BioMark's Liquid Biopsy Platform Selected for Holistic German Lung Cancer Screening Trial
Rhea-AI Summary
BioMark (OTCQB: BMKDF) was selected as the core diagnostic partner for Germany's HANSE lung cancer screening trial, a 10,000‑participant study that began in October 2025. The consortium will integrate metabolomic profiling, radiomics, and clinical data into a risk model to improve early lung cancer detection and nodule classification for adults aged 55–79. The initiative is supported by the EUREKA Network and involves multiple German clinical centers. BioMark cites a recent capital raise that enabled scaling of its Quebec City laboratory, which is progressing toward full certification to handle the trial's sample logistics. Successful execution is expected to provide clinical evidence for regulatory submissions and European commercialization.
Positive
- 10,000‑participant HANSE trial selection (October 2025)
- Partnerships with three German clinical centers and experts
- Support from the EUREKA Network for international validation
- Quebec City lab scaling enabled by a recent capital raise
Negative
- Clinical efficacy data not yet available; trial just started October 2025
- Quebec City laboratory is still progressing toward full certification
Extensive Validation of BioMark's Comprehensive Metabolic Panel in German 10,000-Participant HANSE Study, within the context of an international consortium supported under the EUREKA Network.
Vancouver, British Columbia--(Newsfile Corp. - October 7, 2025) - BioMark Diagnostics Inc. (CSE: BUX) (FSE: 20B) (OTCQB: BMKDF) ("BioMark"), a leading developer of liquid biopsy technologies for early cancer detection, is pleased to announce that the company has been invited to participate in the landmark HANSE lung cancer screening trial in Germany. This strategic clinical collaboration with Prof. Dr. Jens Vogel-Claussen at Medizinische Hochschule Hannover, Prof. Dr. Martin Reck at LungenClinic Grosshansdorf, and Dr. Sabine Bohnet at Universitätsklinikum Schleswig-Holstein, positions BioMark as the core diagnostic partner for German largest and most comprehensive screening study. The trial is designed to encompass 10,000 participants from both high-risk and general population cohorts, providing critical international market validation for BioMark's platform.
The consortium focuses on developing and implementing metabolomic profiling, radiomic, and clinical data into a risk-based model to improve the accuracy of early lung cancer detection and distinguish benign from malignant nodules. BioMark has been collaborating intensively with the German clinical team to finalize work packages and critical logistics for sample handling and processing as the trial started this October. This major initiative, which is supported through the international EUREKA Network Program, leverages BioMark's advanced Quebec City laboratory facilities, which are progressing toward full certification and accreditation to meet the stringent requirements of this large-scale European clinical trial.
"This collaboration represents a transformative milestone for BioMark," said Rashid Ahmed Bux, CEO and President of BioMark Diagnostics. "Our recent successful capital raise has allowed us to scale our laboratory operations to effectively manage this prestigious trial. We are honored to partner with Dr. Vogel-Claussen and his exceptional team. Their scientific rigor validates our liquid biopsy technology on the international stage and establishes a strong pathway to European market commercialization."
Dr. Jens Vogel-Claussen commented, "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, which is currently not eligible for lung cancer screening with low-dose CT according to current risk-assessment criteria. Furthermore, we aim to reduce the number of benign biopsies and surgical resections of positive low-dose CT cases. If successful, the blood test from BioMark Diagnostics could significantly enhance the performance of future lung cancer screening programs."
Successful execution of the HANSE trial is expected to generate critical clinical evidence supporting BioMark's regulatory submissions and commercial expansion strategies throughout North America and Europe. This partnership not only provides substantial validation of the technology platform but also establishes the company as a key player in the global early cancer detection market.
About the HANSE Trial
The HANSE study represents Germany's most ambitious lung cancer screening program, designed to evaluate innovative early detection methodologies across diverse population demographics. Led by key investigators at Medizinische Hochschule Hannover, LungenClinic Grosshansdorf, and Universitätsklinikum Schleswig-Holstein, this landmark trial aims to establish new gold standards for lung cancer screening protocols while addressing Europe's critical need for improved early detection capabilities. The trial's comprehensive design includes both high-risk populations and general screening cohorts, providing unprecedented clinical insights into early lung cancer detection across multiple demographic groups, and the data will be instrumental in advancing screening protocols throughout Europe and globally.
The HANSE study is primarily intended as a pilot to provide evidence that a holistic and effective lung cancer screening program can be implemented in Germany and that such a screening program can be integrated into the current infrastructure of certified lung cancer centers. This study has been registered on https://clinicaltrials.gov/study/NCT04913155.
About BioMark Diagnostics Inc.
BioMark Diagnostics Inc. 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.
Further information about BioMark is available under its profile on the SEDAR+ website www.sedarplus.ca and the CSE website https://thecse.com/.
For further information on BioMark, please Contact:
Rashid Ahmed Bux
President & CEO
BioMark Diagnostics Inc.
Tel. 604-370-0779
Email: info@biomarkdiagnostics.com
Forward-Looking Information:
This press release may include forward-looking information within the meaning of Canadian securities legislation, concerning the business of BioMark. Forward-looking information is based on certain key expectations and assumptions made by the management of BioMark. Although BioMark believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because BioMark can give no assurance that they will prove to be correct. Forward-looking statements contained in this press release are made as of the date of this press release. BioMark disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events, or results or otherwise, other than as required by applicable securities laws.
The CSE has not reviewed, approved, or disapproved of the content of this press release.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/269383
FAQ
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