NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorizations for molecular SARS-CoV-2 tests developed by Fluidigm and Uh-Oh Labs.
Fluidigm's Advanta Dx COVID-19 EASE Assay is a PCR-based test designed to detect SARS-CoV-2 nucleic acid in nasopharyngeal swab, oropharyngeal swab, mid-turbinate nasal swab, and anterior nasal swab specimens. It may be used only by labs CLIA-certified to perform high-complexity tests, according to the FDA.
Uh-Oh's UOL COVID-19 Test uses real-time reverse transcription loop-mediated isothermal amplification to detect SARS-CoV-2 nucleic acid anterior nasal swab specimens and runs on the Santa Clara, California-based company's UOL COVID-19 instrument. It is authorized for use by labs CLIA-certified to perform high-, moderate-, or waived-complexity tests, and may also be used at the point of care.
Late last year, Uh-Oh received funding from the National Institutes of Health's Rapid Acceleration of Diagnostics initiative to develop a rapid COVID-19 test.
Fluidigm, which is planning to change its name to Standard BioTools, received RADx funding in mid-2020 to develop the Advanta Dx COVID-19 EASE test. The South San Francisco, California-based firm received EUA from the FDA for the saliva-based Advanta Dx SARS-CoV-2 RT-PCR assay around that same time.