-- First molecular test indicated for samples from both males and females
SUNNYVALE, California, Sept. 3, 2014 /PRNewswire/ -- Cepheid (NASDAQ: CPHD) today announced the release of Xpert® TV, an on-demand molecular test for rapid, accurate and reproducible identification of Trichomoniasis (TV) infections in both males and females. The test will be marketed as a CE-IVD product under the European Directive on In Vitro Diagnostic Medical Devices, bringing the total number of CE-IVD tests available to nineteen. Xpert TV runs on Cepheid's GeneXpert® System, the world's leading molecular diagnostic platform with more than 7,000 systems installed worldwide.
Trichomoniasis, the most common nonviral sexually transmitted disease, is caused by infection with the protozoan parasite Trichomonas vaginalis. The World Health organization has estimated that 160 million cases of infection are acquired worldwide each year.1 Most people who have the parasite cannot tell they are infected, only about 30% develop any symptoms.
"Xpert TV is the first nucleic acid amplification test to deliver TV results for male urine samples. It has been difficult to identify and contain TV infections in men because traditional diagnostic methods are much less sensitive than real-time PCR," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "Cepheid delivers the industry's most complete line of on-demand sexual health tests on a single molecular platform, enabling clinicians to deliver same day onsite patient consultation and treatment."
Identification of Trichomonas vaginalis infections is problematic. Organism viability, sensitivity issues with wet mount microscopy, and time delays for conclusive diagnosis from culture methods make detection of this asymptomatic infection a challenge. Xpert TV is a next generation solution. Each test cartridge includes three controls to ensure test integrity and performance. Sample adequacy control confirms that a patient sample is genuine and eliminates multiple daily examinations of the same samples.
"A decade ago Trichomonas vaginalis infections in men were virtually ignored. More current research has associated these infections with prostatitis and male factor infertility. In addition, trichomoniasis is emerging as a risk factor for sexual transmission of human immunodeficiency virus (HIV)," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "Increased vaginal and endocervical inflammation in women and urethral inflammation in men with trichomoniasis may contribute to enhanced HIV transmission. Trichomonas vaginalis also likely disrupts the urogenital epithelia and enhances HIV replication. Xpert TV provides accurate actionable results that clinicians need for optimal patient management."
Xpert TV begins shipping this month 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. For more information, visit http://www.cepheid.com.
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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