Mainz Biomed submits FDA breakthrough device designation for its CRC screening test

Mainz Biomed N.V. ( NASDAQ: MYNZ ) submitted its application to the FDA requesting Breakthrough Device Designation for its non-invasive next generation colorectal cancer product including the company’s novel portfolio of mRNA biomarkers.

The regulatory submission follows read-outs of its clinical studies ColoFuture and eAArly Detect, as well as data from a pooled study including both the European and the US arm that were presented at ASCO 2024. Source: Press Release More on Mainz Biomed B.V.

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