SUNNYVALE, Calif., April 2, 2014 /PRNewswire/ -- Cepheid (NASDAQ: CPHD) 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.
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. Cepheid's newly announced Xpert MTB/RIF test can provide rapid information on the presence of TB and potential drug resistance within two hours, which distinguishes it from other available TB tests. For more information, visit http://www.cepheid.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.
This press release contains forward-looking statements that are not purely historical regarding Cepheid's or its management's intentions, beliefs, expectations and strategies for the future, including those relating to the performance, speed and accuracy of our products, including relative to competing products, the breadth and speed of test menu expansion, the results of clinical trials, and future medical practice dynamics. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the Company's current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: test performance in the field; utilization of our tests by clinicians; our ability to successfully develop new products; the completion of clinical trials for new products successfully and in a timely manner; uncertainties related to the United States FDA, European and other regulatory processes; the Company's ability to successfully introduce and sell products in clinical markets; the Company's research and development budget; unforeseen supply, development and manufacturing problems; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; the impact of competitive products and pricing; the Company's ability to manage geographically-dispersed operations; and underlying regulatory, political and market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K, its most recent Quarterly Report on Form 10-Q, and its other reports filed with the Securities and Exchange Commission.
All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.
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