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.
Mainz Biomed N.V.Jul 13 2024 Food and Drug Administration requesting Breakthrough Device Designation for its non-invasive Next Generation colorectal cancer product including the Company’s novel portfolio of mRNA biomarkers. Subject to the FDA’s review, a Breakthrough Device Designation could significantly accelerate approval.
The regulatory submission follows consistently excellent 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.
The configuration of the Next Generation Test was tested in a clinical setting. The analysis involved 295 clinical subjects from 21 specialized gastroenterology centers across the United States and highlighted the remarkable efficacy of Mainz Biomed's multimodal screening test. This combination enables precise differentiation among colorectal cancer , advanced adenomas , non-advanced adenomas, and samples with no pathological findings.
Key findings On the back of our extremely positive clinical results in all our recent studies, finalizing the test which will be used in the pivotal ReconAAsense study and approval process has been an elementary milestone for our Company. Our Next Generation Test has shown a significant improvement in sensitivity for advanced adenomas and high-grade dysplasias, combined with high sensitivity and specificity for CRC.
Colorectal Colorectal Cancer Diagnostic Food Genetics Medical Devices Next Generation
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