Mainz Biomed Initiates U.S. Clinical Study to Evaluate Performance of Next Generation Test on Advanced Adenomas over Large Patient Population

eAArly DETECT 2 feasibility study designed to validate earlier results on advanced adenomas over a large population of average risk patients

Multi-center study expected to complete enrollment in the second half and reporting in the Fourth Quarter of 2025

BERKELEY, Calif. and MAINZ, Germany, Jan. 21, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the launch of eAArly DETECT 2, a U.S. feasibility study to evaluate the Company’s next generation colorectal cancer (CRC) test, integrating its proprietary mRNA biomarkers, AI developed algorithm and FIT test, over a population of approximately 2,000 patients, all of average risk, to validate the industry leading results of previous feasibility studies, which included average risk and identified risk patients.

The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025 and the Company targets reporting topline results by the fourth quarter of 2025. Based on the study’s outcome, Mainz Biomed intends to finalize its protocols for ReconAAsense, the Company’s U.S. pivotal study, which is on track to initiate in 2026. This next-generation CRC test will not only detect cancerous polyps with a high degree of accuracy but can potentially prevent the disease through early detection of precancerous adenomas.

“The launch of eAArly DETECT 2 is an important milestone for the Company as it enables us to accelerate the timeline to evaluate the potential of these biomarkers to be incorporated into our U.S. pivotal study, which is on track to initiate in 2026,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “The potential inclusion of advanced adenomas in Mainz BioMed’s next generation CRC screening test will represent a transformational advancement in self-administered CRC screening. Precise detection of advanced adenomas as well as early-stage CRC supports our mission to transform colorectal cancer screening practices and reduce global cancer mortality rates.”

The five novel gene expression (mRNA) biomarkers, which the Company acquired from the Sherbrooke University in 2022, have demonstrated a unique ability to identify advanced adenomas, i.e. curable precancerous colonic polyps, as well as treatable early-stage CRC. The eAArly DETECT 2 study will further evaluate and confirm the effectiveness of these biomarkers combined with Mainz Biomed’s proprietary AI algorithm to enhance product specifications to extend its capability to include the identification of advanced adenomas while increasing rates of 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 conditions. The Company’s flagship product is ColoAlert^®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert^® is marketed across Europe and the United Arab Emirates. The Company is currently running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on 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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