FDA Approves DNA HPV Test As Primary Cervical Cancer Screening Tool

The FDA approved today (April 24) the first HPV DNA test for cervical cancer screening, for use by women ages 25 and older.

The test, called the cobas HPV Test, works by detecting DNA from 14 types of HPV that are known to be associated with high risk of cervical cancer, including specific identification of HPV 16 and HPV 18 strains (which are responsible for about 70 percent of cervical cancers). While not all HPV infections lead to cancer, about one in 10 women will have a high-risk HPV infection that will lead to cancer; cervical cancer is almost exclusively caused by HPV infections.

If a woman tests positive for HPV 16 or HPV 18, she should then go on to receive a colposcopy in order for a doctor to examine her cervical cells. If she tests positive for one of the other 14 strains, she should undergo a Pap test to determine if a colposcopy is needed, the FDA said.

The test can be used alone as a screening tool when administered by a health care professional.

"Today's approval offers women and physicians a new option for cervical cancer screening," Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, said in a statement. "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 FDA's approval means that the cobas HPV test can be used as a primary screening tool for cervical cancer. Previously, the test was approved in 2011 to be able to be used in conjunction, or follow-up to a Pap test. Pap tests are cervical cancer screening tests, and involve looking at cervical cell samples under a microscope.

Correction: A previous version of this article incorrectly stated women can use this test on their own; it should only be used when administered by a health care professional.