Business
BioMark Diagnostics Advances Commercialization Strategy by Initiating ISO 15189 Accreditation Program
Company engages Standards Council of Canada; targets ISO 15189 accreditation for early 2026Vancouver, British Columbia--(Newsfile Corp. - December 23, 2025) - BioMark Diagnostics Inc. (CSE: BUX) (FSE: 20B) (OTCQB: BMKDF), a leading developer of liquid biopsy technologies for early cancer detection, is pleased to announce that it has officially initiated its ISO 15189 accreditation program with the Standards Council of Canada (SCC) for its medical laboratory in Quebec City. The accreditation...
About this update from Biomark Diagnostics, Inc.
[{"type":"text","content":"Company engages Standards Council of Canada; targets ISO 15189 accreditation for early 2026","length":91,"tagName":"p","attribs":{"class":"nfSubHeading"},"className":""},{"type":"text","content":"Vancouver, British Columbia--(Newsfile Corp. - December 23, 2025) - BioMark Diagnostics Inc. (CSE: BUX) (FSE: 20B) (OTCQB: BMKDF), a leading developer of liquid biopsy technologies for early cancer detection, is pleased to announce that it has officially initiated its ISO 15189 accreditation program with the Standards Council of Canada (SCC) for its medical laboratory in Quebec City. The accreditation process officially commenced on December 19, 2025.","length":455,"tagName":"p"},{"type":"text","content":"BioMark has engaged the Standards Council of Canada (SCC) as its accrediting agency to ensure its laboratory operations meet the highest international benchmarks. The Company will work diligently to comply with all regulatory requirements and expects a formal site visit by SCC auditors in early 2026.","length":301,"tagName":"p"},{"type":"text","content":"This initiative marks a pivotal step in BioMark's transition from research and development to a commercial-stage diagnostic company. The internationally recognized ISO 15189 certification serves as a fundamental accelerator for accessing global markets, providing a streamlined regulatory pathway and reducing potential commercial bottlenecks.","length":347,"tagName":"p"},{"type":"text","content":""By demonstrating compliance with top-tier global standards, BioMark is positioning itself as a trusted provider of clinical mass spectrometry diagnostic solutions," says Dr. Jean-Francois Haince, BioMark's CSO and GM. "This dedication to quality underpins the company's strategy to drive growth through strategic partnerships, licensing agreements, and clinical research services worldwide. Achieving this standard will also provide assurance to hospital procurement teams, biopharma partners, and payors that BioMark's liquid biopsy assays meet stringent quality, safety, and competence requirements."","length":635,"tagName":"p"},{"type":"text","content":"Following the anticipated ISO 15189 accreditation, the Company intends to seek CLIA and CAP accreditations, which will enable BioMark to service the U.S. cancer diagnostic market with its Laboratory Developed Tes...