BioMark's Liquid Biopsy Platform Selected for Holistic German Lung Cancer Screening Trial
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.
BioMark (OTCQB: BMKDF) è stata selezionata come partner diagnostico principale per lo sforzo di screening del cancro ai polmoni HANSE in Germania, uno studio 10.000 partecipanti che è iniziato ottobre 2025. Il consorzio integrerà profili metabolomici, radiomica e dati clinici in un modello di rischio per migliorare la rilevazione precoce del cancro ai polmoni e la classificazione dei noduli per adulti di età 55–79. L'iniziativa è sostenuta dalla Rete EUREKA e coinvolge diversi centri clinici tedeschi. BioMark cita un recente aumento di capitale che ha permesso la scalabilità del suo laboratorio di Quebec City, che sta progredendo verso la certificazione completa per gestire la logistica dei campioni dello studio. Si prevede che l'esecuzione con successo fornirà evidenze cliniche per presentazioni regolatorie e la commercializzazione europea.
BioMark (OTCQB: BMKDF) fue seleccionada como socio diagnóstico principal para el ensayo de cribado de cáncer de pulmón HANSE de Alemania, un estudio de 10.000 participantes que comenzó en octubre de 2025. El consorcio integrará perfil metabolómico, radiómica y datos clínicos en un modelo de riesgo para mejorar la detección temprana del cáncer de pulmón y la clasificación de nódulos para adultos de 55–79. La iniciativa cuenta con el apoyo de la Red EUREKA e involucra múltiples centros clínicos alemanes. BioMark cita una reciente ronda de financiación que permitió escalar su laboratorio de Quebec City, que avanza hacia la certificación completa para manejar la logística de muestras del ensayo. Se espera que una ejecución exitosa proporcione evidencia clínica para presentaciones regulatorias y la comercialización europea.
BioMark (OTCQB: BMKDF)은 독일의 HANSE 폐암 선별 시험의 핵심 진단 파트너로 선정되었으며, 참가자 10,000명 규모의 연구가 2025년 10월에 시작되었습니다. 이 컨소시엄은 대사체 프로파일링, 방사선학(radiomics) 및 임상 데이터를 위험 모델에 통합하여 성인 55–79세에서 조기 폐암 발견과 결절 분류를 개선할 예정입니다. 이 이니셔티브는 EUREKA 네트워크의 지원을 받으며 여러 독일 임상 센터를 포함합니다. BioMark는 퀘벡 시티 연구소의 규모 확장을 가능하게 한 최근의 자본 조달을 인용하며, 연구 샘플 물류를 처리하기 위한 전체 인증을 향해 나아가고 있습니다. 성공적인 실행은 규제 제출 및 유럽 상용화를 위한 임상 증거를 제공할 것으로 예상됩니다.
BioMark (OTCQB: BMKDF) a été sélectionné comme partenaire diagnostique principal pour l essai de dépistage du cancer du poumon HANSE en Allemagne, une étude 10 000 participants qui a débuté en octobre 2025. Le consortium intégrera le profilage métabolomique, la radiomique et les données cliniques dans un modèle de risque afin d'améliorer la détection précoce du cancer du poumon et la classification des nodules chez les adultes âgés de 55–79. L'initiative est soutenue par le Réseau EUREKA et implique plusieurs centres cliniques allemands. BioMark cite une récente levée de fonds qui a permis de faire évoluer son laboratoire de Québec City, qui progresse vers une certification complète pour gérer la logistique des échantillons de l essai. Une exécution réussie devrait fournir des preuves cliniques pour les soumissions réglementaires et la commercialisation européenne.
BioMark (OTCQB: BMKDF) wurde als der zentrale diagnostische Partner für Deutschlands HANSE-Lungenkrebsvorsorge-Studie ausgewählt, eine 10.000‑Teilnehmer‑studie, die im Oktober 2025 begann. Das Konsortium wird metabolomische Profiling, Radiomik und klinische Daten in ein Risikomodell integrieren, um die Früherkennung von Lungenkrebs und Nodulus-Klassifikation für Erwachsene im Alter von 55–79 zu optimieren. Die Initiative wird vom EUREKA-Netzwerk unterstützt und umfasst mehrere deutsche Kliniken. BioMark verweist auf eine jüngste Kapitalbeschaffung, die die Skalierung seines Labors in Quebec City ermöglicht hat, das sich auf eine vollständige Zertifizierung zubewegt, um die Probenlogistik der Studie zu bewältigen. Eine erfolgreiche Umsetzung wird voraussichtlich klinische Evidenz für Zulassungsanträge und die europäische Vermarktung liefern.
BioMark (OTCQB: BMKDF) اختيرت كشريك تشخيصي مركزي لتجربة فحص سرطان الرئة HANSE في ألمانيا، وهي دراسة بـ10,000 مشارك بدأت في أكتوبر 2025. سيتكامل التحليل الميتابولومي، والـ radiomics، والبيانات السريرية في نموذج مخاطر لتحسين الكشف المبكر عن سرطان الرئة وتصنيف العُقيدات للبالغين الذين تتراوح أعمارهم بين 55–79. المبادرة مدعومة من خلال شبكة يوريكا وتشارك عدة مراكز سريرية ألمانية. تشير BioMark إلى جولة جمع رأس مال حديثة مكنت من توسيع مختبرها في مدينة كيبيك، وهو في طريقه نحو الاعتماد الكامل ليعالج لوجستيات عينات التجربة. من المتوقع أن يوفر التنفيذ الناجح أدلة سريرية للطلبات التنظيمية والتسويق الأوروبي.
BioMark (OTCQB: BMKDF) 被选为德国 HANSE 肺癌筛查试验的核心诊断合作伙伴，这是一个 1万名参与者 的研究，始于 2025年10月。该联盟将把代谢组学分析、放射组学和临床数据整合到一个风险模型中，以提高对肺癌的早期检测以及对成年人 55–79 岁结节的分类。该倡议得到 EUREKA 网络 的支持，并涉及多家德国临床中心。BioMark 提到最近的融资使其魁北克市实验室得以扩张，目前正朝着全面认证迈进，以处理试验样本的物流。成功实施预计将为监管提交和欧洲市场化提供临床证据。
- 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
- 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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