On Jan. 29, Chembio Diagnostics, Inc. agreed to license its patented Dual Path Platform (DPP™) technology for use in three disease screening protocols in Brazil. The funding for the project comes from Brazil’s Ministry of Health, under the auspices of the Bio-Manguinhos unit of the Oswaldo Cruz Foundation. The diseases addressed include Leishmaniasis, Leptospirosis, and stage-two positive HIV. In 2004, Chembio and Bio-Manguinhos entered into an analogous agreement based on one of Chembio’s rapid result’s tests for stage-one HIV.
Leishmaniasis, or black fever, is a blood-borne parasitic infection caused by the sand fly. Leptospirosis, or Weil’s disease, is a bacterial infection. Both are persistent in the Brazilian population. The ability to accurately and rapidly test for both, either in the field or in a laboratory would, according to Dr. Akira Homma, founder and Director of Bio-Manguinhos, “…be very valuable for Brazilian Public Health.”
A third test, to confirm the presence of the HIV virus in patients who have already been screened positive, completes the platform of Chembio’s DPP™ agreement with Bio-Manguinhos. As soon as the tests meet the mutual satisfaction of Chembio and Bio-Manguinhos (and the Ministry of Health), and their sale is approved by the Brazilian government, Chembio will be granted a minimum purchase order of at least one million tests during the first year. Future production will then be transferred to the Brazilian government, and Chembio will receive royalties.
Chembio’s DPP™ platform was selected both for its sensitivity and its ability to test for multiple infectious processes across wide parameters. Chembio’s point-of-care screening platform will enhance the deliverability of Bio-Manguinhos current program, which uses laboratory-based technology exclusively. The HIV test will be as effective as the Western blot, and provide definitive diagnosis across multiple antigen screens in 20 minutes.
According to Javan Esfandiari, Senior Vice President of Chembio, both internal and external studies have verified that the DPP™ testing platform provides high sensitivity and specificity when compared with conventional rapid lateral flow technologies. Lawrence Siebert, Chembio’s Chairman and CEO, added, “We are pleased to expand our relationship with Bio-Manguinhos. This agreement also serves to advance the scale up of our DPP™ production capability for future DPP™ collaborations.”
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