Mainz Biomed seeks FDA’s Breakthrough Devices Designation for advanced colorectal cancer test

FHS
July 13, 2024
4:27 am

Mainz Biomed N.V., a molecular genetics diagnostic company specializing in the early detection of cancer, announced that it has submitted its application to the U.S. Food and Drug Administration (FDA) requesting Breakthrough Device Designation for its non-invasive Next Generation colorectal cancer (CRC) product including the Company’s novel portfolio of mRNA biomarkers. Subject to the FDA’s review, a Breakthrough Device Designation could significantly accelerate approval.

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