Cepheid Receives FDA Clearance for Xpert TV, the First On-Demand Test for Same Day Consultation and Treatment of Trichomonas Vaginalis Infection
SUNNYVALE, Calif., Oct. 21, 2015 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® TV, a qualitative in vitro diagnostic test for accurate and reproducible identification of Trichomoniasis in symptomatic and asymptomatic female patients, using urine, endocervical swab or vaginal swabs collected by the patient in a clinical setting. Xpert TV becomes the 18th test available to run on Cepheid’s GeneXpert® System in the US, the world’s leading molecular diagnostic platform, and is an important addition to the Xpert women’s health portfolio which already includes Xpert CT/NG, Xpert Group B Strep and Xpert HPV (only available outside the US).
Trichomoniasis, the most common nonviral sexually transmitted infection, is caused by the protozoan parasite Trichomonas vaginalis and affects an estimated 170 million people globally every year, including an estimated 3.7 million people each year in the United States.1 Of those infected, up to 85% of individuals have minimal to no symptoms. TV infection is associated with a two-to-threefold increased risk of HIV acquisition, preterm birth, and other adverse pregnancy outcomes among pregnant women.2
“The commercial launch of Xpert TV is particularly timely given the CDC’s recently revised recommendation to use highly sensitive and specific NAAT testing for the detection of Trichomonas vaginalis in both symptomatic and asymptomatic patients,” said David Persing, M.D., Ph.D, Cepheid’s Chief Medical and Technology Officer. “Xpert TV provides reference laboratory levels of performance in an on-demand, easy to use format. For the first time, clinicians can offer same-day consultation and treatment for TV, with results available in about an hour, in most cases.”
Xpert TV will begin shipping in the United States in early November. For more information on Cepheid’s GeneXpert Systems or the complete menu of Xpert tests, visit www.cepheid.com.
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 9,200 systems in 182 countries, the GeneXpert System is the world’s most popular molecular diagnostics’ instrument. 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 18 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 to the future availability, performance, technical and product specifications, sensitivity, speed, accuracy, diagnostic utility and clinical efficacy of the GeneXpert tests, including relative to competing products and technologies. 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 our tests by clinicians and future changes in medical practice and protocols; our 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 Gaydos,C. 2010 National STD Prevention Conference, Atlanta, GA | ||
2 Workowski KA, Bolan G. Sexually Transmitted Diseases Treatment Guidelines, 2015. MMWR Recomm Rep 2015;64(No.3):72. | ||
For Cepheid Media & Investor Inquiries:
Jacquie Ross, CFA
+1 408-400-8329
corporate.communications@cepheid.com
SOURCE Cepheid
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