Mainz Biomed N.V., a molecular genetics diagnostic company specializing in early cancer detection, provided a year-end summary of its corporate and product development progress for 2023. The company announced significant advancements in its clinical studies and commercial operations.
Key highlights from the year-end review include:
- Clinical Study Results: Mainz Biomed announced results from two major clinical studies, ColoFuture in Europe and eAArly DETECT in the U.S., evaluating the integration of novel gene expression biomarkers into ColoAlert®, their next-generation colorectal cancer (CRC) detection test. ColoFuture reported a sensitivity of 94% and specificity of 97% for CRC, and 80% sensitivity for advanced adenoma (AA). eAArly DETECT showed a CRC sensitivity of 97% with the same specificity and an AA sensitivity of 82%.
- International Commercialization: The company expanded the commercialization of ColoAlert®, a DNA-based detection test for CRC, in major European markets and Israel. They established commercial operations in Spain, Poland, Romania, Portugal, the UK, and Israel, partnering with local laboratories and distribution networks.
- Corporate Health Program: Mainz Biomed launched a corporate health program in Germany, integrating ColoAlert® into the country’s corporate health management system.
- FDA PMA Clinical Trial: Preparations for the pivotal FDA PMA clinical trial, ReconAAsense, are on track, with patient enrollment expected to commence in mid-2024. This trial aims to establish a gold standard for at-home CRC screening.
- Commercial Strategy: The company executed a commercial plan involving partnerships with third-party laboratories for test kit processing. This strategy differs from the traditional methodology of operating a single facility.
- Partnerships and Market Expansion: Mainz Biomed formed partnerships with laboratories and expanded its presence in established markets, including Germany, where it launched a corporate health program and strengthened its presence in the private health insurance segment.
- Product Development Milestones: The groundbreaking results from the ColoFuture and eAArly DETECT studies positioned the U.S. pivotal clinical trial, ReconAAsense, to evaluate a highly advanced self-administered CRC screening test.
- Leadership and Financial Position: The company bolstered its leadership team, focusing on commercial roles to support international expansion. Financially, Mainz Biomed executed two significant transactions to support its growth and development.
Overall, Mainz Biomed’s year-end review highlights significant progress in clinical studies, international commercial expansion, and preparations for pivotal FDA trials, positioning the company for continued growth and innovation in cancer diagnostics.