Cepheid Receives Emergency Use Authorization from FDA for Xpert Ebola Diagnostic Test

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Mar 24, 2015, 04:05 ET

SUNNYVALE, Calif., March 24, 2015 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced it has received Emergency Use Authorization from the U.S. Food & Drug Administration (FDA) for Xpert^® Ebola, a molecular diagnostic test for Ebola Zaire Virus that delivers results in less than two hours. The test runs on the Cepheid GeneXpert^® Systems, the world's leading molecular diagnostic platform with over 8,000 systems deployed globally in both developed and emerging market countries.

Ebola was first discovered in 1976 near the Ebola River in what is now the Democratic Republic of the Congo. Since then, outbreaks have appeared sporadically in Africa.¹ The 2014 Ebola epidemic is the largest in history, affecting multiple countries in West Africa. In the United States four cases have been reported: two imported cases that included one death, and two locally acquired cases in healthcare workers.²

"We developed Xpert Ebola with a dual-target design to ensure high-accuracy and sensitivity for detecting the Ebola Zaire virus, detected in the West Africa outbreak in 2014. The test runs in Cepheid's self-contained cartridge to minimize potential contamination," said John Bishop, Cepheid's Chairman and CEO. "Cepheid has historically played a leading role in developing molecular diagnostics as an aid to infection control efforts, and the current Ebola crisis represents an extreme example of the need for sensitive, fast, and easy to use diagnostics to aid in patient management and isolation requirements. We believe this is a major step in strengthening the arsenal of tools being deployed to address the current situation."

On August 5, 2014 the U.S. Secretary of Health and Human Services declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus. Cepheid's Xpert Ebola has not been FDA cleared or approved, but will remain available in the U.S. as an EUA product as long as the declared emergency remains in effect or it ceases to be authorized by FDA.

"With support from the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation (provided via the National Philanthropic Trust Fund for Global Health and Development), Cepheid was able to leverage its extensive development experience to expedite delivery from the initial prototype to an emergency use only product in just 90 days," said David Persing, MD, Ph.D., Cepheid's Chief Medical and Technology Officer. "We expect that this technology will help to expedite the evaluation of suspected cases and to enable more effective field surveillance activities already underway in endemic areas."

Xpert Ebola has been authorized by FDA under an Emergency Use Authorization for use by CLIA moderate and high complexity laboratories or similarly qualified non-U.S. laboratories.

The test will begin shipping in April 2015. For more information on Cepheid's entire 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.

References

1. http://www.cdc.gov/vhf/ebola/about.html

2. http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/index.html

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 availability, performance, sensitivity, speed, accuracy, contamination risk, diagnostic utility and epidemiological and clinical efficacy of our products, including relative to competing products and technologies, and future medical practice dynamics, including the utilization of our tests in epidemiological and clinical environments. 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 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 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 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.

For Cepheid Media Inquiries:	For Cepheid Investor Inquiries:
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Cepheid Corporate Communications	Cepheid Investor Relations
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