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FDA grants EUA to Roche’s 20-minute Covid-19 PCR test

June 21, 2021

Roche has received Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for the use of its cobas SARS-CoV-2 Nucleic acid test in point of care settings.

Indicated for screening symptomatic as well as asymptomatic people, the singleplex real-time reverse transcriptase-polymerase chain reaction (RT-PCR) test can detect Covid-19 infections in 20 minutes.

The test could aid in the making of rapid, informed decisions at doctors’ offices, screening sites and emergency or primary care, as well as other point of care settings.

Authorised for use on the cobas Liat System, the test will be made available in markets accepting the FDA EUA and CE mark in July.

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