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FDA approves DNA test for cervical cancer

Written by Community Health Network on 4/25/2014 11:30:00 AM

Thursday, the FDA approved an HPV DNA test for women ages 25 years or older that could be used as a first-line screening method to determine cervical cancer risk.

The test samples women’s cervical cells and looks for 14 high-risk HPV strains. Developed by Roche, the HPV test looks for the most dangerous strains, HPV 16 and HPV 18, while also searching for signs of the additional strains.

Currently, women are tested for HPV after a their Pap test shows abnormal changes on their cervix, or if a physician gives her a test during a standard appointment. Approval for this test, called cobas, means that this should be used as a primary screening tool for HPV.

"FDA approval of primary HPV screening means we can use the HPV test first if we believe that a woman may have, or be at risk for cervical cancer," said Dr. Wafic ElMasri, gynecologic oncology specialist at Community Physician Network. "This is one more option to help us detect and prevent cervical cancer."

ElMasri also states that approval by the FDA means that the test is safe.

"This approval for primary testing means that the HPV test is safe and effective in screening for cervical cancer based on evidence from clinical trials (notably, the ATHENA Trial). The ATHENA trial found that nearly 1 in 7 women who had a normal Pap test and were later found to have a certain type of HPV actually had high-grade cervical precancerous lesions."

However, it is important to note that this test does not replace the Pap test.

"The FDA approval doesn’t mean the HPV test must or should be used first," said ElMasri. "The HPV test does not replace the Pap test. National medical organizations, like The Society of Gynecologic Oncologists, are working on developing new guidelines that will incorporate HPV testing in current cervical cancer screenings."

For more information about current Pap testing visit www.womenshealth.gov or call a Community expert at 800.777.7775.


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