SUNNYVALE, Calif., March 21 /PRNewswire-FirstCall/ -- Cepheid , a broad-based molecular diagnostics company, today announced the introduction of the 3-Agent Biothreat assay for its GeneXpert(R) System. This is the first molecular diagnostic test which enables users to identify B. anthracis (Anthrax), Y. pestis (Bubonic Plague), and F. tularensis (Rabbit Fever) from a single, unprepared suspicious sample. Positive test results are available in approximately 70 minutes. The three organisms covered by the 3-agent assay are listed as "Category A Priority Pathogens" by The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
"Anthrax, Bubonic Plague, and Rabbit Fever are three of the most common and critical biothreat organisms to target for rapid identification," said David A. Norwood, Jr., Ph.D., Chief, Systems Development Branch, Diagnostic Systems Division at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), co-developers of the assays along with Cepheid and ABI. "A test that can quickly and accurately detect the presence of these organisms is an important component of the response effort."
The GeneXpert 3-Agent assay follows the successful introduction of the GeneXpert Anthrax test. Used by government agencies and first response units nationwide, GeneXpert Anthrax tests are most notably in use at the U.S. Department of State and in the United States Postal Service Biohazard Detection System, where more than 2.3 million tests have been run since 2004 without a single false positive.
"The 3-Agent biothreat product is the latest development in Cepheid's planned, comprehensive biothreat detection program," said John Bishop, Cepheid's Chief Executive Officer. "Anthrax has historically been the subject of most headlines, but it is not the only biological threat to public safety. That is why Cepheid is working with organizations like the Public Health Agency of Canada to develop in-field nucleic assays for Ebola, Marburg and Lassa Fever viruses in addition to our on-going program with USAMRIID."
Cepheid's GeneXpert is currently the world's only closed integrated system to combine sample preparation with real time PCR (polymerase chain reaction) amplification and detection -- delivering fully-integrated and automated DNA analysis. The system purifies, concentrates, detects and identifies targeted nucleic acid sequences, delivering answers from unprocessed samples in minutes.
Cepheid , based in Sunnyvale, Calif., is a molecular diagnostics company that develops, manufactures, and markets fully-integrated systems for genetic analysis in the clinical, industrial and biothreat markets. The company's systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. The company's easy-to-use systems integrate a number of complicated and time-intensive steps, including sample preparation, DNA amplification and detection, which enable the analysis of complex biological samples in its proprietary test cartridges. Through its strong molecular biology capabilities, the company is focusing on those applications where rapid molecular testing is particularly important, such as identifying infectious disease and cancer in the clinical market; food, agricultural, and environmental testing in the industrial market; and identifying bio-terrorism agents in the biothreat market. See http://www.cepheid.com for more information.
USAMRIID, located at Fort Detrick, Maryland, is the lead medical research laboratory for the U.S. Biological Defense Research Program, and plays a key role in national defense and in infectious disease research. The Institute's mission is to conduct basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command.
The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.
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 product performance and future product releases. 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: unforeseen development and manufacturing problems, including with respect to the GeneXpert(R) system, cartridges, and reagents; lengthy sales cycles in certain markets; the performance and market acceptance of new products; sufficient customer demand in the other markets; our reliance on distributors to market, sell and support our products; the occurrence of unforeseen expenditures, acquisitions or other transactions; our success in increasing direct sales; the impact of competitive products and pricing; and underlying market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K for 2005 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
At the Company:
John L. Bishop John R. Sluis
CEO, Cepheid CFO, Cepheid
At Financial Relations Board: At Schwartz Communications:
Tricia Ross Chris Stamm / Tom Bain
Investor/Analyst Information 781-684-0770
CONTACT: John L. Bishop, CEO, firstname.lastname@example.org, or John R. Sluis,CFO, email@example.com, both of Cepheid, +1-408-541-4191; orInvestor/Analyst Information, Tricia Ross of Financial Relations Board,+1-617-520-7064, firstname.lastname@example.org, for Cepheid; or ChrisStamm or Tom Bain, both of Schwartz Communications, +1-781-684-0770,email@example.com, for Cepheid