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Medical Devices / Submissions and Approvals

German Devicemaker Gets CE-IVD Mark for Lung Cancer Assay

Dec. 22, 2017

Epigenomics, a Germany-based molecular diagnostics company, received the CE-IVD mark for its blood-based lung cancer test Epi proLung.

The device includes the company’s proprietary DNA methylation biomarkers.

The European Commission provided funding for the development of the assay, the company said.

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