Mainz Biomed NV is a molecular diagnostics company specializing in the development and commercialization of epigenetic and genetic testing solutions for the early detection of cancer. Founded in 2004 and headquartered in Reston, Virginia, with research facilities in Mainz, Germany, the company leverages proprietary methylation marker technology to create non-invasive screening tests. Mainz Biomed’s initial focus on colorectal cancer screening led to the launch of its flagship test, ColoCaller, designed to detect methylated DNA biomarkers in stool samples to identify patients at risk for colorectal neoplasia.
Beyond its core colorectal cancer product, Mainz Biomed has expanded its pipeline to include tests for liver, gastric and pancreatic cancers. The company’s HelioLiver test targets hepatocellular carcinoma, while HelioGastric and HelioPanc are in various stages of validation for gastric and pancreatic cancer screening, respectively. Utilizing a combination of epigenetic markers and advanced bioinformatics, these assays aim to offer high sensitivity and specificity in a simple blood-draw format, addressing unmet needs in early cancer detection and intervention.
Mainz Biomed operates across Europe and the United States, collaborating with academic institutions, research hospitals and commercial partners to validate its assays and prepare for regulatory submissions. The company has established strategic partnerships to facilitate clinical trials, real-world data collection and market access in key geographies. As regulatory frameworks for liquid biopsy and molecular diagnostics evolve, Mainz Biomed continues to engage with governing bodies to secure pathway approvals and reimbursement coverage.
Under the leadership of CEO Dr. Christoph Stegelmann, Mainz Biomed combines scientific expertise with a commercialization-focused approach. The management team includes seasoned professionals in product development, regulatory affairs and business development, all working to transition novel diagnostic tools from laboratory research into routine clinical practice. With a clear strategic roadmap, Mainz Biomed is positioned to address significant gaps in cancer screening and support the global shift toward earlier, more personalized diagnostic protocols.
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