Molecular genetics diagnostic company Mainz Biomed N.V. (NASDAQ:MYNZ) said on Tuesday that it has applied to the US Food and Drug Administration (FDA) for Breakthrough Device Designation for its next-generation colorectal cancer (CRC) screening test.
The test has demonstrated 97% sensitivity for cancer and 88% for advanced adenomas, with high specificity.
This designation, if granted, could expedite approval for the test that combines the Fecal Immunochemical Test (FIT) with mRNA biomarkers and AI analysis.
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