GenScript Files for Emergency Use Authorization of Rapid SARS-CoV-2 Neutralization Antibody Detection Kit

GenScript | June 03, 2020

GenScript Biotech Corp., the world's leading research reagent provider, announced today that the company has filed for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) to market its cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit. This is the first test submitted for regulatory approval that specifically detects neutralizing antibodies to SARS-CoV-2, the virus that causes COV-19, without the use of live virus. Current serological antibody tests identify prior exposure to the virus by detecting the presence of antibodies from an immune response, but do not indicate whether these antibodies are neutralizing antibodies. A virus neutralization test detects the presence of neutralizing antibodies, which are key biomarkers of immunity and act to protect the body by blocking the virus's entry into the cell. Traditional virus neutralization tests require live virus and cells and must be performed in a biosafety containment facility staffed by highly skilled personnel, with results often taking days. The cPass kit enables detection of neutralizing antibodies within an hour, without the need for live virus and biosafety containment, making it broadly available to standard labs in hospitals and clinics. The kit, which is compatible with both manual, automated and high-throughput immunoassay workflows such as ELISA, has received CE marking for commercial use as an in vitro diagnostic product in Europe.

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This white paper series is our way of explaining the biotechnology revolution to our investors and supporters. We wanted to take subject matter that is manifestly complex, and reassemble it into a clear and accessible form. As a team of Healthcare sector specialists, on a daily basis we parse through reams of data, dissect clinical literature, attend medical conferences alongside leading scientists, and analyze biotechnology companies with an eye for precise, narrow details. It is an exacting effort.

Spotlight

This white paper series is our way of explaining the biotechnology revolution to our investors and supporters. We wanted to take subject matter that is manifestly complex, and reassemble it into a clear and accessible form. As a team of Healthcare sector specialists, on a daily basis we parse through reams of data, dissect clinical literature, attend medical conferences alongside leading scientists, and analyze biotechnology companies with an eye for precise, narrow details. It is an exacting effort.

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Access Biologicals Completes the First-ever Commercially Available COVID-19 Seroconversion Panel to Confirm SARS-CoV-2 Antibody Assays

PR Newswire | September 07, 2020

Access Biologicals, a market leader in the collection and manufacturing of biologicals products, today announced it has completed the first-ever commercially available COVID-19 seroconversion panel to confirm the presence of anti-SARS-CoV-2 antibodies. Efforts to contain the spread of COVID-19 rely in part on serological tests to identify the presence of anti-SARS-CoV-2 antibodies in people who have had the illness. Until now, however, many of these tests have been developed rapidly and without the independent data to help assess their analytical performance and enable comparisons between different testing methods. With Access Biologicals' seroconversion panel, diagnostic manufacturers, clinical laboratories and researchers will have a reliable benchmark against which they can develop, validate and troubleshoot other COVID-19 serological assays and testing. "An effective, sensitive and specific way to identify and confirm the SARS-CoV-2 infection is urgently needed," said Mike Crowley, Managing Director Access Biologicals. "Our COVID-19 seroconversion panel will help serological assays bridge the gap through precise validation, establishing sensitivity and helping determine the pre-seroconversion window period, which is the time after infection and before seroconversion, when antibodies appear." Collected in a longitudinal series, the Access Biologicals COVID-19 seroconversion panel consists of 14 members (units) of a unique human plasma sample drawn from a single donor during a developing SARS-CoV-2 infection. The panel illustrates the onset and decline of IgM, IgG and Ig total SARS-CoV-2 virus antibody titers over a period of 87 days.

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CELL AND GENE THERAPY

Phytolon and Ginkgo Bioworks Collaborate to Take Biological Production of Vibrant Food Colors to the Next Level

