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Quanterix Coronavirus Antigen Test Gets FDA Emergency Use Authorization

NEW YORK — The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for Quanterix's Simoa SARS-CoV-2 N Protein Antigen Test.

The test is an automated paramagnetic microbead-based immunoassay that is designed to qualitatively detect the SARS-CoV-2 nucleocapsid protein antigen in nasopharyngeal swab specimens. Samples are collected in Huachenyang Technology's iClean viral transport medium (VTM), the US Centers for Disease Control and Prevention's VTM formulation, normal saline, or phosphate-buffered saline. Results are available in 80 minutes, according to Quanterix.

The test may be used by any lab CLIA-certified to perform moderate- or high-complexity tests, the FDA said.

In October, Billerica, Massachusetts-based Quanterix received $18.2 million from the National Institutes of Health and the Biomedical Advanced Research and Development Authority to develop a SARS-CoV-2 antigen test.