecasts the condition of the market until 2025. It has been created using proven research methodologies such as SWOT analysis and Porters five forces. One of the key aspect of the report is the section on company profiles, wherein several leading players have been estimated for their market share and analyzed for their geographical presence, product portfolio, and recent strategic developments such as mergers, acquisitions, and collaborations.

The global predictive genetic testing and consumer/wellness genomics market, on the basis of test type, can be segmented into predictive testing, consumer genomics, and wellness genetics. The segment of predictive testing can be sub-segmented into genetic susceptibility test, predictive diagnostics, and population screening programs, whereas the segment of wellness genetics can be further divided into nutria genetics, skin and metabolism genetics, and others.

By application, the market can be segmented into breast and ovarian cancer screening, cardiovascular screening, diabetic screening and monitoring, colon cancer screening, Parkinsons or Alzheimers disease, urologic screening or prostate cancer screening, orthopedic and musculoskeletal screening, and other cancer screening. Geographically, the report studies the opportunities available in regions such as Asia Pacific, Europe, North America, and the Middle East and Africa.

Global Predictive Genetic Testing and Consumer/Wellness Genomics Market: Trends and Opportunities

Increasing number of novel partnership models, rapidly decreasing cost of genetic sequencing, and introduction of fragmented point-solutions across the genomics value chain as well as technological advancements in cloud computing and data integration are some of the key factors driving the market. On the other hand, the absence of well-defined regulatory framework, low adoption rate, and ethical concerns regarding the implementation, are expected to hinder the growth rate during the forecast period. Each of these factors have been analyzed in the report and their respective impacts have been anticipated.

Currently, the segment of predictive genetic cardiovascular screening accounts for the maximum demand, and increased investments in the field is expected to maintain it as most lucrative segment. On the other hand, more than 70 companies are currently engaged in nutrigenomics, which is expected to further expand the market.

Global Predictive Genetic Testing and Consumer/Wellness Genomics Market: Regional Outlook

Owing to robust healthcare infrastructure, prevalence of cardiovascular diseases, and high adoptability rate of new technology makes North America the most lucrative region, with most of the demand coming from the country of the U.S. and Canada. Several U.S. companies hold patents, which further extends the outreach of the market in the region of North America.

Companies mentioned in the research report

23andMe, Inc, BGI, Genesis Genetics, Illumina, Inc, Myriad Genetics, Inc, Pathway Genomics, Color Genomics Inc., and ARUP Laboratories are some of the key companies currently operating in global predictive genetic testing and consumer/wellness genomics market. Various forms of strategic partnerships with operating company and smaller vendors with novel ideas helps these leading players maintain their position in the market.

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Predictive Genetic Testing and Consumer/Wellness Genomics Market Analytical Overview and Size(Value and Volume) by 2025 - Cole of Duty

BEDFORD, Mass.--(BUSINESS WIRE)-- Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company pioneering a new way to treat the underlying cause of severe genetic diseases, today announced the publication of data in the journal Nature Communications that support the companys proprietary approach to precisely upregulate protein expression using TANGO (Targeted Augmentation of Nuclear Gene Output) antisense oligonucleotides (ASOs).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200709005385/en/

TANGO (Targeted Augmentation of Nuclear Gene Output)

Stoke was founded on the idea that we could use unique insights in RNA biology to do something that has never been done before, said Isabel Aznarez, Ph.D., Co-Founder and Vice President, Head of Biology of Stoke Therapeutics and the corresponding author on the paper. Rather than address genetic diseases by replacing, repairing or editing faulty genes, we set out to increase or stoke protein output from healthy genes. These data show that we can increase full-length, fully functional protein expression from a variety of healthy genes, which supports our hypothesis and may lead to a new way of treating severe genetic diseases.

To evaluate the approach broadly, Stoke selected four gene targets that vary in type and abundance of non-productive splicing events, gene size and protein function: PCCA (propionic acidemia); SYNGAP1 (autosomal dominant mental retardation 5); CD274 (autoimmune diseases, including uveitis); and SCN1A (Dravet syndrome). Stoke designed TANGO ASOs to target the non-productive splicing events in these genes and their activity was evaluated. Dose-dependent reductions of non-productive mRNA were observed to lead to increases in both productive mRNA and protein levels for each of the target genes.

More than 10,000 genetic diseases are caused by mutations in a single gene, however, current therapeutic approaches address as few as 5% of these diseases. In the experiments published today, a proprietary bioinformatics analysis of RNA sequencing datasets was used to identify a variety of non-productive alternative-splicing events that lead to mRNA degradation and limit protein production. Stoke found 7,757 unique genes that contained at least one non-productive event, of which 16% (1,246) were associated with causing a specific disease.

