Mainz Biomed to Present Results of Colorectal Cancer Screening Study eAArly DETECT at Digestive Disease Week 2024 in Washington, D.C. - Seite 2

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About eAArly DETECT
The eAArly DETECT was performed to identify novel mRNA biomarker for potential integration into the Mainz Biomed’s pivotal FDA PMA clinical trial ReconAAsense. The study enrolled 254 evaluable subjects across 21 sites in the U.S. with a similar design to that of ColoFuture, its European counterpart. Patients aged 45 years and older were invited to participate when referred for a colonoscopy to either screen for CRC (average risk), to follow up on a positive non-invasive test, imaging or symptoms, or if a subject was already identified as having colorectal cancer but before any treatment had been administered. Those who agreed to provide a stool sample in advance of the colonoscopy (or treatment in the case of subjects with already identified colorectal cancer) were eligible for participation. Subjects were classified into groups following central pathology review: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer. Each subject outcome was compared to the results from the ColoAlert test incorporating the novel biomarkers.

About ColoAlert
ColoAlert, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Dollinger et al., 2018, Franck et al., 2024). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert will be evaluated in the FDA-registration trial ‘ReconAAsense.’ Once approved in the US, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.