FDA Approves HPV Test for First-Line Cervical Cancer Screening

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ON JULY 30, 2018, Roche announced approval by the U.S. Food and Drug Administration (FDA) of its cobas HPV Test in first-line screening for cervical cancer in women 25 years and older using cervical specimens collected in SurePath preservative fluid. The FDA first approved the cobas HPV test without an accompanying Pap test for primary cervical cancer screening in 2014. 

The cobas HPV Test identifies the presence of the DNA of human papillomavirus (HPV) genotypes 16 and 18—the two genotypes responsible for about 70% of all cervical cancer—and reports the 12 other high-risk HPV types as a combined result, all in a single test and from a single patient sample. With the recent approval, the cobas HPV test is the only HPV test approved with both SurePath and ThinPrep PreservCyt Solution, the two types of liquid media used to collect samples for the vast majority of Pap or HPV tests in the United States. 

The cobas HPV test is approved for all cervical cancer screening indications that are supported by professional society guidelines—primary screening in women 25 years and older, reflex (follow-up) testing of unclear Pap test results in women 21 years and older, and co-testing with a Pap test in women 30 years and older. 

HPV and Cervical Cancer 

PERSISTENT INFECTION with high-risk HPV is the principal cause of cervical cancer in women, with HPV implicated in more than 99% of cervical cancers worldwide. HPV testing is used in cervical cancer screening protocols to identify women at risk for developing cervical precancer and cancer. According to the National Cancer Institute, there are more than 12,000 new cases of cervical cancer in the United States annually and 4,210 deaths due to the disease. The World Health Organization estimates there are more than 500,000 new cases of cervical cancer annually. ■




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