Study Demonstrated a Sensitivity of 100% and Specificity of 95%Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announces positive topline results from its feasibility study, examining a non-invasive blood-based screening test for the early detection of pancreatic cancer, initiated earlier this year. The study confirmed the strong clinical accuracy and utility of licensed proprietary biomarkers from Liqu ...

BERKELEY, Calif. and MAINZ, Germany, Sept. 30, 2025 (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, is pleased to announce its participation in the upcoming Colorectal Cancer (CRC) Screening Committee Plenary Meeting and Expert Working Group (EWG) Sessions hosted by the World Endoscopy Organization (WEO), taking place on October 3rd, 2025, in Berlin, Germany. This high-level gatherin ...

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]

Core Insights - Mainz Biomed N.V. is focused on molecular genetics diagnostics for early cancer detection and is progressing towards FDA premarket approval for its products [1][4] Company Developments - The company reported significant progress in Q1 2025, driven by strong clinical results from three studies published in 2024 [1] - The eAArly DETECT 2 study has commenced, evaluating a next-generation colorectal cancer test with results expected by the end of 2025 [4] - Mainz Biomed has signed a license agreement with Liquid Biosciences to access novel mRNA biomarkers for early pancreatic cancer detection, achieving 95% sensitivity and 98% specificity in independent validation [4] - A strategic partnership with labor team w ag has been established to introduce the ColoAlert CRC screening test to the Swiss market, addressing the urgent need for early detection in Switzerland [4] - The enhanced ColoAlert CRC screening test has been launched in Germany, coinciding with Colorectal Cancer Awareness Month in March 2025 [4] Regulatory Compliance - Mainz Biomed has regained compliance with Nasdaq's minimum stockholders' equity requirement and the minimum bid price requirement, ensuring full compliance with all Nasdaq continued listing requirements [4]