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Roche Gets FDA Approval for Cobas 5800 HPV Test

NEW YORK – Roche announced on Tuesday that its Cobas HPV test has received approval from the US Food and Drug Administration for use on the Cobas 5800 instrument. 

The real-time PCR test identifies the presence of HPV genotypes 16 and 18, which are responsible for about 70 percent of all cervical cancers, and reports the 12 other high-risk HPV types as a combined result. It is intended for routine cervical cancer screening as per professional medical guidelines, including triage of cytology, co-testing with cytology, and HPV primary screening to assess the risk for cervical precancer and cancer, Roche said in a statement. 

"Expanding access to HPV testing on our new 5800 platform will enable more labs to deliver accurate and reliable results that can lead to the earlier diagnosis of cervical cancer," Whitney Green, senior VP for molecular and pathology lab at Roche Diagnostics, said in a statement. 

The Cobas 5800 molecular platform is a smaller, lower-throughput version of the Cobas 6800/8800 instruments and is designed to test multiple assays simultaneously. It is able to provide up to 144 results in an eight-hour shift, Roche noted. The platform received FDA premarket approval last year.

In 2020, Roche received FDA approval for the Cobas HPV test on the 6800/8800 platforms.