BioMark Diagnostics Inc. announced several updates from ongoing clinical trial using the Company's liquid biopsy test for early cancer detection and monitoring of lung cancer. As clinical trial success relies on effective patient recruitment, BioMark is delighted to announce that enrollment for its pivotal lung cancer screening study exceeded 1,000 participants in less than one year. The lung cancer screening demonstration project led by Dr. Simon Martel, pulmonologist at the Quebec Heart and Lung Institute (Institut Universitaire de Cardiologie et Pneumologie de Québec- Université Laval - IUCPQ-UL), is intended to combine BioMark's metabolomics liquid biopsy test with radiomics and genetics biomarkers to help at-risk Quebecers get access to an accurate and accessible lung cancer screening program.

The multimodal study was designed to recruit 4,000 participants from eight major hospitals across in Quebec, generating data that can support BioMark's implementation within the Province of Quebec. The Company also announces its first international patient recruited as part of a European prospective lung cancer screening trial in France known as the ILYAD study. BioMark's blood-based biomarker panel has been selected to define personalized lung cancer risk assessment in Europe's screen-eligible population who are most likely to benefit from a CT scan.

The study is being conducted by Pr Sébastien Couraud, pulmonologist at the Hospices Civils de Lyon (HCL) and through a partnership with France- based TransDiag. Through the ILYAD study, the investigators are studying the participation rate during the initial round in the lung cancer screening program and assessing the performance of several blood- based biomarkers for the detection of cancers in screened individuals. The test being developed by the consortium would offer the opportunity to screen nearly 4 million individuals in France who are eligible for lung cancer screening under current European guidelines.

These at-risk individuals are aged between 50 and 75 and have a history of heavy smoking. The Company intends to pursue clinical validation of the test as a laboratory developed test (LDT) in parallel with these ongoing studies. The BioMark Lung Cancer Risk Assessment Test will be available through its Quebec-based accredited laboratory, BioMark Diagnostic Solutions Inc., within approximately 9 - 12 months based on the completion of the ISO 15-189 certification.