COVID-19 PCR Test Receives FDA Clearance for use on Cobas Systems

The test has been available under emergency use authorization (EUA) since March of 2020 and was the first commercial molecular test to receive EUA status.

Roche has received FDA 510(k) clearance for the cobas SARS-CoV-2 Qualitative test, one of the first COVID-19 polymerase chain reaction (PCR) tests performed on an automated, high throughput platform.

The clearance is for use on the cobas 6800 and 8800 systems. It is intended for detection of SARS-CoV-2 in nasal and nasopharyngeal samples from symptomatic patients who are suspected of having COVID-19 as determined by a health care provider.

The cobas SARS-CoV-2 Qualitative assay is a single-well dual target assay, including both specific detection of SARS-CoV-2 and pan-sarbecovirus detection for the sarbecovirus subgenus that includes SARS-CoV-2. It is a real-time reverse transcription PCR test and runs on the cobas 6800/8800 systems, which provide results in approximately 3 hours.

The systems provide up to 96 results in about 3 hours, as well as a total of 1440 results for the cobas 6800 System and 4128 results for the cobas 8800 System in 24 hours. The test can be run simultaneously with other assays.

The test has been available under emergency use authorization (EUA) since March of 2020 and was the first commercial molecular test to receive EUA status. The new clearance is based on a comprehensive package submitted to the agency, including analytical and clinical studies.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Results should be used in conjunction with clinical observations, patient history, recent exposures, epidemiological information, and laboratory data.

According to a press release, the clearance will ensure that clinicians and patients have access to timely, reliable, and accurate COVID-19 PCR testing beyond the EUA period.

“We are pleased that we have achieved this regulatory milestone,” said Thomas Schinecker, CEO of Roche Diagnostics, in the press release. “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. 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.”

REFERENCE

Roche receives FDA clearance for COVID-19 PCR test for use on cobas 6800/8800 Systems. News release. Roche; October 24, 2022. Accessed October 24, 2022. https://www.roche.com/media/releases/med-cor-2022-10-24