European Release of a 60-Minute Test for Cervical Cancer-Related Human Papillomaviruses Announced

The release of Xpert® HPV, a 60-minute test for cervical cancer-related human papillomaviruses to be marketed as a CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices. The test runs on Cepheid’s GeneXpert® System, a world leading molecular diagnostic platform. Xpert HPV is a multiplexed test that targets the E6 and E7 oncogenes of 14 cancer-related HPV types and specifically calls out high-risk types 16 and 18/45 in separate detection channels, with 11 other high-risk types detected in a combined channel.

“Accurate detection of HPV, along with specific identification of the most problematic types, is critically important in efforts to successfully detect and potentially reduce the incidence of cervical cancer. Xpert HPV is a major addition to Cepheid’s portfolio of Xpert tests, and one that can help to ensure women at risk for cervical cancer get the care they need immediately,” said John Bishop, Cepheid's Chairman and CEO. “As with all of our tests, Xpert HPV delivers accurate results to assist clinicians in better managing their patients early, before complications arise.”
 
“In our initial clinical evaluations of a colposcopy referral population we observed that, compared to conventional NAAT approaches, Xpert HPV delivered better than expected specificity with equivalent sensitivity, meaning equivalent numbers of true positives and significantly fewer false positives in women with negative biopsies,” said Dr Thomas C. Wright, Jr, Professor Emeritus of Pathology and Cell Biology, Columbia University Medical Center, NY. “This surprising observation could be related to the fact that Xpert HPV is the first diagnostic test to use cell capture technology.”
 
“High-risk human papillomavirus testing is a highly effective and reliable method of screening to prevent cervical cancer,” said Philip E. Castle, PhD, MPH, Chairperson and CEO of the Global Coalition Against Cervical Cancer and Executive Director of Global Cancer Initiative. “It now will be possible to deploy centralised or point-of-care HPV testing for cervical cancer screening in all settings throughout the world using a wide range of clinical algorithms, including same-day screen-and-treat strategies.”