Evotec is building a gene therapy R&D center manned by ex-Takeda scientists and has already landed a multi-year drug discovery pact for it with their former Japanese employer.

Evotecis expanding into the field of gene therapy by building an R&D center in Austria using scientists previously employed by Takeda, whose first project will be a long-term research and discovery project with their former Japanese employer, exploring oncology, rare diseases, neuroscience and gastroenterology.

The entry by the German discovery alliance and development partnership group into gene therapy further expands its capabilities beyond small molecules, cellular therapies and biologics while the research alliance withTakeda Pharmaceutical, announced on 6 April, builds upon an existing collaboration begun last September around drug discovery programs in which Evotec will deliver clinical candidates for Takeda to pursue into clinical development.

Image: iStock/sittithat tangwitthayaphum

This addition of gene therapy is the latest step in a very long strategy at Evotec to build a truly comprehensive organization which can deliver medicines discovery and development right across the different modalities, or scientific tools, that we see in modern medicine today, Evotec chief operating officer Craig Johnstone toldScrip.

He said the move was consistent with Evotecs two-pronged drug discovery strategy, which uses the Hamburg-based groups so-called Execute segment allying with external pharma partners which in turn supports reinvestment into Evotecs internal pipeline within its so-called Innovate segment.

This allows us to bring gene therapy project concepts into the Evotec Innovate pipeline at our choice and discretion. That was not possible before, so we can now use gene therapy to support our partners and also use it to support ourselves.

Johnstone said Evotec already makes broad use of CRISPR in its discovery and development activities. This will only amplify that aspect of Evotecs activities, he added.

Evotec Gene Therapy (Evotec GT) will start operations with a team of gene therapy experts at an R&D site in Orth an der Donau, Austria. Its scientists have deep expertise in vectorology and virology as well as disease insights, in particular in hemophilia, hematology, metabolic and muscle diseases.

We are recruiting the team, which will be composed of ex-Takeda employees. Its leadership has a long history in gene therapy stretching back years and to legacy organizationsBaxaltaandShire which were acquired by Takeda, but who were made redundant. Well be bringing them all on board over the next eight weeks, Johnstone said. Friedrich Scheiflinger, previously head of drug discovery for Takeda in Austria, will head up the new gene therapy unit.

No financial details were disclosed about Evotecs latest collaboration with Takeda.

Its a fairly straight-forwardcontractual framework that has been agreed between Evotec and Takeda, Johnstone said, without elaborating.

Sten Stovall is a London-based editor and writer with 40 years of experience in the field of journalism, including more than 20 years with Reuters and eight years with The Wall Street Journal/Dow Jones Newswires. He can be reached at sten.stovall@informa.com

Originally posted here:
Evotec extends Takeda pact to gene therapy - Bioprocess Insider - BioProcess Insider

Recommendation and review posted by Bethany Smith

REDWOOD CITY, Calif., April 20, 2020 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced the appointment of Scott Whitcup, M.D. to the Companys Board of Directors.

We are delighted to welcomeScott to our board, said Patrick Machado, J.D., Board Chair of Adverum Biotechnologies. Scott's expertise and accomplished track record as an ophthalmologist and successful drug developer fit perfectly with Adverum's mission to substantially elevate the standard of clinical care for patients suffering from neovascular AMD and other vision-threatening indications. My colleagues and I all look forward to working with Scott to realize fully the significant potential benefits our technology offers patients at risk of losing their sight.

This is an exciting time to join Adverums Board as the company strategically executes on expanding its pipeline through its novel vector discovery and drug development expertise to commercialize gene therapies to treat patients with serious ocular and rare diseases, said Dr. Whitcup. The development progress of ADVM-022, including the promising clinical data demonstrated to date in the OPTIC trial, has been impressive. I look forward to partnering with the Board, and the Adverum management team, on further developing the pipeline of drug candidates and advancing ADVM-022 towards commercialization for patients with wet AMD and diabetic retinopathy.

Scott Whitcup, M.D. is the founder and chief executive officer of Akrivista and Whitecap Biosciences, two companies focused on developing new therapies in ophthalmology and dermatology. In addition, he is on the clinical faculty at the UCLA Stein Eye Institute. Previously, Dr. Whitcup was the executive vice president of research and development and chief scientific officer at Allergan, where he led the discovery, clinical development, and medical affairs organizations focused on therapeutic areas including ophthalmology, CNS, urology, dermatology, and medical aesthetics. Earlier at Allergan, he served as vice president and head, ophthalmology therapeutic area, where he secured regulatory approvals for Alphagan P, Lumigan, Restasis, and Ozurdex. Earlier in his career, Dr. Whitcup was the clinical director at the National Eye Institute at the National Institutes of Health (NIH). Dr. Whitcup earned a B.A. from Cornell University and an M.D. from Cornell University Medical College. He completed an internal medicine residency at UCLA and an ophthalmology residency at Harvard University at the Massachusetts Eye and Ear Infirmary.

Dr. Whitcup serves on the board of directors of Scilex Pharmaceuticals and Anivive Lifesciences.

About Adverum BiotechnologiesAdverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is evaluating its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of its lead indication, wet age-related macular degeneration. For more information, please visit http://www.adverum.com.

Investor and Media Inquiries:Investors:Myesha LacyAdverum Biotechnologies, Inc.mlacy@adverum.com1-650-304-3892

Media:Cherilyn Cecchini, M.D.LifeSci Communicationsccecchini@lifescicomms.com 1-646-876-5196

Excerpt from:
Adverum Biotechnologies Appoints Ophthalmology Industry Veteran Scott Whitcup, M.D. to Board of Directors - GlobeNewswire

Recommendation and review posted by Bethany Smith

LOS ANGELES--(BUSINESS WIRE)-- T-Cure Bioscience, Inc., a privately held company focused on developing autologous T cell receptor (TCR) therapy products for the treatment of solid tumors, today announced the appointment of seasoned biopharmaceutical industry executive James G. McArthur, Ph.D. to the Companys Board of Directors. Dr. McArthur brings more than 25 years of experience in drug development, financial, strategic and operational experience. Dr. McArthur has successfully founded five biotech companies and brings extensive knowledge of the healthcare space, having led companies through all phases of development from technology assessment through lead identification and proof of concept human studies.

James extensive knowledge of and experience with all aspects of drug development as well as his broad healthcare industry connections will be vital as we advance the clinical development of our TCR product candidates for the treatment of tumors expressing KK-LC-1 in collaboration with the National Cancer Institute, stated Gang Zeng, Ph.D., Chief Executive Officer of T-Cure. Dr. McArthur has previously established multiple successful biotechnology companies, led the R&D efforts to build out portfolios from the ground up, and found validating partnership opportunities with big pharma. This experience will be essential as T-Cure progresses its pipeline and increases its focus on product development efforts moving forward.

Dr. McArthur is a founder, a member of the Board of Directors and formerly served as CEO of Imara, Inc., a public clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin. He was also a founder of Vtesse, a company developing drugs for patients suffering from Niemann-Pick Type C1 Disease, which was subsequently acquired by Sucampo Pharmaceuticals, and most recently founded Tiburio, a clinical stage company focused on rare neuroendocrine disorders. Prior to co-founding Imara, Vtesse and Cydan, Dr. McArthur was an entrepreneur-in-residence at HealthCare Ventures. There, he helped to create and then served as Chief Scientific Officer of Synovex Co., a rheumatoid arthritis therapeutic company which was subsequently acquired by Roche. He has extensive research and development expertise in a number of areas including rare diseases, oncology, hematologic diseases, vascular diseases as well as gene therapy. Dr. McArthur is a listed investor on 15 issued patents and multiple patent applications. He previously served as a member of the Board of Directors of Nightstar Therapeutics, a clinical stage gene therapy company which was acquired by Biogen. Dr. McArthur obtained a PhD in biochemistry and oncology at McGill University and was a post-doctoral fellow studying Immunology at Massachusetts Institute of Technology and the University of California at Berkeley with Noble laureate James Allison.

About T-Cure Bioscience, Inc.

T-Cure Bioscience, Inc. is an innovative immuno-oncology company committed to delivering effective and durable cell therapies for the treatment of cancer. The Company focuses on isolating high avidity TCR that can be used to engineer a patients T cells to effectively target and destroy solid tumors. The Company maintains a pipeline of TCR under clinical and pre-clinical development targeting HERV-E, KK-LC-1, NY-ESO-1 and other antigens associated with solid tumors with significant unmet medical needs, including kidney cancer, breast cancer, lung cancer, gastric cancer, ovarian cancer, liver cancer, pancreatic cancer, sarcoma, and glioblastoma.

More information is available at http://www.T-Cure.com.

Forward Looking Statements

T-Cure cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industrys actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as may, might, will, should, could, expect, plan, anticipate, believe, estimate, project, intend, future, potential or continue, and other similar expressions are intended to identify forward looking statements. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that we expected. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200420005106/en/

More:
T-Cure Bioscience Announces Appointment of Seasoned Industry Executive James G. McArthur, Ph.D. to Board of Directors - BioSpace

Recommendation and review posted by Bethany Smith

Global Blood Therapeutics reports Q4 earnings, summarizes upcoming catalysts

Global Blood Therapeutics' (GBT) novel sickle cell disease drug, Oxbryta, has officially hit the market, netting a mere $2M in revenue. Meanwhile, R&D costs have nearly doubled in the last year. SG&A costs have nearly tripled! Such is expected when launching a drug, but the question is always, "to what extent is it tolerable?"

Global Blood hopes, following a non-dilutive loan, to be cash flow positive before having to resort back to dilution again:

Entered into a $150 million loan agreement with funds managed by Pharmakon Advisors LP, and drew down on the first $75 million of the non-dilutive loan. The proceeds will be used to advance the discovery and development of potential novel treatments for SCD and other grievous blood-based conditions without diverting financial resources from the launch of Oxbryta. GBT believes that the proceeds from this loan, in conjunction with existing cash and investments, have the potential to provide the necessary runway for the company to achieve positive cash flow while enabling the continued advancement of clinical development programs and other earlier-stage product candidates.

Source: GBT

The company has nearly $700M in cash and investments. This can be expected to get them through mid-2021, even with an additional $75M pending from the loan. I highly doubt the company will be cash flow positive before 2022 and suspect Global Blood will have to dilute once more. This will hopefully occur at a more advantageous pricing and following good news (e.g. successful confirmatory trial, strong sales ramp).

On the clinical front, GBT continues to enroll patients into the confirmatory TCD study.

Source: GBT March '20 corporate slides

Success would likely expand the label to children under the age of 12 as well. The confirmatory trial would also serve to prove its clinical benefit, which Oxbryta has yet to do. Accelerated approval was granted because Oxbryta is theoretically likely to procure a clinical benefit. If the confirmatory trial is to fail, Oxbryta would be pulled from the market and one would have to ask if the drug is a viable one at all. However, I propose success in the TCD trial is likely:

Source: GBT Nov. '19 corporate slides

Remaining catalysts are summarized below:

Source: GBT March '20 corporate slides

Global Blood is also involved with a few non-pivotal trials that aim to shed light on their therapeutic:

Despite achieving accelerated approval and grabbing nearly $90/share in a bull market, major catalysts and upside remain for Global Blood.

While I am not super positive about Oxbryta's revenue prospects prior to full approval, I do expect major clinical developments over the next several months. Such clinical developments could help shed light on the clinical effects of Oxbryta beyond hemoglobin improvement. Global Blood Therapeutics remains a conviction idea as I believe Oxbryta is a game-changer in sickle cell disease due to its ability to improve hemoglobin levels without a worsening of blood viscosity. A ~$3.5B enterprise valuation for Global Blood does not yet fully consider its potential in sickle cell.

Risks include, but are not limited to: Oxbryta confirmatory trial failure, dilution, Oxbryta safety and/or efficacy issues, poor Oxbryta market performance, competition (e.g. gene therapy), and US recession.

To expand on competitive risks, I do not believe gene therapy will serve as a major competitor to Oxbryta within the drug's relevant market time (patent expires in several years). As I've touched upon in previous articles, sickle cell patients are weary of curative therapies and gene therapy would be very costly and for only a select few. Furthermore, I am not aware of any additional drugs in development that share the potentially disease-modifying mechanism of action that Oxbryta bears.

I present and update my best ideas & biotech research only to subscribers of my exclusive marketplace, The Formula. I also maintain a model portfolio of my top biotech ideas whichoutperformed the market (XBI, IBB, SPY) by over 16% in 2019!

Try a free, no-risk 2-week trial today by clicking the flask below!

