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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Tango Therapeutics Announces First Patient Dosed in TNG260 Phase 1/2 Trial in Patients With STK11-Mutant Cancers

Globenewswire | July 25, 2023

Tango Therapeutics, Inc. a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, today announced that the first patient has been dosed in the phase 1/2 trial evaluating TNG260 in combination with pembrolizumab in patients with STK11-mutant cancers. TNG260 is a first-in-class inhibitor of the CoREST complex . “The TNG260 phase 1/2 clinical trial is the first trial to use genetic patient selection in combination with checkpoint inhibitor therapy to reverse the cancer-specific immune evasion caused by STK11 loss of function mutations. Resistance to immunotherapy is a major challenge faced by patients with STK11-mutant cancers, which TNG260 is specifically designed to overcome,” said Adam Crystal, M.D., Ph.D., President of Research and Development of Tango Therapeutics. “Our pipeline of precision oncology treatments based on synthetic lethality has advanced significantly this year, as we now have initiated three clinical trials.” The phase 1/2 trial will evaluate the safety, pharmacokinetics (PK), pharmacodynamics and efficacy of TNG260, with a one cycle single agent run-in phase to evaluate the safety and PK of TNG260, in combination with pembrolizumab, in patients with locally advanced or metastatic solid tumors with an STK11 loss-of-function mutation. STK11 loss-of-function mutations occur in approximately 15% of non-small cell lung cancer, 15% of cervical, 10% of carcinoma of unknown primary, 5% of breast and 3% of pancreatic cancers. Based on preclinical xenograft studies and retrospective clinical analyses, the majority of STK11-mutant cancers are thought to have primary resistance to checkpoint inhibition. The CoREST complex plays a central role in regulating immunomodulatory signaling in STK11-mutant cancers. In preclinical studies, TNG260 reverses the immune evasion effect of STK11 loss-of-function mutations, restoring sensitivity to an anti-PD-1 antibody, inducing complete remissions in the majority of animals and creating immune memory that prevents re-implantation and regrowth of the tumor. In April 2023, the U.S. Food and Drug Administration granted Fast Track designation for TNG260 in combination with an anti-PD-1 antibody for the treatment of patients with previously treated advanced non-small cell lung cancer with STK11-mutations. About Tango Therapeutics Tango Therapeutics is a clinical-stage biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

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Exacta Bioscience and Ginkgo Bioworks Announce Partnership to Optimize Exacta's Crop Protection Product

prnewswire | September 01, 2023

Exacta Bioscience, a biotech company that harnesses the power of nature and its microorganisms for crop protection, and Ginkgo Bioworks which is building the leading platform for cell programming and biosecurity, today announced that Exacta is leveraging Ginkgo's end-to-end agricultural R&D services to run a fermentation optimization and scale-up program to enhance one of its crop protection products, FitoRoot®, paving the way for large-scale commercialization. FitoRoot, a biostimulant product composed of three Bacillus strains, is designed to help crops better absorb water, nutrients and strengthen their defenses against abiotic stress. This can lead to overall better crop health, improved yield and increased resistance to stress conditions such as drought or extreme temperatures. Through this partnership, Exacta will use Ginkgo's fermentation and formulation optimization services to reduce the cost of goods to make its FitoRoot technology more competitive. Accordingly, FitoRoot is currently marketed in Chile and is expected to expand to other Latin American markets, with a planned launch in 2023 by Adama Chile, who is driving biological adoption in the region. Adama Ltd is one of the world's leading crop protection companies. "We chose Ginkgo because their deep expertise in agricultural product development and optimization positions us to make one of our key crop protection products, FitoRoot, more accessible," said José Bustos, CEO at Exacta Bioscience. "We're proud of the progress Exacta has made, and this partnership marks a vital step toward accelerating our efforts to assure the quality and availability of one of our products and creating a stable and safer ecosystem." "Exacta Bioscience's emphasis on microbial solutions in crop health brings more sustainable and differentiated solutions to farmers throughout the Americas," said Magalie Guilhabert, Head of Ag Biologicals, Ginkgo Bioworks. "Together, we can continue to push the boundaries of agricultural innovation through biotechnological solutions that promote a more sustainable future for our food systems." Ginkgo's end-to-end agricultural services can help R&D teams develop more effective biological products across a variety of applications. Find out more. About Ginkgo Bioworks Ginkgo Bioworks is the leading horizontal platform for cell programming, providing flexible, end-to-end services that solve challenges for organizations across diverse markets, from food and agriculture to pharmaceuticals to industrial and specialty chemicals. Ginkgo's biosecurity and public health unit, Concentric by Ginkgo, is building global infrastructure for biosecurity to empower governments, communities, and public health leaders to prevent, detect, and respond to a wide variety of biological threats. About Exacta Bioscience Exacta Bioscience is a pioneering biotech company that uses microorganisms to create innovative bioproducts for agriculture. Their nature-inspired solutions support a future without chemical pesticides and antibiotics. With extensive knowledge of microorganisms and their effects on crops and soil, Exacta tackles modern farming challenges. Their expertise is in formulating microorganism mixtures, providing a wide range of bioproducts, specifically for crop protection. They are dedicated to delivering effective, stable, and safe crop protection and soil-enhancing products. They invite everyone to join in advancing sustainable practices for a healthier future.

