- The cobas SARS-CoV-2 Qualitative test is one of the first COVID-19 PCR tests performed on an automated, high throughput platform to receive FDA 510(k) clearance.
- This FDA clearance will ensure that the healthcare community has access to timely, reliable and accurate COVID-19 PCR testing beyond the EUA period.
- Based on continuous analysis performed since the onset of the pandemic, all Roche molecular tests, including the cobas SARS-CoV-2 Qualitative test, detect all SARS-CoV-2 variants.
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the cobas® SARS-CoV-2 Qualitative PCR test for use on the fully automated cobas® 6800 and cobas® 8800 Systems. This standalone test is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasal and nasopharyngeal samples from symptomatic patients who are suspected of having COVID-19 as determined by their healthcare provider.
The cobas SARS-CoV-2 Qualitative test has been available in the U.S. under Emergency Use Authorization (EUA) since March 2020 and was the first commercial molecular test to receive this status. The FDA clearance is based on a comprehensive package submitted to the agency, including analytical and clinical studies.
“We are pleased that we have achieved this regulatory milestone. Roche is fully committed to continuing our support and innovation for COVID-19 diagnostics to address evolving health care needs and to help keep communities safe,” said Thomas Schinecker, CEO of Roche Diagnostics. “We are actively working with health authorities to pursue FDA-cleared status for the tests in our COVID-19 portfolio. This will ensure clinicians and patients have continued access to accurate, reliable and efficient testing options.”
With the continued evolution of coronavirus variants and frequent surges happening around the world, Roche will continue to add diagnostic solutions to the global portfolio to help in the fight against COVID-19. For more information on how Roche is responding to the global COVID-19 public health crisis, please visit our