Mr. Rashid Bux reports

BIOMARK DIAGNOSTICS ADVANCES COMMERCIALIZATION STRATEGY BY INITIATING ISO 15189 ACCREDITATION PROGRAM

Biomark Diagnostics Inc. has officially initiated its ISO 15189 accreditation program with the Standards Council of Canada for its medical laboratory in Quebec City. The accreditation process officially commenced on Dec. 19, 2025.

Biomark has engaged the Standards Council of Canada 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 general manager. "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 payers 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.

"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," said Rashid Bux, president and chief executive officer of Biomark.

About Biomark Diagnostics Inc.

Biomark 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.

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