Welcome to our dedicated page for Mainz Biomed NV news (Ticker: MYNZ), a resource for investors and traders seeking the latest updates and insights on Mainz Biomed NV stock.
Mainz Biomed NV (MYNZ) pioneers non-invasive cancer detection through advanced molecular diagnostics like its flagship ColoAlert test. This page aggregates official news releases and clinical updates critical for understanding the company’s progress in colorectal and pancreatic cancer screening.
Investors and researchers will find timely updates on regulatory milestones, product developments, and strategic partnerships. Content spans clinical trial results, technology enhancements leveraging AI, and market expansion efforts across Europe and North America.
Key focus areas include advancements in PCR-based testing, collaborations with medical institutions, and data from ongoing studies. Bookmark this page to efficiently track Mainz Biomed’s contributions to early cancer detection and molecular diagnostics innovation.
Mainz Biomed (NASDAQ: MYNZ) has provided its Q1 2025 corporate update, highlighting significant progress in its colorectal cancer (CRC) screening initiatives. The company enrolled its first patient in the eAArly DETECT 2 feasibility study, which will evaluate their next-generation CRC test incorporating mRNA biomarkers, AI algorithms, and FIT testing across 2,000 average-risk patients.
Key developments include a license agreement with Liquid Biosciences for pancreatic cancer biomarkers showing 95% sensitivity and 98% specificity, and a strategic partnership with labor team w ag to introduce ColoAlert® in Switzerland. Additionally, GANZIMMUN Diagnostics launched an enhanced version of ColoAlert across Germany in January 2025.
The company has regained full compliance with Nasdaq listing requirements, including minimum stockholders' equity and bid price requirements.
Mainz Biomed (NASDAQ:MYNZ) reported its 2024 financial results, highlighting a 33% year-over-year increase in lab network revenue for ColoAlert® in Europe. The company achieved significant cost reductions, resulting in a 30% decrease in operating loss and an 18% reduction in net loss.
Key developments include strategic partnerships with Thermo Fisher Scientific for next-generation colorectal cancer screening product development and Quest Diagnostics for clinical trial services. The company completed an $8.0 Million follow-on offering and focused on three core initiatives: European ColoAlert® business growth, next-generation product development, and the 2,000-patient eAArly DETECT 2 study.
Financial highlights for 2024 include:
- Revenue: $893,991
- Gross profit: $574,883 (64% margin)
- Net loss: $21.65 million
- Cash position: $6.24 million as of December 31, 2024
Mainz Biomed (NASDAQ:MYNZ) has enrolled its first patient in the eAArly DETECT 2 clinical study, a significant milestone in evaluating their next-generation colorectal cancer (CRC) test. The study will assess approximately 2,000 average-risk patients and combines proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test.
The study aims to validate previous feasibility results and support the transition from CRC screening to prevention. Enrollment is expected to complete in H2 2025, with top-line results targeted for Q4 2025. The outcome will help finalize protocols for ReconAAsense, the company's U.S. pivotal study planned for 2026.
The test incorporates five novel gene expression biomarkers acquired from Sherbrooke University in 2022, which have shown ability to identify both advanced adenomas (precancerous colonic polyps) and early-stage CRC. The study seeks to enhance diagnostic sensitivity and specificity for early-stage CRC detection.
Mainz Biomed (NASDAQ:MYNZ) has entered into a License and Option Agreement with Liquid Biosciences for novel mRNA biomarkers enabling non-invasive pancreatic cancer detection via blood tests. The groundbreaking discovery analysis demonstrated 95% sensitivity and 98% specificity in detecting pancreatic cancer.
The study involved multiple independent cohorts, with initial discovery using a blood-based cohort of 285 subjects, including 35 pancreatic cancer patients. The agreement grants Mainz exclusive license rights and an option to acquire global rights to the gene expression biomarkers, involving both a license fee and future revenue royalties.
The companies will jointly develop the pancreatic cancer screening test, focusing on commercial assay enhancement, algorithm refinement, and FDA application preparation. If statistical results prove replicable in a new product, this could position Mainz's test as the market's most robust pancreatic cancer screening solution.
Mainz Biomed (NASDAQ:MYNZ) is marking Colorectal Cancer Awareness Month with a focus on transforming screening into prevention. The company highlights that colorectal cancer (CRC) remains the second leading cause of cancer deaths globally, causing over 930,000 deaths annually, with 150,000 diagnoses in the U.S. and 22,836 deaths in Germany.
