DiaCarta test for novel coronavirus gets FDA clearance

2020 01 27 21 38 4451 Lab 2019 Coronavirus Test 400

The U.S. Food and Drug Administration (FDA) has granted DiaCarta emergency use authorization (EUA) for its polymerase chain reaction (PCR) test to detect the novel coronavirus.

The QuantiVirus test evaluates nasopharyngeal swabs, oropharyngeal swabs, and sputum samples for three different RNA-encoded genes of SARS-CoV-2: N, Orflab, and E.

DiaCarta can now manufacture 500,000 tests per week, according to the company. It plans to further expand manufacturing to up to four times its current scale to meet increased demand.

The QuantiVirus test previously received the European CE Mark.

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