<< Back
Cepheid Ships Field-Ready DNA Test Kits Jointly Developed With USAMRIID For Four Bio-Threat Agents
SUNNYVALE, Calif., Jan 7, 2002 /PRNewswire via COMTEX/ --

Milestone Marks Start of Cepheid's Reagent Development Program

Cepheid (Nasdaq: CPHD) today announced it delivered to the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) field-ready DNA test kits for rapid detection of four deadly bio-threat agents -- Bacillus anthracis (anthrax), Yersinia pestis (plague), Francisella tularensis (tularemia) and Clostridium botulinum (botulism). Developed in collaboration with USAMRIID under a Department of Defense contract, the tests combine DNA sequences identified and validated by USAMRIID for bio-threat agent detection with Cepheid's proprietary reagent formulations and "freeze-dry" processing for prolonged stability and ease-of-use.

The testing reagents are the first supplied directly by Cepheid and will be made available to several other U.S. government agencies for evaluation and validation on the company's Smart Cycler(R) line of laboratory and field-portable DNA detection systems.

"Delivery of these assays is the culmination of an intense development partnership between USAMRIID and Cepheid to produce the first comprehensive series of high-performance, high-stability tests for rapid detection of bio-threat agents," said Col. Erik A. Henchal, Chief of Diagnostic Systems at USAMRIID. "Our personnel have evaluated several of the Cepheid kits and are very impressed with their performance."

Unlike most DNA test kits, which degrade and become ineffective after just a few hours without refrigeration, Cepheid's proprietary reagent formulations and processing produce tests that remain stable for many months at room temperature. In addition, each test kit contains all the chemicals and reagents required to perform a PCR-based DNA test pre-measured and freeze-dried in a single tube. This preparation method eliminates sources of error from reagent handling and makes the tests very quick and easy to use, even under field conditions. The prepared DNA sample is simply added to the reagent tube and placed on the Smart Cycler for analysis.

"The completion of this project is another example of our long and productive collaboration with USAMRIID over the past five years," said Thomas Gutshall, chief executive officer and chairman of Cepheid. "It also marks the beginning of Cepheid's reagent development program. The formulations and manufacturing process we've established will be applied to a broad spectrum of applications beyond bio-threat detection, including agricultural, veterinary, environmental, and infectious-disease testing."

The reagent manufacturing process is integral to development of test-specific, preloaded cartridges for Cepheid's next-generation GeneXpert(TM) -- the first platform to fully automate and integrate all the steps required for PCR-based DNA testing. With a prototype delivered to the U.S. Department of Defense at the end of last year and commercial availability in the clinical diagnostics market slated for 2003, the GeneXpert will allow minimally skilled users to obtain PCR test results from a raw sample in 30 minutes, enabling time-critical DNA tests at the point of need. Current techniques for accomplishing this same series of procedures require extensive labor by skilled technicians and can take hours to several days to deliver results.

Cepheid (Nasdaq: CPHD), based in Sunnyvale, Calif., is a leading developer, manufacturer and marketer of miniaturized, fully integrated instrument systems for rapid, on-site detection of DNA -- the universal biological identifier. Founded in 1996, the company is commercializing its technology and products for scientific, medical and industrial applications requiring time-critical detection of human and other genes, infectious disease agents, and industrial and environmental contaminants at the point of need.

Sold directly and through its global partners, its Smart Cycler(R) family of products provides researchers with quantitative DNA analysis in real time, simultaneously supporting multiple users and protocols on a single instrument with results in less than 30 minutes. Cepheid's next-generation GeneXpert(TM) system will provide the first automated integration of all the steps required to detect DNA from complex biological specimens-sample preparation, amplification and detection. Cepheid, Smart Cycler and GeneXpert are registered trademarks of Cepheid. See www.cepheid.com for more information.

USAMRIID is the lead medical laboratory for the U.S. Army Biological Defense research program, and plays a key role in national defense and in infectious disease research. The Institute's mission is to develop medical countermeasures, specifically vaccines, drugs and diagnostics, to protect U.S. service members from biological warfare agents and endemic infectious diseases. USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Materiel Command.

Statements in this release, including those that may relate to revenue growth, trends in financial or operational performance, litigation, new product plans and business prospects are forward-looking statements. Actual results might differ materially from these statements due to risks and uncertainties, including the impact of competitive products and pricing, market acceptance of new products, market conditions and enforcement of intellectual property rights. A more detailed description of these risks and other risks applicable to Cepheid appears in Cepheid's reports filed with the U.S. Securities and Exchange Commission and available upon request from Cepheid. Cepheid disclaims any intent or obligation to update these forward- looking statements.

SOURCE Cepheid

CONTACT: Thomas Gutshall, CEO & Chairman of Cepheid, +1-408-541-4191, or gutshall@cepheid.com; or media, Yvonne Blaxter of Versaggi Biocommunications(R), +1-415-397-3087, or yvonne@versaggibio.com, for Cepheid

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding Cepheid's business which are not historical facts are "forward-looking statements" that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see "Risk Factors" in the Company's Annual Report or Form 10-K for the most recently ended fiscal year.