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Acutis Diagnostics Gets FDA Emergency Use Authorization for COVID-19 RT-PCR Test

NEW YORK — The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for an RT-PCR-based test for COVID-19 infection developed by Acutis Diagnostics.

The SARS-CoV-2 Acutis Multiplex Assay is designed for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab specimens from individuals suspected of having COVID-19.

The test may only be performed by Hicksville, New York-based Acutis, according to the FDA.

Earlier this year, Acutis struck a deal to incorporate Sophia Genetics analytics into a planned hereditary cancer sequencing assay.