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Biomeme, LumiraDx PCR Coronavirus Tests Get FDA Emergency Use Authorization

NEW YORK — The US Food and Drug Administration on Tuesday granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Biomeme and LumiraDx.

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.

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

In May, the FDA granted EUA for an RT-PCR SARS-CoV-2 test from One Health Laboratories that runs on the Franklin instrument.

Waltham, Massachusetts-based LumiraDx's SARS-CoV-2 RNA STAR assay is designed to detect the ORF1a gene of the virus in upper respiratory and bronchoalveolar lavage specimens.

Nucleic acid extraction is performed using Qiagen's QIAsymphony DSP Virus/Pathogen Kit and automated QIAsymphony SP instrument or manually using either Thermo Fisher's MagMax Viral/Pathogen Nucleic Acid Isolation Kit or Qiagen's QIAamp Viral RNA Mini Kit. The test can run on a variety of instruments including Roche's LightCycler 480 II, Thermo Fisher's Applied Biosystems 7500 Fast Dx and QuantStudio 5, and Agilent's AriaMx and Stratagene Mx3005P.

Both tests may be used by any lab CLIA-certified to perform high-complexity testing, the FDA said.