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FDA Grants Emergency Use Authorization for UMass Amherst COVID-19 Molecular Test

NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for a PCR-based COVID-19 test developed by the University of Massachusetts, Amherst.

The ICTC SARS-CoV-2 RT-PCR Assay is designed for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens from people suspected of having COVID-19. Use of the test is limited to UMass Amherst's CLIA-certified IALS Clinical Testing Center, according to the FDA.

The testing center was established at the university's Institute for Applied Life Sciences as a surge facility to provide COVID-19 testing for the UMass Amherst campus and other regional campuses.