A link to the publication, Antisense oligonucleotide modulation of non-productive alternative splicing upregulates gene expression, can be found here: https://www.nature.com/articles/s41467-020-17093-9

Pre-mRNA Splicing and TANGO

Human cells naturally regulate protein production to maintain health. Pre-mRNA splicing, including alternative splicing, is an important mechanism used to regulate how much protein and which protein variant is produced. During splicing, introns are removed and exons are joined together to generate the mRNA template that carries the code to synthesize proteins. More than one third of alternative splicing events in mammals do not produce functional proteins and lead to mRNA degradation through nonsense-mediated mRNA decay (NMD). TANGO ASOs act at the pre-mRNA level and prevent non-productive alternative splicing so that the body produces more protein-coding mRNA and thus more protein. This approach is particularly applicable to diseases that are caused by insufficient protein production.

About Stoke Therapeutics

Stoke Therapeutics, Inc. (Nasdaq: STOK), is a biotechnology company pioneering a new way to treat the underlying causes of severe genetic diseases by precisely upregulating protein expression to restore target proteins to near normal levels. Stoke aims to develop the first precision medicine platform to target the underlying cause of a broad spectrum of genetic diseases in which the patient has one healthy copy of a gene and one mutated copy that fails to produce a protein essential to health. These diseases, in which loss of approximately 50% of normal protein expression causes disease, are called autosomal dominant haploinsufficiencies. The companys lead investigational new medicine is STK-001, a proprietary antisense oligonucleotide (ASO) that has the potential to be the first disease-modifying therapy to address the genetic cause of Dravet syndrome, a severe and progressive genetic epilepsy. Stoke is headquartered in Bedford, Massachusetts with offices in Cambridge, Massachusetts. For more information, visit https://www.stoketherapeutics.com/ or follow the company on Twitter at @StokeTx.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: our expectations about Companys proprietary approach to precisely upregulate protein expression using TANGO ASOs and the potential benefits thereof. These forward-looking statements may be accompanied by such words as aim, anticipate, believe, could, estimate, expect, forecast, goal, intend, may, might, plan, potential, possible, will, would, and other words and terms of similar meaning. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: risks related to the direct and indirect impact of COVID-19; our ability to develop, obtain regulatory approval for and commercialize current and future product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive results in a clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials; the risk that regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; risks related to the occurrence of adverse safety events; risks related to failure to protect and enforce our intellectual property, and other proprietary rights; risks related to failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology failures or breaches; our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions caused by the coronavirus pandemic; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; failure to comply with legal and regulatory requirements; risks relating to access to capital and credit markets; environmental risks; risks relating to the use of social media for our business; and the other risks and uncertainties that are described in the Risk Factors section of our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements.

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Stoke Therapeutics Announces Publication of Data in the Journal Nature Communications That Support the Company's Proprietary Approach to Addressing...

The FDA has put a phase 1 trial of Cellectis off-the-shelf CAR-T therapy UCARTCS1A on clinical hold after learning of a death in the study. Cellectis said the multiple myeloma patient suffered a cardiac arrest after receiving the highest dose of the anti-CS1 allogeneic CAR-T.

Before joining the Cellectis trial, the patient underwent multiple prior lines of treatment, including with autologous CAR-T cells, without success. In the Cellectis trial, the patient was the first person to receive the higher, 3 million cells per kilogram dose of UCARTCS1A. The patient experienced cytokine release syndrome of undisclosed severity and died of a cardiac arrest 25 days after treatment.

The FDA has placed the trial on clinical hold while Cellectis evaluates the case. According to Cellectis, plans were already afoot to expand the lower, 1 million cells per kilogram dose cohort before the patient death. Preliminary data suggest 1 million cells per kilogram may be the phase 2 dose.

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There are signs the lower dose also has some safety issues. Analysts at Jefferies think investigators gave one or more of the three low-dose patients rituximab to activate the CAR-T safety switch. Work is underway to update the phase 1 protocol to mitigate the potential risks posed by UCARTCS1A.

The modifications may include increased monitoring of parameters related to cytokines. The Jefferies analysts think Cellectis should exclude patients previously treated with anti-BCMA CAR-Ts, such as Johnson & Johnsons JNJ-4528, due to risks related to back-to-back rounds of lymphodepletion, but note that management at the biotech think it is important to enroll that pre-treated population.

In a follow-up note, the analysts identified the use of cyclophosphamide, a chemotherapy drug, in the lymphodepletion regimen as a potential cause of the cardiac arrest. The argument is based on a 2017 paper that describes the case of a patient who died of acute heart failure after receiving a high dose of cyclophosphamide as part of an autologous stem cell transplantation treatment.

