New HPV Test Approved

The FDA has approved a new diagnostic test (cobas 4800) for the most carcinogenic strains of human papillomavirus (i.e., HPV types 16 and 18).

The cobas 4800 test detects 14 high-risk HPV genotypes, including types 16 and 18, which are found in 70% of cervical cancer cases, according to the manufacturer.

Approval was based on data from a trial of some 47,000 women who were screened for cervical cancer using both a Pap test and the new HPV test. About 1 in 10 women aged 30 and older who tested positive for HPV types 16 and/or 18 by the cobas test had cervical precancer even though their Pap test results were normal.