Roche, a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics, has submitted a Premarket Approval (PMA) supplement to the US Food and Drug Administration (FDA) seeking the addition of a cervical cancer primary screening indication for the cobas HPV Test. Approval of the expanded indication would mean the cobas HPV Test could be used as the first-line test rather than Pap cytology as part of a cervical cancer screening strategy. The filing includes new three-year follow-up data from the ATHENA study, Roche's landmark US-based registration trial, including more than 47,000 women screened for cervical disease with Pap and HPV (Human Papillomavirus) tests.
"This milestone demonstrates our long-term commitment to cervical cancer prevention and women's health," said Paul Brown, Head of Roche Molecular Diagnostics. "Our ATHENA study validates the value of HPV DNA detection and we are confident that these data will demonstrate to the FDA that we have established the clinical utility of the cobas HPV Test in primary screening for physicians and their patients."
The cobas HPV Test is the only FDA approved test that provides pooled results for known high risk genotypes and in addition, simultaneously provides individual results for the 2 highest risk genotypes, HPV 16 and HPV 18. Data from the ATHENA study published in the American Journal of Obstetrics & Gynaecology in November 2012 by Cox et al. show strategies that incorporate high-risk HPV DNA testing with simultaneous detection of genotypes 16 and 18 as an initial screening test can detect more cervical disease than strategies that use Pap alone, representing significant potential benefits for patients.
The cobas HPV Test received FDA approval in April 2011 to screen patients age 21 and older with abnormal Pap test results and to co-test with Pap in women ages 30 to 65 to assess the presence or absence of high-risk HPV genotypes. In November 2012, the test was also CE marked for use as a primary screening test in countries that accept the CE mark.
Clinically validated by the landmark ATHENA trial, the cobas HPV Test is the only FDA-approved HPV assay that provides specific genotyping information for HPV 16 and 18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result, all in one run, from one patient sample.
The test is performed on the cobas 4800 system, which offers true walk-away automation of nucleic acid purification, PCR (polymerase chain reaction) set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. The system also runs the cobas CT/NG Test (chlamydia/gonorrhea), the cobas® BRAF V600 Mutation Test and the cobas EGFR Mutation Test.