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 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]

Company Overview - Mainz Biomed N.V. is a molecular genetics diagnostic company focused on early cancer detection [1][4] - The company's flagship product, ColoAlert®, is a non-invasive diagnostic test for colorectal cancer, marketed across Europe [4] - Mainz Biomed is conducting a clinical study to prepare for FDA clinical study and US regulatory approval [4] Offering Details - Mainz Biomed announced a follow-on offering of 2,222,222 units, with gross proceeds expected to be approximately $3.0 million [1] - Each unit consists of one ordinary share (or pre-funded warrant) and one Series A warrant to purchase one and one half ordinary shares, priced at $1.35 per unit [1] - The Series A warrants are immediately exercisable at an exercise price of $1.35 per share and will expire five years from issuance [1] Placement Agent and Closing - Maxim Group LLC is acting as the sole placement agent for the offering [2] - The offering is expected to close on or about August 5, 2025, subject to customary closing conditions [2] Regulatory Information - The offering is made pursuant to a registration statement on Form F-1, declared effective by the SEC on August 4, 2025 [3] - A final prospectus relating to the offering will be filed with the SEC [3]

Core Insights - Mainz Biomed is advancing its FDA premarket approval study for its next-generation colorectal cancer screening product and has made a strategic acquisition in pancreatic cancer screening [1] - The company launched the eAArly DETECT 2 study, a US feasibility study involving approximately 2,000 average-risk patients to validate previous colorectal cancer test results [3] - A strategic partnership with labor team w ag introduces the ColoAlert® test to the Swiss market, marking Mainz Biomed's entry into Switzerland [3] - Mainz Biomed has partnered with EDX Medical Group to expand its molecular diagnostic technology in the UK [3] - A License and Option Agreement with Liquid Biosciences aims to develop a blood test for pancreatic cancer detection, showing a sensitivity of 95% and specificity of 98% based on a cohort of 285 subjects [3] - The PancAlert project is progressing with public funding from the Investitions- und Strukturbank Rheinland-Pfalz, covering up to 50% of the project's costs [3] - Mainz Biomed has regained compliance with Nasdaq listing requirements, ensuring continued trading on the Nasdaq Capital Market [3] - The company priced a follow-on offering of 2,000,000 units for gross proceeds of approximately $4.0 million, with each unit sold at an effective price of $2.00 [3] Company Overview - Mainz Biomed specializes in molecular genetic diagnostic solutions for early cancer detection, with its flagship product being the ColoAlert® test for colorectal cancer [5] - The company is conducting a pivotal FDA clinical study for US regulatory approval and is developing the PancAlert test for pancreatic cancer screening [5]

Core Insights - Mainz Biomed N.V. has secured public funding for its pancreatic cancer project from the Investitions- und Strukturbank Rheinland-Pfalz (ISB), which will cover up to 50% of the project's total costs, highlighting the project's scientific and societal value [1][2] - The funding is a significant endorsement of Mainz Biomed's non-invasive, blood-based screening test aimed at early detection of pancreatic cancer, which is crucial for improving treatment outcomes [2][3] - The project is currently in the feasibility phase, focusing on evaluating mRNA biomarkers and a machine learning-driven algorithm using real clinical blood samples, as part of a broader strategy to enhance non-invasive diagnostics for various cancers [4] Company Overview - Mainz Biomed specializes in molecular genetic diagnostic solutions for life-threatening conditions, with its flagship product, ColoAlert®, being a non-invasive early-detection test for colorectal cancer, marketed in Europe and the UAE [5] - The company is also developing PancAlert, an early-stage pancreatic cancer screening test utilizing real-time PCR multiplex detection of molecular-genetic biomarkers in stool samples [5]

Core Viewpoint - Mainz Biomed N.V. has announced a follow-on offering of 2,000,000 units at an effective price of $2.00 per unit, aiming for gross proceeds of approximately $4.0 million [1] Group 1: Offering Details - Each unit in the offering consists of one ordinary share (or pre-funded warrant), one Series A warrant, and one Series B warrant [1] - The Series A and Series B warrants are immediately exercisable at an exercise price of $2.00 per share, with Series A expiring in five years and Series B expiring either 30 days after results from the eAArly Detect 2 study or one year from issuance [1] - The offering is expected to close on or about May 21, 2025, subject to customary closing conditions [2] Group 2: Warrant Amendment Agreement - The company has entered into a Warrant Amendment Agreement to reduce the effective strike price of previously issued Series A and Series B Warrants from December 12, 2024, to an amended exercise price of $2.00 [3] Group 3: Regulatory Information - The newly issued securities are being offered under a registration statement on Form F-1, which was declared effective by the SEC on May 16, 2025 [4] - A final prospectus related to the offering will be filed with the SEC, and copies can be obtained from Maxim Group LLC [4] Group 4: Company Overview - Mainz Biomed specializes in molecular genetic diagnostic solutions for early cancer detection, with its flagship product being ColoAlert®, a non-invasive test for colorectal cancer marketed in Europe [5] - The company is conducting a clinical study to prepare for its pivotal FDA clinical study and US regulatory approval [5] - Mainz Biomed's product portfolio also includes PancAlert, an early-stage pancreatic cancer screening test [5]

Company Overview - Mainz BioMed is developing a novel standard for non-invasive detection of advanced adenomas (AA)[8] - The company has a disruptive, decentralized business model[9] - Mainz BioMed launched its first-generation CRC screening test, ColoAlert®, in Europe[10] - The company possesses a strong intellectual property position[12] Market Opportunity and Product - The US annual market for colorectal cancer (CRC) screening is estimated to be > $30 billion by 2032[14] - ColoAlert® is a highly efficacious, at-home, stool-based screening test for early CRC detection, combining a FIT test with PCR results of specific tumor DNA markers[15] - ColoAlert® has high accuracy with 92% specificity and 85% sensitivity[25] - In a screening population >= 45, 21% sensitivity for adenomas would reduce mortality from CRC by 47%, and 76% sensitivity would reduce mortality from CRC by 67%[21] Partnerships and Financials - Mainz BioMed entered into a Collaboration Agreement with Thermo Fisher Scientific in November 2024, with Thermo Fisher providing resources and discounts on instrumentation[17] - Mainz BioMed also entered into Agreements with Quest Diagnostics in November 2024, with Quest becoming a lab partner for the pivotal study and having a semi-exclusive distributor option right in the U S[17] - For the year ended December 31, 2024, ColoAlert® revenue was $893,991, with a gross profit of $574,883[50]