Skip to main content

Roche Gets FDA Approval for HPV Test Used With Cobas 6800/8800 Platforms

NEW YORK – Roche announced Tuesday that its Cobas HPV test for human papillomavirus was approved by the US Food and Drug Administration for use with its high-throughput Cobas 6800/8800 systems.

The Cobas HPV test was previously approved for use with the Cobas 4800 system in 2014. It detects the presence of the DNA of HPV genotypes 16 and 18 in cervical samples, which are responsible for 70 percent of all cervical cancers, according to Roche. It also reports the 12 other high-risk HPV types as a combined result from one sample.

The test is for routine cervical cancer screening based on professional medical guidelines, including triage of ASC-US cytology, co-testing with cytology, and primary screening to determine risk for cervical precancer and cancer.

With the FDA approval, laboratories can now run HPV DNA tests in tandem with other Cobas tests on the Cobas 6800/8800 systems, Roche said. The agency considered data from the Improving Primary Screening and Colposcopy Triage trial, which enrolled nearly 35,000 US women to clinically validate the test for use with the Cobas 6800/8800 systems.

Last month, Basel, Switzerland-based Roche's CINtec Plus Cytology test to identify women whose HPV infections are most likely to be associated with cervical precancers was approved by the FDA. The cytology test is used in combination with the Cobas HPV test and the company's CINtec Histology test.