Vancouver, British Columbia — December 23, 2025 — Leads & Copy — BioMark Diagnostics Inc. has initiated its ISO 15189 accreditation program with the Standards Council of Canada (SCC) for its medical laboratory in Quebec City, marking a significant step in its transition to a commercial-stage diagnostic company. The accreditation process officially commenced on December 19, 2025.
BioMark has engaged the Standards Council of Canada (SCC) as its accrediting agency to ensure its laboratory operations meet international benchmarks. The company aims to comply with regulatory requirements and anticipates a formal site visit by SCC auditors in early 2026.
The ISO 15189 certification will help BioMark to access global markets and streamline regulatory pathways. According to Dr. Jean-Francois Haince, BioMark’s CSO and GM, demonstrating compliance with global standards positions BioMark as a trusted provider of clinical mass spectrometry diagnostic solutions. This focus on quality supports the company’s strategy to drive growth through strategic partnerships, licensing agreements, and clinical research services. The accreditation will provide assurance to hospital procurement teams, biopharma partners, and payors that BioMark’s liquid biopsy assays meet quality, safety, and competence requirements.
Following the anticipated ISO 15189 accreditation, the company intends to seek CLIA and CAP accreditations to service the U.S. cancer diagnostic market with its Laboratory Developed Tests (LDTs).
BioMark Diagnostics Inc. develops liquid biopsy tests for early cancer detection, leveraging metabolomics and machine learning algorithms. Its technology uses a blood draw to detect cancer-associated biomarkers, potentially enabling earlier diagnosis, improved patient outcomes, and monitoring of treatment response. The company aims to develop diagnostic solutions to address unmet medical needs in oncology.
Rashid Bux, President and CEO of BioMark, thanked the technical lab group for preparing and submitting the certification documentation and establishing the infrastructure to scale lab services.
Rashid Ahmed Bux
President & CEO
BioMark Diagnostics Inc.
Tel. 604-370-0779
Email: info@biomarkdiagnostics.com
Source: BioMark Diagnostics Inc.
