Summary: Mainz Biomed has applied for the FDA’s Breakthrough Device Designation for its advanced non-invasive colorectal cancer screening test, aiming to accelerate its approval.
Takeaways:
- The Next Generation test combines Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers and advanced AI for precise colorectal cancer screening.
- Clinical studies demonstrated high sensitivity for colorectal cancer (97%) and advanced precancerous lesions (88%), along with a specificity of 93%.
- The Breakthrough Device Designation, if granted, would expedite the test’s development and approval process, enhancing access to advanced screening tools.
Mainz Biomed has submitted its application to the U.S. Food and Drug Administration (FDA) requesting Breakthrough Device Designation for its non-invasive Next Generation colorectal cancer (CRC) 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 consistent read-outs of its clinical studies ColoFuture and eAArly Detect, as well as data from a pooled study including both the European and the U.S. arm that were presented at ASCO 2024, the company says. On the basis of these studies Mainz Biomed has now defined the final configuration of its Next Generation Test integrating the Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers, complemented by an advanced AI and machine learning algorithm that the company plans to use in its next-generation product, and the FDA premarket approval study.
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 (CRC), advanced adenomas (AA), non-advanced adenomas, and samples with no pathological findings.
Key Findings
- Sensitivity for Colorectal Cancer: 97% (95% confidence interval: 83.3-99.9)
- Sensitivity for Advanced Precancerous Lesions: 88% (95% confidence interval: 77.2-94.5)
- Specificity: 93% (95% confidence interval: 88.4-98.3)
“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,” says Guido Baechler, CEO at Mainz Biomed. “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. Moreover, we believe that our unique decentralized model of working with third party laboratory partners provides better access to underserved communities and our simple collection process will increase the adherence to testing. These benefits support our mission to transform colorectal cancer screening practices and reduce global cancer mortality rates.”
Further reading: New Industry Collaboration Seeks to Advance Colorectal Cancer Screening
The FDA’s Breakthrough Devices Designation is a program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
It is intended to allow patients and health care providers timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorizations. Breakthrough Devices must meet the FDA’s rigorous standards for device safety and effectiveness in order to be authorized for marketing.
