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FDA Grants Emergency Use Authorization for Rize Laboratory qPCR COVID-19 Test

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for Rize Laboratory's SARS nCoV-2019 Multiplexed Assay.

The reverse transcription qPCR assay is designed for the in vitro qualitative detection of RNA from SARS-CoV-2 in anterior nasal swab samples collected by a healthcare provider or self-collected under the supervision of a healthcare provider. The test may be used in people with or without COVID-19 symptoms.

The test targets sequences in the N1 and N2 genes of the SARS-CoV-2 virus and runs on Thermo Fisher Scientific's ABI 7500 Fast Thermocycler and KingFisher Flex sample prep instrument.

Use of the test is limited to Corvallis, Oregon-based Rize Laboratory, according to the FDA, which is certified under CLIA and meets the requirements to perform high complexity testing.