AstraZeneca, Chembio Diagnostics receive CE mark for point-of-care diagnostic test

Chembio Diagnostics announced Monday that it received a CE mark for its point-of-care diagnostic test developed in collaboration with AstraZeneca. The companies' quantitative diagnostic test detects an undisclosed biomarker, using Chembio's patented Dual Path Platform (DPP). "The CE marked DPP system, which includes the new DPP test and DPP micro reader, provides quantitative results in ten minutes from a small drop of fingertip or venous blood," Chembio said.

John Sperzel, Chembio's CEO, remarked "we are pleased to receive the CE mark within 12 months of announcing the collaboration with AstraZeneca," adding "we look forward to working closely with AstraZeneca in pursuit of additional regulatory approvals."

In December 2017, Chembio announced an 18-month agreement with AstraZeneca, under which Chembio was expected to receive up to $2.9 million from the drugmaker, subject to satisfying certain milestones, to develop a quantitative reader-based point-of-care test using the DPP platform.

Did you like this article?