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FDA Grants Emergency Use Authorization for KorvaLabs, GenoSensor Coronavirus Tests

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

The Curative-Korva SARS-Cov-2 Assay — developed by Menlo Park, California-based KorvaLabs and San Dimas, California-based Curative — is designed to detect SARS-CoV-2 nucleic acid in oropharyngeal swab, nasopharyngeal swab, nasal swab, and oral fluid specimens. Its use is limited to KorvaLab.

Tempe, Arizona-based GenoSensor's GS COVID-19 RT-PCR kit is designed to detect SARS-CoV-2 nucleic acid in nasopharyngeal/oropharyngeal swab, nasal swab, and mid-turbinate swab specimens. It may be used by any CLIA-certified laboratory.

Both tests run on any authorized RT-PCR instrument, according to the FDA.

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