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FDA Approves DNA Test for Cervical Cancer Screening

Update Date: Apr 25, 2014 09:58 AM EDT

The United States Food and Drug Administration (FDA) has approved an alternative to the Pap smear for cervical cancer screening. The federal agency announced that Roche Molecular Diagnostics' DNA test, cobs HPV test, is a viable option and can now be used over the Pap smear if requested.

Prior to this approval, the DNA test was used to confirm the results from Pap tests. With the approval, women can now opt for the DNA test as their first-choice screening tool. The DNA test looks for 14 specific strains of the human papillomavirus (HPV) tied to cervical cancer, which include HPV 16 and HPV 18. Similarly to the Pap test, women still need to provide a sample via a vaginal swab. However, instead of analyzing cervical cells for abnormalities, the DNA test looks for any signs of DNA from the virus.

"The potential benefit of [the HPV test] is that everybody that has a precancerous change or cervical cancer will have a positive test," Dr. Kevin Ault, professor at the University of Kansas Medical Center in Kansas City, told CNN. "You're not going to miss anybody."

If the DNA test comes back positive for a HPV16 or HPV18, patients will need to get a colposcopy, which will look at the cervical cells up close via a magnifying device. If the DNA test comes back positive for one of the other less-threatening types of HPV, patients will undergo a Pap smear to determine if a colposcopy is required.

"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 reported by HuffPost. "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."

Even though the DNA test can be effective in identifying potential cancer cases, many women's and health groups have expressed their concerns over the new test. These groups, which include the American Medical Women's Association and Cancer Prevention and Treatment Fund, believe that the approval was made prematurely based on insufficient data. The groups also stated that the DNA test cannot identify any other abnormalities aside from HPV that could be tied to cancer. In addition, the DNA test costs roughly twice as much as the Pap smear.

The DNA test is limited to women over the age of 24.

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