Cepheid has 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 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 reagent manufacturing process is integral to development of test-specific, preloaded cartridges for Cepheid's next-generation GeneXpert - 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.