FDA Approves New HPV Test

April 20, 2011 -- The FDA has approved Roche's new test for human papillomavirus (HPV), the first one-pass test to specifically identify the two HPV strains that cause 70% of cervical cancers.

The sexually transmitted human papillomavirus causes nearly all cervical cancers. Current HPV tests can detect the presence or absence of over a dozen HPV types linked to cancer. Roche's new cobas 4800 test does this, too, but also tells a woman whether she has HPV-16 or HPV-18.

Another FDA approved HPV test, Hologic Inc.'s Cervista HPV 16/18, can identify these dangerous HPV types but is used only in women who already have tested HPV-positive in less sensitive tests.

In a Roche study of over 47,000 women, those who tested positive for HPV-16 had a 31.5% risk of a precancerous cervical lesion.

"Screening for high-risk HPV genotypes provides important additive information to Pap testing. Screening for the two highest risk types, HPV-16 and HPV-18, can provide predictive information about a woman’s risk for having cervical precancer or cancer," says Mark H. Stoler, MD, professor of surgical pathology at the University of Virginia Health System.

Stoler led the Roche study and has been a consultant for Roche and several other makers of HPV tests.

The new Roche test detects precancerous lesions over 90% of the time. But about 30% of women who test positive for a high-risk HPV type turn out not to have precancerous lesions.

A woman whose Pap smear is abnormal often has to undergo a cervical examination (colposcopy) and possibly a cervical biopsy to determine whether she really has a cancer or precancer. A colposcopy or biopsy would be more likely for women who test positive for high-risk HPV -- particularly when it's HPV-16 or HPV-18.