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Princeton BioMeditech Gets FDA Emergency Use Authorization for Point-of-Care COVID-19, Flu Test

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for a combination COVID-19 and influenza test developed by Princeton BioMeditech.

The ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test is designed for the simultaneous qualitative detection and differentiation of nucleocapsid protein antigen from SARS-CoV-2, influenza A, and influenza B, according to the FDA. It is authorized for use within the first five days of onset of symptoms, when tested at least twice over three days with at least 48 hours between tests.

The test may be used by labs CLIA-certified to perform moderate-, high-, and waived-complexity tests, as well as in point-of-care settings.

Earlier this year, Monmouth Junction, New Jersey-based Princeton BioMeditech received a $1.5 million National Institutes of Health grant with collaborator C2Sense to develop an at-home COVID-19/influenza assay.