Mainz BioMed has recently submitted an application to the U.S. Food and Drug Administration (FDA) for Breakthrough Device Designation for its innovative Next Generation colorectal cancer screening product. This non-invasive test incorporates a novel portfolio of mRNA biomarkers, and achieving this designation could expedite the approval process, significantly benefiting early cancer detection efforts.
According to CEO Guido Baechler, the regulatory submission is supported by consistently strong results from the company's clinical studies, ColoFuture and eAArly Detect, as well as data from a comprehensive pooled study encompassing both European and U.S. cohorts, which were presented at ASCO 2024. These studies culminated in the final configuration of the Next Generation Test. The test integrates the Fecal Immunochemical Test with proprietary mRNA biomarkers and is further enhanced by an advanced AI and machine learning algorithm. This integrated approach is set to be employed in the FDA premarket approval study.
The Next Generation Test configuration was rigorously evaluated in a clinical setting involving 295 subjects from 21 specialized gastroenterology centers across the United States. The results underscored the exceptional efficacy of Mainz BioMed’s multimodal screening test, which allows for precise differentiation among colorectal cancer, advanced adenomas, non-advanced adenomas, and samples with no pathological findings.
The FDA’s Breakthrough Devices Designation program is designed to accelerate the development, assessment, and review of medical devices and combination products that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. This designation for Mainz BioMed's colorectal cancer test could pave the way for quicker market access and wider availability of this critical diagnostic tool.
