SUNNYVALE, Calif., April 26 /PRNewswire-FirstCall/ -- Cepheid today announced a collaboration between Cepheid and the Department of Defense (DOD)/Walter Reed Army Institute of Research (WRAIR) to produce a rapid, Real-Time PCR custom reagent to detect Leishmaniasis on Cepheid's SmartCycler(R) System using Cepheid's proprietary bead technology.
"Cepheid is pleased to have been selected by DOD/WRAIR as their collaborator to make a convenient, IVD-quality Leishmaniasis assay available to our troops," said Emily Winn-Deen Cepheid's Vice President for Strategic Planning and Business Development. "We look forward to working together to help DOD/WRAIR to bring this test through the FDA approval process."
Leishmaniasis is a parasitic disease caused by sand fly bites that has now affected nearly 1,000 service members during Operation Iraqi Freedom. Until now, culture-based methods at WRAIR were taking a significant amount of time to report results, placing extreme demands on the Leishmania Diagnostic Lab. The new Real-Time PCR test is expected to deliver results within one hour following extraction of DNA.
"If you rely on cell culture, it takes two to three weeks," said Lt. Col. Russ Coleman, chief of the WRAIR's Department of Entomology. "With Real-Time PCR we can save valuable treatment time."
"We can basically deliver this service any place that can reach us by overnight express delivery," said Col. Alan Magill, an expert on Leishmaniasis and science director at WRAIR. "We get the package with the sample, we prepare the mixture, we run the assay and we can email the response back to the physician."
The Leishmaniasis project is being produced as part of Cepheid's CSR (Customer Specific Reagent) program, which enables customer-developed assays to take advantage of Cepheid's proprietary bead technology where the customer's reagents are processed at Cepheid. Cepheid's CSR beads enable greater stability, improved reproducibility, and greater lab efficiency. The reformatted assays also allow for easy distribution to additional lab sites.
This collaboration is the first critical step in the ultimate goal of the WRAIR to have an FDA cleared (510k) version of this Real-Time PCR test, which is targeted for release late this year. Cepheid's CSR beads will help make FDA clearance feasible.
"The initial results (of the Cepheid bead) suggest the dried chemistry is substantially better in terms of limit of detection than the current wet chemistry," said Maj. David Shoemaker, a microbiologist experienced with FDA reviews.
About Cepheid
Cepheid , based in Sunnyvale, Calif., is a leading developer, manufacturer and marketer of fully integrated systems that enable genetic assessment when and where it is needed. Founded in 1996, the company is commercializing its technology and products worldwide for research, medical, and industrial applications requiring assessment of the human genome, infectious disease and biothreat agents. See http://www.cepheid.com/ for more information.
Material has been reviewed by the Walter Reed Army Institute of Research. There is no objection to its presentation and/or publication. The opinions or assertions contained herein are not to be construed as official, or as reflecting true views of the Department of the Army or the Department of Defense.
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