Roche’s COVID-19 Molecular Test Granted EUA

Roche has received U.S. 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. This singleplex test is the first real-time reverse transcriptase polymerase chain reaction (RT-PCR) test that can identify SARS-CoV-2 infection within 20 minutes. 
 
The cobas SARS-CoV-2 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. At launch, the test will also be available in markets accepting the CE mark.
 
“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,” said Ian Parfrement, Head of Point of Care for Roche Diagnostics Solutions. “Preventing further spread of the virus is crucial for public health and the continued safe reopening of our communities worldwide.” 
 
Individuals infected with the SARS-CoV-2 virus may not always show symptoms of COVID-19.1 However, they can still spread the infection, which is why a test that can be used to screen asymptomatic people is important in the fight against the virus. The test offers broad strain coverage of SARS-CoV-2 variants providing further reassurance with clinician-care decisions.
 
Utilizing 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. Definitive results are generated in 20 minutes or less to aid in patient care decisions. In addition to the existing tests for SARS-CoV-2 and influenza A/B, influenza A/B and RSV, Strep A and C. diff, assays for other infectious diseases are in development. 

The cobas Liat System is commercially available in select markets.