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Mainz Biomed Appoints Key Clinical Trial Partners for ColoFuture Study
Cutting Edge IVD Developer Sentinel Chosen to Provide Automated FIT Analysis SystemLeading Clinical Research Organization Alcedis Selected to Manage the Study
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[{"type":"text","content":"Cutting Edge IVD Developer Sentinel Chosen to Provide Automated FIT Analysis SystemLeading Clinical Research Organization Alcedis Selected to Manage the Study - ColoFuture on track to complete enrollment in 2H 2022 - BERKELEY, Calif. and MAINZ, Germany, March 17, 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 partnerships with Sentinel Diagnostics and Alcedis GmbH to support ColoFuture, its clinical study evaluating 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 (CRC). Sentinel Diagnostics is a global leader in the development and production of in vitro diagnostics (IVD). Under the terms of the partnership, Mainz will have access to the SENTiFIT® 270 Analyzer, Sentinel’s leading automated Fecal Immunochemical Test (FIT) processing system for the ColoFuture study. An essential component of ColoAlert is the utilization of a FIT which provides a complete review of blood in the stool, a condition often associated with cancerous polyps and colorectal carcinoma. It is the combination of ColoAlert and FIT results that provide the diagnostic outcome. This partnership enables Mainz to transition from deploying a manual FIT processing methodology to a state-of-the-art automated system for potential future use in the EU commercial setting and in the Company’s forthcoming U.S. clinical trial. “We pride ourselves on aligning with companies spearheading diagnostic innovation so it’s a pleasure to provide support for this ground-breaking clinical study,” commented Marco Buonaguidi, Head of Sales and Marketing for Sentinel Diagnostics. “We are particularly excited to play a key role in ColoFuture because if the trial proves successful, it will position ColoAlert as the most robust and effective at-home diagnostic and preventive tool for one of the deadliest forms of cancer.” In addition to the Sentinel appointment, Mainz is pleased to partner with Alcedis GmbH, a full-service state-of-the-art contract research organization (CRO) providing clinical trial management for biotechnology and medical device companies across the globe. Under the terms of the engagement, Alcedis will provid...