Mainz Biomed NV announced a strategic partnership with Liquid Biosciences, a bio-analytics company leveraging its proprietary AI analysis technology platform (EMERGE) to serve the biopharma and diagnostics industries along with academic institutions. The collaboration builds upon Mainz Biomed's initial utilization of EMERGE to analyze the Company's ColoFuture study, which recently reported results including sensitivity for colorectal cancer of 94% with a specificity of 97% and a sensitivity for advanced adenoma of 80%. ColoFuture is an international multi-center clinical trial which assessed the potential to integrate a portfolio of novel gene expression (mRNA) biomarkers into ColoAlert, Mainz Biomed's highly efficacious, and easy-to-use screening test for colorectal cancer (CRC) being commercialized across Europe and in select international territories.

This proprietary family of mRNA biomarkers represents a potentially game-changing innovation in CRC screening as the portfolio has previously demonstrated the ability to detect CRC lesions, including advanced adenomas, a type of pre-cancerous polyp often attributed to this deadly disease. Under the terms of the partnership, the utility of EMERGE in Mainz Biomed's product development pipeline will be extended to include analysis of its eAArly DETECT study (the U.S. arm of the ColoFuture clinical trial), and the forthcoming U.S. pivotal FDA PMA trial (ReconAAsense) which, if successful, will enable Mainz Biomed to further advance its current test's capabilities and commercialize a next-generation, gold standard, self-administered CRC screening tool. The eAArly DETECT clinical trial, a multi-center feasibility study is enrolling 265 subjects across 22 sites and remains on track to report results in Fourth Quarter 2023.

The goal at completion will result in a single fixed machine learning/AI-based algorithm, developed utilizing the evolutionary EMERGE platform, integrated into the next-generation product's test report. Since launching the EMERGE bio-analytics platform, Liquid Biosciences is widely considered to be the premier analytical partner to the life sciences industry. Its technology has been deployed in over 170 projects for Big Pharma and emerging therapeutic and diagnostic companies covering biomarker discovery, clinical trial screening and post-FDA approval services such as patient treatment selection and optimal dosing regiments.

Key attributes of EMERGE that make it superior to mainstream AI and machine learning analytical solutions include its computational speed, ability to handle millions of variables and operate agnostically, without any assumptions or constraints. It was designed as a scalable, unbiased methodology to produce transparent algorithms from complex data, without any prior assumptions. This enables the identification of variables with relatively low expression, but which may be functionally important because of the non-linear interactions pervasive in complex biologic systems.