Using 'Diagnostics First' Could Help Preserve Effectiveness Of Life-Saving Antibiotics

"Since the introduction of antibiotics in the 1940s, doctors have had to rely on their expertise, intuition, and experience to diagnose patients and initiate antibiotic therapy well before diagnostic test results were available," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer.  "Many lives have been saved by empiric therapy, but we are now seeing the rise of drug-resistant bacteria that may soon be resistant to all known antibiotics.  Fortunately, advances in technology have enabled the accurate and fast diagnostics needed to support real-time decision making by healthcare providers to provide the right drug at the right time."

According to the United States Centers for Disease Control and Prevention (CDC), up to 50% of all prescribed antibiotics are not needed, or are not effective as prescribed.¹ Over-use of antibiotics has led to the global rise of drug-resistant infections such as carbapenem-resistant Enterobacteriaceae (CREs) and ceftriaxone-resistant Neisseria gonorrhoeae, as well as an upsurge of Clostridium difficile infections.  All of these have been deemed urgent threats by the CDC.  Multi-drug resistant tuberculosis (MDR-TB) and methicillin-resistant Staphylococcus aureus (MRSA), among others, are also cited as serious threats by the CDC and major global health concerns by the World Health Organization.² Infections from these bacteria lead to over 25,000 deaths annually and 2.5 million additional hospital days in the EU, and over 23,000 deaths per year and 2 million cases of illnesses in the US.³

"Cepheid strongly endorses the important work being done by the CDC, the White House, the World Health Organization and the United Kingdom's Review on Antimicrobial Resistance, among others, to address the rapidly growing threat of drug-resistant organisms while there is still time to act," said John Bishop, Cepheid's Chairman and Chief Executive Officer.  "The objective of Cepheid's 'Diagnostics First' campaign is to further escalate the discussion about the importance of accurate and fast diagnostics as part of the best 'prescription' in this important fight."

Mr. Bishop adds, "It's critical that we all play our part to help target antibiotics where they are needed more precisely, so that we can preserve their value for future generations.  If the improper use of antibiotics continues, it is possible that minor infections could become deadly, much like they were in the pre-antibiotic era."

"As noted in the O'Neill Review on Antimicrobial Resistance, rapid point-of-care diagnostic tests are a central part of the solution to the problem of unnecessary antibiotic use," said Dr. Thierry Naas, Associate Professor in Medical Microbiology at the University of Paris South Medical School, who is currently coordinating the European Joint Programming Initiative on Antimicrobial Resistance.  "We welcome the efforts of Cepheid and others as they continue to innovate and bring these accurate and fast diagnostics into routine clinical use to help ensure patients receive the most appropriate antibiotic therapy."

For more information on the Diagnostics First campaign, visit www.diagnosticsfirst.com and Cepheid's booth #004 at the European Congress of Clinical Microbiology and Infectious Disease (ECCMID).  For more information on Cepheid's GeneXpert Systems or the complete menu of Xpert tests, 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.

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.

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 Omni and Xpert tests, including relative to competing products and technologies and the efficacy of diagnostic testing in helping to solve the problem of drug-resistant infections.  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 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.

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

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SOURCE Cepheid

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