Biomark platform selected for German lung cancer trial

Executive Summary

• Biomark Diagnostics Inc. has been selected as the core diagnostic partner for Germany’s large‑scale HAN SE lung‑cancer screening trial, involving up to 10,000 participants.
• The collaboration provides critical international market validation and is expected to generate clinical data supporting future regulatory submissions and commercial expansion in Europe and North America.
• Biomark’s recent capital raise has funded scaling of its Quebec City laboratory to meet the certification and accreditation requirements for this European trial.

Key Details

• Trial Scope: HAN SE study will enroll ~10,000 participants from high‑risk and general population cohorts across Germany.
• Partners: Prof. Jens Vogel‑Claussen (Medizinische Hochschule Hannover), Prof. Martin Reck (LungenClinic Grosshansdorf), Dr. Sabine Bohnet (Universitätsklinikum Schleswig‑Holstein).
• Technology Used: Biomark’s liquid biopsy platform combining metabolomic profiling, radiomics and clinical data to build a risk‑based early detection model.
• Sample Handling: Biomark will manage sample logistics and processing through its Quebec City laboratory, which is progressing toward full certification/accreditation for the trial.
• Regulatory Impact: Data generated are intended to support Biomark’s regulatory submissions in Europe and North America and underpin commercial rollout of its blood‑based cancer detection test.
• Funding Context: The company cites a recent successful capital raise that enabled scaling of laboratory operations to accommodate the trial’s requirements.
• Trial Objective: Detect early lung cancer in asymptomatic individuals aged 55–79 who are currently not eligible for low‑dose CT screening, and reduce benign biopsies/surgical resections from CT‑positive cases.

Notable Quotes

“This collaboration represents a transformative milestone for Biomark,” said Rashid Ahmed Bux, CEO & President of Biomark Diagnostics. “Our recent successful capital raise has allowed us to scale our laboratory operations to effectively manage this prestigious trial.”

Prof. Jens Vogel‑Claussen: “With the integration of blood‑based biomarkers in the HAN SE study, we aim to detect early lung cancer in the asymptomatic population … If successful, the blood test from Biomark Diagnostics could significantly enhance the performance of future lung cancer screening programs.”