Arbor Vita Launches Open Platform COVID-19 Antibody Test Expanding Access To Higher Quality Diagnostics

Arbor Vita | June 08, 2020

Arbor Vita announced today the availability of its CoVisa™ IgG ELISA-based test for antibodies associated with the novel coronavirus (COVID-19). The test has been found to have a 100 percent sensitivity (positive percentage agreement), and 99.24 percent specificity (negative percentage). Additional validation testing is ongoing in independent laboratories. The company has notified the U.S. Food and Drug Administration under the Emergency Use Authorization (EUA) process. Arbor Vita's CoVisa™ test presents an opportunity to greatly enhance antibody test availability in the U.S.  Currently there are approximately 26,000 high complexity CLIA labs in the U.S. capable of processing COVID-19 antibody tests on ELISA systems. Approximately 200 to 2,000 of those labs have systems that can run currently available tests on a closed platform, that is on a particular manufacturer's laboratory equipment. CoVisa can be used by the additional 24,000 labs that do not have such equipment. This is especially important since those high complexity CLIA labs will not be able to offer COVID-19 antibody testing after the removal by the FDA of 28 non-functioning antibody tests that do not use the higher accuracy ELISA method. Arbor Vita has commenced production of all elements of its test including reagents within its U.S facilities and will initially deliver 2,000,000 tests by the end of June and expand production to 1,000,000 per day by the end of July.

Spotlight

The design of efficient drug delivery vectors requires versatile formulations able to simultaneously direct a multitude of molecular targets and to bypass the endosomal recycling pathway of cells.

Spotlight

The design of efficient drug delivery vectors requires versatile formulations able to simultaneously direct a multitude of molecular targets and to bypass the endosomal recycling pathway of cells.

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Nordic Bioscience and Roche Diagnostics Strengthen Collaboration for Development of Biomarkers for Chronic Diseases

Nordic Bioscience | June 17, 2022

Nordic Bioscience, a growing biomarker company, today announced the strengthening of its ongoing collaboration with Roche Diagnostics for the development of proprietary biomarkers involved in tissue breakdown and build-up. Nordic Bioscience is a world leader in Extra Cellular Matrix (ECM) biomarker development that can provide fast and objective decision-making for compound selection and development in clinical trials as well as provide value for patients in a diagnostic setting. Under the collaboration, Nordic Bioscience will transfer unique and proprietary blood-based biomarkers to Roche Diagnostics to be implemented on the automated COBAS platform. Nordic Bioscience's ECM biomarkers are unique and essential for all chronic diseases involving tissue fibrosis and inflammation. The collaboration will facilitate better clinical decisions in drug development and patient selection as well as enrichment for precision medicine and ultimately improve patient outcomes. Nordic Biosciences has a long and successful collaboration with Roche Diagnostics. To date, two biomarkers have been commercialized and implemented on the Roche automated COBAS platform. Nordic Bioscience's fibrogenesis biomarker PRO-C3 has become a commonly used next-generation and noninvasive biomarker to quantify type III collagen formation which is highly relevant for NASH and other fibrotic diseases. PRO-C6 quantifies type VI collagen formation, which is highly relevant for cardiovascular diseases and various cancer types. The FDA recently published a letter of support for further studies of PRO-C6 as a trial enrichment and patient selection biomarker in relation to Heart Failure with Preserved Ejection Fraction (HFpEF). PRO-C3 and PRO-C6 are part of Nordic Bioscience's portfolio of ECM biomarkers which are being developed and commercialized both as research tools and in the future as diagnostic products. Both biomarkers have completed the technical development from manual ELISA to automated version on the COBAS platform. They are validated and currently running in routine in the CAP-accredited laboratory of Nordic Bioscience. The collaboration with Roche Diagnostics is an important step for Nordic Bioscience in our efforts to help accelerate drug development. Having our biomarkers on the Roche Diagnostics' platform and our combined capabilities will secure global availability of our best ECM biomarkers. This also adds significant value to Nordic Bioscience offerings as we transform our biomarkers from tools used only in clinical development to globally available diagnostics products." Morten Karsdal Chief Executive Officer of Nordic Bioscience. Nordic Bioscience has a long track record of research in ECM remodeling, which previously has resulted in the transfer of the FDA-approved bone biomarker CTX-I to the Roche COBAS platform. Nordic Bioscience has developed more than 125 ELISA biomarkers focusing on quantifying unique fragments of the ECM. These tools are used in all phases of drug development and for patient selection in various diseases. About Nordic Bioscience Nordic Bioscience is a Danish biomarker company headquartered in Herlev, Denmark. Nordic Bioscience is engaged in biomarker development using our unique neoepitope technology. We combine our expertise in biomarker development with preclinical and clinical research. This enables us to develop biomarkers that provide fast and objective decision-making for compound selection and development in clinical trials as well as provide value for patients in a diagnostic setting.

