Chembio Diagnostics Inc, Medford, NY, has been awarded a conditional long-term arrangement from the United Nations Childrens’ Fund (UNICEF) for purchases of the company’s Zika virus diagnostic system.
The arrangement is valid through December 31, 2019, and includes a firm purchase commitment of $1.5 million and possible additional purchases of up to $3.4 million, for a potential total of $4.9 million. Under the terms of the arrangement, purchases of the DPP Zika system will begin after Chembio has met the following conditions: receipt of an emergency use assessment and listing from the World Health Organization (WHO), completion of a clinical and analytical performance evaluation, and a successful quality management system inspection.
Last February, UNICEF issued a request for proposals for the supply of Zika virus diagnostics for testing at the point of care through 2019. UNICEF’S request is supported by a $10 million advance purchase commitment from the US Agency for International Development (USAID), which aims to reduce demand uncertainty risks for manufacturers who invest in the research and development of new products. UNICEF is collaborating with partners such as WHO and the Pan American Health Organization (PAHO) to make point-of-care diagnostics for Zika virus commercially available.
Chembio’s DPP Zika system includes the company’s DPP Zika IgM/IgG assay and handheld DPP micro reader, which was developed to reduce the risk of human error during test interpretation. The system requires just 10 µL of fingertip blood, and provides quantitative test results in 15 minutes.
“We are delighted that our DPP Zika system has been chosen by UNICEF, and we look forward to working with UNICEF, USAID, WHO, PAHO, and other supporting organizations to begin supplying our DPP Zika assay and DPP micro reader under this agreement,” says John Sperzel, CEO of Chembio. “Given the limitations of laboratory-based Zika tests, we believe our point-of-care DPP Zika assay and DPP micro reader will become essential tools in the battle against the Zika virus.”