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Roche Receives FDA EUA for PCR-Based, Point-of-Care SARS-CoV-2 Test

NEW YORK – Roche announced on Friday that its RT-PCR-based Cobas SARS-CoV-2 nucleic acid test for use on the Cobas Liat system has received Emergency Use Authorization from the US Food and Drug Administration.

The test can return results in 20 minutes and can be used for screening both asymptomatic and symptomatic people. It is the first molecular, point-of-care test that has received EUA for detecting SARS-CoV-2 in asymptomatic people, the company said in a statement.

Roche said the test is for use at a variety of POC settings including emergency and primary care, physician offices, and screening locations. A Roche spokesperson said the price of the test usually depends on the specific contract with users.

The test will be available in the US and in countries accepting the CE mark in July, Roche said.

In February, Roche's Cobas Influenza A/B & RSV nucleic acid test received 510(k) clearance from the FDA for use on the Liat system. Last September, the firm received EUA for its Cobas SARS-CoV-2 & Influenza A/B test on the Liat system.

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