Many patients receive cyclophosphamide without suffering cardiac complications, but the analysts see reasons to think the subject enrolled in the Cellectis trial may have been at higher risk. Notably, prior exposure may increase risk, according to the analysts, suggesting the patients previous round of lymphodepletion may have been a factor.

Even if cyclophosphamide is at the heart of the problem, the analysts still think the UCARTCS1A dose is a contributing factor. With patients in the low-dose cohort also experiencing adverse events, the analysts see dosing at below 1 million cells per kilogram as one possible outcome of the situation.

Shares in Cellectis fell 13% in after-hours trading following news of the clinical hold. The value of Allogene Therapeutics, which licensed CAR-T assets that originated at Cellectis, held steady, likely reflecting a belief that the safety issue is limited to UCARTCS1A.

The Jefferies analysts see little or no read-through to other allogeneic programs, noting that the UCARTCS1A trial started at a higher dose than Cellectis two other clinical programs and that Allogene is testing several lymphodepletion regimens. The FDA placed a clinical trial of another Cellectis CAR-T, UCART123, on hold in 2017 after a patient died, but cleared it to resume months later.

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Death in Cellectis off-the-shelf CAR-T trial triggers FDA hold - FierceBiotech

By Alexandra Marvar | July 9th, 2020

For nearly a century, scientists have been studying Alzheimers a disease that kills hundreds of thousands of people per year but that still has no cure. Currently drugmakers and scientists test preventative Alzheimers drug treatments by identifying participants who are at higher risk of developing the disease, and then observing whether the treatment in question prevents the diseases onset. One in ten people develop Alzheimers after age 65, and one in three after age 85. Thus, this observation may take years or even decades which is part of why progress has moved at a snails pace.

An added challenge is that trial participants must have symptoms of Alzheimers to be eligible but the sheer appearance of symptoms indicates that many brain cells have already died, so by the time symptoms have appeared and candidates join trials, it is generally too late for any treatment to have a significant effect on their symptoms.

In a breakthrough, a research team team at Queen Mary University of London has developed a new system to efficiently screen potential Alzheimers treatments that may be able to greatly expedite the path to a cure.

For this study, published Thursday evening Eastern Daylight Time in the Nature group journal Molecular Psychiatry, the research group consisted of a cohort of people living with Down syndrome, who have as much as a 70 percent higher likelihood of developing Alzheimers during their lifetime. Those with the syndrome carry an extra chromosome 21, which contains a gene that increases Alzheimers risk.Researchers collected hair cells from the participants and reprogrammed the hair cells to become stem cells. Then, in a petri dish environment, they grew those stem cells into brain cells.

In these brain-like cells, the researchers observed a rapidly developing pathology that resembled Alzheimers, down to the hallmark trio of Alzheimers indicators: amyloid plaque-like lesions, progressive neuron death and accumulations of tau protein tangled up inside neurons.

With access to this test environment, the team then experimented with two drugs known to inhibit beta-amyloid production, applying them to the new brain cells. In six weeks, they found the drugs successfully prevented the onset of Alzheimers-pathology.

Although the two drugs the Queen Mary University of London researchers experimented with have failed clinical trials for other reasons and therefore arent suitable treatments for Alzheimers in the end, they were able to demonstrate proof of concept: This system of obtaining and developing cells and creating Alzheimers-prone, brain-like cells as a test environment could be used as an Alzheimers drug testing platform for other preventative drugs in the future.

The hope is that, by creating a lab-controlled cellular environment that replicates the human brain as it develops Alzheimers, the time it takes to test potential treatments could be diminished greatly, and the path to a cure could be significantly shortened. The researchers saw results within six weeks. If that expedited timeline to determine the effectiveness of a drug saves years of research, it could save millions of lives not to mention the suffering on the part of people living with Alzheimers and their loved ones.

This work represents a remarkable achievement, as this is the first cell-based system that has the full trio of Alzheimers pathologies, without any artificial gene over-expression, said Queen Mary University of London Professor Dean Nizetic, lead author on the study. This system opens up the prospect for screening for new drugs aimed at delaying or even preventing Alzheimers before neuronal death starts.

Although its still early days, the system raises a theoretical possibility for further development as a tool to predict who might develop Alzheimers. The same stem cell process could be used on anyones hair follicles, the resulting brain cells of which may or may not then develop Alzheimers-pathology in the dish. The idea would be to catch the people at higher risk of early disease in a cell-based system, before it starts in a persons brain and allow for the possibilities of individualized preventive interventions.

However, he said, they are still a long way from reaching this goal, though study co-author Professor John Hardy added that the potential development of a new, human model of the disease would be a great step forward.

