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 Generation Colorectal Cancer Diagnostic

• Groundbreaking topline results demonstrated sensitivity for colorectal cancer of 92% with specificity of 90% and best-in-class sensitivity for advanced adenoma of 82%
• 690 subjects analyzed including previously unexamined and reported patients from Company’s ColoFuture and eAArly DETECT studies utilizing the mRNA biomarkers, FIT test, and a proprietary AI Algorithm
• The power to determine advanced adenoma, lesions in a pre-cancerous stage, can change the entire CRC diagnostic field, by treating the patient before the polyps can progress to cancer

Excerpt from the Press Release:

BERKELEY, Calif. and MAINZ, Germany, April 25, 2024 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today groundbreaking topline results from a pooled clinical study which included new patients and subjects from Mainz Biomed’s ColoFuture (Europe) and eAArly DETECT (U.S.) clinical trials evaluating the potential to integrate its portfolio of proprietary novel gene expression (mRNA) biomarkers into a next generation version of the Company’s colorectal cancer (CRC) screening tool. The topline results confirm the positive efficacy results previously reported with a sensitivity for colorectal cancer of 92% with a specificity of 90% and a sensitivity for advanced adenoma of 82%, which is best-in-class and compare favorably to existing commercial products.

“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.

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