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Mainz Biomed Engages DCN Dx to Support Clinical Study Evaluating Novel mRNA Biomarkers for Potential Integration into ColoAlert
Results of European study potentially incorporated into U.S. regulatory strategy for FDA approval Opportunity for ColoAlert to become the gold standard
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[{"type":"text","content":"Results of European study potentially incorporated into U.S. regulatory strategy for FDA approval Opportunity for ColoAlert to become the gold standard at-home screening test for colorectal cancer BERKELEY, Calif. and MAINZ, Germany, Jan. 19, 2022 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today it has formally contracted with DCN Dx, a leading international developer of point-of-care diagnostics, and provider of comprehensive product development services. An integral part of the engagement will be the role of Emily Friedland, Vice President of Clinical Research at DCN Dx, who will spearhead the preparation and initiation of Mainz’s European centric clinical study to evaluate the potential to integrate a portfolio of recently acquired novel mRNA biomarkers into ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer. This suite of biomarkers which were in-licensed from Socpra Sciences Santé Et Humaines S.E.C. (“TTS”) in early January 2022, have demonstrated the unique ability to detect pre-cancerous lesions including advanced adenomas (AA), a type of pre-cancerous polyp often attributed to colorectal cancer (CRC). The study is on track to commence in the first half of 2022. “We are excited to work with the DCN Dx team and in particular, Emily Friedland who brings tremendous expertise in designing and managing clinical trials for molecular genetic diagnostic tests in development,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “If this study proves statistically significant, it will position ColoAlert as the most comprehensive and accurate CRC self-administered screening test on the market, as its enhanced technical profile will detect cancerous polyps with a high degree of accuracy and potentially eliminate CRC via its ability to detect lesions associated with contracting this deadly disease.” Under the terms of the engagement, DCN Dx will be responsible for the selection of additional clinical research organizations (CRO) and assist Mainz’s management with the development of robust study protocols and associated clinical processes. Emily brings to the project over 20 years of clinical research experience as a scientist and execu...