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Scientists Have Discovered a Way to Speed Up Alzheimer's Drug Testing - Being Patient

By Associated Press

WASHINGTON: Desperate to solve the deadly conundrum of COVID-19, the world is clamouring for fast answers and solutions from a research system not built for haste.

The ironic, and perhaps tragic, result: Scientific shortcuts have slowed understanding of the disease and delayed the ability to find out which drugs help, hurt or have no effect at all.

As deaths from the coronavirus relentlessly mounted into the hundreds of thousands, tens of thousands of doctors and patients rushed to use drugs before they could be proved safe or effective.

A slew of low-quality studies clouded the picture even more.

'People had an epidemic in front of them and were not prepared to wait,'said Dr.Derek Angus, critical care chief at the University of Pittsburgh Medical Center.

'We made traditional clinical research look so slow and cumbersome.'

ALSO READ |Hydroxychloroquine has become highly politicised in US but India uses it widely: White House official

It wasn't until mid-Junenearly six months in when the first evidence came that a drug could improve survival.

Researchers in the United Kingdom managed to enroll one of every six hospitalized COVID-19 patients into a large study that found a cheap steroid called dexamethasone helps and that a widely used malaria drug does not.

The study changed practice overnight, even though results had not been published or reviewed by other scientists.

In the United States, one smaller but rigorous study found a different drug can shorten recovery time for seriously ill patients, but many questions remain about its best use.

Doctors are still frantically reaching for anything else that might fight the many ways the virus can do harm, experimenting with medicines for stroke, heartburn, blood clots, gout, depression, inflammation, AIDS, hepatitis, cancer, arthritis and even stem cells and radiation.

'Everyone has been kind of grasping for anything that might work.And that's not how you develop sound medical practice,'said Dr.Steven Nissen, a Cleveland Clinic researcher and frequent adviser to the U.S.Food and Drug Administration.

ALSO READ |'Feelingbetter': BrazilPresident Bolsonaro says will use hydroxychloroquine to cure his COVID-19

'Desperation is not a strategy.Good clinical trials represent a solid strategy.'

Few definitive studies have been done in the U.S., with some undermined by people getting drugs on their own or lax methods from drug companies sponsoring the work.

And politics magnified the problem.

Tens of thousands of people tried a malaria medicine after President Donald Trump relentlessly promoted it, saying, 'What have you got to lose?'Meanwhile, the nation's top infectious disease expert, Dr.Anthony Fauci, warned 'I like to prove things first.'

For three months, weak studies polarized views of hydroxychloroquine until several more reliable ones found it ineffective.

'The problem with 'gunslinger medicine,' or medicine that is practiced where there is a hunch ...is that it's caused society as a whole to be late in learning things,'said Johns Hopkins University's Dr.Otis Brawley.

'We don't have good evidence because we don't appreciate and respect science.'

He noted that if studies had been conducted correctly in January and February, scientists would have known by March if many of these drugs worked.

Even researchers who value science are taking shortcuts and bending rules to try to get answers more rapidly.

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And journals are rushing to publish results, sometimes paying a price for their haste with retractions.

Research is still chaoticmore than 2,000 studies are testing COVID-19 treatments from azithromycin to zinc.

The volume might not be surprising in the face of a pandemic and a novel virus, but some experts say it is troubling that many studies are duplicative and lack the scientific rigor to result in clear answers.

'Everything about this feels very strange,'said Angus, who is leading an innovative study using artificial intelligence to help pick treatments.

'It's all being done on COVID time.It's like this new weird clock we're running on.'Here is a look at some of the major examples of 'desperation science'underway.

To scientists, it was a recipe for disaster: In a medical crisis with no known treatment and a panicked population, an influential public figure pushes a drug with potentially serious side effects, citing testimonials and a quickly discredited report of its use in 20 patients.

Trump touted hydroxychloroquine in dozens of appearances starting in mid-March.

The Food and Drug Administration allowed its emergency use even though studies had not shown it safe or effective for coronavirus patients, and the government acquired tens of millions of doses.

Trump first urged taking it with azithromycin, an antibiotic that, like hydroxychloroquine, can cause heart rhythm problems.

After criticism, he doubled down on giving medical advice, urging 'You should add zinc now ...I want to throw that out there.

In May, he said he was taking the drugs himself to prevent infection after an aide tested positive.

Many people followed his advice.Dr.Rais Vohra, medical director of a California poison control center, told of a 52-year-old COVID-19 patient who developed an irregular heartbeat after three days on hydroxychloroquine from the drug, not the virus.

'It seems like the cure was more dangerous than the effects of the disease,' Vohra said.

Studies suggested the drug wasn't helping, but they were weak.

