Cepheid today 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, the world's 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 Chief Executive Officer. "As with all of our tests, Xpert HPV delivers accurate results to assist clinicians in better managing their patients early, before complications arise."
Human papillomavirus (HPV) infection is the most common sexually transmitted infection worldwide. On a global basis, HPV types 16 and 18 are associated with approximately 71% of all cases of cervical cancer, and HPV type 45 is associated with approximately 6% of additional cases of cervical cancer.1
"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."
Cervical cancer screening and treatment programs vary, based upon local guidance that consider testing algorithms, resources, skill set and infrastructure. Most of today's HPV NAAT (Nucleic Acid Amplification Test) tests are complicated to use and batch testing can delay results critical in scheduling patient consultations for follow-up testing or colposcopy.
"High-risk human papillomavirus testing is a highly effective and reliable method of screening to prevent cervical cancer," said Philip E. Castle, Ph.D., 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 centralized 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."
Early detection of the high-risk HPV DNA responsible for E6/E7 oncoprotein expressed in cervical cells is critical. Viral oncogenes E6 and E7 lead to cell cycle modifications which support conditions favorable to HPV viral replication. HPV viral genome integration into the host DNA, and E6/E7 oncoprotein expression correlate to the development of cervical cancer.2
"Cervical cancer is a preventable disease — and it is well documented that HPV is the cause. Women deserve improved access to screening tools to significantly reduce their risk of developing this disease," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "Xpert HPV is unlike any test currently available. It's essentially a cellular analysis in a cartridge, and can quickly help physicians to risk stratify patients. It is the only diagnostic test that leverages the combined power of cell capture and HPV genotyping to identify women in need of follow-up."
Xpert HPV is now available as a CE-IVD Mark product. For more information on Cepheid's GeneXpert Systems or complete menu of CE-IVD Xpert tests, visit www.cepheidinternational.com.
- de SanJose, S.et al.Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study.Lancet Oncol 2010; 11: 1048–56.
- Cox JT, Castle PE, Behrens CM, et al.Comparison of cervical cancer screening strategies incorporating different combinations of cytology, HPV testing, and genotyping for HPV 16/18: results from the ATHENA HPV study.Am J Obstet Gynecol 2013;208:184.e1-11.