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Mainz Biomed Reports Positive Topline Results from Pooled Study Evaluating Novel mRNA Biomarkers and Proprietary AI Algorithm for Integration into Pivotal FDA PMA Clinical Trial for Next-Gen CRC Test - Seite 2

“We conducted this pooled study to fine-tune the minimal biomarker set to be used to optimize sensitivity and specificity of the results in Mainz Biomed’s next generation CRC screening tool.  The new data read-out demonstrates that our next generation product candidate for early-stage CRC detection utilizing mRNA biomarkers, a FIT test and a proprietary AI algorithm has consistently delivered high sensitivity and specificity for both advanced adenomas and colorectal cancer,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “This strong performance is particularly noteworthy as the pooling a significantly higher number of patients, namely two entirely separate patient cohorts from two continents as well as previously unexamined patient samples.  Hence these results represent a critical milestone on our path to launching our FDA PMA pivotal study ReconAAsense, which is planned to recruit up to 15,000 patients. ”

The pooled results include 690 evaluable subjects across 21 sites in the U.S. and 9 sites in Europe. The two cohorts included patients (US cohort aged 45 and older and European cohort aged 40 and older) that provided a stool sample before undergoing 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. Following colonoscopy and any applicable histopathology, subjects were classified into groups: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer. Each subject outcome was compared to the results from the next generation test incorporating the novel mRNA biomarkers and FIT.

The Company plans to publish results of this study at a major medical conference during the second quarter of 2024.

According to the Centers for Disease Control and Prevention (CDC), colorectal cancer is the second most lethal cancer in the U.S. and Europe, but also the most preventable, with early detection providing survival rates above 90%. Mainz Biomed’s proprietary portfolio of mRNA biomarkers has previously demonstrated the ability to detect CRC lesions, including advanced adenomas, a type of pre-cancerous polyp often attributed to this deadly disease . The power to determine lesions in a pre-cancerous stage can change the entire CRC diagnostic field, by treating the patient before the polyps can progress to a cancerous stage. This is especially remarkable as recent studies reveal that blood tests, despite their perceived convenience, lack the sensitivity to detect pre-cancerous conditions effectively. In the landscape of early colon cancer diagnostics with non-invasive tests, stool-based screening methods proved to be the most precise. Subject to a positive outcome of the FDA PMA study, Mainz Biomed’s innovative next generation test has the potential to disrupt the at-home CRC diagnostic screening market by providing the most robust and accurate test and become new gold standard.