NEW YORK (GenomeWeb News) – Roche today said that it has submitted a Premarket Approval supplement to the US Food and Drug Administration seeking the addition of a cervical cancer primary screening indication for its cobas HPV Test.
If the FDA approves the indication, the cobas test could then be used as a first-line test, rather than Pap cytology, as part of a cervical cancer screening strategy, said Roche. The test was initially approved by the FDA in April 2011 to screen patients age 21 and older with abnormal Pap test results as well as to co-test with Pap in women ages 30 to 65 to assess the presence or absence of high-risk human papillomavirus genotypes.
The filing includes three-year follow-up data from the firm's ATHENA study, which has collected data on more than 47,000 women screened for cervical disease with Pap and HPV tests.
The test is performed on Roche's cobas 4800 system, an automated molecular diagnostic instrument platform.