30 Minute Or Less Molecular Flu/RSV Test Now Available Outside The US

Why Choose Between Fast or Accurate When You Can Have Both?

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Oct 27, 2016, 08:00 ET

SUNNYVALE, Calif., Oct. 27, 2016 /PRNewswire/ -- With the flu season fast approaching, healthcare providers no longer need to choose between a fast test result or an accurate test result for patients suspected of influenza infection. Now, they can have both, with Xpert® Xpress Flu/RSV from Cepheid (Nasdaq: CPHD), a new test that delivers reference-quality molecular test results in as little as twenty minutes.¹

"For too long, clinicians have been asked to treat suspected cases of influenza empirically, since gold-standard RT-PCR based tests took too long to process in the critical first 24 hours of symptom onset," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "With the arrival of fast molecular tests like Xpert Xpress Flu/RSV, patients and their healthcare providers can now expect an accurate diagnosis, and access to targeted therapies substantially more quickly. Unnecessary treatment with antimicrobial agents can also be avoided. This supports clinical efforts to improve the patient experience, and further streamlines workflow in the laboratory, which can be particularly challenging in the midst of a busy respiratory virus season."

Upper respiratory infections are among the most common reasons for outpatient visits in the United States and worldwide.^2,3 Early symptoms for a wide variety of viral and bacterial respiratory infections are often clinically indistinguishable, yet treatment is different depending on the cause of infection, highlighting the importance of accurate diagnostic tests like Xpert Xpress Flu/RSV. With this development, hospitals and clinics can reliably diagnose influenza and respiratory syncytial virus (RSV) infection in 30 minutes or less.

Xpert Xpress Flu/RSV is twice as fast as its predecessor, Xpert Flu/RSV XC, but has comparable performance characteristics. The new assay features a novel design, which employs multiple targets for each virus. The built-in redundancy provides very high test sensitivity, avoiding the impact of seasonal drift that has been a problem historically with molecular tests, while maintaining high specificity. This assay is the first in a series of tests from Cepheid that will deliver results in 30 minutes or less.¹

The new test is available immediately in the EU and all countries recognizing the CE-Mark.

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 24 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 and clinical efficacy of the Xpert Xpress Flu/RSV test, the test's impact on speed of access to targeted therapy, improving patient experience and streamlining the workflow in the lab, and the launch of future Cepheid tests targeting results in 30 minutes or less. 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, particularly those targeting results in 30 minutes or less; 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 Results from negative specimens are reported in approximately 30 minutes. When running in a Flu only or an RSV only reporting mode, positive results can be reported in soon as 20 minutes.
² "Upper Respiratory Tract Infection" Medscape. Menegetti et al; June 2016 (http://emedicine.medscape.com/article/302460-overview)
³ http://www.cdc.gov/rsv/research/us-surveillance.html

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

SOURCE Cepheid