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FDA approves two DNA tests to detect HPV

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On Friday, the FDA announced that it has approved the first DNA test that can identify the two types of human papillomavirus, HPV types 16 and 18, which cause the majority of cervical cancers in women in the United States.

The results of the test, Cervista HPV 16/18 (Third Wave Technologies), indicate whether types 16, 18 or both are present in a cervical cell sample. It will give health care professionals more information on a patient’s risk for subsequently developing cervical cancer.

The FDA also approved the Cervista HPV HR test. This test detects essentially all of the high-risk HPV types in cervical cell samples. It uses a method similar to the Cervista HPV 16/18 test.

In women aged 30 and older or women with borderline cytology, the Cervista HPV 16/18 test can be used together with cytology and the Cervista HPV HR test to assess risk of cervical disease.