Phytolon; Ginkgo Bioworks | February 28, 2022

Phytolon, a growing startup company making natural food colorants, announced a partnership today with Ginkgo Bioworks the leading horizontal platform for cell programming, to produce vibrant cultured food colors via fermentation of yeast. Under this partnership, Phytolon is leveraging Ginkgo's ability to engineer biology at scale to work together on the production of vibrant betalain pigments, the healthy and colorful compounds found in foods like beets and cactus fruit. The project aims to take Phytolon's colors across the full 'yellow-to-purple' spectrum to the next level, and to potentially maximize the business opportunity of Phytolon's vibrant colors for applications in the food and cosmetics industries. Scientists have developed hundreds of artificial food dyes by using the tools of synthetic chemistry to convert petrochemical sources into a wide range of colors. Biotechnology offers an opportunity to tap into the vibrant colors of biology to produce more sustainable, yet equally vibrant, colors. While artificial dyes are visually appealing and cheap to manufacture, many have been banned in food and feed due to health concerns. As consumers increasingly seek out more sustainable and nature-derived products, the food industry is working to find food colors that have equivalent pigment vibrancy to those found in synthetic chemical dyes but which come from biological rather than petrochemical sources. Phytolon has developed a proprietary process for producing betalain pigments through precision fermentation of certain yeast strains. Together, Phytolon and Ginkgo are partnering with the goal of maximizing the production efficiency of purple and yellow betalain-producing strains. "We're excited to work with Ginkgo to develop natural food colors that can potentially outperform conventional artificial dyes in cost and performance. We believe biotechnology makes it possible to produce a wider range of colors than ever before that may outperform current benchmark colorants, and we look forward to building products that may meet and even exceed consumer expectations for healthier, sustainable foods, all while aiming to maintain industry requirements for high quality and cost-efficiency." Dr. Tal Zeltzer, Co-founder and CTO of Phytolon "We love enabling growing startups like Phytolon through our platform, using biotechnology to challenge industry norms and attempt to build a fundamentally better product than what's on the market today," said Jennifer Wipf, Head of Commercial, Cell Engineering at Ginkgo Bioworks. "The planet needs new sustainable solutions, and we are excited to partner with Phytolon to support a more sustainable food system." About Phytolon Phytolon is a biotechnology startup company that is taking food coloring to the next level by leveraging a novel technology for production of natural pigments via precision fermentation of yeast. Phytolon's products have been successfully validated by global leaders in the food industry, and Phyloton expects to enter into commercialization agreements with initial strategic partners in the near term. Phytolon is supported by partners such as The Trendlines Group Millennium Foodtech, EIT-Food, Consensus Business Group, Arkin Holdings and others. About Ginkgo Bioworks Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery.

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CELL AND GENE THERAPY

Tevogen Bio™ Further Strengthens IP Portfolio With Additional Patent for Method of Preparing Its Investigational SARS-CoV-2 Specific T cell Therapy

Tevogen Bio | January 13, 2022

Tevogen Bio, a clinical stage biotechnology company specializing in cell and gene therapies in oncology and viral infections, announced that the U.S. Patent and Trademark Office has granted a new patent for the method of preparing COVID-19 peptide specific cytotoxic T cells for the treatment of COVID-19 infection. The patent further reinforces the biotech pioneer’s expanding IP portfolio. “Omicron’s extensive mutations and its subsequent ability to evade antibodies highlights the importance of Killer T cells, which can still recognize and eliminate virus-infected cells. Millions among us suffer from inadequate T cell response for various reasons. After two years of the pandemic and witnessing the challenges posed by the ever-evolving virus, we must explore scientific options beyond our current approaches. CTL therapeutics for large patient populations is not an easy undertaking, but Tevogen’s ability to manufacture hundreds of doses from a single donor gives me hope,” Tevogen CEO Ryan Saadi, M.D., M.P.H The granted patent covers Tevogen’s investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T Lymphocytes therapy, TVGN-489, for high-risk COVID-19 patients. The product is currently undergoing a proof of concept clinical trial at Jefferson University Hospitals in Philadelphia. Trial details are available at Clinical Trials - Tevogen. About TVGN-489 TVGN-489 is a highly purified, SARS-CoV-2-specific cytotoxic CD8+ T lymphocyte product, which detects targets spread across the entire viral genome. These targeted CTLs are expected to recognize and kill off virally infected cells, allowing the body to replace them with healthy, uninfected cells. TVGN-489 demonstrated strong antiviral activity toward SARS-CoV-2 targets in preclinical studies. About Tevogen Bio Tevogen Bio is driven by a team of distinguished scientists and highly experienced biopharmaceutical leaders who have successfully developed and commercialized multiple franchises. Tevogen’s leadership believes that accessible personalized immunotherapies are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation in the post-pandemic world.

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