Biomeme SARS-CoV-2 Real-Time RT-PCR Test Granted FDA Emergency Use Authorization

Biomeme, Inc. (Philadelphia, PA, USA) has been granted Emergency Use Authorization by the US Food and Drug Administration (FDA) for its SARS-CoV-2 Real-Time RT-PCR Test.

The Biomeme SARS-CoV-2 Test detects the RNA of severe acute respiratory syndrome coronavirus 2 that causes coronavirus disease 2019 (COVID-19). Two RNA targets for the novel coronavirus are multiplexed together with Biomeme's process control assay for RNA extraction and RT-PCR (MS2). The assay targets include SARS-CoV-2-Orf1ab gene, SARS-CoV-2-S gene, and RNA Process Control (RNA extraction and RT-PCR control utilizing MS2 bacteriophage).

The test uses Biomeme's M1 Sample Prep Cartridge for RNA extraction and runs on the company's Franklin portable, handheld PCR instrument using its three-well Go-Strips. The Biomeme SARS-CoV-2 Test can also be run using the company’s 96-well Go Plates on Bio-Rad's CFX96 or Thermo Fisher Scientific's Applied Biosystems QuantStudio 5 RT-PCR systems.

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