Enzo Biochem Receives FDA Emergency Use Authorization for Testing Pooled Samples on Three Platforms Including company’s GENFLEX™ Proprietary System for Detection of Coronavirus SARS-Cov-2
January 04, 2021 at 05:30 pm IST
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Enzo Biochem, Inc. announced that it has received an expansion of its Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) authorizing the use of pooled samples containing up to five individual swab specimens with the Company’s AMPIPROBE® SARS-Cov-2 Test System utilizing tests on three different platforms including Enzo’s proprietary GENFLEX™ automated high-throughput platform. Pooling samples involves qualitative detection of nucleic acid from SARS-CoV-2 in up to five individual upper respiratory swab specimens collected in separate vials containing transport media from individuals that healthcare providers consider to be suspected of COVID-19 infection. Samples can include nasal, mid-turbinate, nasopharyngeal, or oropharyngeal swabs. The now authorized “pooled” approach significantly increases the number of individuals who can be tested with available testing resources. In its letter of authorization dated December 30, 2020, the FDA stated that the AMPIPROBE® SARS-Cov-2 Test System is authorized under EUA and the “product described in the Scope of Authorization of this letter (Section II) meets the criteria set forth in Section 564(c) of the (Federal, Food, Drug, and Cosmetic) Act concerning safety and potential effectiveness.
Enzo Biochem, Inc. is focused on molecular diagnostics and has a portfolio of technical platforms and reagent sets supporting a diverse range of biomedical research and translational science needs. The Company operates through the product segment, which manufactures, develops and markets products and tools for clinical research, translational research, drug development and bioscience research customers worldwide. The Company is engaged in product development and manufactures and supplies a comprehensive portfolio of products, including antibodies, genomic probes, assays, biochemicals and proteins. The Company's products and technologies are used in translational research and drug development areas, including cell biology, genomics, assays, immunohistochemistry and small molecule chemistry. Its life science division supports the work of research centers and industry partners. It has built a portfolio of intellectual property assets, comprised of around 457 owned patents worldwide.
Enzo Biochem Receives FDA Emergency Use Authorization for Testing Pooled Samples on Three Platforms Including company’s GENFLEX™ Proprietary System for Detection of Coronavirus SARS-Cov-2