FDA Approves Stand Alone DNA Test for Cervical Cancer


The US Food and Drug Administration has given approval for a molecular test for human papillomavirus (HPV) DNA to be used as a front-line, stand-alone screen for cervical cancer.

The cobas HPV test has been approved to screen women aged 25 and older for infection with 14 high-risk HPV strains, including HPV 16 and 18, the strains that account for most cases of cervical cancer in the US and worldwide.

"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."

This molecular test was first approved by the FDA in 2011, but at that time it was only approved for use in conjunction with or as a follow-up to a Pap test.

Now, healthcare professionals can use either the HPV test alone or they can use it 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.

The manufacturer, Roche, submitted data from a study involving 47,000 women who had been evaluated by both the HPV test and cervical cytology. The DNA test outperformed the Pap test on all key outcome parameters, and last month the FDA's Medical Devices Advisory Committee Microbiology Panel concluded that the test was safe, effective, and that its benefits as a stand-alone screening test outweighed the risks.


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