BioMark Diagnostics Advances Commercialization Strategy by Initiating ISO 15189 Accreditation Program

Core Insights - BioMark Diagnostics Inc. has initiated its ISO 15189 accreditation program with the Standards Council of Canada for its medical laboratory in Quebec City, marking a significant step towards commercial operations in cancer diagnostics [1][2][3] Group 1: Accreditation Process - The accreditation process officially began on December 19, 2025, with expectations for a formal site visit by SCC auditors in early 2026 [1][2] - Engaging the Standards Council of Canada as the accrediting agency ensures that BioMark's laboratory operations will meet high international standards [2] Group 2: Strategic Importance - Achieving ISO 15189 certification is crucial for BioMark's transition from research and development to a commercial-stage diagnostic company, facilitating access to global markets and reducing regulatory bottlenecks [3] - The company plans to pursue additional accreditations, including CLIA and CAP, to enable service in the U.S. cancer diagnostic market with its Laboratory Developed Tests (LDTs) [4] Group 3: Company Vision and Technology - BioMark specializes in liquid biopsy technologies that utilize metabolomics and machine learning algorithms for early cancer detection, aiming to improve patient outcomes through earlier diagnosis [6] - The company is committed to developing innovative diagnostic solutions to address unmet medical needs in oncology, enhancing its position as a trusted provider of clinical diagnostic solutions [4][6]