And the most influential one, published in the journal Lancet, was retracted after major concerns arose about the data.

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'Desperation science' slows the hunt for coronavirus drugs amid rising death toll - The New Indian Express

There have been 108,614 confirmed cases of coronavirus in Arizona and 1,963 coronavirus-related deaths, as of Wednesday morning.

The number of coronavirus cases and deaths in Arizona continues to rise.

In an effort to track the changes, 12 News has started a daily live blog.

Here is the live blog for Wednesday, July 8.

Joe Biden makes statement on "testing failures" in Arizona

Former vice president and 2020 presidential candidate Joe Biden made a statement Wednesday calling for federally-managed, community-based testing in Arizona.

Biden called continued and growing spread of coronavirus in the state a result of President Trump's words to slow testing down.

Below is the full statement from Biden:

"Arizonans have been forced to endure 13 hours in line in the boiling heat for a COVID-19 test, hospitals are overwhelmed, the test positivity rate is soaring, and the pleas of local leaders for help were repeatedly dismissed. Enough. The Trump Administration must immediately resume operating federally-managed community-based testing around the country and establish multiple sites in Arizona.

It must open them in every hot spot in the country and in every underserved community, and it must keep increasing the number of testing sites until there are no more lines. The crisis in Arizona is the direct result of Donald Trump's failure to lead and his desire to "slow the testing down," and Americans are suffering the consequences. The President must act."

COVID-19 cases reported in Arizona on Wednesday

There have been108,614confirmed cases of coronavirus in Arizona and 1,963coronavirus-related deaths as of Wednesday, according to the state's latest numbers.

That is an increase from 105,094 cases and 1,927 coronavirus-related deaths reported as of Tuesday.

A week ago, there were 84,092cases and 1,720deaths reported in Arizona.

Cases reach 108,000 on Wednesday, two days after reaching 100,000

The Arizona Department of Health Services said the number of confirmed coronavirus cases topped 108,000, one day after reaching the 105,000 mark and two days after reaching 100,000.

Wednesday also marked the fourth straight day with more than 3,000 new cases reported in Arizona.

Arizona reached 50,000 coronavirus cases a little over two weeks ago, on June 21.

Gov. Doug Ducey announced in a tweet that state officials are working with the federal government to increase testing in Maryvale and west Phoenix.

Wednesday's high case day came one day after Arizona reported a record-high 117 deaths on Tuesday. Health officials said 52 of those deaths were from death certificate matching.

There were 5,025 cases reported on the collection date of June 29, the day with the most collected diagnoses so far. That is subject to change.

Health officials said the days with the highest numbers of reported deaths was June 23 and 25, when 38 people died each day. That is subject to change.

Health officials continued to stress that people should continue social distancing, wearing masks in public and stay home when possible.

New York Times: Arizona has the world's worst coronavirus outbreak

Arizona is No. 1 -- but not in a good way.

According to the New York Times, Arizona is the No. 1 spot in the entire world with the most new coronavirus cases per million residents in the last seven days.

Florida and South Carolina followed shortly behind.

"There is no country in the world where confirmed coronavirus cases are growing as rapidly as they are in Arizona, Florida or South Carolina. The Sun Belt has become the global virus capital," the outlet reported.

The chart ranked the countries with the most confirmed new cases over the past week, adjusted for population size, and treated each U.S. state as if it were a country.

Patrick Ptak, Gov. Doug Ducey's spokesman, said in an email that the report from the New York Times was "misleading at best."

United States reaches 3 million cases of coronavirus

The United States has become the first country to reach three million confirmed cases of COVID-19.

The milestone was reached Wednesday morning, according to tracking by Johns Hopkins University.

By comparison, just one other country -- Brazil -- has passed the 1 million mark.

The Johns Hopkins University tracker shows more than 131,000 people in the U.S. have died from COVID-19. There have been more than 936,000 recoveries.

Phoenix restaurant closes doors after positive test among employees

MacAlpine's Diner & Soda Fountain in Phoenix was forced to close its doors after one of its employees tested positive for COVID-19.

The company said it would temporarily close after an employee tested positive.

"The last day she worked was on June 25, when her symptoms were not yet present," the company said in an email.

"She had asked for the next week off due to a prior engagement."

The employee entered the building on July 2 to pick up her paycheck and her temperature was taken, but it was in the regular range. The employee had a mild case.

"Although the last day she worked was quite some time ago, we feel it is our responsibility to notify our customers of this situation and take any extra precautions necessary," the email continued.

"We will be temporarily closed for the next few weeks and will be thoroughly sanitizing the diner and antique stores."

"We want to reassure you that we will reopen again when it is safe for the public and our employees."

