BioMark Diagnostics Advances Commercialization Strategy by Initiating ISO 15189 Accreditation Program
Rhea-AI Summary
BioMark Diagnostics (OTCQB: BMKDF) has initiated an ISO 15189 accreditation program with the Standards Council of Canada for its medical laboratory in Quebec City, formally commencing on December 19, 2025.
The company expects an SCC site visit in early 2026 and says ISO 15189 will support its shift from R&D to a commercial-stage diagnostic provider by easing global market access and regulatory pathways. After achieving ISO 15189, BioMark intends to pursue CLIA and CAP accreditations to enable U.S. Laboratory Developed Test services. Management highlighted the accreditation as a quality milestone to reassure hospital procurement teams, biopharma partners, and payors.
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Company engages Standards Council of Canada; targets ISO 15189 accreditation for early 2026
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.
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.
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.
"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."
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 Tests (LDTs).
"I would like to take this opportunity to thank our dedicated technical lab group for doing an excellent job in preparing and submitting our certification documentation expediently while establishing the infrastructure to scale our lab services," says Rashid Bux, President and CEO of BioMark.
About BioMark Diagnostics Inc.
BioMark Diagnostics Inc. is a leading developer of liquid biopsy tests for the early detection of cancer that leverages the power of metabolomics and machine learning algorithms. The company's proprietary technology utilizes a simple blood draw to detect the presence of cancer-associated biomarkers, enabling earlier diagnosis and improved patient outcomes. The technology can also be used for measuring response to treatment and potentially for serial monitoring of cancer survivors. BioMark is committed to developing innovative and accessible diagnostic solutions to address unmet medical needs in oncology.
Further information about BioMark is available under its profile on the SEDAR+ website www.sedarplus.ca and the CSE website https://thecse.com/.
For further information on BioMark, please Contact:
Rashid Ahmed Bux
President & CEO
BioMark Diagnostics Inc.
Tel. 604-370-0779
Email: info@biomarkdiagnostics.com
Forward-Looking Information:
This press release may include forward-looking information within the meaning of Canadian securities legislation, concerning the business of BioMark. Forward-looking information is based on certain key expectations and assumptions made by the management of BioMark. Although BioMark believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because BioMark can give no assurance that they will prove to be correct. Forward-looking statements contained in this press release are made as of the date of this press release. BioMark disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events, or results or otherwise, other than as required by applicable securities laws.
The CSE has not reviewed, approved, or disapproved of the content of this press release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/278748
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