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BioIVT Acquires PrecisionMed, a Leading Global Provider of Biospecimens for Neurology and Oncology Research

PRNewswire | July 19, 2023

BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, announced today that it has acquired PrecisionMed, LLC, a leading supplier of high-quality human biological material for genetics, drug discovery, and biomarker research and in vitro diagnostics. Based in Carlsbad, CA, PrecisionMed has been collecting biospecimens for neurology and oncology research for more than 27 years, and it has the largest private, global repository of longitudinally collected human CSF for scientific research. Its collection contains both normal and diseased CSF samples together with other matched biofluids, such as plasma, sera, and whole blood. "We are thrilled to announce BioIVT's acquisition of PrecisionMed. Our vision is to lead the biospecimen industry through expertise and innovation and our acquisition of PrecisionMed pushes us even closer to this goal. We are excited about the possibilities that lie ahead as we expand our supply network and inventory and strengthen our capacity to meet the increasing customer demand for CSF and liquid biopsy products. Together, we will drive even greater value for our customers and further our mission of enabling smarter science," said BioIVT Chief Executive Officer Richard Haigh, PhD. "The vision at PrecisionMed has always been centered around positively impacting patients' lives through fueling innovation and scientific discovery. We have long viewed BioIVT as the gold standard in our industry with the track record and global reach to back that up. This partnership magnifies our collective ability to reach the research community and impact patient lives. We are proud to pair our talent and resources with the world-class team at BioIVT," said PrecisionMed CEO Eric Leach. PrecisionMed's regulatory-compliant and privacy-protected biorepository contains more than 170,000 samples of CSF, whole blood, serum, plasma, PBMCs, and urine collected under Institutional Review Board-approved clinical protocols. This extensive collection of high-quality, well annotated biospecimens was amassed from PrecisionMed's sizable network of donors and collection sites. Each biospecimen includes detailed clinical data, such as the donor's diagnosis, demographics, family medical histories, treatment responses, and disease progression. Underscoring the value of its contributions, PrecisionMed has received more than 120 citations in scientific journals and its collections have been part of U.S. NIH grants and have formed the basis of U.S. FDA submissions and subsequent U.S. FDA clearance for diagnostics. Looking ahead, PrecisionMed will continue to operate out of its current headquarters and maintain its existing network of donor and collection sites. Financial details about this transaction were not disclosed. About PrecisionMed, LLC. PrecisionMed is a leading supplier of high-quality human biological material for research, and it is the largest private global source of longitudinally collected human cerebrospinal fluid (CSF) from living normal controls and diseased populations. Since 1996, its accurately annotated human biological samples have been utilized by more than 600 pharmaceutical and biotechnology companies, and academic research organizations worldwide. About BioIVT BioIVT enables smarter science and accelerates medical breakthroughs by delivering high-quality personalized biospecimen solutions and research services to the life science and diagnostic industries. Recognized as an industry leader, BioIVT specializes in control and disease state samples including human and animal tissues or preparations, ADME-Tox products and research services, cell and gene therapy products, blood, and other biofluids. By combining technical expertise and exceptional customer service with unmatched access to biological specimens, BioIVT serves the research community as a trusted partner in ELEVATING SCIENCE®.

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