Bullhead City to close beaches, boat launches on weekends

All beaches, boat launches and associated parks in Bullhead City will be closed on weekends through Labor Day because of the coronavirus pandemic.

Mayor Tom Brady issued an emergency proclamation Tuesday about the closures on Fridays, Saturdays and Sundays to slow the spread of COVID-19.

Most parks will be open to the public Mondays through Thursdays in the northwestern Arizona city along the Colorado River.

Gates and fencing will be installed to prevent beach and boat launch access.

Brady says out-of-towners crowded Bullhead Citys beaches last weekend at "unacceptable levels.

He says non-compliance and overcrowding are not acceptable in trying to stem the spread of the coronavirus.

The above article is from the Associated Press.

Navajo Nation cases grow by 27, one more death

The Navajo Department of Health reported 27 new COVID-19 positive cases for the Navajo Nation and one more death.

The total number of COVID-19 positive cases for the Navajo Nation is 7,941.

The total number of deaths has reached 379 as of Tuesday.

Reports from all 12 health care facilities on and near the Navajo Nation indicate that approximately 5,650 individuals have recovered from COVID-19.

60,323 people have been tested for COVID-19.

CDC expands list of groups at higher risk of severe COVID-19 illness

The Centers for Disease Control and Prevention expanded its list of individuals who are considered at an increased risk of getting severely ill from COVID-19.

The CDC explained that it's clear a substantial number of Americans are at increased risk of severe illness from the coronavirus pandemic highlighting the importance of continuing to follow preventive measures.

Experts determined there was consistent evidence these conditions increase a person's risk, regardless of age:

Masks now required in public

Gov. Doug Ducey allowed individual Arizona cities to create their own policies about face-covering requirements and enforcement on Wednesday.

A face covering has proven to be effective at limiting the spread of COVID-19, according to the CDC. The virus is primarily spread by in-person contact through sneezes and coughs.

Many cities, including Phoenix, have adopted their own mask requirement that is now in effect.

How to get tested for coronavirus

If you have reason to believe you have contracted coronavirus, also known as COVID-19, this is what you should do.

Arizona releases ZIP code locations of coronavirus cases, other data

The Arizona Department of Health Services has released expanded data points regarding coronavirus cases in the state.

The AZDHS website now features the location of confirmed cases in Arizona by zip code.

You can see the current ZIP code map here and can find yours by clicking around or searching for your ZIP code in the top right of the map.

More information on coronavirus cases from Wednesday

There have been 108,614 confirmed cases of coronavirus in Arizona and 1,963 coronavirus-related deaths as of Wednesday.

That is an increase from 105,094 cases and 1,927 coronavirus-related deaths reported as of Tuesday.

That's an increase of 3,520 new cases reported on Wednesday, a slight decrease from the 3,653 new cases reported on Tuesday.

There was 36 new deaths reported on Wednesday, a major decrease from the record-high 117 deaths reported on Tuesday.

There were 5,025 cases reported on the collection date of June 29, the day with the most collected diagnoses so far. That is subject to change.

Health officials said the days with the highest numbers of reported deaths was June 23 and 25, when 38 people died each day. That is subject to change.

In total, 15,219 new tests were reported on Wednesday, an increase from the 11,418 new tests reported on Tuesday.

There have been a total of 827,089 PCR and Serology tests reported to the state as of Wednesday.

11.4% of those tests have been positive, an increase from 11.3% on Tuesday.

Here's a county breakdown:

Click on the links below to find more information from each county's health department:

COVID-19 is believed to be primarily spread through coughs or sneezes.

It may be possiblefor the virus to spread by touching a surface or object with the virus and then a person touching their mouth, nose or eyes, but this is not thought to be the main method of spread, the CDC says.

You should consult your doctor if you traveled to an area currently affected by COVID-19 and feel sick with fever, cough or difficulty breathing.

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Coronavirus in Arizona on July 8: Cases, deaths on the rise - 12news.com KPNX

By David Bautz, PhD

NASDAQ:BCLI

READ THE FULL BCLI RESEARCH REPORT

Business Update

KOL Event for Alzheimers Program

On July 8, 2020, BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI) conducted a Key Opinion Leader (KOL) webinar to discuss the companys upcoming Phase 2a clinical trial of NurOwn in patients with Alzheimers Disease (AD). The event included presentations by two of the lead investigators for the upcoming trial, Dr. Philip Scheltens, Professor of Cognitive Neurology and Director of the Alzheimer Centre at VU University Medical Center in Amsterdam, Netherlands, and Dr. Bruno Dubois, Professor of Neurology at the Neurological Institute of the Salptrire University Hospital in Paris, France. The presentation can be found here.

