BioMark: 2025 Achievements & 2026 Vision

Executive Summary

• BioMark Diagnostics reports $4.5 M of capital raised in 2025 and multiple strategic partnerships, positioning the company for U.S. market entry and European expansion.
• The company submitted ISO 15189 certification documents and was selected for the 10,000‑patient HANSE lung‑cancer trial, providing strong clinical validation for its liquid‑biopsy platform.
• BioMark outlines a roadmap of 2026 catalysts—including regulatory accreditation, commercialization of lab‑developed tests (LDTs), and additional licensing agreements—aimed at driving revenue growth and market leadership.

Key Details

• Capital Raised: $4.5 M secured in a challenging small‑cap environment, demonstrating strong investor confidence.
• Regulatory Progress: ISO 15189 certification documents submitted (Dec 2025); pending approval will enable CLIA/CAP accreditation for U.S. market entry.
• Clinical Validation: Selected as exclusive partner for the 10,000‑patient HANSE lung‑cancer trial; completed a 7,000‑patient Canadian study generating extensive real‑world evidence.
• Scientific Output: 6+ peer‑reviewed publications in high‑impact journals; recipient of CQDM Innovation Prize; featured in CSE Technology Issue (June 2025).
• Funding & Grants: Received NRC Horizon Europe funding for European expansion, City of Quebec funding, Manitoba Lung Association grant for First Nations pilot program, and submitted LOI to Québec RNA Hub for AReNA program support.
• Operational Scale‑up: Doubled laboratory throughput capacity; expanded technical team with strategic talent additions; invested in AI/ML data analytics to improve diagnostic accuracy.
• 2026 Catalysts – Regulatory & Market Access: Anticipated ISO 15189 accreditation, CLIA/CAP application, development of U.S. reimbursement strategy.
• IP & Competitive Positioning: Plans to broaden patent estate around biomarker discovery and diagnostic innovations.
• Commercial Expansion: Ongoing industry licensing negotiations; launch of ISO‑certified clinical diagnostic services and CRO offerings; expansion of distribution channels through medical and clinic networks.
• Leadership Additions: New Board member appointed to support U.S. market entry; upcoming hires for patient‑engagement, revenue‑generating, and medical director roles.

Notable Quotes

“Validated Platform: HANSE trial selection and 7,000+ patient data provide strong clinical evidence for commercialization.” – Rashid Ahmed Bux, President & CEO

All forward‑looking statements are subject to risks and uncertainties detailed in the full press release.