- This is the first SARS-CoV-2 real-time RT-PCR test authorised for use in screening and testing asymptomatic and symptomatic individuals with results within 20 minutes, allowing health care professionals to take action quickly and confidently.
- The new test offers broad SARS-CoV-2 strain coverage as monitored by Roche's ongoing variant surveillance program providing further reassurance with healthcare decisions.
- The test, which runs on the cobas® Liat® System, will also be available in markets accepting the CE mark, and it reinforces Roche’s continued commitment to address the COVID-19 public health crisis.
Basel, 18 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted 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 every day 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.
The test will be available in July.