The first human papillomavirus DNA test to screen women for cervical cancer was approved Thursday by the U.S. Food and Drug Administration. The stand-alone test can be used to assess whether women need to undergo additional testing and their risk of developing cervical cancer in the future.
HPV is the most common sexually transmitted infection, according to the Centers for Disease Control and Prevention. There are about 40 types of genital HPV, and high-risk types can cause cellular changes in the cervix that lead to cervical cancer. The cobas HPV Test from Roche Molecular Systems, approved for women 25 and older, detects DNA of HPV types 16 and 18, which are associated with 70% of the two most common types of cervical cancers, the FDA said.
The test can also detect 12 other high-risk types. Women testing positive for one or more of the 12 other high-risk HPVs would need to undergo a Pap test to determine if a colposcopy is needed.