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Medical Devices / Submissions and Approvals

Chembio Diagnostics Earns CE Mark for Biomarker Test

Jan. 9, 2019

Point-of-care diagnostics firm Chembio Diagnostics received the CE Mark for a biomarker diagnostic test developed in collaboration with AstraZeneca.

The quantitative diagnostic test can detect an undisclosed biomarker using Chembio’s DPP platform.

The DPP system, which has also received the CE Mark, gives quantitative results within ten minutes using a drop of fingertip or venous blood. The DPP platform is also used for Chembio's FDA-approved DPP HIV 1/2 assay.

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