Mainz Biomed Announces IRB Approval and Initiation of US Pivotal FDA Clinical Study
- ReconAAsense study examining the clinical performance of mRNA and DNA test combined with a fecal immunochemical test for early detection of advanced adenoma and colorectal cancer to enroll 15,000 subjects across the United States, results expected in 2025
- Aims to enhance technical profile of the Mainz Biomed test to identify advanced adenomas (AA), a type of pre-cancerous polyp that can lead to colorectal cancer (CRC)
- Study will form the basis of the data package for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization
BERKELEY, Calif. and MAINZ, Germany, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today that it has received approval from an independent Institutional Review Board (IRB) for the protocol ReconAAsense, the Company’s U.S. pivotal study to evaluate the clinical performance of its highly efficacious and easy-to-use detection test for colorectal cancer (CRC). Mainz Biomed will now initiate the study, which will form the basis of the data package to be submitted for review by the U.S. Food and Drug Administration (FDA) to achieve marketing authorization.
ReconAAsense is a prospective clinical study that will include approximately 15,000 subjects from 150 sites across the United States. The study objectives include calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) in average-risk subjects for CRC and advanced adenomas (AA).
Integral to the Company’s development strategy concerning the evolution of the product’s specifications is the potential to upgrade its technical profile to achieve a transformational advancement in self-administered CRC screening. To this end, Mainz Biomed recently initiated eAArly DETECT, its U.S. extension of ColoFuture, the Company’s European feasibility study evaluating the integration of a portfolio of novel gene expression (mRNA) biomarkers into its next-generation product. These biomarkers have demonstrated a unique ability to identify precancerous colonic polyps and early-stage CRC (Herring et al., 2021). The eAArly DETECT study was initiated in November of 2022 and is evaluating the effectiveness of these biomarkers to enhance product specifications to extend its capability to include the detection of advanced adenomas while increasing rates of diagnostic sensitivity and specificity for colorectal cancer. Mainz Biomed expects to complete eAArly DETECT enrollment in Q1 2023 and targets reporting topline results in 1H 2023. Based on the study’s outcome, Mainz Biomed will decide on the integration of the biomarkers evaluated in ColoFuture’s eAArly DETECT into the ReconAAsense study.