Mainz Biomed has enrolled the first subject in its eAArly DETECT 2 feasibility study, aimed at evaluating the company’s colorectal cancer (CRC) test.
This test integrates messenger ribonucleic acid (mRNA) biomarkers, an AI-developed algorithm, and a faecal immunochemical test (FIT) for supporting the transition of CRC screening to prevention.
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The trial is set to conclude subject enrolment by the second half of this year, with expectations to announce top-line outcomes by the fourth quarter.
Study findings will be instrumental in finalising the protocols for ReconAAsense, Mainz Biomed’s pivotal US study scheduled to begin next year.
The company’s CRC and advanced precancerous lesions (APL) test aims to identify cancerous polyps and potentially prevent CRC by identifying precancerous adenomas early.
Mainz Biomed noted that it acquired five novel gene expression biomarkers from Sherbrooke University in 2022, which have shown promise in detecting advanced adenomas and early-stage CRC.
The ongoing study will confirm and assess the effectiveness of these biomarkers in conjunction with the company’s algorithm, to enhance the product specifications.
Mainz Biomed CEO Guido Baechler said: “The first patient-in milestone marks the conclusion of several months of intensive preparatory work to ensure the trial is optimally managed and signifies the formal commencement of the study.
“By precisely detecting advanced precancerous lesions and early-stage CRC, we aim to advance our mission of eliminating colorectal cancer and ultimately reducing global cancer mortality rates.”
Mainz Biomed’s flagship product, ColoAlert, is an early-detection diagnostic test for CRC, currently available across Europe.
The company is also working on finalising the next-generation CRC screening test for the pivotal FDA clinical study required for US regulatory approval.
In December 2024, the company announced a collaboration with Quest Diagnostics to facilitate the commercialisation of ColoAlert.
