Mainz Biomed N.V. (MYNZ), a leader in molecular genetic diagnostics, announced on Tuesday that it has submitted an application to the U.S. Food and Drug Administration (FDA) for Breakthrough Device Designation for its non-invasive Next Generation colorectal cancer (CRC) product. This innovative product integrates the company’s cutting-edge portfolio of mRNA biomarkers. If granted by the FDA, this designation could significantly accelerate the product’s approval process.
The regulatory submission is underpinned by consistently positive results from the ColoFuture and eAArly Detect clinical trials, as well as combined data from both European and U.S. study arms presented at ASCO 2024. Leveraging insights from these studies, Mainz Biomed has finalized the design of its Next Generation Test, which combines the Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers. Additionally, the company intends to enhance its product with an advanced AI and machine learning algorithm, which will be evaluated in the FDA premarket approval study.
The efficacy of the Next Generation Test was validated through clinical testing involving 295 subjects from 21 specialized gastroenterology centers across the United States. The study highlighted the impressive performance of Mainz Biomed’s multimodal screening approach, which effectively differentiates between colorectal cancer, advanced adenomas (AA), non-advanced adenomas, and samples with no pathological findings.
