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CorDx, Osang Healthcare Get Emergency Use Authorizations for COVID-19, Flu Combo Tests

NEW YORK — The US Food and Drug Administration recently granted separate Emergency Use Authorizations for combination COVID-19 and influenza antigen point-of-care tests developed by CorDx and Osang Healthcare.

CorDx's Tyfast Flu A/B & COVID-19 Multiplex Rapid Test and Osang's OHC COVID-19/Flu Antigen Test Pro are both designed for the simultaneous detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens.

The lateral flow immunochromatographic assays are authorized for use within the first four days of symptom onset when tested at least twice over three days with at least 48 hours between tests. They may be performed by labs CLIA-certified to perform moderate-, high-, or waived-complexity tests, as well as at the point of care, according to the FDA.

About two years ago, South Korea-based Osang received EUA from the FDA for an over-the-counter COVID-19 antigen self-test.

San Diego-based CorDx, which submitted the Tyfast test for EUA last month, received authorization for an at-home COVID-19 antigen test in late 2022.