Core Insights - Mainz Biomed N.V. is set to present its blood-based mRNA signature for pancreatic ductal adenocarcinoma (PDAC) detection and differentiation from intraductal papillary mucinous neoplasms (IPMN) at the AACR 2026 Annual Meeting in San Diego from April 17 to 22, 2026 [1][3] - The company will showcase results from a verification study involving a proprietary combination of blood-derived mRNA biomarkers and AI-assisted modeling, tested on a cohort of 30 subjects [2] - The aim of this study is to revolutionize pancreatic cancer screening practices and contribute to reducing cancer mortality rates globally [3] Company Overview - Mainz Biomed specializes in developing molecular genetic diagnostic solutions for life-threatening conditions, with its flagship product being ColoAlert, a non-invasive early-detection test for colorectal cancer marketed in Europe [4] - The company is currently conducting the eAArly DETECT 2 clinical study in preparation for a pivotal FDA study for regulatory approval in the U.S. [4] - Additionally, Mainz Biomed is developing PancAlert, an early-stage pancreatic cancer screening test utilizing real-time PCR multiplex detection of molecular-genetic biomarkers in blood and stool samples [4]

Core Insights - Mainz Biomed N.V. announced its participation in the 2025 Maxim Growth Summit, scheduled for October 22-23, 2025, at The Hard Rock Hotel NYC [1] - The summit will feature industry leaders and discussions on various sectors, including biotechnology and artificial intelligence [2] Company Overview - Mainz Biomed specializes in molecular genetic diagnostic solutions for early cancer detection, with its flagship product, ColoAlert, aimed at colorectal cancer [4] - The company is conducting the eAArly DETECT 2 clinical study in preparation for a pivotal FDA study for U.S. regulatory approval [4] - Mainz Biomed's product portfolio also includes PancAlert, an early-stage pancreatic cancer screening test utilizing real-time PCR multiplex detection [4] Event Participation - During the Maxim Growth Summit, Mainz Biomed will engage in one-on-one meetings with institutional investors and senior analysts from Maxim [3]

Core Insights - Mainz Biomed announced positive topline results from a feasibility study for a non-invasive blood-based screening test for early detection of pancreatic cancer, achieving 100% sensitivity and 95% specificity in a cohort of 30 subjects [1][2][3] Group 1: Study Results - The study confirmed the clinical accuracy of licensed proprietary biomarkers from Liquid Biosciences, with the leading panel achieving 100% sensitivity and 95% specificity [1] - Previous datasets demonstrated strong performance with 95% sensitivity and 98% specificity, reinforcing confidence in the biomarker panel's robustness [2] - The algorithm successfully detected precancerous lesions, allowing for earlier intervention and monitoring of at-risk individuals [3] Group 2: Future Plans - Mainz Biomed plans to conduct a larger clinical study to finalize biomarker selection using banked retrospective samples, evaluating performance across different stages of pancreatic cancer [4] - A validation study using a larger cohort and Polymerase Chain Reaction (PCR) technology is intended to optimize the test for clinical utility and prepare for potential FDA submission [5] - The pancreatic cancer project aligns with the company's broader strategy to develop accessible molecular diagnostics for early cancer detection in areas with limited screening tools [5]

Core Insights - Mainz Biomed is participating in the Colorectal Cancer Screening Committee Plenary Meeting and Expert Working Group Sessions hosted by the World Endoscopy Organization on October 3, 2025, in Berlin, Germany [1][2] - The meeting aims to evaluate emerging technologies and shape future strategies for early detection and prevention of colorectal cancer (CRC) [2][4] - Dr. Lena Krammes will present findings from the eAArly DETECT study, focusing on RNA-based diagnostics for identifying colorectal cancer and precancerous lesions [3][5] Company Overview - Mainz Biomed specializes in molecular genetic diagnostic solutions for life-threatening conditions, with its flagship product being ColoAlert, a non-invasive early-detection test for colorectal cancer marketed in Europe [6] - The company is conducting the eAArly DETECT 2 clinical study in preparation for a pivotal FDA study for US regulatory approval [6] - Mainz Biomed's product portfolio also includes PancAlert, an early-stage pancreatic cancer screening test utilizing real-time PCR for detecting molecular-genetic biomarkers [6] Clinical Findings - The eAArly DETECT study highlights the potential of stool RNA testing to identify colorectal cancer and precancerous lesions, emphasizing its role in early detection and prevention [3] - Key clinical data includes 97% sensitivity and 97% specificity for detecting colorectal cancer, 82% sensitivity for advanced adenomas, and 100% detection of advanced adenomas with high-grade dysplasia [7]

