Approval of the expanded indication would mean the Cobas 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 study that involved more than 47,000 women being 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, chief 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 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.
Persistent infection with Human Papillomavirus is the principal cause of cervical cancer in women, with HPV implicated in greater than 99% of cervical cancers worldwide. According to the National Cancer Institute, there are 12,200 new cases of cervical cancer in the U.S. annually and 4,210 deaths due to the disease. The World Health Organization estimates there are 470,000 new cases of cervical cancer annually.