Disclosure: I am/we are long GBT. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: The intention of this article is to provide insight, not investment advice. While the information provided in this article is intended to be factual, there is no guarantee and prospect investors are encouraged to do their own fact-checking and research before investing in a company. One must also consider one's own financial standings, risk tolerance, portfolio diversification, etc. before making a decision to buy shares in a company. Many of my articles detail biotechnology companies with little or no revenue. These stocks are, therefore, speculative and volatile. Even when prospects seem promising, there is no predicting the future. Losses incurred may be significant.

Here is the original post:
Global Blood Therapeutics: Key Catalysts Remain As The Search For Clinical Benefit Continues - Seeking Alpha

Recommendation and review posted by Bethany Smith

Competitive landscape section of this Gene Therapy Products Mreport covers strategic profiling of key players in the market, comprehensively analyzing their core competencies, and strategies. The global market document compiles exhaustive information acquired through proven research methodologies and from dedicated sources across several industries. Gene Therapy Products market report puts forth an absolute overview of the market that contains various aspects of market analysis, product definition, market segmentation, key developments, and existing vendor landscape. This Gene Therapy Products market document also includes geographical markets and key players that have adopted significant strategies for business developments.

Get ExclusiveSample Copy of This Report Herehttps://www.databridgemarketresearch.com/request-a-sample?dbmr=global-gene-therapy-products-market

Global gene therapy products market is set to witness a substantial CAGR in the forecast period of 2019- 2026. The report contains data of the base year 2018 and historic year 2017. Rising cancer cases and unused potential for emerging markets are the major factors for the growth of this market.

Few of the major competitors currently working in the globalgene therapy products marketareAdaptimmune., Anchiano Therapeutics, bluebird bio, Inc., CELGENE CORPORATION, GlaxoSmithKline plc., Merck KGaA, Novartis AG, Achieve Life Sciences, Inc., Spark Therapeutics, Inc., Abeona Therapeutics, Inc, Adverum, agtc, Arbutus Biopharma, Audentes Therapeutics, AveXis, Inc., CRISPR Therapeutics, Intellia Therapeutics, Inc and Gilead Sciences,Inc. among others.

Market Definition:Global Gene Therapy Products Market

Gene therapy or human gene therapy is a process which is used to modify gene for the treatment of any disease. Plasmid DNA, bacterial vector, human gene editing technology and viral vectors are some of the most common type of gene therapy products. The main aim of the gene therapy is to replace the dysfunctional genes. Somatic and germline are some of the most common type of the gene therapy.

Complete report on Global Gene Therapy Product Market Research Report 2019-2026 spread across 350 Pages, profiling Top companies and supports with tables and figures

Segmentation: Global Gene Therapy Products Market

Gene Therapy Products Market : By Product

Gene Therapy Products Market : By Application

Gene Therapy Products Market : ByGeography

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Key Developments in the Gene Therapy Products Market:

Gene Therapy Products Market Drivers

Gene Therapy Products Market Restraints

Competitive Analysis: Gene Therapy Products Market

Global gene therapy products market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of gene therapy products market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

Key questions answered in the report :-

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Gene Therapy Products Market Shows Evolving Opportunities in 2020. Major Players are Adverum, agtc, Arbutus Biopharma, Audentes Therapeutics, AveXis...

Recommendation and review posted by Bethany Smith

Pairwise will blend CRISPR gene-editing technology with germplasm of existing berries to create new varieties. Plant Sciences, Inc. (PSI), a berry breeder and ag research company in California, will be Pairwises germplasm provider.

As a result of this fruitful partnership, consumers could see new varieties of black raspberries, red raspberries and blackberries in the supermarkets produce aisle within a few years.

Together, Pairwise and PSI aim to improve berries taste and convenience while also increasing their shelf life and off-season availability.

PSI will use its commercial nurseries to initially grow the new crop plantlets. Pairwise and PSI ultimately will license farmers to plant, grow and produce the new berries.

At Pairwise, we want to make healthy eating easier, said the companys CEO Tom Adams, Ph.D. Now, more than ever, people are focused on their food options and looking for ways to make healthy choices at home. Through the collaboration with PSI, we are moving from science partnerships to product partnerships that will bring new berries to market.

Gene editing and berry (trait) pickingWith CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) gene-editing technology, Pairwise will modify the DNA sequences of berry germplasm supplied by PSI. Pairwise will pick (or retain) good traits and dispose of less desirable traits to cultivate new berry variations.

Pairwise has licensing agreements with Massachusetts General Hospital (MGH) and the Broad Institute of MIT and Harvard for the CRISPR gene-editing technology that makes its berry breeding possible. Pairwise has the exclusive license to specific MGH CRISPR technology for developing agricultural applications.

In a previous interview with the North Carolina Biotechnology Center, Adams explained genomics and data science enable the company to breed the best berry. It is not developing genetically modified, or GMO, berries, which could include adding genes from different organisms.

We really have a mission to drive up consumption of fruits and vegetables through improvements of the crops and making them more available to people, said Adams.

For example, black raspberries have a limited growing season and are not widely available to American consumers. They naturally have five times more antioxidants than blueberries. With genetic modification, black raspberries could grow year-round and become much more available.

The Pairwise/PSI collaboration builds on a unique public/private partnership Pairwise and PSI previously established with the U.S. Department of Agriculture and several leading academic institutions to identify diverse, novel types of berries that are not broadly bred for commercial sale today.

Pairwise is one of the Triangle areas fast-growing agriculture and food biotech companies. Founded in 2018, Pairwise credits the North Carolina Biotechnology Center for being a supportive partner during its startup days.

Now the company is garnering national attention. Its even featured in a new documentary from CNBC Digital,How Scientists Create New Fruits & Vegetables, in which Chief Business Officer Haven Baker is featured in some of the interview segments.

For more information:www.ncbiotech.orgpairwise.comwww.plantsciences.com

More here:
Improving berries through CRISPR - hortidaily.com

Recommendation and review posted by Bethany Smith

One of the major limitations of the first-generation rDNA-based GM methods is the randomness of DNA insertions into plant genomes, just as the earlier mutagenesis methods introduced mutations randomly. The newer methods increase the specificity and precision with which genetic changes can be made. Known under the general rubric of sequence-specific nuclease (SSN) technology or gene/genome-editing, this approach uses proteins or protein-nucleic acid complexes that bind to and cut specific DNA sequences.1 SSNs include transcription activator-like effector nucleases (TALENs), zinc-finger nucleases (ZFNs), and meganucleases.2

[This is part three of a four-part series on the progress of agricultural biotechnology. Read part one, part two and part four.]

The DNA cuts made by SSNs are repaired by cellular processes that often either change one to several base pairs or introduce deletions and/or insertions (aka indels) at the target site. Another recently added technology capable of editing gene sequences is termed oligonucleotide-directed mutagenesis (ODM) and uses short nucleic acid sequences to target mutations to selected sites.3

The hottest and the coolest

What is rapidly emerging as the most powerful of the SSN technologies is known by the uninformative acronym CRISPR/Cas, which contracts the unwieldy designation clustered regularly interspaced short palindromic repeats (CRISPR)CRISPR-associated protein (Cas9). Its based on a bacterial defense system against invading viruses and promises extraordinary versatility in the kinds of genome changes that it can make.1,4

The CRISPR/Cas editing molecular machine is comprised of an enzyme (Cas9 and other variants) that binds an RNA molecule (called the guide RNA or gRNA) whose sequence guides the complex to the matching genomic sequence, allowing the Cas9 enzyme to introduce a double-strand break within the matching sequence. The CRISPR/Cas system can be used to edit gene sequences, to introduce a gene or genes at a pre-identified site in the genome, and to edit multiple genes simultaneously, none of which could be done with rDNA methods.1,5

Many of the genetic changes created using either SSN or ODM are indistinguishable at the molecular level from those that occur in nature or are produced by mutation breeding. Since both spontaneous mutants and chemical- and radiation-induced mutants have been used in crop improvement without regulation, there is no scientific rationale for regulating mutants produced by the newer methods. In hopes of creating a distinction that will permit exemption of gene-edited crops from regulation, the newer methods are increasingly referred to as new plant breeding techniques (NPBTs or just NBTs).

Quick successes for NBTs?

Prime targets of gene editing are cellular proteins that are involved in pathogenesis.6 Virus reproduction requires the recruitment of cellular proteins for replication, transcription and translation. There can be sufficient redundancy in the requisite protein infrastructure so that partial or complete virus resistance can be achieved by disrupting genes that code for proteins required for viral replication without damaging crop productivity.

For example, work with mutants of the model plant Arabidopsis identified translation initiation factor eIF4E as required for potyvirus translation. CRISPR/Cas-induced point mutations and deletions have recently been reported to enhance viral resistance not only in Arabidopsis, but in cucumber and cassava, as well.7

The many ways that plants and their bacterial and fungal pathogens interact offer opportunities to use gene editing to enhance plant disease resistance and reduce agricultures dependence on chemical control agents.6 The two main strategies are to inactivate genes whose products render the host plant sensitive to pathogen invasion and to enhance the ability of the host plant to resist invasion by providing functional resistance factors they lack.

An example of the former is provided by the mildew resistance resulting from the inactivation of all three homeoalleles of the mildew resistance locus (MLO) of hexaploid wheat.8 The efficiency of targeting both multiple alleles and multiple loci has taken a further jump with the development of multiplexed gene editing using vectors carrying several gRNA sequences capable of being processed by cellular enzymes to release all of them. This allows the gRNAs to edit multiple genes simultaneously.9

The second approach is to capitalize on the formidable arsenal of resistance genes residing in plant genomes.10 Fungal resistance genes have long been a major target of breeders efforts and have proved frustratingly short-lived, as pathogens rapidly evolve to evade recognition.11 While desirable resistance genes missing from domesticated crops still reside in wild relatives, extracting them by conventional breeding methods can be time-consuming or impossible.

European academic researchers created transgenic potatoes resistant to the late blight (Phytophthora infestans) that caused the Irish potato famine by inserting resistance (R) genes cloned from wild potato species into commercial potato varieties.12 A blight-resistant variety, called the InnateTM Generation 2 potato, is being commercialized by J.R. Simplot company in the U.S. and Canada and is already being marketed in the U.S. as the White Russet TM Idaho potato.13 Transgenic disease-resistance traits have been introduced in other crops, but have yet to be commercialized.14

Plant genomes contain hundreds to thousands of potential R genes, but it is not yet possible to determine whether a given one will confer resistance to a particular pathogen. Methods are currently being developed to accelerate the identification and cloning of active ones.14 Once identified, CRISPR/Cas can be used to introduce cassettes carrying multiple R genes, making it possible to create more durable resistance than can be achieved by introducing a single R gene through conventional breeding14. Finally, direct editing of resident inactive R genes using a ribonucleoprotein (RNP) strategy that avoids creating a transgenic plant may prove useful, although no such products appear to be in the pipeline to commercialization at present.15,16

Multiplexed editing has proved particularly useful for editing genes in polyploid species. For example, Cas9/sgRNA-mediated knockouts of the six fatty acid desaturase 2 (FAD2) genes of allohexaploid Camelina sativa was reported to markedly improve the fatty acid composition of Camelina oil.17 Using a different approach, Yield10 Biosciences is moving toward commercialization of a high-oil Camelina developed by editing a negative regulator of acetyl-CoA carboxylase.18

As of this writing, the only gene-edited product that has been commercialized is a soybean oil with no trans-fat, trademarked CalynoTM, developed by Calyxt.19 Gene-edited crops that have been approved but not commercialized or are still in the regulatory pipeline include miniature tomatoes, high-fiber wheat, high-yield tomatoes, improved quality alfalfa, non-browning potatoes and mushrooms, as well as high starch-content and drought-resistant corn, most being developed by small biotech companies.19

Getting beyond the low-hanging fruit

It is becoming increasingly clear that yield increases in our major crops by traditional breeding approaches are not keeping pace with demand.20 The gap is likely to widen as climate warming moves global temperatures farther from those prevailing when our crops were domesticated.

Overexpression of stress-related transcription factors has been reported to increase yields under water-stress conditions, but such increases are generally not maintained under optimal conditions.21 Monsantos drought-tolerant (Genuity DroughtGardTM) corn hybrids are based on the introduction of bacterial chaperone genes.22 Fortunately, research into drought stress tolerance in wheat and other grains continues apace, although no drought-tolerant varieties have yet reached farmers.23

Real progress on crop yield is slow. What stands in the way is that we have so limited an understanding of how plants work at the molecular level. At every level of analysis, organisms are redundant networks of interconnected proteins that adjust their manifold physical and enzymatic interactions in response to internal signals and external stimuli, then send messages to the information storage facilities (DNA) to regulate their own production and destruction rates.

