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Mainz Biomed Initiates Clinical Study to Evaluate Integrating Novel mRNA Biomarkers Into ColoAlert
Results to impact ColoAlert profile for FDA submission Provides opportunity for ColoAlert to achieve gold standard status as the premier at-home screening
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[{"type":"text","content":"Results to impact ColoAlert profile for FDA submission Provides opportunity for ColoAlert to achieve gold standard status as the premier at-home screening test for colorectal cancer BERKELEY, Calif. and MAINZ, Germany, Feb. 04, 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 commenced ColoFuture, an international clinical study to evaluate the potential to integrate a portfolio of novel mRNA biomarkers into ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer which is being commercialized across Europe. The novel gene expression (mRNA) biomarkers, which we acquired an exclusive option to in-license from the Université de Sherbrooke in early January 2022, have demonstrated a unique ability to identify curable precancerous colonic polyps, as well as treatable early-stage colorectal cancer (CRC). The ColoFuture study will evaluate the effectiveness of these biomarkers to enhance ColoAlert’s technical profile to extend its capability to include the identification of advanced adenomas (AA), a type of pre-cancerous polyp often attributed to CRC, while increasing ColoAlert’s rates of diagnostic sensitivity and specificity. “Initiating the ColoFuture study is an exciting opportunity for the company, the patient and medical communities as the outcome could be a game-changer for the role ColoAlert will play in the prevention and treatment of CRC. We look forward to reporting the study’s clinical results by early 2023,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “In its current configuration, the test already represents a top-tier discretionary diagnostic option, and we are thrilled with the commercial traction ColoAlert has achieved to date via our unique business model of partnering with third-party laboratories for test kit processing. However, if the study’s results prove positive, it will be a transformative milestone for the Company as it will solidify ColoAlert’s position as the premier at-home diagnostic tool for this deadly form of cancer.” The exclusive option to in-license these mRNA biomarkers from the Université de Sherbrooke is the result of the institution’s pioneering work in the field, where researchers ...