Roche SARS-CoV-2 molecular test granted first FDA Emergency Use

19 June 2021 | Saturday | News

Roche SARS-CoV-2 molecular test granted first FDA Emergency Use Authorization for PCR testing of both symptomatic and asymptomatic individuals at the point of care
Image Source : Public Domain

Image Source : Public Domain

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


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 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.

The test will be available in July.

About the cobas Liat System

Utilising 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 & influenza A/B, influenza A/B & RSV, Strep A and C. diff, assays for other infectious diseases are in development. More information is available at

The cobas Liat System is commercially available in select markets.

About Emergency Use Authorization status

The cobas SARS-CoV-2 Test for use on the cobas Liat system has not been FDA cleared or approved. It has been authorised by the FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. The test has been authorised only for the detection of RNA from SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection, not for any other viruses or pathogens. It is only authorised for the duration of the declaration that circumstances exist justifying the authorisation of the emergency use of in vitro diagnostics for detection of SARS-CoV-2 virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorisation is terminated or revoked sooner.


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