As well, many genes are present in families of between two and hundreds or thousands of similar members, making it difficult to determine either the function or the contribution of any given member to a complex trait such as stress tolerance or yield. That said, gene family functions are identifiable and some, such as transcription factor genes, encode proteins that influence multiple other genes, making them among the likeliest candidates for manipulation. Indeed, studies on the genetics of domestication often point to changes in transcription factor genes.24

But while there have been reports that constitutive overexpression of single transcription factor gene can increase grain yield in both wheat and maize, none appear to have been commercialized yet.25 The challenge of developing a yield-improved variety by simply overexpressing transcription factor genes is illustrated by a recent report from Corteva.26 It describes a tour-de-force involving generation and testing of countless transgenic plants to identify a single transcription factor gene, ZMM28, that reproducibly increased yield when incorporated into 48 different hybrids and tested over a 4-year period in 58 locations.26

Getting there by a different route

Might gene-editing facilitate the task of generating and identifying yield-enhancing genetic variation? While the CRISPR/Cas toolkit is growing at dizzying speed, its utility in crop improvement has so far been limited to the simple traits controlled by individual genes, albeit including multiple alleles.1,27

Crop domestication and plant breeding have vastly narrowed genetic diversity because the very process of selecting plants with enhanced traits imposes a bottleneck, assuring that only a fraction of the ancestral populations genetic diversity is represented in a new elite variety. This, in turn, limits what can be done by mutagenizing existing elite varieties, a process that is also burdened with the necessity to eliminate deleterious mutations through back-crossing.

But to widen the genetic base and to modify genes that contribute to quantitative traits, it is still first necessary to identify the genes that contribute to agronomically important traits. Identifying such genes is currently a slow and tedious process of conventional and molecular mapping.28 A recent report describes a method for combining pedigree analysis with targeted CRISPR/Cas-mediated knockouts that promises to markedly accelerate the identification of the individual contributing genes in the chromosomal regions that are associated with quantitative traits, technically known as quantitative trait loci (QTLs).29

Even as the QTL knowledge gap narrows, gRNA multiplexing is extending the power of SSNs to understanding and modifying complex traits in crop plants. For example, using multiplexed gRNAs, Cas nuclease was simultaneously targeted to three genes known to be negative regulators of grain weight in rice.30 The triple mutants were reported to exhibit increases in the neighborhood of 25% in each of the three grain weight traits: length, width and thousand grain weight.

In another study, 8 different genes affecting rice agronomic traits were targeted with a single multiplexed gRNA construct and all showed high mutation efficiencies in the first generation.31 Conversely, it has been reported that editing the same QTLs gives different outcomes in different elite varieties, improving yield in some but not other.32

Mutations affecting the expression of regulatory genes, such as transcription factors genes, account for a substantial fraction of the causative genetic changes during crop domestication.33 Multiplexed gRNAs constructs targeting cis-regulatory elements (CREs) have been used to generate large numbers of allelic variants of genes affecting fruit size in tomato, mimicking some of the mutations accumulated during domestication and breeding of contemporary tomato varieties.34

Knowledge of domestication genes can also be used to accelerate domestication of wild plants that retain traits of value, such as salt tolerance, as reported for tomato.35 This opens the possibility of rapidly domesticating wild species better adapted to the harsher climate conditions of the future.

While the above-described advances have been based on the CRISPR/Cas-mediated deletions, approaches to more precise sequence editing are developing as well. While Cas-generated cuts in the DNA are most commonly repaired by the non-homologous end joining pathway (NHEJ), the less frequent homology-directed repair pathway (HDR) has been shown to edit sequences at useful frequencies using Cas-gRNA ribonucleoprotein complexes.15,36

As well, mutant Cas9 proteins lacking nuclease activity have been fused with base-editing enzymes such as cytidine and adenosine deaminases to direct gene editing without DNA cleavage.37,38 This approach can change single base pairs precisely in both coding and non-coding regions, as well alter mRNA precursor processing sites.38 Finally, the sequence targeting properties of the CRISPR-Cas system can be used to deliver other types of hybrid proteins to target sequences to regulate gene expression and DNA methylation.27

In sum, the many variations on gene editing now developing hold the promise of revolutionizing crop breeding, prompting several colleagues to whimsically title a recent review of CRISPR/Cas-based methodology: Plant breeding at the speed of light.39 And indeed, the new methods make it possible to replace chemicals with biological mechanisms in protecting plants from pests and disease, as well as increase their resilience to stress.

That said, extraordinary progress in increasing grain yields has already been accomplished by what are now considered to be traditional breeding methods and increased fertilizer use. Further improvements continue, but will likely be harder won than the many-fold increases in corn, wheat and rice yields of the last century and its Green Revolution. But there is a persistent disconnect between what can be done to accelerate plant breeding using the new gene-editing toolkit and what is actually being done by both the public and private sectors to get varieties improved by these methods out to farmers.

1Zhang Y et al. (2019). The emerging and uncultivated potential of CRISPR technology in plant science. Nature Plants 5:778-94.

2Podevin N et al. (2013). Site-directed nucleases: a paradigm shift in predictable, knowledge-based plant breeding. Trends Biotechnol 31:375-83.

3Sauer NJ et al. (2016). Oligonucleotidedirected mutagenesis for precision gene editing. Plant Biotechnol J 14:496-502.

4Zhang D et al. (2016). Targeted gene manipulation in plants using the CRISPR/Cas technology. J Genet Genomics 43:251-62.

5Cong L et al. (2013). Multiplex genome engineering using CRISPR/Cas systems. Science 339:819-23.

6Borrelli VM et al. (2018). The enhancement of plant disease resistance using CRISPR/Cas9 technology. Frontiers Plant Sci 9:Article 1245.

7Chandrasekaran J et al. (2016). Development of broad virus resistance in nontransgenic cucumber using CRISPR/Cas9 technology. Molec Plant Pathol 17:1140-53; Pyott DE et al. (2016). Engineering of CRISPR/Cas9mediated potyvirus resistance in transgenefree Arabidopsis plants. Molec Plant Pathol 17:1276-88; Gomez MA et al. (2019). Simultaneous CRISPR/Cas9mediated editing of cassava eIF 4E isoforms nCBP1 and nCBP2 reduces cassava brown streak disease symptom severity and incidence. Plant Biotechnol J 17:421-34.

8Wang Y et al. (2014). Simultaneous editing of three homoeoalleles in hexaploid bread wheat confers heritable resistance to powdery mildew. Nature Biotechnol 32:947.

9Xie K et al. (2015). Boosting CRISPR/Cas9 multiplex editing capability with the endogenous tRNA-processing system. Proc Natl Acad Sci 112:3570-5; Wang W et al. (2018). Transgenerational CRISPR-Cas9 activity facilitates multiplex gene editing in allopolyploid wheat. The CRISPR J 1:65-74.

10Petit-Houdenot Y and Fudal I (2017). Complex interactions between fungal avirulence genes and their corresponding plant resistance genes and consequences for disease resistance management. Frontiers Plant Sci 8:1072.

11Bebber DP and Gurr S (2015). Crop-destroying fungal and oomycete pathogens challenge food security. Fungal Genet Biol 74:62-4; van Esse HP et al. (2020). Genetic modification to improve disease resistance in crops. New Phytol 225:70-86.

12Jones JD et al. (2014). Elevating crop disease resistance with cloned genes. Phil Trans Royal Soc B: Biol Sci 369:20130087; Haesaert G et al. (2015). Transformation of the potato variety Desiree with single or multiple resistance genes increases resistance to late blight under field conditions. Crop Protection 77:163-75.

13Halsall M. Innate outlook. Spudsmart, 24 April 2019 https://spudsmart.com/innate-outlook/

14Dong OX and Ronald PC (2019). Genetic engineering for disease resistance in plants: recent progress and future perspectives. Plant Physiol 180:26-38.

15Svitashev S et al. (2016). Genome editing in maize directed by CRISPRCas9 ribonucleoprotein complexes. Nature Communications 7:1-7.

16Mao Y et al. (2019). Gene editing in plants: progress and challenges. Nat Sci Rev 6:421-37.

17Morineau C et al. (2017). Selective gene dosage by CRISPRCas9 genome editing in hexaploid Camelina sativa. Plant Biotechnol J 15:729-39; Jiang WZ et al. (2017). Significant enhancement of fatty acid composition in seeds of the allohexaploid, Camelina sativa, using CRISPR/Cas9 gene editing. Plant Biotechnol J 15:648-57.

18Yield10 Bioscience (Jan 16, 2020 ). Yield10 Bioscience submits Am I Regulated? letter to USDA-APHIS BRS for CRISPR genome-edited C3007 in Camelina to pave the way for U.S. field tests. https://www.globenewswire.com/news-release/2020/01/16/1971418/0/en/Yield10-Bioscience-Submits-Am-I-Regulated-Letter-to-USDA-APHIS-BRS-for-CRISPR-Genome-Edited-C3007-in-Camelina-to-Pave-the-Way-for-U-S-Field-Tests.html

19Genetic Literacy Project (2020). Global Gene Editing Regulation Tracker. https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/united-states-crops-food/

20Ray DK et al. (2013). Yield trends are insufficient to double global crop production by 2050. PloS One 8:e66428.

21Rice EA et al. (2014). Expression of a truncated ATHB17 protein in maize increases ear weight at silking. PLoS One 9:e94238; Araus JL et al. (2019). Transgenic solutions to increase yield and stability in wheat: shining hope or flash in the pan? J Experimental Bot 70:1419-24.

22Castiglioni P et al. (2008). Bacterial RNA chaperones confer abiotic stress tolerance in plants and improved grain yield in maize under water-limited conditions. Plant Physiol 147:446-55.

23Mwadzingeni L et al. (2016). Breeding wheat for drought tolerance: Progress and technologies. J Integrative Agricult 15:935-43; Sallam A et al. (2019). Drought stress tolerance in wheat and barley: Advances in physiology, breeding and genetics research. Internat J Mol Sci 20:3137.

24Swinnen G et al. (2016). Lessons from domestication: targeting cis-regulatory elements for crop improvement. Trends Plant Sci 21:506-15.

25Nelson DE et al. (2007). Plant nuclear factor Y (NF-Y) B subunits confer drought tolerance and lead to improved corn yields on water-limited acres. Proc Natl Acad Sci 104:16450-5; Qu B et al. (2015). A wheat CCAAT box-binding transcription factor increases the grain yield of wheat with less fertilizer input. Plant Physiol 167:411-23; Yadav D et al. (2015). Constitutive overexpression of the TaNF-YB4 gene in transgenic wheat significantly improves grain yield. J Experiment Bot 66:6635-50.

26Wu J et al. (2019). Overexpression of zmm28 increases maize grain yield in the field. Proc Natl Acad Sci 116:23850-8.

27Chen K et al. (2019). CRISPR/Cas genome editing and precision plant breeding in agriculture. Annu Rev Plant Biol 70:667-97.

28Cavanagh C et al. (2008). From mutations to MAGIC: resources for gene discovery, validation and delivery in crop plants. Curr Opin Plant Biol 11:215-21.

29Huang J et al. (2018). Identifying a large number of high-yield genes in rice by pedigree analysis, whole-genome sequencing, and CRISPR-Cas9 gene knockout. Proc Natl Acad Sci 115:E7559-E67.

30Xu R et al. (2016). Rapid improvement of grain weight via highly efficient CRISPR/Cas9-mediated multiplex genome editing in rice. J Genet Genom 43:529.

31Shen L et al. (2017). Rapid generation of genetic diversity by multiplex CRISPR/Cas9 genome editing in rice. China Sci Life Sci 60:506-15.

32Shen L et al. (2018). QTL editing confers opposing yield performance in different rice varieties. J Integrative Plant Biol 60:89-93; Zhou J et al. (2019). Multiplex QTL editing of grain-related genes improves yield in elite rice varieties. Plant Cell Rep 38:475-85.

33Meyer RS and Purugganan MD (2013). Evolution of crop species: genetics of domestication and diversification. Nature Rev Genet 14:840-52.

34Rodrguez-Leal D et al. (2017). Engineering quantitative trait variation for crop improvement by genome editing. Cell 171:470-80. e8.

35Li T et al. (2018). Domestication of wild tomato is accelerated by genome editing. Nature Biotechnol 36:1160-3; Zsgn A et al. (2018). De novo domestication of wild tomato using genome editing. Nature Biotechnol 36:1211-6.

