FDA Approves New Test for HPV

Cervical cancer affects about 470,000 women each year, according to the World Health Organization, and now the disease has a new tool to combat its spread. The FDA has approved the Roche cobas HPV (human papillomavirus) Test, a qualitative in vitro test for the detection of HPV in patient specimens.

Human papillomavirus is a sexually transmitted virus, but it can also be passed on through skin-to-skin contact. At least 50% of people who have had sex will have HPV at some time in their lives. Many types of HPV occur without symptoms and go away without treatment within a few years, but the National Cancer Institute has identified about 15 high-risk HPV types, including HPV types 16 and 18, which together cause about 70% of cervical cancers.

The cobas test specifically identifies types 16 and 18 while concurrently detecting the other high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). It uses amplification of target DNA by polymerase chain reaction and nucleic acid hybridization to detect 14 high-risk (HR) HPV types in one analysis.

The 2006 Consensus Guidelines from the American Society of Colposcopy and Cervical Pathology suggest that cytology-negative women, ages 30 years and older, who are high-risk HPV DNA positive obtain genotyping assays for HPV 16 and 18. Women with positive tests should be referred for immediate colposcopy, while those who are HPV 16/18 negative but positive for other high-risk types should be followed with repeat cytology and high-risk HPV testing in 12 months.

“Screening for high-risk HPV genotypes provides important additive information to Pap testing, and screening for the two highest risk types, HPV 16 and 18, can provide predictive information about a woman’s risk for having cervical precancer or cancer,” said Mark H. Stoler, MD, professor and associate director of Surgical Pathology and Cytopathology, at the University of Virginia Health System.