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FDA Grants Emergency Use Authorization for Luminostics Coronavirus Antigen Test

NEW YORK — The US Food and Drug Administration on Monday granted Emergency Use Authorization for a point-of-care SARS-CoV-2 antigen test developed by Luminostics.

The Clip COVID Rapid Antigen Test is a lateral flow immunoluminescent assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 directly from anterior nasal swab specimens collected within the first five days of the onset of symptoms. It uses proprietary luminescent nanoparticles that are detected using the camera of an Apple iPhone SE smartphone that is integrated into the company's Clip Analyzer and is only capable of running the Clip COVID app.

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

In October, Milpitas, California-based Luminostics received $26.1 million from the National Institutes of Health and the Biomedical Advanced Research and Development Authority to develop the test.