BioMark's Liquid Biopsy Platform Selected for Holistic German Lung Cancer Screening Trial

Executive Summary

• BioMark Diagnostics has been selected as the core diagnostic partner for Germany’s landmark HANSE lung cancer screening trial, involving 10,000 participants.
• The collaboration provides significant international market validation and is expected to generate clinical evidence supporting regulatory submissions and commercial expansion in North America and Europe.
• The trial leverages BioMark’s liquid‑biopsy platform and its Quebec City laboratory, which is progressing toward full certification to meet European trial requirements.

Key Details

• Trial Scope: HANSE study will enroll ~10,000 high‑risk and general‑population participants across Germany, aiming to improve early lung cancer detection using metabolomic, radiomic, and clinical data integration.
• Partners: Prof. Dr. Jens Vogel‑Claussen (Medizinische Hochschule Hannover), Prof. Dr. Martin Reck (LungenClinic Grosshansdorf), Dr. Sabine Bohnet (Universitätsklinikum Schleswig‑Holstein).
• Role of BioMark: Core diagnostic partner responsible for blood‑based biomarker analysis; provides sample handling, processing, and assay execution from its Quebec City lab.
• Regulatory Impact: Clinical data expected to support future regulatory submissions for BioMark’s liquid biopsy test in both North America and Europe.
• Commercial Implications: Successful trial outcomes could accelerate European market entry and strengthen positioning in the global early‑cancer detection space.
• Funding Note: The announcement references a recent successful capital raise that enabled scaling of laboratory operations to support the trial.
• Trial Registration: ClinicalTrials.gov Identifier NCT04913155.

Notable Quotes

“This collaboration represents a transformative milestone for BioMark,” said Rashid Ahmed Bux, CEO and President of BioMark Diagnostics.

“With the integration of blood‑based biomarkers in the HANSE‑Study, we aim to detect early lung cancer in the asymptomatic population aged 55‑79 years… If successful, the blood test from BioMark Diagnostics could significantly enhance the performance of future lung cancer screening programs.” – Dr. Jens Vogel‑Claussen.