Roche receives FDA clearance for COVID-19 PCR test for use on cobas 6800/8800 Systems

Thecobas SARS-CoV-2 Qualitative test is one of the first COVID-19PCR 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 thecobas SARS-CoV-2 Qualitative test, detect all SARS-CoV-2 variants.Basel, 24 October 2022 - 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 suspect ed 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 addre...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news