The U.S. Food and Drug Administration (FDA) approved “the first DNA test that identifies the two types of human papillomavirus (HPV) that cause the majority of cervical cancers among women in the United States.” The test, called Cervista HPV 16/18, detects the DNA sequences for HPV type 16 and HPV type 18 in cervical cells. A positive Cervista 16/18 test result indicates whether HPV type 16, 18 or both types are present in the cervical sample. Differentiating these HPV types “gives health care professionals more information on a patient’s risk of subsequently developing cervical cancer.” The FDA also approved yesterday the Cervista HPV HR test, which is the second DNA test that detects essentially all of the high-risk HPV types in cervical cell samples. The Cervista HPV HR test uses a method similar to the Cervista HPV 16/18 test to detect the DNA sequences of these HPV types. Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health, said, “Results from these two tests, when considered with a physician’s assessment of the patient’s history, other risk factors, and professional guidelines, can help physicians better determine risk and could lead to better patient management.”
http://www.fda.gov/bbs/topics/NEWS/2009/NEW01974.html