SUNNYVALE, Calif., Aug. 30 /PRNewswire-FirstCall/ -- Cepheid , a broad-based molecular diagnostics company, today announced the receipt of Phase 2 funding from the National Institute of Allergy and Infectious Disease (NIAID) for their Small Business Technology Transfer (STTR) Grant entitled, “Sample Processing Cartridges for Rapid PCR TB Detection.” Cepheid’s academic partner for this program is Dr. David Alland, of the University of Medicine and Dentistry of New Jersey (UMDNJ).
Cepheid and UMDNJ previously announced a program for development of an easy-to-use PCR cartridge that detects the presence of Mycobacterium tuberculosis and also predicts drug resistance in about one hour. This program is being supported by FIND, a Geneva-based non-profit organization partnered with the Bill and Melinda Gates Foundation. The newly awarded NIAID funding will complement these efforts by focusing on development of sample collection devices and on development of proprietary nucleic acid dyes, quenchers, interpretive software and other technologies associated with commercial implementation of a 6-color GeneXpert system. The ultimate goal of both programs is to develop a rapid test with accuracy that is equal to or better than current methods, thus shifting the burden away from culture techniques which require weeks to months to generate the same results.
“Our GeneXpert system enabled the recent attainment of the first ever moderate complexity categorization for a PCR-based assay. This gives us confidence that we can deliver, for use in developed and developing countries alike, rich-featured molecular diagnostics assays that provide medically actionable results in real time,” said David Persing, MD, PhD, Cepheid’s Chief Medical and Technology Officer and Principal Investigator on the award. “We are delighted that NIAID has recognized the ability of the GeneXpert system to deliver the most sophisticated molecular diagnostics capabilities for tuberculosis to areas of the world that need it most. At the same time, we believe that the same platform technology will enable this test to be performed on a STAT basis for at-risk patients presenting to hospitals and clinics in the US and developed countries around the world.”
About the GeneXpert System
The GeneXpert System is the only molecular diagnostic system to combine sample preparation with real time PCR (polymerase chain reaction) amplification, detection functions and internal controls for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences and deliver answers from unprocessed samples. Cepheid’s Xpert GBS test was recently cleared by the FDA for in vitro diagnostic use under the “Moderately Complex” CLIA category, the first-ever such designation for a PCR-based test.
Representing a major paradigm shift in the automation of molecular diagnostics, the GeneXpert System enables unprecedented speed and ease-of-use in the clinical environment.
About Cepheid
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 www.cepheid.com for more information.
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 usage in the clinical diagnostics market and future products for the clinical market. 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; our ability to successfully obtain regulatory approvals for additional products and to introduce new products in the clinical market; customer market acceptance of new products; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; the impact of competitive products and pricing; potentially lengthy sales cycles in some markets; reimbursement rates for the products; 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 in its most recent quarterly report on Form 10-Q, each 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.
CONTACTS: At the Company: John L. Bishop John R. Sluis CEO, Cepheid CFO, Cepheid 408-541-4191 408-541-4191 john.bishop@cepheid.comjohn.sluis@cepheid.com