36Puchta H et al. (1996). Two different but related mechanisms are used in plants for the repair of genomic double-strand breaks by homologous recombination. Proc Natl Acad Sci 93:5055-60; Zhang Y et al. (2016). Efficient and transgene-free genome editing in wheat through transient expression of CRISPR/Cas9 DNA or RNA. Nature Communications 7:1-8.

37Komor AC et al. (2016). Programmable editing of a target base in genomic DNA without double-stranded DNA cleavage. Nature 533:420-4; Hua K et al. (2019). Expanding the base editing scope in rice by using Cas9 variants. Plant Biotechnol J 17:499-504.

38Kang B-C et al. (2018). Precision genome engineering through adenine base editing in plants. Nature Plants 4:427-31.

39Wolter F et al. (2019). Plant breeding at the speed of light: the power of CRISPR/Cas to generate directed genetic diversity at multiple sites. BMC Plant Biol 19:176.

Nina V. Fedoroff is an Emeritus Evan Pugh Professor at Penn State University

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Next-generation gene-editing technology: Path to a second Green Revolution? - Genetic Literacy Project

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Chinese Officials Confirm China Won't Restrict Exports of Medical Products Needed to Fight Coronavirus

Company in Late-Stage Negotiations to Secure Distribution Agreement for Additional COVID-19 IgG/IgM Rapid Test Which is Approved by China's National Medical Products Administration (NMPA)

ENGLEWOOD, CO / ACCESSWIRE / April 17, 2020 / Aytu BioScience, Inc. (AYTU), (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that export and delivery of the Company's incoming COVID-19 rapid tests remains on track as previously announced.

Additionally, the Company is in late-stage negotiations to secure rights to distribute a second COVID-19 IgG/IgM rapid test, which is approved by China's National Medical Products Administration (NMPA).

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "Since the Company began taking the fight to COVID-19, we have continued to aggressively search for and evaluate diagnostic tests and other novel technologies that may complement our current product offering and benefit COVID-19 patients. Also, given the nationwide shortage of tests, we believe we are obligated to secure as many additional tests as we can to help with this shortage. To that end, I am excited to say we're in the final stages of securing yet another IgG/IgM antibody rapid test for U.S. distribution. This test is already approved by China's NMPA, is being regularly exported from China, and has strong clinical performance. By securing this additional antibody test, we expect to have an even greater supply to fulfill the substantial demand we're experiencing. We all need to continue to do the very best we can to help COVID-19 patients and those medical professionals for whom they care."

Mr. Disbrow continued, "On March 31, an announcement was made by China's Ministry of Commerce restricting the export of medical materials that have not obtained approval from the NMPA. It is important to note that just yesterday the Associated Press released an article titled, China says no plans to limit export of anti-virus supplies.' The article states: Commerce Ministry spokesman Gao Feng said Beijing has taken steps to speed up customs clearance while ensuring the quality of exported epidemic-prevention goods. Gao said Thursday, China has not and will not restrict the export of epidemic prevention materials.' These statements provide us with confidence and are consistent with the information we continue to receive from our test kit licensor. We remain confident about the timely delivery of the Company's incoming order of COVID-19 IgG/IgM tests," commented Mr. Disbrow.

Mr. Disbrow concluded, "We have received further confirmation that the COVID-19 IgG/IgM Rapid Test manufactured by Zhejiang Orient Gene is in the approval process with NMPA. We remain highly confident in the test's clinical performance as recently demonstrated in a published, third-party peer-reviewed study and believe that the Zhejiang Orient Gene COVID-19 IgG/IgM Rapid Test is a reliable test in detecting COVID-19 antibodies. The independent study demonstrates test accuracy of 98.0% and 94.1% for IgG and IgM, respectively, when using PCR-positive cases as true positives, which we believe establishes strong clinical utility of the test."

The Company will continue to inform our stakeholders about our continuing developments relating to our COVID-19 fight and the progress of the Aytu BioScience business.

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Story continues

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing Zhejiang Orient Gene's COVID-19 Rapid Test (the "COVID-19 Rapid Test"), shipping delays or regulatory processes and their impact on our ability to introduce the COVID-19 Rapid Test, the ability of the COVID-19 Rapid Test to accurately and reliably test for COVID-19, Zhejiang Orient Gene's ability to manufacture the COVID-19 Rapid Test on a high volume scale, manufacturing problems, customs problems or delays related to the COVID-19 Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 Rapid Test Kit, the demand or lack thereof for the COVID-19 Rapid Test Kit, Zhejiang Orient Gene's ability to obtain approval from China's National Medical Product Administration ("NMPA") to continue to manufacture and export the COVID-19 Rapid Test, the impact the ongoing disputes surrounding COVID-19 between the People's Republic of China and the United States of America may have on our ability to import additional COVID-19 Rapid Tests from Zhejiang Orient Gene, our ability to successfully identify and enter into an agreement with an alternative manufacture of a COVID-19 rapid test that is approved by the NMPA, the timing of any agreement with an alternative manufacture of a COVID-19 rapid test, any reputational or business harm that we may incur in the event the COVID-19 Rapid Test is not reliable or accurate in testing for COVID-19, any reputational or business harm that we may incur for selling the COVID-19 Rapid Test from a manufacture that is not currently approved by the NMPA, whether the testing standards of the NMPA are comparable to the FDA's standards and any market inference whether positive or negative that may be derived from selling rapid tests that are or are not manufactured by companies approved by the NMPA, scientific and market acceptance of antibody tests as acceptable tests for the detection of COVID-19, the reliability of independent third-party study as it relates to the measure of effectiveness of the COVID-19 Rapid Test, our ability to obtain COVID-19 rapid tests from NMPA approved manufactures on acceptable terms, our ability to meet the demand for COVID-19 rapid tests, unfavorable media coverage related to the COVID-19 Rapid Test, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

CONTACT:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/585517/Aytu-BioScience-Confirms-Export-and-Incoming-Delivery-of-COVID-19-IgGIgM-Rapid-Tests

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Aytu BioScience Confirms Export and Incoming Delivery of COVID-19 IgG/IgM Rapid Tests - Yahoo Finance

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Independent clinical study demonstrates test accuracy of 98.0% and 94.1% for IgG and IgM, respectively, when using PCR-positive cases as true positives

ENGLEWOOD, CO / ACCESSWIRE / April 16, 2020 / Aytu BioScience, Inc. (AYTU), (the "Company"), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that results from an independent clinical study using the Company's licensed Coronavirus Disease 2019 ("COVID-19") IgG/IgM Rapid Test were published in the journal Infection Ecology & Epidemiology, further validating the accuracy, specificity and performance of the antibody rapid test.

In this recently published clinical study which included 29 COVID-19 positive cases confirmed by PCR and 124 healthy donors, the rapid test showed an overall specificity of 100% and 99.2% for IgM and IgG, respectively. The authors note, "The high negative predictive value indicates that the rapid test will be useful for detecting past infections and possible immunity, which may be crucial for restoring social functions after lockdown."

Capillary blood samples or serum from PCR-confirmed COVID-19 patients were analyzed with results from the COVID-19 IgG/IgM Rapid Test. Sixty-nine percent of samples from PCR-confirmed COVID-19 patients tested IgM positive, and 93.1% tested IgG positive. These results are well in line with the previously reported specificity of 91.9% for IgG and IgM. The authors note that variability in samples obtained during COVID-19 disease or convalescence period means that in the PCR-confirmed cases, antibodies may not yet have had time to develop. If this were the case, sensitivities of the test could actually be higher.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented "This independently conducted study, which was peer-reviewed and published earlier this week, demonstrates the clinical performance of this COVID-19 IgG/IgM rapid test and establishes the test's utility in understanding a patient's past exposure to COVID-19 and its potential to assess patient immunity as we move past this pandemic and get our society back to work. We are happy to see a leading clinical institution further establish the clinical utility of this important serological test."

The COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma. This point-of-care test has now been validated in multiple independent trials and is CE marked.

https://www.tandfonline.com/doi/full/10.1080/20008686.2020.1754538

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the company's proprietary Beyond Human marketing and sales platform.

Story continues

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the completion of the registered direct offering, the satisfaction of customary closing conditions related to the registered direct offering and the intended use of net proceeds from the registered direct offering, the regulatory and commercial risks associated with introducing the COVID-19 Rapid Test, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

CONTACT:

James CarbonaraHayden IR(646) 755-7412james@haydenir.com

SOURCE: Aytu BioScience, Inc.

View source version on accesswire.com: https://www.accesswire.com/585321/Aytu-BioScience-Announces-Positive-Results-from-an-Independently-Conducted-Clinical-Study-of-the-Companys-Licensed-COVID-19-IgGIgM-Point-of-Care-Rapid-Test

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Aytu BioScience Announces Positive Results from an Independently Conducted Clinical Study of the Company's Licensed COVID-19 IgG/IgM Point-of-Care...

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Company Places Third Purchase Order for One Million Tests

ENGLEWOOD, CO / ACCESSWIRE / April 15, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs today provided an update on the supply and distribution of the company's licensed COVID-19 IgG/IgM Rapid Test. The company has sold or allocated the initial 100,000 tests to U.S. customers and is awaiting delivery of the next 500,000 tests.

Additionally, the company has increased the size of its third purchase order to one million tests. The company has been informed the order has been accepted by the manufacturer.

Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "The company has been working on multiple fronts to distribute the initial shipment of COVID-19 IgG/IgM Rapid Tests while coordinating the incoming supply of our next shipment of 500,000 tests. We are pleased that the manufacturer has completed this second order, which is now awaiting customs clearance. Further, we have been informed the manufacturer has accepted another purchase order, which was increased to one million tests. We are proud to be helping the medical community in delivering our initial shipment of tests to those professionals in need. We look forward to having additional supply to further fulfill the significant demand we have for COVID-19 tests. With the 500,000 tests now awaiting clearance, we'll be in a position to fulfill the pending orders very soon."

About Aytu BioScience, Inc.

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The Company currently markets a portfolio of prescription products addressing large primary care and pediatric markets. The primary care portfolio includes (i) Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist, the only FDA-approved oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved 12-hour codeine-based antitussive syrup. The pediatric portfolio includes (i) AcipHex Sprinkle, a granule formulation of rabeprazole sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor, a second-generation cephalosporin antibiotic suspension; (iii) Karbinal ER, an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor, two complementary prescription fluoride-based supplement product lines containing combinations of fluoride and vitamins in various for infants and children with fluoride deficiency. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test. This coronavirus test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole blood, serum or plasma.

Aytu recently acquired Innovus Pharmaceuticals, a specialty pharmaceutical company commercializing, licensing and developing safe and effective consumer healthcare products designed to improve men's and women's health and vitality. Innovus commercializes over thirty-five consumer health products competing in large healthcare categories including diabetes, men's health, sexual wellness and respiratory health. The Innovus product portfolio is commercialized through direct-to-consumer marketing channels utilizing the Company's proprietary Beyond Human marketing and sales platform.

Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com and visit innovuspharma.com to learn about the Company's consumer healthcare products.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as ''may,'' ''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,'' ''suggest,'' ''believe,'' ''estimate,'' ''continue,'' ''anticipate,'' ''intend,'' ''plan,'' or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: market and other conditions, the regulatory and commercial risks associated with introducing the COVID-19 IgG/IgM Rapid Test, shipping delays and their impact on our ability to introduce the COVID-19 IgG/IgM Rapid Test, our ability to enforce our exclusive rights to distribute the COVID-19 IgG/IgM Rapid Test in the jurisdictions set forth in the distribution agreement, the ability of the COVID-19 IgG/IgM Rapid Test to accurately and reliably test for COVID-19, the manufacture of the COVID-19 IgG/IgM Rapid Test's ability to manufacture such testing kits on a high volume scale, manufacturing problems or delays related to the COVID-19 IgG/IgM Rapid Test, our ability to satisfy any labelling conditions or other FDA or other regulatory conditions to sell the COVID-19 IgG/IgM Rapid Test Kit, the ability to obtain a sufficient number of COVID-19 IgG/IgM Rapid Test kits to meet demand if any, the demand or lack thereof for the COVID-19 IgG/IgM Rapid Test Kit, effects of the business combination of Aytu and the Commercial Portfolio and the recently completed merger ("Merger") with Innovus Pharmaceuticals, including the combined company's future financial condition, results of operations, strategy and plans, the ability of the combined company to realize anticipated synergies in the timeframe expected or at all, changes in capital markets and the ability of the combined company to finance operations in the manner expected, the diversion of management time on Merger-related issues and integration of the Commercial Portfolio, the ultimate timing, outcome and results of integrating the operations the Commercial Portfolio and Innovus with Aytu's existing operations, risks relating to gaining market acceptance of our products, obtaining or maintaining reimbursement by third-party payors for our prescription products, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ''Risk Factors'' in Part I, Item 1A of the company's Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.