The company's research has yielded promising results through their ColoFuture and eAArly DETECT studies, achieving 82% sensitivity in advanced adenoma detection with 97% specificity using mRNA biomarkers, FIT test, and AI algorithms. Their flagship product, ColoAlert®, is expanding through laboratory partnerships, including a recent collaboration in Switzerland.
To increase accessibility, Mainz Biomed has implemented at-home testing solutions through European Oncology Lab's web platform. The company emphasizes that while CRC is highly preventable, low screening participation continues to make it a leading cause of cancer deaths, driving their mission to enhance early detection and prevention strategies.
Mainz Biomed (NASDAQ:MYNZ) has announced a strategic partnership with labor team w ag to launch ColoAlert®, a DNA-based colorectal cancer (CRC) screening test, in Switzerland. This marks Mainz Biomed's first entry into the Swiss market, where thousands of new CRC cases are diagnosed annually.
The partnership combines Mainz Biomed's DNA-based diagnostic expertise with labor team w's established laboratory services network. The ColoAlert® test will be available through labor team w's healthcare provider network starting in spring 2025, offering Swiss patients access to advanced CRC screening technology.
This collaboration aims to increase CRC screening participation rates and improve early detection capabilities in Switzerland. The partnership represents an expansion of Mainz Biomed's European market presence with its flagship product ColoAlert®, which is the first DNA-based CRC screening test in Europe.
Mainz Biomed (NASDAQ:MYNZ) and GANZIMMUN Diagnostics have launched an enhanced version of the ColoAlert colorectal cancer screening test across Germany, timing the release with March's Colorectal Cancer Awareness Month. The improved test, first introduced in mid-2024, features a proprietary DNA stabilizing buffer that ensures accurate results regardless of sample volume variations.
The launch coincides with Germany's updated national screening guidelines, which now provide equal access to colorectal cancer screening for both men and women starting at age 50, eliminating previous gender-based differences. This change follows research by the Institute for Quality and Efficiency in Health Care (IQWiG) that found no significant gender-based variations in recommended screening methods.
According to Tarrin Khairi-Taraki, VP Commercial Operations at Mainz Biomed, this development advances their mission of improving colorectal cancer prevention and detection. The collaborative effort between Mainz Biomed and GANZIMMUN demonstrates their commitment to enhancing cancer diagnostics through innovative solutions.
Mainz Biomed (NASDAQ:MYNZ) has successfully regained full compliance with Nasdaq Capital Market listing requirements. The company received formal notice from Nasdaq on January 23, 2025, confirming its compliance with the minimum stockholders' equity requirement under Listing Rule 5550(b)(1). This follows their previous confirmation of compliance with the minimum bid price requirement under Rule 5550(a)(2). As a result, MYNZ will maintain its listing and continue trading on the Nasdaq Capital Market.
Mainz Biomed (NASDAQ:MYNZ) has launched eAArly DETECT 2, a U.S. feasibility study to evaluate its next-generation colorectal cancer (CRC) test. The study will assess the performance of the company's proprietary mRNA biomarkers, AI-developed algorithm, and FIT test across approximately 2,000 average-risk patients.
The study aims to validate previous promising results and is expected to complete enrollment in the second half of 2025, with topline results targeted for Q4 2025. Following this study, Mainz Biomed plans to finalize protocols for ReconAAsense, their U.S. pivotal study scheduled for 2026.
The next-generation test incorporates five novel gene expression biomarkers acquired from Sherbrooke University in 2022, designed to detect both advanced adenomas (precancerous polyps) and early-stage CRC with high accuracy.
Mainz Biomed (NASDAQ:MYNZ) has partnered with Quest Diagnostics to advance its colorectal cancer screening test. Quest will provide laboratory services for Mainz's ReconAAsense FDA study, which will involve approximately 15,000 subjects across 150 US sites. The agreement includes an option for Quest to obtain semi-exclusive rights for testing services pending FDA approval.
The company's ColoAlert test, utilizing PCR technology to analyze stool samples for cancer DNA, has demonstrated promising sensitivity in detecting colorectal cancer and advanced adenomas. This development targets a significant market opportunity, as about one-third of US residents aged 50-75 have never undergone colorectal cancer screening, representing a potential $4.0B+ market in the US.
