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FDA Grants Emergency Use Authorization for Princeton BioMeditech At-Home COVID-19 Antigen Test

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

The Status COVID-19 Antigen Rapid Test for Home Use is a nonprescription lateral flow immunoassay designed for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in self-collected anterior nasal swab samples.

It is authorized for use by symptomatic individuals when tested at least twice over three days with at least 48 hours between tests, according to the FDA. It is also authorized for use by individuals without symptoms when tested at least three times over five days with at least 48 hours between tests.

In early 2021, Princeton BioMeditech received EUA from the FDA for a combination SARS-CoV-2/influenza point-of-care antigen test. That same year, the Monmouth Junction, New Jersey-based company received funding through the US National Institutes of Health's Rapid Acceleration of Diagnostics initiative to develop a rapid COVID-19 test.