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Aytu BioScience Provides Update on its Licensed COVID-19 IgG/IgM Rapid Test Supply and Ongoing U.S. Distribution - Yahoo Finance

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Before the COVID-19 pandemic, way back in the 1300s, there was a pestilence known as the Black Death, also called bubonic plague.

Estimated to have killed millions during several outbreaks, the bubonic plague is caused by a bacteria known as Yersinia pestis.

Although the new coronavirus pandemic has captured headlines and attention around the world over the past two months, bubonic plague has once again reared its head, this time in the Greater Yellowstone Ecosystem. Recently published research by Mark Elbrock and his associates showed 47% of the 17 cougars that were captured and had their blood drawn in the southern GYE tested positive for exposure to the plague.

This suggests that: (1) Y. pestis may be present at higher levels in the GYE than previously assumed, Elbrock wrote in the Cambridge University Press, noting that the disease was also found in four of 11 mountain lions that were necropsied. His co-authors were Winston Vickers and Howard Quigley.

Earlier sample

The study is not the first time that exposure to Y. pestis has been found in Greater Yellowstone Ecosystem cougars. In 2006 a study co-authored by Roman Biek and Toni Ruth, along with others, tested blood from 150 cougars collected over 15 years and found relatively low exposure to the bacteria less than 20%.

Ruth also found Yellowstone cougars in 2004 and 2005 that had succumbed to bubonic plague. When captured in the winter they were infested with fleas. The animals died in the following summer.

Its a relatively common bacteria found in wildlife, more so in southern drier areas, said Dan Stahler, leader of the Yellowstone National Park Cougar Project.

The bacteria is commonly transmitted by fleas that infest rodents, everything from mice to ground squirrels. The cougars, along with other predators like coyotes, are exposed to the virus when they catch and eat infected animals.

However, felines including bobcats and lynx seem to be more susceptible to Y. pestis than canines, Stahler said. For some reason bears appear impervious to such infections, he added.

Being aware of contagions is why Stahler and his team approach any dead animal cautiously while conducting wildlife research.

Precautions

Anyone in contact with animals needs to have such diseases at the forefront of their mind, he said.

Not to be fearful, or to panic, but its important to screen for it and be careful of it," he said.

In humans, bubonic plague causes enlarged lymph nodes in the armpits, groin and neck. It can also be accompanied by fever and muscle aches, along with other flu-like symptoms. Unlike COVID-19, it cant be transmitted from an infected person to others via respiratory droplets. Luckily, bubonic plague is also easily treated with a vaccine if caught soon enough.

According to Montana Fish, Wildlife and Parks website, detailed data on the distribution of plague in wildlife in Montana is not available, although it is believed to be present throughout the state. The most recent human case of plague in Montana was in 1992 when a hunter contracted the disease from a bobcat. In 1987, a hunter was infected after skinning an infected antelope.

Across the United States only about seven people a year are infected, according to the Centers for Disease Control and Prevention. More prevalent in the Southwest, the United States saw spikes in human infections in 2006 and 2015, according to the CDC.

Ferrets

Prairie dogs are another species that is often infected by bubonic plague. In trying to reintroduce black-footed ferrets across the West, outbreaks of plague have repeatedly frustrated scientists' efforts. Prairie dogs are the main food source for the ferrets, which also use the rodents dens as their living quarters.

The incidence of plague seems to increase in years with cooler summers that follow wet winters, Stahler said, possibly because those conditions are more conducive to flea survival.

Study

Yellowstone National Parks cougar study continued this winter with the capture of seven cougars. Eight of the big cats are now wearing GPS collars allowing researchers to track their movements.

Soon-to-be published research based on a graduate students work on non-invasive genetic testing, like hair samples, is being used to provide insight to the parks cougar population. Stahler said the work shows that in the Northern Range of the park which includes the Lamar Valley there are about 35 to 45 cougars, a robust population.

The research team also continues to collect data via remote camera traps, which also will help with population estimates of the secretive animals. At one elk calf carcass five different lions were photographed feeding over several days.

We had one cool trigger where a mule deer went racing by and was then followed by a cougar, Stahler said.

Another series showed a whitetail deer racing past a camera near Hellroaring Creek, soon followed by a wolf. The wolf later walked back past the camera looking dejected.

Unfortunately the parks winter predator study was cut short in mid-March due to the coronavirus pandemic, Stahler said. Yellowstone National Park was closed to the public on March 23.

We decided to get our people home safely, he said.

More:
Tale of bubonic plague in pumas revived by southern Yellowstone study - Walla Walla Union-Bulletin

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Analysis of the Global Predictive Genetic Testing And Consumer/Wellness Genomics Market

The report on the global Predictive Genetic Testing And Consumer/Wellness Genomics market reveals that the market is expected to grow at a CAGR of ~XX% during the considered forecast period (2019-2029) and estimated to reach a value of ~US$XX by the end of 2029. The latest report is a valuable tool for stakeholders, established market players, emerging players, and other entities to devise effective strategies to combat the impact of COVID-19

Further, by leveraging the insights enclosed in the report, market players can devise concise, impactful, and highly effective growth strategies to solidify their position in the Predictive Genetic Testing And Consumer/Wellness Genomics market.

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Competitive Landscape

The competitive landscape section offers valuable insights related to the business prospects of leading market players operating in the Predictive Genetic Testing And Consumer/Wellness Genomics market. The market share, product portfolio, pricing strategy, and growth strategies adopted by each market player is included in the report. The major steps taken by key players to address the business challenges put forward by the novel COVID-19 pandemic is discussed in the report.

Regional Landscape

The regional landscape section provides a deep understanding of the regulatory framework, current market trends, opportunities, and challenges faced by market players in each regional market. The various regions covered in the report include:

End-User Assessment

The report bifurcates the Predictive Genetic Testing And Consumer/Wellness Genomics market based on different end users. The supply-demand ratio and consumption volume of each end-user is accurately depicted in the report.

The following manufacturers are covered:IlluminaBGIGenesis GeneticsMyriad Genetics23andMe, IncColor Genomics IncPathway GenomicsARUP Laboratories

Segment by RegionsNorth AmericaEuropeChinaJapanSoutheast AsiaIndia

Segment by TypePredictive TestingConsumer GenomicsWellness Genomics

Segment by ApplicationBreast & Ovarian CancerCardiovascular screeningDiabetic Screening & MonitoringColon CancerOther

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Coronavirus business impact: Predictive Genetic Testing And Consumer/Wellness Genomics Market Size, Trends, Analysis, Regional Demand, Leading Players...

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Progenesis

Preimplantation Genetic Testing Market: Competitive Landscape

The last chapter of the Preimplantation Genetic Testing market research report focuses exclusively on the competitive landscape. It examines the main market players. In addition to a brief overview of the business, analysts provide information on their assessment and development. The list of important products in preparation is also mentioned. The competitive landscape is analyzed by understanding the companies strategies and the initiatives they have taken in recent years to overcome intense competition.

Preimplantation Genetic Testing Market: Drivers and Restraints

The report explains the drivers of the future of the Preimplantation Genetic Testing market. It assesses the different forces which should have a positive impact on the whole market. Analysts have looked at investments in research and development for products and technologies, which should give players a significant boost. In addition, the researchers undertook an analysis of the evolution of consumer behavior which should have an impact on the cycles of supply and demand in the Preimplantation Genetic Testing market. In this research report, changes in per capita income, improvement in the economic situation and emerging trends were examined.

The research report also explains the potential restrictions on the Preimplantation Genetic Testing market. The aspects assessed are likely to hamper market growth in the near future. In addition to this assessment, it offers a list of opportunities that could prove lucrative for the entire market. Analysts offer solutions to turn threats and restrictions into successful opportunities in the years to come.

Preimplantation Genetic Testing Market: Regional Segmentation

In the following chapters, analysts have examined the regional segments of the Preimplantation Genetic Testing market. This gives readers a deeper insight into the global market and allows for a closer look at the elements that could determine its evolution. Countless regional aspects, such as the effects of culture, environment and government policies, which affect regional markets are highlighted.

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Market Dynamics: The report contains important information on influencing factors, market drivers, challenges, opportunities and market trends as part of the market dynamics.

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Market Competition: In this section, the report provides information on the situation and trends of competition, including mergers and acquisitions and expansion, the market shares of the three or five main players and the concentration of the market. Readers could also get the production, revenue, and average price shares of manufacturers.

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BOSTON, April 17, 2020 /PRNewswire/ -- COVID-19 is an infectious disease caused by SARS-CoV-2. The outbreak of COVID-19 started in December 2019 with the first case reported in China. The World Health Organization (WHO) recognized the outbreak of COVID-19 as a pandemic on 11 March 2020. By April 2020, there are over 2 million confirmed cases, and it has brought the economies of many countries to a halt.

Diagnostic testing is possibly the only efficient way to monitor the spread of the SARS-CoV-2 in time and space, enabling policymakers and healthcare workers to track and mitigate the outbreak of COVID-19. The WHO has appealed for global mass testing. The demand for COVID-19 testing is estimated to be over 600 million tests, including 120 million genetic tests and over 500 million rapid tests.

The need for universal and massive testing across the population has led to a race for technology innovations for COVID-19 diagnostics. The new IDTechEx report, "COVID-19 Diagnostics", surveys the technology landscape, with an in-depth analysis of the technology innovations that are enabling quick access to COVID-19 diagnosis in response to the global pandemic.

Molecules derived from the virusnucleic acids like RNA or DNA, or proteinsform the basis of diagnostics, as well as being essential for developing new therapies and vaccines. Depending on the target biomarkers, the diagnostic methods can be separated into two categories: genetic testing (detecting the viral genome) and serological & antigenic testing (detecting antibodies and viral antigens, respectively). From the technological perspective, molecular diagnostics (MDx) and lateral flow assays (LAFs) dominate COVID-19 diagnostics. The gold standard used across clinical laboratories is quantitative Reverse Transcription-Polymerase Chain Reaction (qPT-PCR, MDx), which requires a central lab setting. Such qRT-PCR testing lasts for more than 2 hours and the sample shipment cost up to several days. With the demand for quicker tests at community settings, the market is moving into point-of-care (POC) devices, including POC MDx and POC LFAs.

Story continues

All molecular diagnostics tests detecting viral genomes share three common steps: sample collection from Nasopharyngeal swab and extraction of viral RNA, amplification of the analyte and read-out. The amplification step is performed reliably by RT-PCR. However, alternatives that do not require expensive and bulky equipment exist, i.e. isothermal amplification. This approach, although less sensitive than PCR, allows for a quicker amplification step at a constant temperature.

The read-out of the amplified signal is normally achieved through fluorescence probes in the sample and detectors in qRT-PCR devices. Many companies have resorted to lateral flow assays and alternative read-out methods that require proprietary detection equipment. These "hybrid systems" benefit from the high specificity and sensitivity of MDx and the speed and low cost of LFAs.

The new IDTechEx report, "COVID-19 Diagnostics", identifies key innovations and technology trends currently being developed in the diagnostics ecosystem that will enable quick and sensitive diagnosis of COVID-19 at point-of-care settings.

Apart from genetic testing, antigenic tests and serological tests, so-called rapid tests, are also becoming central tools in the fight against the pandemic. Both types of immunoassays rely on antibody-antigen recognition. Antigen tests are able to detect the presence of viral proteins in the blood sample. On the other hand, antibody tests detect the presence of antibodies against SARS-CoV-2, which are normally present in the blood sample after 7 days of infection and may remain for months or years. Antibody tests are an important tool to assess the extent of the pandemic and to identify the real number of cases and level of immunization in a population.

Rapid tests have been developed using lateral flow assay technology. LFAs tests are usually much faster and cheaper than qRT-PCR tests. It does not need expensive and large equipment. Therefore, it can be suitable for home testing and is the preferred choice for many governments to guide their response to the pandemic. However, their sensitivity and specificity can be far from ideal, as these tests lack a step of signal amplification, as opposed to qRT-PCR. Therefore, they measure directly the viral load or the antibody concentration. Such tests require extensive validation before widespread deployment.

Apart from the effort from biotech, multiple software companies have developed algorithms to identify signs of COVID-19-related pneumonia in patient scans. CT imaging is an effective way of detecting abnormalities indicative of COVID-19, and image recognition AI algorithms have the potential to detect these abnormalities faster and more efficiently than radiologists.

