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Mainz BioMed CEO Guido Baechler joined Steve Darling from Proactive to announce the company has submitted an application to the U.S. Food and Drug Administration requesting Breakthrough Device Designation for its innovative non-invasive Next Generation colorectal cancer screening product. This product incorporates a novel portfolio of mRNA biomarkers. Achieving this designation could potentially expedite the approval process, significantly benefiting early cancer detection efforts.

Baechler emphasized that the regulatory submission is backed 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 the European and U.S. cohorts, which were presented at ASCO 2024. These studies have culminated in the final configuration of the Next Generation Test. This test integrates the Fecal Immunochemical Test with proprietary mRNA biomarkers and is 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.

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Proactive North America

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