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Medical Devices / Submissions and Approvals

Biocartis Wins CE Mark for IVD Test for Lung Cancer

June 14, 2017

Biocartis has received the CE mark for its Idylla EGFR mutation test, which allows the detection of 51 EGFR mutations directly from one slice of FFPE tissue.

The device is designed to improve EGFR testing workflows. Results are delivered in approximately 2.5 hours with less than 2 minutes hands-on time. — Cynthia Jessup

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