On April 24 the U.S. Food and Drug Administration approved the first FDA-approved HPV DNA test for women 25 and older that can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can provide information about the patient’s risk for developing cervical cancer in the future. This approval “offers women and physicians a new option for cervical cancer screening,” said 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. The FDA first approved the test in 2011 for use in conjunction with a Pap smear, but this recent approval expands the use of the test to include use as either a co-test or as a primary cervical cancer screening test.
Read more about the FDA’s decision to approve this HPV test:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394773.htm