Core Insights - Mainz Biomed N.V. has received official registration for its ColoAlert® test from the Medicines and Healthcare products Regulatory Agency (MHRA), allowing it to be marketed in the UK [1][4] - The approval follows a technology partnership with EDX Medical Group plc, aimed at increasing accessibility of the DNA-based colorectal cancer screening test [2] - Colorectal cancer is the fourth most common cancer in the UK, with around 44,000 new cases diagnosed each year, and ColoAlert offers a non-invasive screening option [3] Company Developments - The approval of ColoAlert enables the UK laboratory partner to provide a reliable and user-friendly test, supporting the goal of increasing participation in preventive screening [4] - Mainz Biomed is committed to expanding access to innovative diagnostic solutions for early cancer detection, addressing a leading cause of cancer-related mortality [4] - The company is also running a pivotal FDA clinical study for US regulatory approval and has other product candidates like PancAlert for pancreatic cancer screening [5]

Core Insights - Mainz Biomed has received regulatory approval from Swissmedic for its non-invasive colorectal cancer screening test, ColoAlert, allowing it to be distributed in Switzerland [1][3][4] - The target demographic for colorectal cancer screening in Switzerland includes individuals aged 50 to 74, with an estimated population of 2.8 million in this age group, representing approximately 31.4% of the total population [2] - Current participation rates in existing screening programs are below 50%, indicating a significant opportunity for ColoAlert to enhance participation and support national health objectives [2][4] Company Overview - Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection, with ColoAlert being its flagship product [5] - The company is expanding its market presence through partnerships with local laboratories and healthcare providers to ensure broad access to its diagnostic solutions [4][5] - In addition to ColoAlert, Mainz Biomed is developing PancAlert, an early-stage pancreatic cancer screening test [5]

Core Insights - Mainz Biomed has announced a collaboration with CARE diagnostica Laborreagenzien GmbH to enhance colorectal cancer screening services in Germany [1][2][3] - The partnership will expand the service offerings to include the ColoAlert test, which utilizes molecular genetic analysis of stool samples to improve early detection rates [2][3] - This collaboration aligns with the increasing demand for personalized screening solutions focused on early intervention in cancer detection [3] Company Overview - Mainz Biomed specializes in developing molecular genetic diagnostic solutions for life-threatening conditions, with its flagship product being the ColoAlert test for colorectal cancer [4] - The company is also conducting a pivotal FDA clinical study for regulatory approval in the United States and has additional product candidates like PancAlert for pancreatic cancer screening [4] - CARE has over 40 years of experience in colorectal cancer screening in Germany and collaborates with more than 15 statutory health insurance companies [5]

Core Insights - Mainz Biomed is advancing its PancAlert project, focusing on a non-invasive blood test for early pancreatic cancer detection, aiming to confirm previous findings of 95% sensitivity and 98% specificity [1][5] Group 1: Project Development - The feasibility phase will verify candidate mRNA biomarkers and an accompanying machine learning algorithm in clinical blood samples to assess diagnostic performance [2][3] - The company plans to collaborate with Crown Bioscience, a CRO specializing in oncology, to support the verification process [2] Group 2: Objectives and Future Plans - The primary goal of the feasibility stage is to evaluate the robustness, reproducibility, and diagnostic performance of the assay, including sensitivity and specificity [3] - Following the feasibility phase, Mainz Biomed intends to conduct a validation study with a larger cohort, which is crucial for optimizing the test for clinical use and potential FDA submission [5] Group 3: Market Context - Early detection of pancreatic cancer is a significant unmet need in oncology, and the company is committed to improving patient outcomes through its diagnostic solutions [4] - The PancAlert project is part of Mainz Biomed's broader strategy to develop accessible molecular diagnostics for early cancer detection in areas with limited screening tools [5][7]

Core Insights - Mainz Biomed N.V. plans to provide an interim readout of its eAArly DETECT 2 feasibility study by the end of summer 2025, with top-line results expected in Q4 2025 [1][2] - The study aims to validate a next-generation colorectal cancer screening test that combines proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test on approximately 2,000 average-risk patients [1][3] - The company is on track to initiate its U.S. pivotal trial, ReconAAsense, in 2026 based on the outcomes of the eAArly DETECT 2 study [2][3] Study Details - The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025, targeting the reporting of top-line results by Q4 2025 [2] - The study will evaluate the effectiveness of five novel mRNA biomarkers acquired from Sherbrooke University in 2022, which have shown the ability to identify advanced adenomas and early-stage colorectal cancer [3] Company Mission - The company aims to advance its mission of eliminating colorectal cancer and reducing global cancer mortality rates through precise detection of advanced precancerous lesions and early-stage colorectal cancer [3]

Core Insights - Mainz Biomed has entered into a technology partnership with EDX Medical Group to enhance cancer diagnostics in the UK [1][3] - The partnership will allow EDX Medical to utilize Mainz Biomed's molecular diagnostic technology, expanding its product offerings [2] Company Overview - Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection [1] - The company's flagship product, ColoAlert, is a non-invasive test for colorectal cancer, currently marketed in Europe and undergoing FDA clinical studies for US approval [4] - Mainz Biomed's product pipeline includes PancAlert, an early-stage pancreatic cancer screening test [4] EDX Medical Group Overview - EDX Medical Group, based in the UK, develops digital diagnostic products for various diseases, including cancer [1][5] - The company aims to improve disease detection and treatment personalization through advanced biological and digital technologies [6]