HPV Screening Test Approved by FDA

April 25, 2014
Rachel Lutz

The FDA has approved the first human papillomavirus (HPV) DNA test for primary cervical cancer screening.

The first human papillomavirus (HPV) DNA test for primary cervical cancer screening has been approved by the US Food and Drug Administration (FDA).

The cobas HPV Test is a DNA test for women 25 and older that screens a sample of cervical cells for 14 high-risk HPV strains, including specifically seeking out HPV 16 and HPV 18. Women who test positive for HPV 16 or HPV 18 are then recommended to have a colposcopy so a physician can directly observe cervical cells. If a patient tests positive for any of the other 12 high-risk strains, a Pap test — cell cytology, which examines cervical cells for changes that indicate cervical cancer – is recommended to determine the need for further testing.

The FDA notes that this test should be used with other diagnostic information including patient history, risk factors, and current professional guidelines not regulated by the FDA.

“Today’s approval offers women and physicians a new option for cervical cancer screening,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, said in a press release. “Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer.”

Most HPV infections go away on their own and do not cause any additional health problems, though the Centers for Disease Control and Prevention (CDC) note HPV is the most common sexually transmitted infection. Essentially all cervical cancers are caused by HPV, specifically HPV 16 and HPV 18, which account for 70% of cervical cancers.

The FDA approved the test after reviewing results of a study that included more than 40,000 women aged 25 years or older who underwent routine checkups. Colposcopies and cervical tissue biopsies were given to women whose Pap tests or cervical cells screened positive for HPV and women whose Pap tests and HPV tests were both negative. The biopsy results were then compared to the Pap and cobas HPV Test results. Women who underwent colposcopy were included in a 3-year follow-up. Data showed the cobas HPV Test is safe and effective for its indicated use.