The FDA approved Thursday a human papillomavirus (HPV) DNA test for women aged 25 or older for use as a first-line screening method to determine a woman’s risk for cervical cancer.
The new tool samples women’s cervical cells and looks for 14 high-risk HPV strains. The so-called cobas HPV test, developed by Roche, looks specifically for the most dangerous strains, HPV 16 and HPV 18, while also searching for signs of the 12 other strains.
An FDA advisory committee unanimously agreed in March that the test should be approved by the FDA as a primary screening tool for HPV. Some argue the cobas test is a better screening tool than the pap smear. Currently, women are tested for HPV after a Pap smear shows abnormal changes on their cervix or if a physician gives her a test during a standard appointment. But the new test from Roche is a more precise diagnostic because it can identify the risk of cervical cancer in the pre-cancer stages.
The FDA also provided guidelines for how the test should be used. Women who test positive for HPV 16 or HPV 18 should have a colposcopy, which magnifies the cervix so a physician can better assess the abnormal cells. Women who test positive for the other strains should then have a pap test to determine if they need to undergo a colposcopy.
As TIME previously reported, it’s not likely the new test will completely replace the pap smear, as it will take some time for physicians to start implementing it. However, Roche’s trials showed it was better than the Pap smear in detecting cancerous lesions.
HPV is the most common cause of cervical cancer, making screening for the virus extremely important. In most cases, a high-risk infection will go away on its own, but about 10% of infected women become at risk for developing cervical cancer. Almost all cervical cancer cases are caused by HPV.
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