BioMark Diagnostics Announces Landmark Publication Validating High Specificity and Accuracy of Its Early-Stage Lung Cancer Test

Vancouver, British Columbia--(Newsfile Corp. - May 12, 2025) - BioMark Diagnostics Inc. (CSE: BUX) (FSE: 20B) (OTCQB: BMKDF) ("BioMark"), a leading developer of liquid biopsy tests for early cancer detection, today announced the publication of a pivotal study as part of the special issue Molecular Pathogenesis and Diagnostics of Lung Diseases of the International Journal of Molecular Sciences. The research, titled "Clinical Validation of Plasma Metabolite Markers for Early Lung Cancer Detection", provides significant external validation for BioMark's metabolomics and machine learning powered technology, particularly highlighting its high specificity and accuracy in detecting early-stage non-small cell lung cancer (NSCLC) and differentiating it from other non-cancerous lung conditions.

The study utilized a large, clinically diverse patient cohort, analyzing 680 archived plasma samples in a discovery cohort and an independent set of 216 plasma samples for validation. A key strength of the research was the composition of the control group, which included not only healthy individuals but also patients with various non-cancerous lung diseases. This design allowed for a rigorous assessment of the test's ability to accurately identify lung cancer, minimizing the potential for false positives due to other lung conditions.

Dr. Jean-François Haince, Chief Scientific Officer of BioMark, commented, "We are exceptionally pleased with these results, which builds upon our previous research using a much larger and more clinically complex patient cohort. The inclusion of patients with non-malignant lung conditions in our control group was crucial for truly testing the specificity of our metabolite panel. The models achieved Area Under the ROC Curve (AUROC) values of over 93% for distinguishing stage I-II NSCLC from the complex control group. The high AUROC values achieved, especially for the earliest stages of lung cancer, confirm the robustness of our metabolomic and machine learning approach. This validation is a significant step forward in advancing our liquid biopsy technology towards broader clinical adoption to aid in early cancer diagnosis and management."

"This publication in a respected peer-reviewed journal is a tremendous milestone for BioMark and a powerful external validation of our team's dedicated work," said Rashid Ahmed Bux, President and CEO of BioMark Diagnostics. "The study's demonstration of high accuracy, particularly its ability to differentiate early-stage cancer from other lung diseases, is critical. It gives us, and the clinical community, greater confidence in our test's potential to become an essential tool in the fight against lung cancer, where early detection is paramount for improving patient survival rates."

The ability to detect lung cancer at its earliest stages significantly improves patient outcomes and survival rates. Current screening methods, such as low dose computed tomography (LDCT), have limitations, including lower sensitivity and specificity compared to regular CT scans, and can result in false positives leading to unnecessary invasive procedures. BioMark's minimally invasive blood test offers a promising approach to complement current screening methods, potentially leading to earlier interventions and better patient prognoses.

The full publication, "Clinical Validation of Plasma Metabolite Markers for Early Lung Cancer Detection", can be downloaded on the International Journal of Molecular Sciences website at https://www.mdpi.com/1422-0067/26/10/4519.

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/.

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.

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