Biomeme, Inc. announces SARS-CoV-2 Test approval by FDA under the Emergency Use Authorization

Biomeme, Inc. announced today that the U.S. Food and Drug Administration (FDA) gave Biomeme’s SARS-CoV-2 Real-Time RT-PCR Test Emergency Use Authorization (EUA) for use in any lab CLIA-certified to perform high complexity testing. It is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is designed to detect the virus’ Orf1ab and S genes in nasopharyngeal, nasal, and oropharyngeal swab specimens, as well as nasopharyngeal wash/aspirate or nasal aspirate specimens. Unlike wet assays, which must be stored frozen and require pipetting of multiple reagents by an experienced biologist, Biomeme’s SARS-CoV-2 test is lyophilized (freeze-dried) to not only maximize shelf-life but to also enable easier transportation and storage without a cold chain.