Chembio Diagnostic Systems, Inc., a wholly-owned subsidiary of Chembio Diagnostics, Inc. (Chembio), has won a three-year $3 million Small Business Innovative Research (SBIR) Phase II grant from the US National Institutes of Health (NIH). Grant funds will used to develop, validate, and commercialize a rapid diagnostic test for leptospirosis for general use worldwide.

The test will be developed by using Chembio’s patented Dual Path Platform (DPP) technology together with proprietary reagents developed by Cornell University and the Oswaldo Cruz Foundation at the Brazilian Ministry of Health.

Development of the test will be in collaboration with the Division of Infectious Diseases, Weill Medical College, Cornell University in New York and the Oswaldo Cruz Foundation, the largest biomedical research institution in Latin America. In the Phase I work completed in 2008, which occurred with this same collaborative group, novel diagnostic targets were identified and evaluated in a prototype test in Chembio’s patented DPP format. The studies demonstrated that the test prototype had an overall sensitivity of 85% and a specificity of 90% using serum samples of leptospirosis patients from Brazil and Thailand. Furthermore, the DPP(R) prototype had a sensitivity of 78% in identifying leptospirosis in the first 7 days of illness, the window-of-opportunity during which initiation of antimicrobial therapy provides the greatest benefit.

The lack of an effective diagnostic test has been one of the major barriers to addressing leptospirosis, a life-threatening zoonotic disease, whose global burden is estimated to be as high as 500,000 cases annually. Leptospirosis is an emerging infectious disease problem in industrialized countries such as the US, and is a significant cause of mortality and morbidity among impoverished populations in developing countries. Leptospirosis, especially in the early stage of illness, is often misdiagnosed as dengue, malaria and other causes of acute fever. The delay in detecting leptospirosis has potentially severe consequences since the disease progresses to cause life-threatening manifestations such as pulmonary hemorrhage syndrome and acute renal failure.

Dr. Albert Ko, Associate Professor of Medicine at Weill Medical College, Cornell University and Visiting Researcher at Oswaldo Cruz Foundation, commented, The collaboration with Chembio has been successful in applying the selected markers to Chembio’s DPP format. This grant enables us to complete development of the assay and make it available to health professionals and public health authorities as part of an effort in combating this important global infectious disease problem.

Javan Esfandiari, senior vice president of R&D of Chembio, commented, We are pleased with the recognition that the awarding of this grant by NIH provides Chembio and to our patented DPP(R) technology. I am most appreciative of the excellent work of Dr. Albert Ko from Cornell and Dr. Konstantin Lyashchenko, Chembio’s Senior R&D Director, as well as the rest of Chembio’s R&D team.

About DPP

The Dual Path Platform immunoassay is a recent innovation in the field of rapid testing for which Chembio received a US patent in 2007. DPP(R) technology employs two separate and distinct membrane strips, one for the sample migration and one for the test reagents. This unique dual-flow design allows for improved control and management of the sample flow. As a result, the immunological reaction is more efficient than lateral flow tests based upon studies performed by Chembio.