Research & Development
Roche wins FDA's EUA for the cobas SARS-CoV-2 Nucleic acid test for both symptomatic and asymptomatic individuals
21 June 2021 -

Pharmaceutical company Roche (SIX:RO) (ROG;OTCQX:RHHBY) reported on Friday the receipt of US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System for both symptomatic and asymptomatic individuals.

At the July launch, the company said its cobas SARS-CoV-2 Nucleic acid test will be available in markets accepting the CE mark.

In addition, the company's cobas SARS-CoV-2 singleplex test is the first RT-PCR test that screens within 20 minutes both asymptomatic and symptomatic persons, enabling quick, informed decisions at the point of care. The test is for use at a wide range of point-of-care settings, including but not limited to emergency and primary care, physician offices and screening locations, enabling greater access for patients.

The company added the test offers broad strain coverage of SARS-CoV-2 variants providing reassurance with clinician-care decisions.

Based on the company's PCR technology, the cobas Liat System fully automates the testing process, simplifies workflow and enables healthcare providers to perform molecular testing in a variety of point-of- care settings with speed, reliability and minimal training.



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