Mainz BioMed Seeks FDA Breakthrough Device Designation for Advanced Colorectal Cancer Test
TL;DR
Seeking FDA Breakthrough Device Designation could give Mainz BioMed a competitive advantage in the cancer screening market.
Mainz BioMed has submitted an application to the FDA for Breakthrough Device Designation for its non-invasive colorectal cancer screening product.
Mainz BioMed's innovative cancer screening product could lead to earlier detection, potentially saving lives and improving patient outcomes.
Mainz BioMed has developed an advanced non-invasive colorectal cancer screening product incorporating a novel portfolio of mRNA biomarkers.
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Mainz BioMed has announced the submission of an application to the U.S. Food and Drug Administration (FDA) for Breakthrough Device Designation of its Next Generation colorectal cancer screening product. This innovative, non-invasive test utilizes a novel portfolio of mRNA biomarkers, aiming to potentially expedite the approval process and benefit early cancer detection efforts.
The regulatory submission is supported by robust clinical study results, including the ColoFuture and eAArly Detect studies, as well as data from a comprehensive pooled study of European and U.S. cohorts presented at ASCO 2024. These studies have led to the final configuration of the Next Generation Test, which integrates the Fecal Immunochemical Test with proprietary mRNA biomarkers and advanced AI and machine learning algorithms. This integrated approach will be used in the FDA premarket approval study.
Rigorous evaluation of the Next Generation Test was conducted in a clinical setting with 295 subjects from 21 specialized gastroenterology centers across the United States. The results highlighted the exceptional efficacy of Mainz BioMed’s multimodal screening test, which precisely differentiates colorectal cancer, advanced adenomas, non-advanced adenomas, and samples with no pathological findings.
The FDA’s Breakthrough Devices Designation program aims to accelerate the development, assessment, and review of medical devices and combination products that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. Receiving this designation for Mainz BioMed's colorectal cancer test could lead to quicker market access and wider availability of this critical diagnostic tool.
Curated from News Direct
