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Foundation to Market Chembio Diagnostics' Syphilis Test

By LabMedica International staff writers
Posted on 23 May 2011
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The Oswaldo Cruz Foundation of Brazil, known as FIOCRUZ (Rio de Janeiro, Brazil), has received regulatory approval to market Syphilis Treponemal tests.

The Dual Path Platform (DPP) Syphilis point-of-care test is a product of Chembio Diagnostics Inc. (Medford, NY, USA) and it is one of two DPP Syphilis tests that are covered by an agreement between FIOCRUZ and Chembio.

Chembio is committed to transfer technology to FIOCRUZ for these products in exchange for FIOCRUZ's completion of specified minimum purchase commitments. The technology transfer is anticipated to occur over a three-year period. In order for Chembio to complete the transfer, the agreement requires purchases totaling at least $5.7 million by FIOCRUZ from Chembio, and an additional $1.8 million in additional components after the transfer is completed in the fourth and fifth years.

The first DPP Syphilis product now approved is a single parameter Treponemal test for the detection of antibodies specific to Syphilis. The second product, Chembio's DPP Syphilis Screen & Confirm Assay, is a multiplex test that incorporates the Treponemal as well as a Non-Treponemal parameter, thereby better enabling the detection and differentiation of active infections from past infections in one rapid, point-of-care device. Syphilis remains a significant global public health problem with the World Health Organization (WHO; Geneva, Switzerland), estimating 12 million new cases of the disease worldwide each year including 100,000 per year in the United States and 140,000 per year in Western Europe.

Lawrence Siebert, J.D., Chembio's president and CEO, commented, "We are very pleased at the overall progress of our collaboration with FIOCRUZ, and the positive impact I believe it will have on our 2011 operating results. I appreciate the work that our team has done to support FIOCRUZ's efforts to obtain regulatory approval and support the strong demand for these products by the public health sector in Brazil."

Related Links:
Oswaldo Cruz Foundation
Chembio Diagnostics Inc.
World Health Organization


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