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FDA Grants EUAs for RTA Laboratories, Cormeum Laboratory Services Coronavirus Tests

NEW YORK — The US Food and Drug Administration of Friday granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by RTA Laboratories and Cormeum Laboratory Services.

RTA's Diagnovital SARS-CoV-2 Real-Time PCR Kit is designed to detect the virus' E and RdRP genes in anterior nasal and mid-turbinate nasal swabs, nasopharyngeal or oropharyngeal swabs, nasopharyngeal wash/aspirates or nasal aspirates, and bronchoalveolar lavage. According to the Turkish company, the test runs on either Bio-Rad's CFX96 RT-PCR system or Thermo Fisher Scientific's Applied Biosystems QuantStudio 5 RT-PCR system. The test may be performed by any lab CLIA-certified to perform high-complexity testing.

Cormeum's SARS-CoV-2 assay is designed to detect the N, S, and Ofr1ab regions within the virus' genome in nasopharyngeal swabs. It runs on the Applied Biosystems QuantStudio 12K Flex RT-PCR instrument using software version 1.1.2 and may only be performed by the Marrero, Louisiana-based company.