NEW YORK (360Dx) – Chembio Diagnostics said today that it has entered a collaboration with biopharma company AstraZeneca to develop a point-of-care diagnostic test that detects an undisclosed biomarker.
Under the terms of an 18-month agreement, AstraZeneca will provide Chembio with up to $2.9 million in funding that's subject to satisfying certain milestones. Chembio said that under the agreement it will develop a quantitative, reader-based POC test that employs its patented dual-path-platform (DPP) immunoassay technology, and it will apply for US Food and Drug Administration 510k clearance of the test.
Chembio noted that during the third quarter of 2017, it "successfully" completed technical feasibility activities for the detection of the undisclosed biomarker in collaboration with AstraZeneca.
The new DPP System, consisting of the assay and a micro reader, will build upon previously-completed technical feasibility activities, Chembio said. The test is expected to provide quantitative results in 10 minutes from a 10 μl sample of fingertip or venous blood.