First and Only Trichomonas NAAT Test with Male Urine Claims Cleared for Use in United States
SUNNYVALE, Calif., Sept. 6, 2016 /PRNewswire/ -- Men in the United States can now have easier access to fast and accurate testing for a potentially dangerous sexually transmitted infection, thanks to expanded claims allowed by the Food and Drug Administration (FDA) for the Xpert TV assay by Cepheid (Nasdaq: CPHD), a sensitive urine-based test for Trichomonas vaginalis that delivers results in as little as 35 minutes.
Trichomoniasis (“Trich”) is considered to be the most common non-viral sexually transmitted infection in the United States, infecting an estimated 1.4 million men.1 Trich is particularly challenging because as many as 85% of infected individuals have minimal to no symptoms, allowing for potentially silent spread of the infection.2
“A decade ago, Trichomonas vaginalis infections in men were virtually ignored, but recent research has associated these infections with urethritis, prostate inflammation and possibly male infertility3,” said David Persing, M.D., Ph.D., Cepheid’s Chief Medical and Technology Officer. “Further, there is strong evidence that suggests Trich acts as a co-factor in sexual transmission of HIV4, highlighting the importance of easily accessible diagnostics for all patients, regardless of gender.”
Following initial clearance of Xpert TV for three types of female specimens in October of 2015, the latest clearance extends the range of potential uses of the assay, and positions Xpert TV as the only cleared Nucleic Acid Amplification Testing (NAAT) test for urine samples from symptomatic and asymptomatic men.
Xpert TV extends the reach of Cepheid’s portfolio of 20 Xpert tests in the United States for the GeneXpert System, the world’s leading molecular diagnostic platform with more than 11,000 systems installed globally. Xpert TV with the extended claim is expected to begin shipping later this month.
About Cepheid
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 23 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, speed, accuracy, diagnostic utility, accessibility, and clinical efficacy of the GeneXpert TV Assay in testing for Trichomoniasis in symptomatic and asymptomatic men and the timing of initial shipments of the test for such purpose. 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; delays in the initial shipment of the GeneXpert TV Assay for expanded male urine claims; 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 Am J Trop Med Hyg. 2014 May 7; 90(5): 800804.
2http://www.cdc.gov/std/tg2015/trichomoniasis.htm
3 A Review of Evidence-Based Care of Symptomatic Trichomoniasis and Asymptomatic vaginalis Infections. Meites et al, Critical Infectious Disease, 2015
4 Sex Transm Infect. 2013 September ; 89(6): 426-433. Doi: 10.1136/sextrans-2012-051005
For Cepheid Media & Investor Inquiries:
Jacquie Ross, CFA
+1 408-400-8329
corporate.communications@cepheid.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/cepheids-xpert-tv-now-cleared-for-testing-symptomatic-and-asymptomatic-men-300322275.html
SOURCE Cepheid
