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

By LabMedica International staff writers
Posted on 14 Aug 2020

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).

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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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