FDA approves HPV test that identifies women most at risk for cervical cancer

April 28, 2011

On April 20, the United States Food and Drug Administration (FDA) approved a human papillomavirus (HPV) test that identifies women at greatest risk for developing cervical cancer. The cobas HPV Test individually detects the 2 highest-risk HPV genotypes?16 and 18?that cause more than 70% of cervical cancer cases, and simultaneously identifies 12 other high-risk HPV genotypes.

On April 20, the United States Food and Drug Administration (FDA) approved a human papillomavirus (HPV) test that identifies women at greatest risk for developing cervical cancer. The cobas HPV Test individually detects the 2 highest-risk HPV genotypes-16 and 18-that cause more than 70% of cervical cancer cases, and simultaneously identifies 12 other high-risk HPV genotypes.

FDA approval was predicated on data from the Addressing THE Need for Advanced HPV Diagnostics (ATHENA) HPV study of 47,208 women in the US.

The study, conducted by the University of Virginia Health System and published in the American Journal of Clinical Pathology (2011;135[3]:468-475), showed that 10% of women 30 years of age and older who were positive for genotypes 16 or 18 on the cobas HPV Test actually had cervical precancer in spite of having normal results with Pap cytology testing. In addition to genotypes 16 and 18, the test concurrently identifies high-risk HPV genotypes 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 using polymerase chain reaction and nucleic acid hybridization of target DNA.

“Screening for high-risk HPV genotypes provides important additive information to Pap testing, and screening for the 2 highest risk types, HPV 16 and 18, can provide predictive information about a woman’s risk for having cervical precancer or cancer,” says Mark H. Stoler, MD, the lead author of the ATHENA HPV study report. The study was funded by Roche Molecular Systems (Pleasanton, California).