Cepheid To Develop Xpert Ebola For Countries Worst Hit By Epidemic

SUNNYVALE, Calif., Nov. 13, 2014 /PRNewswire/ -- Cepheid (NASDAQ: CPHD) today announced that it has been awarded a grant of up to $3.3 million co-financed by the Paul G. Allen Family Foundation and the Bill & Melinda Gates Foundation to develop Xpert® Ebola, a rapid test that could be run on Cepheid's installed base of more than 3,500 GeneXpert® Systems in developing countries, including more than 1,000 in Africa.  The test is expected to be offered on an emergency use only basis.

"While we are all hopeful that the Ebola epidemic dissipates quickly, we welcome the opportunity to develop an accurate, rapid and easy-to-use test with the potential to strengthen the arsenal of tools being deployed to address the current situation," 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, rapid, and easy to use diagnostics to inform patient management and isolation requirements."

"Cepheid is well positioned to respond quickly to this urgent imperative. We are leveraging our significant investments in development of ultrasensitive HIV and TB detection technologies, and are borrowing on previous experience with an Ebola project to expedite delivery of the initial prototype and emergency use only product," said David Persing, MD, PhD, Cepheid's Chief Medical and Technology Officer. "We expect this technology to facilitate high throughput testing requirements of Ebola Treatment Units, as well as deployment of mobile laboratories for field surveillance."

In addition to Xpert Ebola, Cepheid and the Gates Foundation are evaluating deployment of Cepheid's RemoteXpert cloud-based monitoring software, currently implemented for TB testing on a pilot basis in South Africa and India. In the pilot phase, RemoteXpert has collected real-time data streams from nearly 2.5 million cases being evaluated for tuberculosis and drug resistance.  RemoteXpert could enable authorized agencies, for the first time, to access real-time testing activity and geopositioned Ebola test results in order to track the spread of the virus and the effectiveness of ongoing efforts to contain it.   

A more comprehensive view of the test's features will be available as the project progresses, but Cepheid currently expects the sample type for Xpert Ebola to be an oral swab or capillary whole blood specimen in order to avoid needle exposure and venipuncture.

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 access the full power of molecular diagnostics. The company's systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. 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 development, regulatory clearance, efficacy, rapidity, usability, sample type and time-to-delivery of a diagnostic test for Ebola and cloud-based monitoring software for such tests. 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: our ability to successfully develop new products; the completion of clinical trials for new products successfully and in a timely manner; problems in manufacturing; interruptions in supply; test performance in the field, including in remote, mobile or other non-clinical environments; uncertainties related to regulatory processes in applicable jurisdictions; the Company's research and development budget; the availability of third party financing and the proposed terms of such financing; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; 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.

SOURCE Cepheid