The new IDTechEx report, "COVID-19 Diagnostics", benchmarked more than 100 commercial devices across various technologies, providing a deep insight into the technology trends and biotech innovations surrounding the COVID-19 global response. For more information on this report, please visit http://www.IDTechEx.com/COVID.

IDTechEx guides your strategic business decisions through its Research, Consultancy and Event products, helping you profit from emerging technologies. For more information on IDTechEx Research and Consultancy, contact research@IDTechEx.com or visit http://www.IDTechEx.com.

Media Contact:Jessica AbineriMarketing Coordinator press@IDTechEx.com+44-(0)-1223-812300

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New IDTechEx Report on COVID-19 Diagnostics: Technologies, Players and Trends - Yahoo News

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Provincial health offier Dr. Bonnie Henry says a new type of COVID-19 testing will soon help British Columbians better understand the true depth of infection in the community, as well as whether having had the disease leaves a patient with immunity.

So far, B.C., along with most of the world, has basically relied on genetic testing that detects whether the virus itself is in a patient, but soon testing will begin to detect whether a person has antibodies produced in reaction toSARS-CoV-2.

"Serology [testing] is a way of looking back and saying 'OK, how many people actually did get infected?' and giving us a better sense of the truenumbers in the province," said Henry on Friday.

She said, so far, testing hasn't been done on everyone who has shown signs and symptoms of COVID-19, the disease caused by the virus, because the focus has been on clusters of infection and people more likely to catch the disease and wind up in the health-care system.

"Serology testing will be an important part of our future," said Henry, adding that she expects it to start in the coming weeks before the province begins reducing restrictions to allow somebusiness and postponed medical procedures to resume.

She said a sample of the community can be tested to see how many people actually had COVID-19 perhaps they weren't prioritized for testing or perhaps they never showed symptoms and thought to get testing.

Henry said serology testing can also help us understand whether infected people who have recovered have become immune to the virus something she says health officials believe is the case.

"We can do testing on our health-care workers, for example, to give them confidence around being able to care for people with COVID-19," she said.

Henry also said if COVID-19 cases arise in a few months, serology testing could help us understand where unrecognized transmission had taken place, making it easier for public health officials to contain and prevent further transmission.

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Serology testing expected to shed new light on extent of COVID-19 infections in B.C. - CBC.ca

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DENVER, April 18, 2020 /PRNewswire/ -- In response to current media stories regarding Low T Center's commitment to meeting the needs of Colorado patients during this COVID-19 Emergency, Low T Center provides the following for immediate release.

On April 9, the Colorado Department of Public Health & Environment released its 4th Updated Public Health Order (PHO) 20-24, encouraging Critical Businesses to remain open: "Critical Businesses, as defined below, are exempt, subject to certain limitations, from this PHO and are encouraged to remain open." Part C of PHO 20-24 states, "Any business . . . engaged primarily in any of the service activities listed below, may continue to operate as normal." PHO 20-24 defines a Critical Business as "Healthcare Operations, Including: . . . clinics, and walk-in health facilities . . . Medical . . . care, including ambulatory providers . . . [and] laboratory services." On April 6, 2020, Governor Polis issued Executive Order 2020 024 stating, "I direct all Coloradans to stay at home, unless necessary to provide, support, perform, or operate Necessary Activities . . . Necessary Travel or Critical Businesses as such terms are defined in PHO 20-24 . . . " The Order provides that "Necessary Activities" include . . . "Engaging in activities . . . including, but not limited to . . . without limitation, obtaining medical supplies . . . obtaining durable medical equipment, obtaining medication, [and] visiting a healthcare professional . . . " On that same day, the Governor issued an amended Executive Order D 2020 027, prohibiting voluntary or elective surgical procedures, if same could be safely postponed for at least three months.

Low T Center is a multi-specialty medical clinic with forty-six clinic locations spanning eleven states. Low T Center is not a hospital or outpatient surgery or procedure provider. It is not a gym or supplement store. Each clinic operates a certified and licensed moderately complex CLIA/COLA medical laboratory facility, which can accommodate a variety of important medical diagnostic tests. Pursuant to recently issued Department of Homeland Security regulations, Low T Center's facilities and its healthcare team members are classified as part of the Essential Critical Infrastructure Workforce.

Low T Center physicians treat chronic health diseases and conditions, as well as acute medical issues, ranging from low testosterone, to obstructive sleep apnea (a respiratory condition), to hypertension, high cholesterol, thyroid disorders, severe allergies, cardiometabolic issues, and other conditions that make men feel bad, and if left untreated, can be life-threatening. These conditions are often correlated with a serious medical condition known as hypogonadism. Hypogonadism is a clinical syndrome that results from the body's failure to produce physiologic concentrations of the hormone Testosterone.Hypogondal men require medically necessary hormone therapy to restore normal body functions. Failure to adequately treat and monitor these conditions can lead to serious problems such as heart disease, diabetes, obesity and cancer as well as adversely effecting overall well-being and quality of life. Treatment for hypogonadism is recognized as "medically necessary" by every major insurance carrier in Colorado.

Proper treatment of chronic hypogonadism requires office visits, labs, and continued therapy.For the individuals that require this therapy, interrupting, deferring or otherwise discontinuing therapy for a period of three months would lead to severe adverse effects, and place these patients at risk. Similarly, failing to provide treatment for diabetic patients, patients suffering from respiratory disorders, and serious cardiologic issues, is simply not acceptable, and would be contrary to the treatment guidelines employed at Low T Center.Remote treatment protocols are enabled for patients whose medical conditions do not require an in-person visit to the clinic.

For many of our patients, Low T Center is the sole provider of their preventive and primary care services. As noted above, in addition to having extensive clinical and research experience in diagnosing and treating hypogonadism, Low T Center also provides vital and continuous life-saving evaluation, diagnosis, treatment, and control of a variety of chronic, serious, and potentially life-threading disorders including cardiometabolic health, obstructive sleep apnea, hypertension, cholesterol disorders, metabolic syndrome, diabetes, and other chronic men's health issues including cardiovascular risk assessment and prevention. Because of the nature of the practice, many patients require close follow-up including appropriate physical exams as well as critical laboratory services, that if delayed "for a minimum of three months" would place these patients at "undue risk to both the current [and] future health of the patient." The treatment programs for these chronic, progressive and potentially fatal conditions (if not appropriately diagnosed, managed, and treated) are evidence- and guideline-based using the most recent literature and approaches and have been developed by a protocol committee comprised of medical school faculty and Harvard-trained distinguished leaders in their respective fields.

Consistent with Executive Order D 2020 027, these important primary care assessments and treatments cannot be delayed (as with any primary care office) as there would be 1) "a threat to the patient's life," 2) "a threat of permanent dysfunction of an extremity or organ system," (e.g., chronic limb ischemia risking amputations or progression of chronic kidney disease or heart failure.) These conditions require close physical and laboratory follow-up and monitoring of both the disease as well as the response to therapy. Furthermore, there is 3) "risk of . . . progression" particularly of the target organs of hypertension, cholesterol disorders, and diabetes manifesting as preventable strokes, heart attacks, limb damage, blindness, kidney failure, and heart failure - all of which require close medical management and adjustment of medical therapy to prevent.

Executive Order D 2020 027 rightly lets "the doctor make the decision," by granting the "treating medical facility" the exclusive discretion to determine whether a three month delay or interruption in treatment would risk the health of the patient. It would be unfortunate indeed that a hypertensive Coloradan would die, because the access to the care he needed, was postponed for three months. The Governor's Order expressly recognizes this principle, by leaving the classification of "voluntary" to the patient's medical professionals.

Low T Center does not believe Governor Polis' Order prohibits Coloradans from obtaining medically necessary treatment for diabetes, hypogonadism, hypertension, hypercholesterolemia, receiving allergy antigens, obtaining medical laboratory testing, receiving treatment for thyroid disorders, obtaining continuous positive airway pressure devices for the treatment of respiratory conditions, or any of the other medically necessary services provided to patients at Low T Center healthcare facilities. The Order uses the words "without limitation" which means Low T Center's patients should have the right to visit their healthcare provider - without limitation, for these important continuing care services.By signing the Order, Governor Polis assured Coloradans that they would be able to continue to receive their medical care during this time, by expressly classifying these activities as "Necessary Activities." Low T Center physicians, nurse practitioners, and medical staff are persons involved in operating a Critical Business which are necessary to help patients with these Necessary Activities.

Also, very relevant to the current COVID-19 crisis, outpatient centers like Low T Center significantly reduce the likelihood of requiring care in both Emergency Departments and acute care hospitals - where patients may have enhanced risk of both contracting SARS-CoV-2 and developing a potentially life-threatening and/or fatal complication of COVID-19.

Finally, Low T Center's protocol committee has mandated a series of workplace safety initiatives designed to implement social distancing guidelines. The clinic operational teams continue to adhere to enhanced cleaning and sterilization protocols. Sick persons or those exhibiting any COVID-19 like symptoms are prohibited from coming to work, but may work from home in some situations. Consistent with good medical practice, all team members are required to wash hands and use hand sanitizer between each patient visit in increasing frequency throughout the day. Patients are educated about covering coughs and sneezes, and recognizing signs or symptoms associated with COVID-19.

Low T Center's healthcare team members recognize their role as healers, and status as members of critical infrastructure, and are committed to remaining available to protect patients' rights, while adhering to all public health orders and directives issued in this state.

Media contact:David J. Moraine, J.D., M.A., LL.M. Chief Legal Officer, david@mailproglobal.com 469-990-3626

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Low T Center Is Committed To Meeting The Needs Of Colorado Patients During The COVID-19 Emergency - The Grand Junction Daily Sentinel

Recommendation and review posted by Bethany Smith

Even if youve been staying mostly inside during the COVID-19 outbreak and laying off heavy makeup, your skin may be acting out.

Reports of increased acne and dry skin are not uncommon, even for people who previously had their skin under control.

For many people, stress can be a trigger for acne and we are certainly living in stressful times, said Dr. Julia Carroll, a Toronto-based dermatologist at Compass Dermatology.

But stress is only one culprit.

Here are some reasons why you may be experiencing acne or overly dry skin during coronavirus isolation.

Stress

Like Carroll said, the outbreak of the novel coronavirus is understandably causing a lot of people stress. From job loss to health concerns, many Canadians are experiencing a pique in anxiety.

Unfortunately, stress can wreak havoc on our skin and the stress hormone, cortisol, can lead to acne flare-ups. Theres also stress-related habits that we develop.

With so many people working from home all day in isolation, Ive had a lot of my patients confess to touching and picking at their face, Carroll said.

Its a common habit when people are stressed, bored or procrastinating.

Carroll said people should try to keep their hands off their face, which is not only important for acne, but for preventing the transmission of COVID-19.

To help lower stress levels, try to find ways to relax, like exercising, deep breathing, meditation or doing something creative.

New skincare routines

With more free time on our hands, some people are experimenting with their skincare routine, Carroll said. This can include using different and new products, like cleansers and leave-on face masks.

Many of the patients I have been seeing virtually are trying new routines while isolating and this has caused some breakouts, she said.

Others are abandoning their routine all together, which is also causing changes in the skin.

Carroll suggests people take a look at their skincare routine and make modifications accordingly. If you tend to have breakouts, she said to add products with either salicylic or glycolic acid.

This could be in the form of a cleanser or a medicated cream, she added.

For people who are wearing masks, their skin may also see a change.

Carroll said shes seeing a lot of acne-like breakouts due to the humidity in closed-off masks, like the N95 model.

Stress may also be a factor here, she said.

Others are reacting to the mask material with contact dermatitis. This could be a true allergy or just an irritation. The mask marks are another common complaint.

To treat mask irritation, Carroll suggests people use a gentle cleanser before putting on the mask and after they remove it.

Moisturizer can also be used, but she cautions against over-applying as it can affect the masks material, she said.

Lifestyle and environment

Because health officials urge people to stay at home to help curb the spread of COVID-19, many of us are not getting the same amount of fresh air we are used to.

Im seeing a lot of patients with dry skin, Carroll said. This comes from low humidity in some of our dwellings.

Theres also lifestyle changes, including diet and exercise, that many of us are experiencing.

Research shows exercise can help reduce inflammation, which can be a culprit of acne. Exercise also helps reduce stress, and might even lead to younger-looking skin, according to research out of McMaster University.

Our eating patterns may also be out of whack, and what we eat might affect our complexion.

While this varies from person to person, Carroll said, some people do have specific triggers to certain foods.

According to the Canadian Dermatology Association, if a certain kind of food seems to aggravate your acne, its best to avoid it.

There is evidence that avoiding dairy products or having a diet with a low glycemic index may reduce symptoms for some people, the association said on its website.

