FDA approves first-line cervical cancer screen test

The Food and Drug Administration approves the cobas HPV test as a first-line screening test for primary cervical cancer.

The cobas HPV test uses a sample of cervival cells to detect DNA from 14 high-risk human papilloma virus types. The test, approved for women aged 25 years and older, identifies HPV16 and 18. It can concurrently detect 12 other types of high-risk HPVs, according to the FDA.

The FDA recommended that women who test positive for HPV 16 or HPV 18 using the cobas HPV test have a colposcopy. Those who test positive for one or more of the 12 other high-risk HPV types should have Pap test to determine the need for a colposcopy.

The cobas HPV test results should be used with patients screening history and risk factors, and current professional guidelines, when making clinical decisions, the FDA advised.

The test was first approved in 2011 for use in conjunction with or as a follow-up to a Pap test.

With the current approval, the cobas test can be used as the primary cervical cancer screening test.

“They conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when [the test was] used as a primary screening tool for cervical cancer,” the director of the FDA Office of In Vitro Diagnostics and Radiological Health, said in a statement.

Despite concerns about the potential for confusion and its off-label use, the FDA’s Microbiology Devices Advisory Committee voted unanimously to support expanding the approval of the cobas HV test to include first-line use for primary cervical cancer screening. Some panelists said it will be up to professional societies to integrate the new test into their practice guidelines.

The approval was based on the result of ATHENA, a prospective study of 47,208 women in the United States, and three-year follow-up data. The result indicates that HPV testing alone provides greater protection against CIN3 (Cervical intraepithelial neoplasia grade 3) and invasive cervical cancer than does cytology alone, and that primary HPV testing provides similar level of protection against CIN3 and invasive cervical cancer as does contesting with HPV testing and cytology.