SUNNYVALE, Calif., Oct. 5, 2016 /PRNewswire/ -- There's now an easier way to confidently rule out bladder cancer recurrence, thanks to a new test from Cepheid (Nasdaq: CPHD), Xpert® Bladder Cancer Monitor, now commercially available in Germany and cleared for commercial availability in all countries accepting the CE Mark.
Bladder cancer is the 5th most common cancer in Europe, affecting over 150,000 patients annually1,2 and is among the most expensive cancers on a cost per treatment basis3, in part due to high recurrence rates and invasive surveillance strategies, including cystoscopy, that have traditionally been required to manage the condition. Xpert Bladder Cancer Monitor is designed to provide up-to-date information on cancer recurrence for bladder cancer patients, using a noninvasive urine specimen. The test has an overall 93.9% negative predictive value, providing urologists with actionable results to more confidently risk manage their patients, potentially reducing the need for as-frequent invasive testing.
"Xpert Bladder Cancer Monitor delivers accurate results noninvasively in just 90 minutes, which may improve compliance in patients being monitored for bladder cancer recurrence," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "We believe the test will also likely improve workflow management for urologists and their bladder cancer patients because it provides same day, clinically actionable results that inform important downstream management decisions."
"Bladder cancer continues to have the highest lifetime treatment costs per patient out of all of the cancers and - with a rising population - those costs will continue to add up," said Maximilian Burger of the Department of Urology, University of Regensburg. "Bladder cancer continuously demands treatment decisions that can impact outcomes and quality of life. Guidance tools tailored to patient management fill this unmet need."
Xpert Bladder Cancer Monitor features an overall sensitivity of 75%, sensitivity for high grade tumors, specifically, of 84%, and an overall specificity of 80.6%. The new test is available immediately in Germany, and will launch throughout Europe in the coming months.
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. For more information, visit www.cepheid.com.
About GeneXpert Systems and Xpert Tests
With more than 11,000 systems in 182 countries, the GeneXpert System is the world's most popular molecular diagnostics' system. The GeneXpert System's modular configuration means that the system is the most scalable available, offering the ability to perform from one to eighty Xpert tests at the same time. As a result, the GeneXpert System meets the throughput requirements of customers of all sizes - from lower volume point-of-care settings to higher volume reference laboratories – enabling accurate, fast and cost effective test results.
GeneXpert Systems run proprietary Xpert test cartridges. The Xpert test menu spans healthcare-associated infections, sexual health, critical infectious disease, and oncology, and today offers 24 tests outside the US, and 20 tests in the US. More information on the GeneXpert System and the Xpert tests is available on our website at www.cepheid.com.
Forward Looking Statements
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 performance, technical and product specifications, sensitivity, specificity, speed, accuracy, diagnostic utility and clinical efficacy of the Xpert Bladder Cancer Monitor test, the timing of the test's commercial availability, the test's ability to reduce costs of cancer treatment for bladder cancer, and the test's ability to improve hospital workflow in the treatment of bladder cancer patients and to manage recurrence risks and reduce the need for, and frequency of, invasive testing. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from Cepheid'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 the Company's tests by clinicians and future changes in medical practice and protocols; the ability of hospitals to better allocate urology resources and direct patient care based on information obtained from the tests; delays in commercial launch of the tests throughout Europe; the Company's ability to successfully and timely 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 global 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 costs of product components and other factors affecting product 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.
1 EUCAN Bladder Cancer Fact Sheet (published 2012). Retrieved from http://eco.iarc.fr/eucan/Cancer.aspx?Cancer=32
2 Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JWW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027.
3 Svatek, Robert S., et al. "The economics of bladder cancer: costs and considerations of caring for this disease." European urology 66.2 (2014): 253-262.
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Jacquie Ross, CFA