Mainz Biomed NV, a leading molecular genetics diagnostic company specializing in early cancer detection, made a groundbreaking announcement today, revealing topline results from its eAArly DETECT U.S. clinical study. This multi-center feasibility study aimed to assess the potential integration of a portfolio of novel gene expression (mRNA) biomarkers into a next-generation version of ColoAlert®, the company’s highly effective colorectal cancer (CRC) screening test. ColoAlert® has already been successfully commercialized across Europe and in select international territories.
The eAArly DETECT topline results reported an impressive sensitivity for colorectal cancer at 97%, coupled with a specificity of 97%. Moreover, the sensitivity for advanced adenoma, a pre-cancerous polyp associated with CRC, was reported at 82%. These results, paralleling the positive outcomes from ColoFuture, its European counterpart with data released in October 2023, mark a significant advancement in the field of CRC diagnostics.
Despite these groundbreaking results, the company’s stock experienced a decline in value following the announcement.
At the time of this publication, Mainz Biomed NV stock (MYNZ) has witnessed a decline.
Mainz Biomed NV
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Guido Baechler, Chief Executive Officer of Mainz Biomed, emphasized the significance of the eAArly DETECT and ColoFuture study results, not only for the company but also for CRC disease treatment and personal healthcare management. Baechler highlighted the unique promise offered by a self-administered screening tool capable of highly effective detection of adenomas (AA), a crucial element in the early identification of CRC.
The upgraded technical configuration of Mainz Biomed’s at-home CRC screening test, including AA diagnostic capability, represents a major innovation in CRC diagnostics. Baechler expressed excitement about presenting the full dataset at an upcoming medical conference and initiating patient enrollment in ReconAAsense, their pivotal FDA pre-market approval trial. Success in this trial would position the next generation ColoAlert® as the most robust and accurate at-home CRC diagnostic screening test available.
The eAArly DETECT study enrolled 254 evaluable subjects across 21 sites in the U.S., mirroring the design of ColoFuture. Participants, aged 45 and older, were invited to join when referred for a colonoscopy, either for CRC screening (average risk), follow-up on a positive non-invasive test, imaging, or symptoms. Those identified as having colorectal cancer, before any treatment, were also eligible. Subjects providing a stool sample in advance were classified into groups, and their outcomes were compared to ColoAlert® results.
The eAArly DETECT results not only confirm but surpass the positive outcomes of ColoFuture, reporting a sensitivity for colorectal cancer of 94%, specificity of 97%, and advanced adenoma sensitivity of 80%.
The mRNA biomarkers evaluated in the eAArly DETECT/ColoFuture studies were acquired from the Université de Sherbrooke in January 2022. Mainz Biomed aimed to enhance ColoAlert®’s technical profile, extending its capabilities to include the identification of advanced adenomas. Specifically selected mRNA biomarkers demonstrated the ability to detect disease signals and the unique potential to identify signals from patients with advanced adenomas.
Mainz Biomed’s pioneering work holds the promise of changing the CRC diagnostic landscape by detecting lesions in a pre-cancerous stage. Early identification of advanced adenomas is crucial, as they are curable. Timely treatment can prevent the progression of polyps to a cancerous stage, offering a potential breakthrough in CRC prevention.
