The U.S. Food and Drug Administration (FDA) has granted Roche Emergency Use Authorization (EUA) for its PCR cobas® SARS-CoV-2 Nucleic acid test. The EUA was granted for use on the cobas® Liat® System, and is the first RT-PCR (reverse transcriptase polymerase chain reaction) test that can identify COVID-19 infections in both asymptomatic and symptomatic individuals in under 20 minutes. The test will be available in markets accepting the CE marking for a wide range of point-of-care systems including screening locations, doctor’s offices, and more. Ian Parfrement, Head of Point of Care for Roche Diagnostics Solutions, stated, “We learn more about COVID-19 everyday and Roche continues to develop solutions that will help healthcare systems around the world slow and eventually defeat this pandemic. We are pleased that we can now provide a test to enable healthcare professionals to identify both asymptomatic and symptomatic infected individuals at the point of care.”
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