Mainz Biomed Enrolls First Patient in eAArly DETECT 2 Study

Mainz Biomed N.V., a molecular genetics diagnostic company listed on NASDAQ, has embarked on a significant clinical study to further its pioneering work in colorectal cancer (CRC) detection. The study, named eAArly DETECT 2, has enrolled its first patient and aims to evaluate the company's innovative CRC test. This advanced test incorporates proprietary mRNA biomarkers, an AI-derived algorithm, and a Fecal Immunochemical Test (FIT) across a participant pool of roughly 2,000 average-risk individuals. The objective is to corroborate the outstanding results observed in previous feasibility studies, thereby supporting the transformation of CRC screening into a preventive measure.

The eAArly DETECT 2 study is on course to complete participant enrollment by the latter half of 2025, with Mainz Biomed planning to release the primary results by the fourth quarter of the same year. Depending on the findings, the company intends to refine its study protocols for ReconAAsense, a pivotal U.S.-based study anticipated to commence in 2026. This next-generation test not only aims to detect cancerous polyps with high precision but also has the potential to prevent CRC by identifying precancerous adenomas at an early stage.

Guido Baechler, the Chief Executive Officer of Mainz Biomed, remarked that reaching the first patient-in milestone is the culmination of extensive preparatory work, leading to the formal start of the study. Baechler emphasized the significance of this clinical trial for the company, patients, and medical professionals, as it strives to accurately detect advanced precancerous lesions and early-stage CRC. The ultimate goal is to contribute to the eradication of colorectal cancer and reduce global cancer mortality rates.

The study will leverage five novel gene expression (mRNA) biomarkers, acquired from Sherbrooke University in 2022. These biomarkers have shown a unique ability to detect advanced adenomas, which are curable precancerous colonic polyps, as well as treatable early-stage CRC. Through the eAArly DETECT 2 study, the company plans to further validate these biomarkers' effectiveness in combination with its proprietary algorithm. This endeavor aims to enhance the test’s specifications, broadening its capability to identify advanced adenomas while boosting diagnostic sensitivity and specificity for early-stage CRC detection.

Mainz Biomed is known for developing ready-to-market molecular genetic diagnostic solutions for critical health challenges. One of their flagship products, ColoAlert®, is a non-invasive, user-friendly diagnostic test for early detection of colorectal cancer and is currently marketed across Europe. The company is engaged in a development study to refine the next-generation CRC screening test, in preparation for a pivotal FDA clinical study necessary for U.S. regulatory approval. Their product portfolio also includes PancAlert, a screening test for early-stage pancreatic cancer employing real-time PCR-based multiplex detection of molecular-genetic biomarkers.

Mainz Biomed is committed to advancing cancer diagnostics through innovative solutions aimed at early detection and prevention, with the ultimate goal of reducing cancer-related deaths worldwide.