Cepheid Announces European Approval of Xpert HCV Viral Load

SUNNYVALE, Calif., April 15, 2015 /PRNewswire/ -- Cepheid (NASDAQ: CPHD) today announced that Xpert^® HCV Viral Load, a quantitative test that provides on-demand molecular testing for confirmation of infection and monitoring of Hepatitis C virus (HCV), has achieved CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices. The test runs on the Cepheid GeneXpert^® System, the world's leading molecular diagnostic platform with over 8,000 systems deployed globally in both developed and emerging market countries.

The objective of treatment for HCV is for a patient to have sustained virologic response, defined as undetectable HCV RNA by a sensitive test 12 or 24 weeks after the end of treatment, depending on the type of anti-HCV therapy used.¹ Xpert HCV Viral Load is intended for use as an aid in the management of HCV infected patients undergoing antiviral therapy. The test can be used to measure HCV RNA levels at baseline and during treatment, and to help predict sustained and nonsustained virological responses to HCV therapy. In addition, the test can be used for confirmation of HCV serologic test results.

"Existing HCV viral load tests run on complex systems that require highly-trained technicians to operate, and generally lack the flexibility to provide on-demand answers when required," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "Xpert HCV Viral Load, our 21^st CE-IVD Xpert test, provides reliable results in less than 2 hours, making it a valuable tool for clinicians in the management of HCV infected patients on antiviral therapy."

An estimated 185 million people, or roughly 3% of the world's population, have been infected with HCV. Most of these people are unaware of their infection.²

"Cepheid's Xpert HCV Viral Load test delivers results in hours rather than days — with the simplicity and ease of use of a point-of-care test. It is a very sensitive test for confirmation of infection and monitoring of HCV, and will assist in better patient management," said Dr. Jean-Michel Pawlotsky M.D., Ph.D., Professor of Medicine at the University of Paris-Est, and Director of the National Reference Center for Viral Hepatitis B, C and Delta, Director of the Department of Virology at the Henri Mondor University Hospital in Créteil, France, and Director of the Department of Molecular Virology and Immunology at the Institut Mondor de Recherche Biomédicale.

"The Xpert HCV Viral Load test incorporates a number of novel technologies including our 'BigTube' design, which allows us to take full advantage of the efficiency of integrated GeneXpert cartridge fluidics," said David H. Persing, MD, Ph.D., Cepheid's Chief Medical and Technology Officer. "This helps us to avoid dead volume losses incurred with competitive first generation systems and to achieve unprecedented sensitivity levels for detection of HCV RNA."

Xpert HCV Viral Load begins shipping this month as a CE-IVD Mark product. For more information on Cepheid's GeneXpert Systems or the complete menu of CE-IVD Xpert tests, visit www.cepheidinternational.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 http://www.cepheid.com.

References

1. Ghany MG, Strader DB, Thomas DL, et al. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009;49 (4):1335-1374.
2. http://www.amfar.org/uploadedFiles/_amfarorg/Articles/On_The_Hill/2015/amfAR%20HCV%20Issue%20Brief%20Feb%202015.pdf

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.

SOURCE Cepheid

Related Links

http://www.cepheid.com