The U.S. Food and Drug Administration has today approved the cobas human papillomavirus (HPV) DNA test for women 25 and older, which can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. It is the first HPV DNA test approved by the FDA for this indication.
“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 news 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.”
The test uses a sample of cervical cells to detect DNA from 14 high-risk HPV types, specifically identifying HPV 16 and HPV 18, while concurrently detecting 12 other types of high-risk HPVs. Women who test positive for HPV 16 or HPV 18 based on those results should have a colposcopy; and women who test positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for colposcopy. Virtually all cervical cancers are caused by HPV infections, with just two types, HPV 16 and HPV 18, responsible for approximately 70 percent of cervical cancers.
Health care professionals should consider cobas test results together with other information, including patients’ screening histories and risk factors, as well as current professional guidelines, according to a news release from the FDA.
The FDA previously approved the cobas HPV Test in 2011 for use in conjunction with or as a follow-up to a Pap test (OT 5/25/11 issue). But the latest approval expands the indication of the test to include use as either a co-test or a primary cervical cancer screening test—though it does not change current medical practice guidelines for cervical cancer screening (which are developed or written by the FDA).
Data supporting the use of the cobas HPV Test as a primary screening test for cervical cancer included a study of more than 40,000 women 25 years and older undergoing routine cervical exams. Women who had a positive Pap test or whose cervical cells screened positive for HPV, as well as a subset of women whose Pap and HPV tests were both negative, underwent a colposcopy and cervical tissue biopsy. All biopsy results were compared to the Pap and cobas HPV Test results. Data from this study, which included three years of follow-up on women who went to colposcopy, showed that the cobas HPV Test is safe and effective for the new indication for use.
The cobas HPV Test is manufactured by Roche Molecular Systems, Incorporated.