Treatment

If you have dry skin, Carroll suggests adding a hydrating wash to your routine, as well as moisturizers or serums with ceramides and hyaluronic acid.

If your acne does not get better with a consistent skincare routine and lifestyle changes, you might want to see a dermatologist, Carroll said.

Whatever you do, do not pop your pimples or pick at your skin. Squeezing pimples only leaves behind holes, or worse, acne scars.

Once scars are on your face, you cant do anything, Dr. Faisal Al-Mohammadi, a Mississauga, Ont.-based dermatologist and pathologist at Dermcare clinic, previously told Global News.

He said that for for some adults, laser scar removal treatments only improve scars by 40 to 50 per cent.

We will not be able to bring your skin back, he said.

Questions about COVID-19? Here are some things you need to know:

Health officials caution against all international travel. Returning travellers are legally obligated to self-isolate for 14 days, beginning March 26, in case they develop symptoms and to prevent spreading the virus to others. Some provinces and territories have also implemented additional recommendations or enforcement measures to ensure those returning to the area self-isolate.

Symptoms can include fever, cough and difficulty breathing very similar to a cold or flu. Some people can develop a more severe illness. People most at risk of this include older adults and people with severe chronic medical conditions like heart, lung or kidney disease. If you develop symptoms, contact public health authorities.

To prevent the virus from spreading, experts recommend frequent handwashing and coughing into your sleeve. They also recommend minimizing contact with others, staying home as much as possible and maintaining a distance of two metres from other people if you go out.

For full COVID-19 coverage from Global News, click here.

Laura.Hensley@globalnews.ca

- Global News

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COVID-19: Here's how isolation might be impacting your skin - TimminsToday

Recommendation and review posted by Bethany Smith

When Dr Phil McGraw was 29, he had a vasectomy. At the time his wife was pregnant and he had made up his mind that he didnt want more children. Six years later, he would walk back into the clinic and demand for a reversal. Six months later, his wife was expectant.Having the procedure at such a young age was the biggest mistake I ever made.It is for this reason that doctors advice that when going for some long term family planning measures, you need to be absolutely sure. Vasectomy offers 99 per cent effectiveness and is suitable for men who are certain that they do not want any more children. According to Marie Stopes Kenya, this male sterilisation surgical procedure takes approximately 15 minutes and its failure rate is about 1 in 2,000 men. The Kenya Obstetrical and Gynecological Society reports that only one per cent of Kenyan men have undergone vasectomy despite its high effectiveness and surgical simplicity. However, since most vasectomies are performed in private facilities rather than in the public health system, the statistics could be an underestimation.It is estimated that 40 per cent of pregnancies globally are unplanned. In addition, most women are shunning hormonal contraceptives due to associated side effects. The modern man has grown more aware of the struggles their female partners go through and is more willing to take up family planning options. The options are nevertheless limited for men. Condoms, withdrawal (coitus interruptus and vasectomies are the most readily available artificial methods men can use. A man produces over 1,500 sperms per second which makes it challenging to come up with the most suitable reversible family planning method for men. But not to worry, there are options in the pipeline that will give the man more options and power over how many children he can have.WATCH OUT FOR:1. The Contraceptive gel

For More of This and Other Stories, Grab Your Copy of the Standard Newspaper. Read Now

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Birth control options for the man who wants to take charge - The Standard

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In recent weeks, a flurry of headlines about healthcare workers treating people with COVID-19 have utilized a wide array ofmilitary metaphors: Doctors are fighting on the frontlines without sufficient ammunition. They are battling the enemy. They are at war.

But we are not at war. And we certainly have not enlisted. We are doctors. What we are doing is working extraordinarily hard to keep our patients alive.

Are there similarities between treating an enormous number of patients with a rapidly spreading, potentially fatal virus and armed conflict against an enemy invader? Perhaps. But the differences are just as, if not more, important.

To adopt a wartime mentality is fundamentally to allow for anall-bets-are-off, anything-goes approach to emerging victorious. And while there may very well be a time for slapdash tactics in the course of weaponized encounters on the physical battlefield, this is never how one should endeavor to practice medicine.

Of course, we all want to contain the virus, posthaste, and to treat as many as patients as we possibly can. But todo so under the banner of war implies the necessity of a heedless approach that leaves both doctors and patients open to an indefensible level of risk.

In medicine, emergencieseven pandemicsare never an excuse for shortcuts. If the careful study of our own mistakes and oversights has taught us anything it is that, even in the most critical of situations, we must confirm the birthdate on every wristband and review every item on the checklist. In day-to-day practice, these procedures may begin to feel redundant and banal, but they are what keep us from operating on the wrong limb or ordering insulin for the wrong patient.

In times of crisis such as this when levels of the stress hormone cortisol are high and health care workers are particularly susceptibleto distraction and exhaustion, our reliance on basic safety protocols is more important than ever.

Wartime rhetoric, the kind that pervades nearly every news article about those of us who are involved in the care of COVID-19 patients, calls this logicinto question. It makes a desperate appeal to the necessity of chaos. It argues for the inevitability of abandoning the rule of law in exchange for the promise of a swift resolution. And, in so doing, it sends a precarious message.

Furthermore, using militaristic dictionto describe doctors' sense of duty conflates and confuses the reality of our responsibilities. Until a few months ago, those involved in the practice of modern medicine could be reasonably confident that, regardless of the patient's ailment, the provider was not putting their own lifeat risk in the process of proffering treatment (although of course, with regard toinfectious, communicable diseases, some chance of contagion always exists).

Now, doctors from every specialty have been redeployed. And while every health care worker involved in efforts to mend the afflicted deserves the utmost in admiration and accolades, it is incumbent upon the media to tread lightly with language suggesting that giving our lives to this pandemic is in any way our charge.

A wartime mindset demands death, suffering and sacrifice in the service of one's country. But aglobal pandemic should not demand the same of its medical workforce. Young doctors who have not yet finished school should not feel pressured into risking their own lives in response to the promise ofmartyrdom or glory. Older doctors, or those with conditions that put them at greater risk of becomingseriously ill, should be encouraged to stand up for their own needs without fearing any form of dishonorable discharge. In times of war, following orders may mean every single recruit charging ahead, even in sub-optimal conditions, even without proper equipment. But applying such a framework to our current situation would do more harm than good. War is dangerous by definition, but danger should never be inherent to the hospital.

Of course, it is important to acknowledge that the linguistic militarization of modern medicine is hardly a novel phenomenon. The British physician Thomas Sydenham (posthumously annointed the English Hippocrates) is credited with inviting armor into Western medical discourse by writing, in his 1676 Observationes Medicae, that a"murderous array of disease has to be fought against, and the battle is not a battle for the sluggard."And this pandemic is not the first to borrow language from the special forces. In 1918, the flu outbreak that ravaged the United States took place while this country was also, quite literally, at war. It is unsurprising, then, that the sudden arrival of a deadly and unbridled illness was characterized as an invasion, an attack, and as dangerous as poison gas shells.

In spite of their age, however, these military metaphors are not dead. And, the problem with the inexact use ofliving metaphors is that they have the potential to influence the ways we think and behave. As George Lakoffand Mark Johnson write in Metaphors We Live By, The heart of metaphor is inference[and] because we reason in terms of metaphor, the metaphors we use determine a great deal about how we live our lives.

Thus, we must be extremely careful about the words we, and others,use to describe the job we do.

None of this is to suggest that doctors arenot brave. Every medical professional I know is eager to assist, in every possible capacity, in tending to the ill and taming this outbreak. And, indeed, we are more than willing to fightwith insurance companies, hospital administrators and lawmakersin order to get what we need to care for our patients.

This evening at 7 PM, a collective roar of gratitude, composed ofdrums, chimes, and all manner of vocalization, sprang forth from thousands of balconies,windows, roofs and fire escapes, briefly enlivening the all-but-empty streets of New York City. I listened from insidemy bedroom, where I have been quarantined for almost a week, recovering from the virus that has tormented the hospital where I work for more than a month. I was still too weak to join in the appreciative outcry, but I am in full agreement with the sentiment. After all, there is undeniable strength, great honor and inconceivable sacrifice in what we do.

Go here to see the original:
Military Metaphors Distort the Reality of COVID-19 - Scientific American

Recommendation and review posted by Bethany Smith

The American Civil Liberties Union filed a lawsuit Wednesday challenging Idahos first-in-the-nation law banning biological males who identify as female from competing against girls and women in school sports.

The lawsuit, filed in U.S. District Court in Boise, named as the plaintiff Lindsay Hecox, a transgender track athlete at Boise State University, as well as 17-year-old girls soccer player at Boise High School who is not transgender, but fears the law could invade her privacy by requiring her to prove her sex if challenged.

In Idaho and across the country, transgender people of all ages have been participating in sports consistent with their gender identity for years. Inclusive teams support all athletes and encourage participation this should be the standard for all school sports, said Gabriel Arkles, senior staff attorney with the ACLUs LGBT & HIV Project.

The lawsuit, which argued that the law violates the plaintiffs constitutional rights under the Equal Protection Clause, named as defendants Idaho school officials and Republican Gov. Brad Little, who signed HB 500 into law on March 30.

I think that the issue is the girls right to participate without having to be concerned about who theyre competing with, Mr. Little told KTVB-TV in an interview last week. And thats why I signed the bill.

The bills sponsor, Republican state Rep. Barbara Ehardt, a former Division I college basketball athlete and coach, argued that allowing transgender athletes to compete in girls and womens sports creates an unfair playing field, citing the natural physical advantages of boys and men.

It is sad to think that there are those who would prevent girls and women from competing in their own sports while continuing to give more opportunities to boys and men, said Ms. Ehardt in an email.

The bill states, Athletic teams or sports designated for females, women, or girls shall not be open to students of the male sex.

For athletes whose sex is disputed, a student may establish sex by presenting a signed physicians statement that shall indicate the students sex based solely on (a) The students internal and external reproductive anatomy; (b) The students normal endogenously produced levels of testosterone, and (c) Analysis of the students genetic makeup.

Ms. Ehardt said an athletes sex could be determined through routine sports physicals that students undergo before participating on school teams, but Mr. Arkles said the law subjects all female athletes to the possibility of invasive genital and genetic screenings.

In Connecticut, the conservative Alliance Defending Freedom sued in February on behalf of three teen girls track athletes sued to overturn state rules allowing transgender participation in girls sports, arguing that their scholarship opportunities have been threatened after losing races to transgender competitors.

The Justice Department issued last month a statement of interest challenging the Connecticut Interscholastic Athletic Conference, saying that interpreting Title IX to encompass gender identity would turn the statute on its head.

Title IX and its implementing regulations prohibit discrimination solely on the basis of sex, not on not on the basis of transgender status, and therefore neither require nor authorize CIACs transgender policy, said the DOJ statement.

The Idaho lawsuit, which was filed by the ACLU as well as attorneys from the law firm Cooley, LLP, took the opposite stance.

By discriminating and invading privacy, HB 500 violates the U.S. Constitution and Title IX, and we look forward to presenting our arguments to the court, said Kathleen Hartnett of Cooley, LLP in San Francisco.

While similar bills were filed this year in other states, Idaho was the first state to impose an outright ban on participation of transgender athletes and the only with a statewide law regulating transgender and intersex athletes in the country, said the ACLU.

Ms. Ehardt, who played point guard at Idaho State University, said she felt an obligation to preserve the same opportunities for those girls who follow.

Boys and men are just physically bigger, stronger and faster, she said. We cannot compete against the inherent physiological advantages that they possess, regardless of hormone usage.

Read the original:
Idaho sued over first-in-nation law banning transgender participation in girls' sports - Washington Times

Recommendation and review posted by Bethany Smith

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Best CBD Oil for Sleep That Will Make You Doze Off in a Second - LoudCloudHealth

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At the front lineof advances in personalized medicine are cell and gene therapies. These are two overlapping fields of medical research whereby the overall aim is to treat the underlying causes of both genetic and acquired diseases.

Is the promise of personalized medicine on the edge of being delivered? Decades of research and advances in genomics, cell biology, cancer and analytical technologies have permitted exciting progress in the cell and gene therapy space recently. Technology Networks recently spoke with three of the leaders in this space, Allogene Therapeutics, bluebird bioInc. andMogrify to gain their insights on the next developments in cell and gene therapy.

Joe Foster, COO, Mogrify.

"We are on the cusp of new breakthroughs in this field and that evolution of engineered cell therapy has the potential to expand beyond cancer. Engineering, synthetic biology and gene editing has opened the door beyond allogeneic cell therapy. There is a bright future with transformative technologies that may hold the key to addressing solid tumors."

