Cobas HPV test approved for use on cobas 6800/8800 system.- Roche

Roche announced FDA approval for the cobas HPV test for use on the fully automated, high-throughput cobas 6800/8800 Systems. The cobas HPV test identifies women at risk for cervical cancer by detecting the presence of high-risk human papillomavirus (HPV) DNA in cervical samples. Persistent high-risk HPV infections can develop into precancerous lesions and, if left untreated, these lesions can progress to cervical cancer. The cobas HPV test was previously approved for the cobas 4800 System in 2011. The FDA considered data from the registrational IMPACT (IMproving Primary screening And Colposcopy Triage) trial, which enrolled almost 35,000 women in the US to clinically validate cobas HPV for use on the cobas 6800/8800 Systems. Study data will be broadly shared, pending publication of the key findings.