The companys Phase 2a trial (BCT-201-EU) is expected to enroll approximately 40 patients with prodromal to mild AD. It will be taking place at medical centers in France and the Netherlands. To be eligible for the trial, patients must have been diagnosed with prodromal to mild dementia at least six months prior to enrollment. In addition, patients must score between 20-30 on the Mini-Mental State Exam (MMSE) and have a Clinical Dementia Rating (CDR) global score of 0.5-1.0. The MMSE is a series of questions that are designed to assess a patients mental skills, with the maximum score being 30 points and a score of 20-24 suggesting mild dementia. The CDR is a scale used to characterize six domains of cognitive and functional performance with a score of 0.5 suggesting very mild dementia and a score of 1.0 suggesting mild dementia.

The primary objective of the trial is to assess the safety and tolerability of three intrathecal injections of NurOwn in AD patients. Following bone marrow aspiration during a 10-week run-in period, patients will be treated three times with NurOwn, with eight weeks between treatments. Follow-up visits will occur 12 and 26 weeks following the final injection of NurOwn for a total trial length of 52 weeks. The following figure gives an overview of the trial design.

Cerebrospinal fluid (CSF) and serum will be collected prior to treatment and again at Weeks 0, 8, and 16 to assess changes in various neurotropic, neurodegenerative, and inflammatory factors (e.g., VEGF, HGF, NfL, NfH, MCP-1, IL-6), markers associated with amyloid deposition (e.g., a40, a42), and markers of tau protein levels (e.g., p-tau, t-tau). Additional clinical outcome measures will be analyzed through administration of the following tests:

Clinical Dementia Rating ScaledSum of Boxes (CDR-SB)

Free and Cued Selective Reminding Test (FCSRT)

Neuropsychological Test Battery (NTB)

Delis-Kaplan Executive Function System (D-KEFS) subtests

Mini Mental State Examination(MMSE)

AmsterdamInstrumentalActivitiesofDailyLivingQuestionnaire-ShortVersion(A-IADL-Q-SV)

Alzheimers Disease

Alzheimers disease (AD) is the most common form of dementia in older adults. The disease is named after Dr. Alois Alzheimer, who identified the first case in a 50-year-old woman named Auguste Deter in 1902. Dr. Alzheimer followed her case until her death in 1906, at which point he first publicly reported on it (Alzheimer, 1907).

After Ms. Deters death, Dr. Alzheimer examined her brain and found many abnormal clumps (now known as amyloid plaques) and tangled bundles of fibers (now known as neurofibrillary tangles). Over the next five years, 11 similar cases were reported in the medical literature, with some of them already using the term Alzheimers disease (Berchtold et al., 1998).

The most common early symptom of AD is a gradually worsening ability to remember new information. This is due to neurons associated with forming new memories dying off first. As neurons in other parts of the brain die, individuals experience different symptoms, which include:

Memory loss that disrupts daily life

Inability to plan or solve problems

Difficulty completing familiar tasks

Confusion with location and time

Difficulty with visual images and spatial relationships

Problems with words in speaking or writing

Withdrawal from social activities

Changes in mood, including apathy and depression

Each person progresses through AD at a different rate, and little is known about how or why there is such a marked variation, thus predicting how it will affect someone is quite difficult. One thing that is common to everyone diagnosed with AD is that his or her cognitive and functional abilities will gradually decline. As the disease progresses symptoms can include confusion, irritability, aggression, mood swings, and long-term memory loss. In the final advanced stage of the disease, people need help with the basic activities of living (e.g., bathing, dressing, eating, and using the restroom), they lose the ability to communicate, fail to recognize loved ones, and eventually become bed bound and reliant on round-the-clock care (Frstl et al., 1999). The inability to move makes them more prone to infections, including pneumonia, which are often a contributing factor to the death of those with AD.

Competing Theories for the Cause of Alzheimers

The root cause of Alzheimers is still unknown; however, it is likely to involve a number of different factors as opposed to being due to one single cause. These factors are likely a combination of genetic, environmental, and lifestyle. There are a number of hypotheses that exist to explain the cause of the disease, with the two dominant hypotheses focused on amyloid and tau.

Amyloid hypothesis: This hypothesis proposes that extracellular beta-amyloid deposits are the fundamental cause of the disease (Hardy et al., 1991). Beta-amyloid is a fragment of the larger protein amyloid precursor protein (APP), mutations of which are known to cause FAD. Several lines of evidence support the amyloid hypothesis: 1) the location of APP is on chromosome 21, while those with Down Syndrome (trisomy 21) almost all show signs of AD by 40 years of age (Lott et al., 2005); 2) APOE4 is a major genetic risk factor for AD, and while apolipoproteins enhance the breakdown of beta-amyloid, some isoforms are less capable of performing this task than others, leading to more beta-amyloid buildup on the brain (Polvikoski et al., 1995); 3) mice that harbor a mutant form of APP develop amyloid plaques and Alzheimers-like pathology (Games et al., 1995). Lastly, amyloid plaques are readily identifiable by microscopy in the brains of AD patients (Tiraboschi et al., 2004). While the brains of many older individuals develop some plaques, the brains of AD patients show severe pathological changes specifically within the temporal neocortex (Bouras et al., 1994).

