DNA-based Colorectal Cancer Screening as a Home TestBERKELEY, Calif. and MAINZ, Germany, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company“), molecular genetics diagnostic company specializing in the early detection of cancer, today announced that its test ColoAlert® has been added to the portfolio of DoctorBox, one of Germany’s leading pioneers in digital health. This marks another important milestone in Mainz Biomed’s European growth strategy and highlights ...

Core Insights - Mainz Biomed has signed a Memorandum of Understanding (MOU) with OncoVanguard8 to introduce its DNA-based colorectal cancer screening test, ColoAlert®, to South America, starting with Peru [1][2][3] Company Overview - Mainz Biomed specializes in molecular genetics diagnostics, focusing on early cancer detection, with its flagship product being ColoAlert®, a non-invasive colorectal cancer diagnostic test [4] - The company is currently conducting the eAArly DETECT 2 clinical study in preparation for a pivotal FDA study for regulatory approval in the US [4] Market Opportunity - Colorectal cancer is one of the most prevalent yet preventable cancers globally, with approximately 17,000 new cases diagnosed annually in the initial launch markets of Peru, Colombia, and Ecuador [2] - The introduction of a DNA-based screening solution is expected to significantly increase screening participation and improve early diagnosis, aligning with public health initiatives to reduce colorectal cancer mortality [2] Strategic Partnership - The MOU outlines the commercial, legal, and regulatory terms, as well as the go-to-market strategy for the initial territory, with a final distribution agreement expected to be signed in the coming weeks [3] - OncoVanguard8 aims to bridge the technological gap in cancer prevention and early detection in Latin America, developing partnerships with insurers, hospitals, and healthcare networks [5]

Core Insights - Mainz Biomed N.V. is participating in MEDICA 2025, a leading healthcare trade show in Düsseldorf, Germany, from November 17-20, 2025 [1] - The event will feature over 5,000 exhibitors from 70 countries and is expected to attract 80,000 visitors, serving as a platform for innovation and business development in medical technology [2] - MEDICA will host healthcare experts, industry leaders, and policymakers, providing opportunities for collaboration and relationship building in cancer prevention and molecular diagnostics [3] Company Highlights - Mainz Biomed will showcase its flagship product, ColoAlert®, a molecular stool-based screening test for early detection of colorectal cancer, along with other upcoming diagnostic solutions [4] - The company is currently conducting the eAArly DETECT 2 clinical study in preparation for a pivotal FDA study for US regulatory approval [5] - Mainz Biomed's product portfolio also includes PancAlert, an early-stage pancreatic cancer screening test utilizing real-time PCR multiplex detection of biomarkers in blood and stool samples [5]

Core Insights - Mainz Biomed N.V. is participating in the 38th Annual Meeting of the Gastroenterological Working Group of Rhineland-Palatinate (GARPS) from November 14-15, 2025, in Bad Kreuznach, Germany, focusing on early cancer detection [1][2] Company Overview - Mainz Biomed specializes in molecular genetics diagnostics, particularly for early cancer detection, with its flagship product being ColoAlert®, a non-invasive test for colorectal cancer [5] - The company is currently conducting the eAArly DETECT 2 clinical study in preparation for a pivotal FDA study aimed at obtaining regulatory approval in the US [5] Industry Engagement - The GARPS conference serves as a platform for knowledge exchange among clinical and scientific experts in gastroenterology and hepatology, fostering dialogue between universities, hospitals, and the diagnostics industry [2] - Mainz Biomed aims to strengthen relationships with key opinion leaders in gastroenterology and discuss future cancer prevention strategies during the conference [3] Product Promotion - Attendees at the GARPS conference are invited to learn about the importance of early colorectal cancer detection and explore potential collaborations to offer ColoAlert® to patients [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 has launched its flagship product, ColoAlert®, in Switzerland, marking a significant milestone for the company [1] - The launch follows a strategic partnership with labor team w ag, a leading diagnostic laboratory in Switzerland, which will facilitate the distribution of ColoAlert® [2] - Swissmedic has granted official registration and marketing approval for ColoAlert®, allowing its distribution in Switzerland and enhancing patient access to colorectal cancer screening [3] Company Developments - Mainz Biomed completed a technology transfer with labor team, enabling local processing and analysis of ColoAlert® samples in Switzerland, ensuring operational efficiency and high-quality diagnostics [4] - The company is progressing with its eAArly DETECT clinical study, aiming to enroll 2,000 patients from the average risk population by the end of 2025, without pausing for interim readouts [5] - Mainz Biomed is also preparing for a pivotal FDA study for US regulatory approval, indicating its commitment to expanding its market presence [6]

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]