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Mainz Biomed Enrolls First Patient in ColoFuture Study Evaluating Integration of Novel mRNA Biomarkers into ColoAlert
Multi-center clinical trial impacting ColoAlert’s profile for FDA submissionOn track to report results by early 2023 BERKELEY, Calif. and MAINZ, Germany, June
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[{"type":"text","content":"Multi-center clinical trial impacting ColoAlert’s profile for FDA submissionOn track to report results by early 2023 BERKELEY, Calif. and MAINZ, Germany, June 28, 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 enrolled the first patient in ColoFuture, an international clinical study assessing the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert, the Company’s highly efficacious, and easy-to-use detection test for colorectal cancer (CRC) which is being commercialized across Europe. The mRNA biomarkers were acquired from the Université de Sherbrooke in January 2022 and are the result of the institution’s pioneering work in the field, where researchers tested multiple novel transcriptional biomarkers using colon cancer samples and precancerous lesions. The results from these studies demonstrated that the mRNA targets chosen by Mainz provided the greatest sensitivity and specificity of detection. (Herring et al 2021). The ColoFuture study is evaluating 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. “The first patient in milestone marks the conclusion of several months of intensive preparatory work to ensure the trial is optimally managed and signifies the formal commencement of the study,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “This is a particularly exciting clinical trial for the Company and of course, the patient and medical communities as the outcome could potentially position ColoAlert as the gold standard at home screening test for this deadly form of cancer.” Mainz is currently marketing ColoAlert as a top-tier discretionary diagnostic option in Europe through its unique business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. In addition, the Company is preparing for ColoAlert’s U.S. pivotal trial, and Mainz’s clinical team is in the process of preparing the protocols...