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]

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]