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]

Initiation of eAArly DETECT 2 - U.S. Clinical Study to Evaluate Performance of Next Generation Test on Advanced Adenomas over Large Patient Population in Preparation for ReconAAsense U.S. FDA Pivotal Trial Results from Feasibility Study of Biomarker Panel in Pancreatic Cancer ProjectStudy Demonstrated a Sensitivity of 100% and Specificity of 95% BERKELEY, Calif. and MAINZ, Germany, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagn ...

Vancouver, British Columbia--(Newsfile Corp. - December 31, 2025) - BioMark Diagnostics Inc. (CSE: BUX) (FSE: 20B) (OTCQB: BMKDF) ("BioMark" or the "Company"), a leading developer of liquid biopsy technologies for early cancer detection, today issued a Year-End Letter to Shareholders and Team from its Chief Executive Officer and Founder, Rashid Ahmed Bux.Dear BioMark Shareholders and Team,As we reflect on 2025, we celebrate a transformative year that positions BioMark as the leader in early cancer detectio ...

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 Points - Urteste S.A. has launched a European multicenter clinical study for the Panuri test, aimed at detecting pancreatic cancer through urine samples [1][2] - The study will take place in Poland, Hungary, and Italy, with a total of 550 participants [1][5] - The Panuri test has shown promising diagnostic parameters, including 89% sensitivity and 75% specificity [6] Company Overview - Urteste S.A. specializes in innovative technology for early cancer detection, focusing on urine-based diagnostic tests [8] - The company has developed 12 prototypes for various cancers, addressing nearly 70% of global cancer deaths [7] - The technology measures enzyme activity in urine, indicating potential cancer presence through color intensity changes [7][8] Study Details - The primary objective of the study is to evaluate the effectiveness of the Panuri test in detecting pancreatic cancer, focusing on sensitivity and specificity [2] - Two interim analyses will be conducted during the study to assess participant enrollment and diagnostic outcomes [5] - The results will contribute to the certification process for the IVD medical device in Europe and may supplement clinical data for a planned US study [4]

Core Insights - The company began as a biotech startup focused on early cancer detection and is now transitioning into a clinically validated enterprise [1] Group 1: Company Overview - The company has evolved from its initial vision of early cancer detection to becoming a clinically validated entity [1] Group 2: Leadership and Expertise - Mr. Mavroudis, a professional portfolio manager, specializes in risk management and financial market analysis, investing across various financial instruments globally [1] - He has successfully navigated major crises, including the COVID-19 pandemic, showcasing his expertise in managing institutional and private portfolios [1] - Mr. Mavroudis holds multiple degrees and certifications, including an MSc in Financial and Banking Management and is a certified portfolio manager [1]

Core Insights - A new blood test, Galleri, has shown promising results in detecting over 50 types of cancer, with a more than seven-fold increase in detection rates when combined with standard screenings [2][4][5] Group 1: Study Results - The PATHFINDER 2 study revealed that over half of the detected cancers were at early stages (stage I or II), which are more treatable [3][4] - Approximately 75% of the cancers detected by Galleri do not have existing standard screening programs, including pancreatic, liver, ovarian, and stomach cancers [3][4] Group 2: Implementation and Future Plans - The UK's National Health Service (NHS) is conducting a large-scale trial of the Galleri test with over 140,000 participants, aiming to reshape cancer outcomes through population-level deployment [4][5] - If the trial results align with U.S. findings, the NHS plans to expand the test to an additional one million people, potentially establishing the first national MCED screening program [5] Group 3: Economic and Health Implications - Current cancer screening programs only cover a limited number of cancer types, with about 70% of cancer deaths arising from cancers without standard screening [7] - Early detection through Galleri could significantly reduce the economic burden of late-stage cancer treatment, which is considerably more expensive than early interventions [8] Group 4: Test Mechanism and Accuracy - Galleri analyzes cell-free DNA fragments in the bloodstream to identify cancer through chemical methylation patterns, rather than searching for a single type of cancer [9] - The test boasts a specificity of 99.6% and a positive predictive value of approximately 62%, indicating that nearly two-thirds of positive results are accurate [10] - Galleri can accurately identify the origin of cancer in 92% of cases, allowing for more focused diagnostic efforts and minimizing unnecessary procedures [11] Group 5: Historical Context and Future Outlook - Grail was founded in 2016, inspired by a discovery at Illumina, Inc. regarding DNA signals from cancers detected in prenatal tests [12][13] - The success of Galleri will ultimately depend on whether early detection leads to reduced mortality rates, with ongoing trials moving towards regulatory review and potential population rollout [14]

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]