Tau hypothesis: Tau is a protein located mainly within the axonal compartment of neurons and is an important element in microtubule stabilization and neurite outgrowth. In AD, a proportion of tau protein becomes abnormally phosphorylated, dissociates from axonal microtubules, and accumulates in paired helical filaments inside the neuron (Goedert et al., 1991). When this occurs, the microtubules disintegrate causing the collapse of the neurons transport system (Igbal et al., 2005). Just as with beta-amyloid plaques, tau tangles are readily observable in the brains of those affected by AD.

In addition to amyloid and tau, inflammation has been an underappreciated and often overlooked mediator in patients with AD (Akiyama et al., 2000). A multitude of inflammatory markers are found in AD patients brains and a number of studies have shown a link between chronic inflammation and an increased risk of developing AD (Walker et al., 2017; Tao et al., 2018). Thus, a treatment such as NurOwn that can decrease inflammatory mediators could prove beneficial in AD patients.

On Track to Repot Topline Data from Phase 3 ALS Trial in 4Q20

On July 2, 2020, BrainStorm announced that all doses have been administered in the pivotal Phase 3 trial ofrecen NurOwn in patients with amyotrophic lateral sclerosis (ALS) and that it remains on track to report topline data in the fourth quarter of 2020.

The ongoing randomized, double blind, placebo controlled, multi-dose Phase 3 clinical trial is testing the ability of NurOwn to alter disease progression as measured by the ALSFRS-R (NCT03280056). Cells were extracted once from each patient prior to treatment, with all administrations of NurOwn derived from the same extraction of cells due to a cryopreservation process the company developed for long-term storage of mesenchymal stem cells (MSC). Just as with the companys prior studies, there was a 3-month run-in period prior to the first treatment with two additional NurOwn treatments occurring two and four months following the first treatment. The company is focusing the trial on faster-progressing ALS patients since those patients demonstrated superior outcomes in the Phase 2 trial of NurOwn.

BrainStorm Joins Russell 2000 and Russell 3000; Granted SME Status by EMA

On June 23, 2020, BrainStorm announced that its shares would be included in the Russell 2000 Index and the Russell 3000 Index. The annual reconstitution of the Russell indexes is done to capture the 4,000 largest U.S. stocks by market capitalization.

On June 15, 2020, BrainStorm announced that the company has been granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency (EMA). SME status allows the company to participate in a number of financial incentives including a 90-100% reduction in the EMA fee for scientific advice, clinical study protocol design, endpoints and statistical considerations, quality inspections of facilities, and fee waivers for selective EMA pre- and post-authorization regulatory filings, including Orphan Drug and PRIME designations.

Conclusion

Were excited about the potential for NurOwn in AD and we look forward to the initiation of the Phase 2a trial later in 2020. We have recently made a few changes to our model, including the inclusion of NurOwn in AD and lowering of the discount rate from 20% to 15% for all indications. We model for the company to file for approval of NurOwn in AD in 2026 and to be granted approval in 2027. We currently estimate peak sales of over $2 billion for NurOwn in AD in both the U.S. and E.U. Using a 25% probability of approval leads to an NPV of $113 million. Combined with the NPV for NurOwn in ALS ($700 million) and MS ($41 million) along with the companys current cash position and potential cash from warrants leads to a valuation for the company of a bit less than $900 million. Dividing by the companys current fully diluted share count of 35.7 million leads to a valuation of $25 per share.

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BCLI: KOL Event Gives Overview of the use of NurOwn in Alzheimer's Disease; Raising Valuation to $25/Share - Zacks Small Cap Research

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Global Neuropathy Pain Treatment Market 2020-2024 The analyst has been monitoring the neuropathy pain treatment market and it is poised to grow by $ 1702. 89 mn during 2020-2024 progressing at a CAGR of 5% during the forecast period.

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The Global Neuropathy Pain Treatment Market is expected to grow by $ 1702.89 mn during 2020-2024 progressing at a CAGR of 5% during the forecast...

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Market segment by Type, the product can be split into:Product Type Segmentation: Epicel, IntegraIndustry Segmentation: Chemical, Cosmetic, Pharmaceutical

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