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MEDICAL

Resilience and MD Anderson Launch Joint Venture to Accelerate Development and Manufacturing of Innovative Cell Therapies for Cancer

Resilience | June 07, 2022

National Resilience, Inc. (Resilience) and The University of Texas MD Anderson Cancer Center today announced the launch of a joint venture, the Cell Therapy Manufacturing Center, to accelerate the development and manufacturing of innovative cell therapies for patients with cancer. Uniting the strengths of Resilience and MD Anderson, the joint venture will advance its work within a culture of academic innovation alongside industrial expertise. The Cell Therapy Manufacturing Center will be based in a state-of-the art 60,000-square-foot manufacturing facility in the Texas Medical Center, with a team of 70 employees focused on process and analytical development as well as early-phase and clinical-stage Good Manufacturing Practices (GMP). The joint venture combines MD Anderson’s expertise in immunotherapy and cell therapies as well as a leading clinical trials infrastructure, with Resilience’s innovative biomanufacturing technologies, advanced analytics and a national network for developing and producing cell therapies. Together, the parties aim to accelerate the path of cell therapies to the clinic, while enabling scalability and a smooth transition to late-phase clinical and commercial activities. Cell therapies have had a dramatic impact for patients with certain cancers, but progress has been hampered by structural challenges, This novel joint venture was conceived to address those challenges by harnessing the complementary capabilities of two world-class organizations, allowing us to advance innovative programs to deliver impactful therapies to patients.” Jason Bock, Ph.D., Chief Executive Officer of the Cell Therapy Manufacturing Center. The joint venture will engage with MD Anderson researchers and external industry collaborators to advance new therapies through preclinical and clinical development, ensuring consistent and safe products that can be evaluated rapidly in clinical trials led by MD Anderson physicians. Resilience customers will be able to leverage this offering as part of the company’s growing network of biomanufacturing facilities that are flexible enough to scale projects from small-batch pre-clinical to large-scale commercial production. Resilience has 10 facilities across North America, with more than 1 million square feet of manufacturing space. The promise of cell therapies to help patients in need has been limited by a lack of innovation in biomanufacturing, This collaboration aims to overcome those hurdles by extending our network with this unique partnership, creating opportunities to incubate innovative ideas and provide cutting-edge biomanufacturing technologies and processes to researchers, with a goal of bringing more cell therapies to patients.” Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience. The joint venture will advance the most promising cell therapy modalities to answer unmet clinical needs, including engineered tumor infiltrating lymphocytes (TILs), chimeric antigen receptor (CAR)-modified T cells, endogenous T cells (ETCs), engineered natural killer (NK) cells and other emerging technologies, for patients with hematological and solid tumors. MD Anderson researchers are leaders in the field of cancer cell therapy, responsible for advancing the translational and clinical development of many of the currently approved and experimental cell therapies. The joint venture is built upon MD Anderson’s Biologics Development platform, formerly part of the institution’s Therapeutics Discovery division. Current strategic collaborations with MD Anderson’s Biologics Development platform will continue; collaborative relationships with MD Anderson’s Therapeutics Discovery division, as well as physicians and scientists across the institution, also will be maintained. We believe in the tremendous potential of cell therapies to deliver solutions that offer cures, not merely prolonged survival. Resilience offers unique capabilities that make it an ideal choice for unlocking that potential and accelerating impactful cell therapies, Our mission at MD Anderson is to end cancer, and this joint venture is a strategic step toward realizing that goal.” Ferran Prat, Ph.D., J.D., senior vice president for Research Administration and Industry Relations at MD Anderson. About Resilience Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development.

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NCCN Oncology Research Program and Puma Biotechnology, Inc. Collaborate to Research on Neratinib in Various Cancers

National Comprehensive Cancer Network | October 16, 2020

The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) today announced plans to evaluate neratinib, a type of tyrosine kinase inhibitor (TKI) that works as a dual inhibitor of the epidermal growth factor receptor 1 (EGFR) and human epidermal growth factor receptor 2 (HER2). The research funding is supported by a $2-million grant from Puma Biotechnology, Inc. Projects may include pre-clinical, translational and clinical trials. They will focus on treatment of: Pediatric tumors(including neurofibromatosis Type 2 and progressive Vestibular Schwannoma). Early-stage and metastatic breast cancer, including those with HER2+ brain metastases. Other HER2-amplified tumors. EGFR-mutated glioblastoma multiforme. Specific research areas will be determined by a group of cancer research experts from NCCN Member Institutions who form a Request for Proposals (RFP) Development Team.

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