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.