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Roche Obtains FDA 510(k) Clearance for COVID-19 PCR Test

NEW YORK – Roche announced on Monday that its SARS-CoV-2 Qualitative PCR test has received 510(k) clearance from the US Food and Drug Administration.

The RT-PCR test runs on Roche's high-throughput Cobas 6800 and 8800 systems and is intended to detect SARS-CoV-2 from nasal and nasopharyngeal samples in symptomatic patients. The assay has been available in the US under Emergency Use Authorization since March 2020. 

Roche said in a statement that the test's clearance was based on a comprehensive package that included analytical and clinical studies and noted that the assay is able to detect all SARS-CoV-2 variants. 

The firm is also "actively working with health authorities to pursue FDA-cleared status for the tests in our COVID-19 portfolio," Roche Diagnostics CEO Thomas Schinecker said in a statement. 

According to Roche, the Cobas 6800 and 8800 systems can provide results in three and a half hours. The 6800 system can provide a total of 1,440 results in 24 hours while the 8800 system can provide 4,128 results over that same time period.