Roche Diagnostics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its cobas SARS-CoV-2 Qualitative PCR test.
The new real-time RT-PCR test has been designed for the qualitative detection of nucleic acids from SARS-CoV-2 in nasal and nasopharyngeal samples collected from symptomatic individuals.
With the ability to run on the fully automated cobas 6800 and cobas 8800 Systems, the test also has a full-process negative control, positive control and internal control.
The single-well dual target assay includes specific detection of SARS-CoV-2, as well as pan-sarbecovirus detection for the sarbecovirus subgenus that has SARS-CoV-2.
It is claimed to be the first commercial molecular test to receive FDA 510(k) clearance.
The regulatory approval is based on a comprehensive package, including analytical and clinical studies, which were submitted to the FDA.
Roche Diagnostics CEO Thomas Schinecker said: “Roche is fully committed to continuing our support and innovation for Covid-19 diagnostics to address evolving healthcare needs and to help keep communities safe.
“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.”
Since March 2020, the cobas SARS-CoV-2 Qualitative PCR test has been available in the country under Emergency Use Authorization.
Recently, Roche announced the launch of three next-generation SARS-CoV-2 rapid antigen tests (‘2.0’) for self-test and professional use.
The tests include the SARS-CoV-2 Rapid Antigen Test 2.0 Nasal, the SARS-CoV-2 Rapid Antigen Test 2.0 for professional use, and the SARS-CoV-2 Antigen Self Test Nasal for self-test.