The Food and Drug Administration on April 24 approved the cobas HPV test as a first-line screening test for primary cervical cancer.
The cobas HPV test uses a sample of cervical cells to detect DNA from 14 high-risk human papillomavirus types. The test, which is approved for women aged 25 years and older, identifies HPV 16 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 a Pap test to determine the need for a colposcopy.
The cobas HPV test results should be used along with patient screening history and risk factors, and current professional guidelines when making clinical decisions, the FDA advised.
The test, which is manufactured by Roche Molecular Diagnostics, 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 now be used as the primary cervical cancer screening test.
The approval means women will have more screening options, said Alberto Gutierrez, Ph.D., director of the FDA Office of In Vitro Diagnostics and Radiological Health.
"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," Dr. Gutierrez said in a statement.
Despite some concerns about the potential for confusion and its off-label use, the FDA’s Microbiology Devices Advisory Committee voted unanimously on March 12 to support expanding the approval of the cobas HPV test to include first-line use for primary cervical cancer screening. Some panelists noted that it will be up to professional societies to integrate the new test into their practice guidelines and to educate physicians and patients about its use.
The decision to approve the test was based on the results of the ATHENA trial, a prospective study of 47,208 women in the United States, and 3-year follow-up data. The results indicate 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 a similar level of protection against CIN3 and invasive cervical cancer as does cotesting with HPV testing and cytology, according to Roche.
mschneider@frontlinemedcom.com
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