Mainz Biomed Launches U.S. Clinical Trial of Next-Generation Colorectal Cancer Test on Advanced Adenomas “`

January 22, 2025 by No Comments

The eAArly DETECT 2 feasibility study will validate earlier findings on advanced adenomas using a large group of average-risk patients.

This multi-center trial anticipates completing enrollment in the second half of 2025, with results expected in the fourth quarter of 2025.

BERKELEY, Calif. and MAINZ, Germany, Jan. 21, 2025 — Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostics company focused on early cancer detection, today announced the launch of eAArly DETECT 2. This U.S. feasibility study will assess the Company’s next-generation colorectal cancer (CRC) test. The test integrates proprietary mRNA biomarkers, an AI-driven algorithm, and a FIT test. Approximately 2,000 average-risk patients will participate, validating previous study results which included both average and high-risk individuals.

eAArly DETECT 2 enrollment should conclude in the second half of 2025, with topline data anticipated in the fourth quarter of 2025. Results will inform protocols for ReconAAsense, Mainz Biomed’s pivotal U.S. study planned for 2026. This next-generation CRC test aims for highly accurate cancerous polyp detection and, through early precancerous adenoma identification, potential disease prevention.

“Launching eAArly DETECT 2 is a significant step, accelerating the evaluation of these biomarkers for our U.S. pivotal study, slated to begin in 2026,” stated Guido Baechler, Mainz Biomed’s Chief Executive Officer. “Including advanced adenomas in our next-generation CRC screening test would revolutionize self-administered CRC screening. Precise detection of advanced adenomas and early-stage CRC aligns with our mission to transform colorectal cancer screening and lower global cancer mortality.”

Five novel gene expression (mRNA) biomarkers, acquired from Sherbrooke University in 2022, uniquely identify advanced adenomas (curable precancerous polyps) and treatable early-stage CRC. eAArly DETECT 2 will further evaluate and confirm these biomarkers’ effectiveness, combined with Mainz Biomed’s proprietary AI algorithm. This will enhance product specifications, extending its capability to include advanced adenoma identification while increasing diagnostic sensitivity and specificity for early-stage CRC.

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About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening diseases. The Company’s flagship product, ColoAlert®, is an accurate, non-invasive, and user-friendly early-detection diagnostic test for colorectal cancer. ColoAlert® is available in Europe and the United Arab Emirates. A pivotal FDA clinical study is underway for U.S. regulatory approval. Mainz Biomed’s pipeline also includes PancAlert, an early-stage pancreatic cancer screening test using real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit or follow us on , and .

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Forward-Looking Statements
This press release contains forward-looking statements, subject to risks and uncertainties. Actual results may differ materially. Factors that could cause such differences include, but are not limited to: failure to meet development targets; changes in laws or regulations; the COVID-19 pandemic’s impact; and other risks detailed in the Company’s SEC filings (available at www.sec.gov). Any forward-looking statements reflect current information and speak only as of the date made. Mainz Biomed does not undertake any obligation to publicly update forward-looking statements.