Mainz Biomed NV - MYNZ STOCK NEWS

Mainz Biomed N.V. (NASDAQ:MYNZ) has reported increased demand for its enhanced ColoAlert product, launched in July 2024. The improved version of this colorectal cancer (CRC) screening test is being adopted by existing partners and attracting new ones across Europe and select international markets. GANZIMMUN Diagnostics, a leading German laboratory, will fully implement the enhanced ColoAlert by early next year.

The enhanced ColoAlert features a proprietary DNA stabilizing buffer and streamlined collection devices, reducing retesting needs and offering faster results in 2-3 days. GANZIMMUN will showcase ColoAlert at the 57th Medizinische Woche Baden-Baden, a medical congress focusing on complementary medicine, from October 30 to November 3, 2024. This event will promote Mainz Biomed's DNA-based CRC screening test to medical professionals and researchers interested in advanced diagnostic solutions.

Mainz Biomed N.V. (NASDAQ:MYNZ), a molecular genetics diagnostic company, has released a statement highlighting its strategic plans for 2025. CEO Guido Baechler anticipates a transformative year with major growth and U.S. FDA trials for their innovative cancer diagnostic solutions. The company's mRNA-based next-generation CRC screening test has shown significant clinical success, with sensitivities exceeding 90% for colorectal cancer and 80% for advanced adenomas.

Mainz Biomed plans to submit comprehensive data to the FDA in 2025, aiming to penetrate the U.S. market. The company is also advancing a pipeline of diagnostic technologies, including PancAlert. Despite current stock price concerns, management remains focused on delivering key milestones and executing their strategy to unlock shareholder value.

Mainz Biomed N.V. (NASDAQ:MYNZ), a molecular genetics diagnostic company focusing on early cancer detection, has announced the addition of Petra Smeltzer Starke as a Brand Ambassador. In this role, Starke will assist in developing and disseminating messaging about the importance of early colorectal cancer detection. The company aims to launch a pivotal PMA trial for its next-generation colorectal cancer screening product by the end of 2025.

CEO Guido Baechler expressed excitement about Starke joining the team, highlighting her extensive experience as invaluable to their mission. Starke, in turn, expressed pride in working with Mainz Biomed as they advance early detection of colorectal cancer and pre-cancerous polyps.

Mainz Biomed (NASDAQ:MYNZ) has expanded its collaboration with Liquid Biosciences to leverage AI for optimizing biomarker selection in PancAlert, its next-generation pancreatic cancer detection test. The partnership aims to enhance early-stage disease detection, potentially combining PancAlert with Mainz Biomed's colorectal cancer screening product.

The first phase of collaboration showed promising results, leading to a second phase that will include microbiome biomarkers analyzed with Microba Life Sciences in 2023. The companies plan to complete this analysis in Q4 2024. Pancreatic cancer, with a global mortality rate of 466,000 annually, has one of the lowest survival rates among major cancers, emphasizing the critical need for early detection methods.

Mainz Biomed N.V. (NASDAQ: MYNZ) has announced significant improvements to its ColoAlert product, a highly efficacious at-home detection test for colorectal cancer (CRC). The enhancements include:

1. A novel DNA stabilizing buffer that accommodates varying sample volumes, reducing the need for retesting and enabling results delivery within 2-3 days.

2. Refined kit features for improved usability, including an enhanced collection device and new tube design.

These upgrades aim to enhance customer satisfaction, streamline lab operations, and maintain ColoAlert's position as a leading CRC screening solution. The improved product is now available to existing and prospective laboratory partners.

Mainz Biomed has submitted an application to the FDA for Breakthrough Device Designation for its Next Generation CRC Screening Test, which incorporates novel mRNA biomarkers. The submission follows promising results from the ColoFuture and eAArly Detect studies, showing 97% sensitivity for colorectal cancer and 88% for advanced adenomas, with 93% specificity. The test uses a combination of Fecal Immunochemical Test (FIT) and proprietary mRNA biomarkers, supported by AI and machine learning algorithms. If approved, the FDA designation could accelerate the product's market release, providing more effective cancer detection and potentially improving global CRC screening practices.

Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company focusing on early cancer detection, has provided a mid-year corporate update for 2024. The company highlighted its significant accomplishments in the first half of 2024, emphasizing the strong clinical data from various studies.

Mainz Biomed presented pooled study results at ASCO 2024, confirming previous findings with a 92% sensitivity for colorectal cancer (CRC) and 82% for advanced adenomas, including 95.8% for high-grade dysplasia. Additionally, the company received a Poster of Distinction at Digestive Disease Week for its eAArly DETECT study, demonstrating 97% sensitivity for CRC and 82% for advanced precancerous lesions.

Mainz Biomed engaged in strategic partnerships, notably with Trusted Health Advisors for its U.S. go-to-market strategy and TomaLab for launching ColoAlert® in Italy. These collaborations are pivotal for the company's FDA premarket approval plans and market expansion efforts.

The company remains on track for its U.S. FDA pivotal CRC study, set to begin enrollment in the second half of 2024.

Mainz Biomed presented findings from their largest cohort study at the ASCO 2024 Annual Meeting. The study, involving 690 clinical subjects from 30 specialized gastroenterology centers across Europe and the US, confirmed the high sensitivity and specificity of their multimodal screening test for colorectal cancer (CRC) and advanced adenomas (AA). The test integrates Fecal Immunochemical Test (FIT) with proprietary mRNA biomarkers, supported by AI and machine learning algorithms. The results showed a 92.3% sensitivity for CRC, 90.1% specificity, and 82.2% sensitivity for AA, with a 95.8% detection rate for high-grade dysplasia, demonstrating superior performance over existing non-invasive methods.

Mainz Biomed held its 2024 Annual General Meeting on May 31, 2024, in Amsterdam. Shareholders representing 10.9% of the company's ordinary shares attended, meeting the quorum requirement. All proposals, including the adoption of the statutory annual accounts, discharge of directors, amendments to the articles of association, and reappointment of directors, were approved with significant majorities. The company also disclosed a non-compliance notice from Nasdaq for failing to meet the minimum bid price requirement, giving Mainz Biomed 180 days to regain compliance. Failure to comply by November 25, 2024, could result in delisting, although an extension may be granted.