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
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.
CONTACT: Thomas Gutshall, CEO & Chairman of Cepheid, +1-408-541-4191, or
firstname.lastname@example.org; or media, Yvonne Blaxter of Versaggi
Biocommunications(R), +1-415-397-3087, or email@example.com, for Cepheid