David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder, Allogene Therapeutics.

"Although gene therapies are still a nascent technology, they present a new paradigm for healthcare, offering a one-time treatment that can address the underlying genetic cause of certain severe genetic diseases and cancer. We anticipate that the three techniques being studied for gene therapy gene editing, gene addition and gene-based immunotherapy will become more distinct and that the entire treatment journey will become more efficient."

Martin Butzal, Head of Medical Europe, bluebird bio.

Read more here:
Looking to the Future of Cell and Gene Therapies - Technology Networks

Recommendation and review posted by Bethany Smith

Gene Therapy R&D and Revenue Forecasts 2020-2030

Retroviruses, Lentiviruses, Adenoviruses, Adeno Associated Virus, Herpes Simplex Virus, Poxvirus, Vaccinia Virus, Naked/Plasmid Vectors, Gene Gun, Electroporation, Lipofection, Cancer, Rare Diseases, Cardiovascular Disorders, Ophthalmologic Conditions, Infectious Disease, Neurological Disorders, Diabetes Mellitus

LONDON, April 17, 2020 /PRNewswire/ -- The gene therapy market is projected to grow at a CAGR of 32% in the first half of the forecast period. In 2019, the cancer treatment submarket accounted for 55.8% of the gene therapy drug market. Visiongain estimated that gene therapy for rare diseases will be the driver for market growth in the first half of the forecast period.

How this report will benefit youRead on to discover how you can exploit the future business opportunities emerging in this sector.

In this brand-new 215-page report you will receive 157 charts all unavailable elsewhere.

The 215-page Visiongain report provides clear detailed insight into the gene therapy market. Discover the key drivers and challenges affecting the market.

By ordering and reading our brand-new report today you stay better informed and ready to act.

To request sample pages from this report please contact Sara Peerun at sara.peerun@visiongain.com or refer to our website: https://www.visiongain.com/report/gene-therapy-rd-and-revenue-forecasts-2020-2030/#download_sampe_div

Report Scope

Gene Therapy market forecasts from2020-2030

This report assesses the approved gene therapy products in the market and gives revenue to 2030

Provides qualitative analysis and forecast of the submarket by indication for the period 2020-2030: Cancer Cardiovascular disorders Rare diseases Ophthalmological diseases Infectious Diseases Neurological Disorders Diabetes Mellitus Other therapeutic uses

Profiles leading companies that will be important in the development of the gene therapy market. For each company, developments and outlooks are discussed and companies covered in this chapter include: UniQure Biogen Bluebird Bio Spark Therapeutics Applied Genetics Technologies Corporation Oxford Biomedica GenSight Biologics & Other Companies

Assesses the outlook for the leading gene treatment R&D pipeline for 2019 and discusses technological progress and potential. Profiles appear for gene therapy drug candidates, with revenue forecasts for four leading agents: Collategene (AMG0001, AnGes MG/Vical) BC-819 (BioCancell) BC-821 BioCancell SPK-CHM Spark Therapeutics SPK-FIX Spark Therapeutics/Pfizer SPK-TPP1- Spark Therapeutics Lenti-D (Bluebird Bio) LentiGlobin (Bluebird Bio) VM202-DPN ViroMed

Provides qualitative analysis of trends that will affect the gene therapies market, from the perspective of pharmaceutical companies, during the period 2020 to 2030. SWOT analysis is provided and an overview of regulation of the gene therapy market by leading region given.

Our study discusses factors that influence the market including these: Translation of research into marketable products modifying human DNA gene transfer for therapeutic use, altering the nuclear genome Genomic editing technology and other supporting components Collaborations to develop and launch gene-based products acquisitions and licensing deals Supporting technologies for human genetic modification, gene replacement and targeted drug delivery Gene therapies for ophthalmologic diseases next-generation medicines Regulations in the United States, the European Union and Japan overcoming technological and medical challenges to pass clinical trials.

Story continues

To request a report overview of this report please contact Sara Peerun at sara.peerun@visiongain.com or refer to our website: https://www.visiongain.com/report/gene-therapy-rd-and-revenue-forecasts-2020-2030/

Did you know that we also offer a report add-on service? Email sara.peerun@visiongain.comto discuss any customized research needs you may have.

Companies covered in the report include:

4DMT (4D Molecular Therapeutics)AbeonaAGTC (Applied Genetics Technologies Corporation)AMT (Amsterdam Molecular Therapeutics) AnGes MGAsklepios BioPharmaAstraZenecaAudentes TherapeuticsAvalanche BiotechBayer HealthcareBeijing Northland Biotech CoBenda PharmaceuticalBenitec BiopharmaBioCancellBiogenBiogen IdecBluebird BioBMS (Bristol-Myers Squibb)Broad Institute/Whitehead InstituteCelgeneCell Therapy CatapultCellectisChiesi Farmaceutici Clearside BiomedicalConvergence PharmaceuticalsDaiichi Sankyo Dimension TherapeuticsEditas MedicineFondazione TelethonFrancis Crick Institute Genable Technologies LtdGenethonGenSight BiologicsGenVecGoogleGSK (GlaxoSmithKline)Henry Ford Health SystemHSCI (Human Stem Cells Institute)HSR-TIGET (San Raffaele Telethon Institute for Gene Therapy), ImaginAbImmune Design Corp InoCardInovioIntellia TherapeuticsInvetechKite PharmaKolon GroupKolon Life ScienceLysogeneMitsubishi Tanabe Pharma Corporation NeuralgeneNightstaRxNorthwestern Memorial HospitalNovartisOXB (Oxford Biomedica)PfizerPNP TherapeuticsPrecision Genome Engineering Inc aka PregenenProNaiProtek GroupRaffaele HospitalREGENX BiosciencesRenova TherapeuticsRocheRoszdravnadzorSangamo BiosciencesSanofiSarepta TherapeuticsShanghai Sunway BiotechShenzhen SiBiono GeneTechSotex Pharm Firm Spark TherapeuticsSynerGene TherapeuticsTakara BioTAP BiosystemsThermo Fisher ScientificTissueGeneToolGenUC BerkeleyUC San Francisco uniQureUS Business Innovation Network Vertex PharmaceuticalsVical IncorporatedViroMedVM BiopharmaVoyage Therapeutics

List of Organisation Mentioned ASCO (American Society of Clinical Oncology)ASI (Agency for Strategic Initiatives) CAT (Committee for Advanced Therapies) CBER (Center for Biologics Evaluation and Research)CHMP (Committee for Medicinal Products for Human Use)CHOP (The Children's Hospital of Philadelphia)DCGI (Drugs Controller General of India)DHHS (Department of Health and Human Services)EMA (European Medicines Agency)FDA (US Food and Drug Administration)INSERM (Institut National de la Sant et de la Recherche Mdicale) IRB (Institutional Review Boards) MFDS (Korean Ministry of Food and Drug Safety) MHLW (Ministry of Health, Labour, and Welfare)MHRA (Medicines and Healthcare Products Regulatory Agency)Ministry of Health Commission NHS (National Health Service)NICE (the National Institute for Health and Care Excellence)NIH (National Institutes of Health) OHRP (Office for Human Research Protections)PMDA (Pharmaceuticals and Medical Devices Agency) RCGM (Review Committee of Genetic Manipulation) Russian Ministry of Healthcare and Social DevelopmentSFDA (State Food and Drug Administration of China) SMC (Scottish Medicines Consortium) The Fund for Promotion of Small Innovative Enterprises in Science and TechnologyThe IGI (Innovative Genomics Initiative)The Innovative Genomics Initiative The Walter and Eliza Hall Institute The Wellcome Trust Sanger Institute WFH (World Federation of Hemophilia)WHO (World Health Organization)

To see a report overview please e-mail Sara Peerun on sara.peerun@visiongain.com

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Global Stem Cell Technologies and Applications Market 2019-2029

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Biobanking Market Forecasts 2019-2029

Global Liquid Biopsy Market Forecast to 2029

Next-Generation Biologics Market Forecast to 2029

View original content:http://www.prnewswire.com/news-releases/visiongain-report-the-gene-therapy-market-is-projected-to-grow-at-a-cagr-of-32-in-the-first-half-of-the-forecast-period-301040367.html

SOURCE Visiongain

View post:
Visiongain Report: The Gene Therapy Market is Projected to Grow at a CAGR of 32% in the First Half of the Forecast Period - Yahoo Finance

Recommendation and review posted by Bethany Smith

How do we learn when to cooperate, and when to cheat? It likely depends in part on the social interactions we observe growing up. Turns out that the same is true for cleaner fish (Labroides dimidiatus), according to a recent study.

Cleaner fish, also known as bluestreak cleaner wrasse, feed on ectoparasites found on other fishes their clients. What cleaner fish really like to eat, however, is the protective mucus that covers their clients bodies. While eating ectoparasites is great for client fishes, cheating by eating mucus is bad. Client fishes will punish cheaters by fleeing, or by chasing the cheaters around.

Photo by David Clode on Unsplash

Whats the best option, to cheat and eat a brief but delicious snack (and risk being chased around), or to cooperate and eat a larger, peaceful, but not as tasty meal? A group of researchers led by Noa Truskanov, from the University of Neuchtel, set out to understand how juvenile cleaner fish learn to answer that question.

In a series of experiments recently published in Nature Communications, Truskanov and her collaborators allowed juvenile cleaner fish to observe adults interacting with model clients. They then placed these juveniles in the same situations they had just observed, and tested if they copied the adult fish, learned from the adult fish, or behaved independently of what they had just seen.

Their results show that juvenile fish are actively learning to cooperate by observing the interactions of adult fish with their clients. Juvenile fish are more cooperative when client fishes are intolerant of cheating. When given the choice, however, they prefer clients who allow them to cheat a little. Juvenile fish also didnt just imitate random adult preferences, showing that there are not copying, but rather learning.

Although both social learning and cooperation are widespread in nature, examples of animals that learn socially how to cooperate are extremely scarce. This leads us, humans, to erroneously assume that we are the only ones who learn to cooperate by observing others. Cleaner fish are putting us right back in our place: they can do it, too.

See the original post here:
Your socially isolated brain craves interaction with other people just as much as it craves a meal when you are hungry - Massive Science

Recommendation and review posted by Bethany Smith

Analysis Report on Gene Therapy Market

A report on global Gene Therapy market has hit stands. This study is based on different aspects like segments, growth rate, revenue, leading players, regions, and forecast. The overall market is getting bigger at an increased pace due to the invention of the new dynamism, which is making rapid progress.

The given report is an excellent research study specially compiled to provide latest insights into critical aspects of the Global Gene Therapy Market.

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Some key points of Gene Therapy Market research report:

Strategic Developments: The custom analysis gives the key strategic developments of the market, comprising R&D, new product launch, growth rate, collaborations, partnerships, joint ventures, and regional growth of the leading competitors operating in the market on a global and regional scale.

Market Features: The report comprises market features, capacity, capacity utilization rate, revenue, price, gross, production, production rate, consumption, import, export, supply, demand, cost, market share, CAGR, and gross margin. In addition, the report offers a comprehensive study of the market dynamics and their latest trends, along with market segments and sub-segments.

Analytical Tools: The Global Gene Therapy Market report includes the accurately studied and assessed data of the key industry players and their scope in the market by means of a number of analytical tools. The analytical tools such as Porters five forces analysis, feasibility study, and many other market research tools have been used to analyze the growth of the key players operating in the market.

COVID-19 Impact on Gene Therapy Market

Adapting to the recent novel COVID-19 pandemic, the impact of the COVID-19 pandemic on the global Gene Therapy market is included in the present report. The influence of the novel coronavirus pandemic on the growth of the Gene Therapy market is analyzed and depicted in the report.

The global Gene Therapy market segment by manufacturers include

segmented as follows:

Global Gene Therapy Market, by Product

Global Gene Therapy Market, by Application

Global Gene Therapy Market, by Region

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Important queries addressed in the report:

Moreover, the report highlighted revenue, sales, manufacturing cost, and product and the States that are most competitive in the lucrative market share idea. There is a discussion on the background and financial trouble in the global Gene Therapy economic market. This included the CAGR value during the outlook period leading to 2025.

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Inimitable Expertise: Analysts will provide deep insights into the reports.

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Conclusively, this report will provide you a clear view of each and every fact of the market without a need to refer to any other research report or a data source. Our report will provide you with all the facts about the past, present, and future of the concerned Market.

See the original post:
The Economic Impact of Coronavirus on Gene Therapy Market Analysis and Value Forecast Snapshot by End-use Industry 2019-2022 - Jewish Life News

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