WASHINGTON -- The FDA has approved a molecular test for human papillomavirus (HPV) DNA as a first-line, stand-alone screen for cervical cancer.

The agency approved the cobas HPV test to screen women ≥25 for infection with 14 high-risk HPV strains, including HPV 16 and 18, which account for most cases of cervical cancer in the U.S. and worldwide.

The approval follows a unanimous recommendation from an FDA advisory committee that reviewed evidence on test results presented by FDA staff and by the test manufacturer, Roche Molecular Systems.

"Today's approval offers women and physicians a new option for cervical cancer screening," Alberto Gutierrez, PhD, of the FDA 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 initially approved the molecular test in 2011 for use in conjunction with or as a follow-up to a Pap test. The new approval gives healthcare professionals the option to use the HPV test alone or as a co-test with cervical cytology (Pap).

According to the FDA, women who test positive for HPV 16 or 18 should proceed directly to colposcopy. A positive test for one or more of the other 12 high-risk HPV strains should be followed by a Pap test to determine the need for colposcopy.

In support of the approval application, Roche submitted data from a study involving 47,000 women who were evaluated by both the HPV test and cervical cytology. The DNA test outperformed the Pap test on all key outcome parameters: sensitivity for cervical intraepithelial neoplasia (CIN) scores ≥3, positive and negative predictive values, and false-positive rate.

Following a day-long hearing last month, the FDA's Medical Devices Advisory Committee Microbiology Panel agreed unanimously that results with the test provided positive answers to three key questions: Is the test safe? Is it effective? Do the benefits of the test as a stand-alone screen outweigh the risks?