Mainz Biomed Seeks FDA Breakthrough Status For Next-Generation CRC Screening Test

(RTTNews) - Molecular genetics diagnostic company Mainz Biomed N.V. (MYNZ), on Tuesday, announced the submission of its application to the U.S. Food and Drug Administration or FDA seeking Breakthrough Device Designation for its non-invasive Next Generation colorectal cancer or CRC product. This product encompasses the company's innovative portfolio of mRNA biomarkers. If granted by the FDA, the Breakthrough Device Designation has the potential to expedite the approval process significantly.

The regulatory submission is a result of the consistently positive outcomes from the clinical trials ColoFuture and eAArly Detect, as well as data from a combined study of the European and US arms, which were presented at ASCO 2024. Based on these studies, Mainz Biomed has finalized the design of its Next Generation Test, incorporating the Fecal Immunochemical Test or FIT with proprietary mRNA biomarkers. Additionally, the company plans to integrate an advanced AI and machine learning algorithm into its Next Generation product, which will be evaluated in 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, advanced adenomas or AA, non-advanced adenomas, and samples with no pathological findings.