WHO Lists Cepheid’s Xpert Ebola As Eligible For Procurement To Ebola Affected Countries

SUNNYVALE, Calif., May 13, 2015 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced that the World Health Organization (WHO) has assessed and listed Xpert^® Ebola as eligible for procurement to Ebola affected countries. The program details can be found at: http://www.who.int/medicines/ebola-treatment/xpert_test_approval/en/. Xpert Ebola is 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.

The first reported case in the Ebola outbreak in West Africa was reported in December 2013 in Guinea near the border of Liberia and Sierra Leone. By June of 2014, over 750 people had been infected making this the worst Ebola outbreak ever. As of May 9th 2015, 26,722 cases and 11,064 deaths have been reported worldwide, the majority of them in these same three countries.¹

“We developed Xpert Ebola with a dual-target design to ensure high-accuracy and sensitivity for identifying the Ebola Zaire virus detected in the West Africa outbreak in 2014. The test runs in Cepheid’s self-contained cartridge to guard against 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 challenge 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 March 24, 2015, Cepheid announced that Xpert Ebola had been authorized by the U.S. Food and Drug Administration under an Emergency Use Authorization for use by CLIA moderate and high complexity laboratories or similarly qualified non-U.S. laboratories.²

“There is an urgent need for a point-of-care diagnostic test that can quickly and accurately diagnose Ebola cases and rule out non-cases. During the height of the epidemic, many health clinics in the affected countries were closed because patients were concerned that they were not safe,” 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 can play a key role in allowing routine health services to stay intact during current and future outbreaks.”

The test will begin shipping this month. For more information on Cepheid’s entire 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 www.cepheid.com.

References

1. http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/case-counts.html
2. http://ir.cepheid.com/releasedetail.cfm?ReleaseID=903155

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 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 including in remote, mobile or other non-clinical environments; our ability to successfully and timely develop new products; the Company’s research and development efforts ; 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.

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SOURCE Cepheid