The U.S. Food and Drug Administration issued an approval for Roche Holding AG's first HPV DNA test for women aged 25 and above which can serve as a Pap smear alternative. The test would help health professionals assess a woman's need to undergo additional tests for cervical cancer. It also provides information about a woman's risk of cervical cancer in the future.
There are no medical guidelines that recommend only HPV testing for cervical cancer diagnostic screening. In representing the American College of Obstetrics and Gynecology, David Chelmow of Virginia Commonwealth University advised doctors to hold off using the new test until the medical community can answer key questions about it. Pap smear was the only testing method for cervical cancer for decades and it has proven successful. Increased Pap screening helped decrease over 50% of cervical cancer cases in the last 30 years and because of the new HPV tests from Qiagen, Roche and other makers, 12,000 cervical cancer cases are still expected to be diagnosed in 2014.
Doctors use DNA-based tests but only to confirm Pap smear results and the recent FDA approval allows Roche to sell its HPV DNA test as a first option for cervical cancer screening. With the use of cervical cell samples, the HPV test would detect DNA from 14 high-risk HPV types and identifies HPV 16 and HPV 18 while detecting the rest. Women who are positive for HPV 16 or HPV 18 would be advised to undergo a colposcopy, a test that magnifies and illuminates the cervix so the doctor can study the cervical cells. Those who test positive for one of the 12 other types would be advised to get a Pap smear to see if a colposcopy is needed.
"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," In Vitro Diagnostics and Radiological Health director at FDA Center for Devices and Radiological Health Alberto Gutierrez said.
The U.S. Department of Health and Human Services advised women to undergo a Pap test every two years starting at 21 years. Women who are 30 years and above and who had three consecutive Pap tests can undergo the screening every three years while women above 65 can stop having tests after consulting with their doctors.
HPV is typically self-healing but around 10 percent of women with high-risk HPV build a persistent infection that could lead to cancer. Regular screening for cervical cancer is one of the best way to prevent the disease. HPV doesn't have symptoms and there is still no treatment for it but detecting cervix cell changes early can save lives.