First DNA Tests for HPV Approved

March 13 (HealthDay News) -- The first DNA test to screen for two types of human papillomavirus (HPV) that are responsible for most cases of cervical cancer in the United States has been approved by the U.S. Food and Drug Administration.

The Cervista HPV 16/18 screens for the DNA sequences of HPV types 16 and 18 in cervical cells, the agency said in a news release.

A second newly approved diagnostic, the Cervista HPV HR test, can detect "essentially all of the high-risk HPV types in cervical cancer samples," the FDA said.

HPV is the most common sexually transmitted infection in the United States, accounting for more than 6 million infections annually, the agency said. While most infected women do not develop complications, some HPV strains can cause cell abnormalities on the cervix lining that go on to become cancerous.

"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," said Dr. Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health.

The two tests are produced by Wisconsin-based Third Wave Technologies.


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