Cepheid Announces European Approval Of Xpert MRSA Next Generation (NxG) Screening Test

SUNNYVALE, Calif., March 29, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced commercial availability, outside the United States, of Xpert® MRSA NxG, a next generation version of the market-leading molecular diagnostic test for Methicillin-Resistant Staphyloccus aureus (MRSA). Xpert MRSA NxG has been updated to identify mecA- and mecC- containing MRSA strains and detect new and emerging SCCmec subtypes with enhanced performance.  The assay has achieved CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices.  Xpert MRSA NxG is an important update to the menu of 23 tests available internationally to run on Cepheid's GeneXpert® System, the world's leading molecular diagnostic platform with over 10,000 systems deployed globally in both developed and emerging market countries.

MRSA is one of the most commonly identified antibiotic-resistant pathogens globally, with up to 53 million people worldwide estimated to carry MRSA.¹  Furthermore, approximately 171,000 healthcare-associated MRSA infections are acquired annually in the European Union (EU), resulting in 5,400 attributable deaths, more than 1 million excess days of hospitalization, and €380 million in excess in-hospital costs.²

"New and emerging MRSA clones, such as livestock-associated strains, and distinct homologues of mecA resistance genes, such as mecC,³ pose a threat to efforts to contain the spread of antimicrobial resistance around the globe, which are predicated on the fast and accurate diagnosis of infections to guide patient treatment and management," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer.  "Xpert MRSA NxG is the latest tool in the fight against MRSA.  Its enhanced features, such as room temperature storage, ability to rule out empty cassette strains, and validation on multiple swab types, provide additional convenience and ease-of-use to laboratories to support improved infection control outcomes."

"MRSA is known as a genetically variable pathogen and for a diagnostics provider it is of utmost importance to improve test components able to detect emerging MRSA clones with high accuracy," said Prof. Udo Reischl at the University of Regensburg in Germany. "A rapid and more sensitive method for surveillance of MRSA represents a definite advantage for patient care and infection control programs, and Xpert MRSA NxG fulfils the current need for MRSA detection."

Xpert MRSA NxG will begin shipping in countries accepting the CE-mark in April.  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 10,000 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 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 to the future availability, performance, technical and product specifications, sensitivity, speed, accuracy, diagnostic utility and clinical efficacy of GeneXpert System and Xpert 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 the Company's tests by clinicians and future changes in medical practice and protocols; 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 Grundmann H, et al. Emergence and resurgence of methicillin-resistant Staphylococcus aureus as a public-health threat. Lancet. 2006 Sep 2;368(9538):874-85.
² Köck R, et al. Systematic literature analysis and review of targeted preventive measures to limit healthcare-associated infections by methicillin-resistant Staphylococcus aureus. Euro Surveill. 2014 Jul 24;19(29).
³ Paterson G.K., et al. The emergence of mecC methicillin-resistant Staphylococcus aureus. Trends Microbiol. 2014 Jan;22(1):42-7.

For Cepheid Media & Investor Inquiries:
Jacquie Ross, CFA
+1 408-400-8329
[email protected]

SOURCE Cepheid

Related Links

http://www.cepheid.com