March 16, 2009

FDA OKs DNA test for two types of HPV

The U.S. Food and Drug Administration says it has approved the first DNA test that identifies the two types of human papillomavirus.

The test, called Cervista HPV 16/18, detects the DNA sequences for HPV type 16 and HPV type 18 in cervical cells. Human papillomavirus causes most cervical cancers among women and is the most common sexually transmitted infection in the United States.

FDA officials said differentiating the HPV types gives healthcare professionals more information on a patient's risk of subsequently developing cervical cancer. A positive Cervista 16/18 test result indicates whether HPV type 16, 18 or both types are present in the cervical sample.

The federal agency said it also has approved a Cervista HPV HR test, which is the second DNA test that detects essentially all of the high-risk HPV types in cervical cell samples. In women age 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, the FDA said.

Both tests are manufactured by Third Wave Technologies Inc. of Madison, Wis.