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BioMark Launches ISO 15189 Accreditation Drive to Accelerate Global Commercialization

Story Highlights
  • BioMark has initiated ISO 15189 accreditation for its Quebec lab, advancing its shift toward commercial-stage cancer diagnostics.
  • The accreditation is expected to open global markets and precedes planned CLIA and CAP certifications targeting the U.S. market.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
BioMark Launches ISO 15189 Accreditation Drive to Accelerate Global Commercialization

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An update from BioMark Diagnostics ( (TSE:BUX) ) is now available.

BioMark Diagnostics Inc. has begun the process to obtain ISO 15189 accreditation for its medical laboratory in Quebec City through the Standards Council of Canada, with the accreditation program officially launched on December 19, 2025 and a site visit expected in early 2026. The move represents a key step in the company’s shift from an R&D-focused operation to a commercial-stage diagnostic business, as ISO 15189 is expected to facilitate access to global markets, support strategic partnerships and licensing deals, and reassure hospitals, biopharma partners and payors about the quality and reliability of its mass spectrometry-based liquid biopsy assays. Following ISO 15189, BioMark plans to pursue CLIA and CAP accreditations to serve the U.S. cancer diagnostics market with its laboratory-developed tests, underscoring its broader commercialization and international expansion strategy.

The most recent analyst rating on (TSE:BUX) stock is a Hold with a C$0.49 price target. To see the full list of analyst forecasts on BioMark Diagnostics stock, see the TSE:BUX Stock Forecast page.

Spark’s Take on TSE:BUX Stock

According to Spark, TipRanks’ AI Analyst, TSE:BUX is a Neutral.

BioMark Diagnostics’ stock score is driven by positive corporate events that enhance its strategic position and growth potential. However, financial performance challenges and valuation concerns weigh on the overall score. Technical analysis indicates bullish momentum, but overbought signals suggest caution.

To see Spark’s full report on TSE:BUX stock, click here.

More about BioMark Diagnostics

BioMark Diagnostics Inc. is a cancer diagnostics company specializing in liquid biopsy tests for the early detection of cancer, using metabolomics and machine learning to identify cancer-associated biomarkers from a simple blood draw. Its proprietary technology is designed to support earlier diagnosis, monitor treatment response, and enable serial surveillance of cancer survivors, with a focus on delivering innovative, accessible solutions for unmet medical needs in oncology.

Average Trading Volume: 17,165

Technical Sentiment Signal: Buy

Current Market Cap: C$46.24M

Learn more about BUX stock on TipRanks’ Stock Analysis page.

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