BioMark's blood-based metabolomics platform detects lung cancer at Stage I with 96.8% sensitivity — faster, cheaper, and far less invasive than any existing method. First commercial revenue expected Q4 2026.
Only 16% of lung cancer cases are diagnosed at an early stage. The current gold-standard screening — Low-Dose CT — produces a 96% false-positive rate. BioMark is built to fix both.
Lung cancer accounts for 1 in 5 of all cancer deaths globally. In the US, 240,000 new cases and 134,000 deaths every year. Colorectal cancer survival is 65%, breast 90%, prostate 98% — the gap is driven by late detection.
Detect it early and survival triples. Stage I localised lung cancer carries a 56% five-year survival rate. Stage II drops to 35%. Early detection is the single most powerful clinical lever available — and the one most under-used.
96% of nodules found by Low-Dose CT are benign — triggering unnecessary biopsies, radiation, patient anxiety, and avoidable cost. LDCT is also inaccessible in rural areas where smoking rates — and lung cancer risk — are highest.
Unlike genomics, metabolomics measures the downstream biochemical output of cancer — small molecules that shift measurably before tumours are visible on imaging. Less inter-patient variability means more reliable early signals.
A minimally invasive blood test using quantitative mass spectrometry (LC-MS/MS) and an XGBoost AI model. Validated across 2,910 cancer subjects and 677 controls at 7 hospitals. Designed for annual screening in adults aged 50–80 with smoking history. Only ~300 µL plasma required; under 5 minutes per sample using the proprietary LDTD-MS/MS platform. ISO 15189 lab certification underway. Commercial launch targeted Q4 2026.
Retrospective study of 260 samples including triple-negatives and receptor subtypes. Revalidated at 2 sites using machine learning. Presented at SABCS December 2023 and 2024. Lobular sensitivity 97%, ductal 95%. Clinical revalidation mid-2026; larger study late 2026. Invited to present again at SABCS late 2026.
Genomic heterogeneity limits early-detection accuracy — genomic biomarkers may not yet be abundant at Stage I. Metabolic biochemistry is a more conserved, regulated process. Inter-individual variation in metabolite profiles is far smaller than for genes or proteins, making metabolomics a more predictable and reproducible early signal.
BioMark uses Phytronix's patented Laser Diode Thermal Desorption (LDTD) technology with mass spectrometry — under 5 minutes per sample, ~300 µL plasma. The XGBoost AI model was benchmarked against Random Forest, Logistic Regression, SVM, and Gradient Boosting. Trained on 80/20 splits with 10-fold cross-validation at 100 repetitions. Uses standard instruments already deployed in clinical labs — designed for easy adoption.
Published in peer-reviewed journals. Presented at ASCO 2023, USCAP 2023, SABCS 2023–2024. Results from the IUCPQ Quebec cohort — 5,439 blood samples across multiple collection waves.
| Risk | Score | Clinical Action |
|---|---|---|
| Low | <0.62 | Routine care — no imaging needed. Very high NPV minimises unnecessary procedures. |
| Intermediate | 0.62–0.89 | Follow-up LDCT within 6 months per guidelines. Balances watchful waiting with early detection. |
| High | >0.89 | Immediate LDCT + confirmatory biopsy and referral. High PPV aligns with guideline urgency. |
Stage I+II cohort: AUC 97.4%, sensitivity 97.0%, specificity 98.8%. Validated in patients with benign lung disease (COPD, asthma) ensuring real-world specificity. False Positive Rate 1.2%.
BioMark's platform was exclusively selected for the Holistic German Lung Cancer Screening trial — 10,000 patients, supported by AstraZeneca and the EUREKA Network. The largest longitudinal lung cancer trial since NELSON 2013. Over 60 German radiologists and oncologists have been trained on BioMark's risk score index.
Results published in peer-reviewed journals and presented at ASCO, USCAP, and SABCS. The table below reflects published and symposium-presented data.
| Cancer Type | Comparison | Sensitivity | Specificity |
|---|---|---|---|
| Lung Cancer — AI / ML Enhanced | |||
| Lung Cancer Stages I & II | Stages I & II vs. Control | 95% | 94% |
| Adenocarcinoma | Adeno vs. Control | 97% | 86% |
| Squamous Cell Carcinoma | SCC vs. Control | 95% | 94% |
| Small Cell (SCLC) | SCLC vs. Control | 97% | 85% |
| Large Cell NEC (LCNEC) | LCNEC vs. Control | 97% | 87% |
| Neuroendocrine Tumours (NETs) | |||
| NET | NET vs. Control | 96% | 96% |
| Carcinoid | Carcinoid vs. Control | 94% | 96% |
| Breast Cancer | |||
| Breast Cancer Stages I & II | Stages I & II vs. Control | 91% | 90% |
| Lobular Breast Cancer | Lobular vs. Healthy | 97% | 96% |
| Ductal Breast Cancer | Ductal vs. Healthy | 95% | 94% |
*Results published in peer-reviewed journals and presented at ASCO, USCAP, and SABCS. NETs paper published in Cancers Journal, September 2024.
Glioblastoma Multiforme (GBM) is one of the deadliest brain cancers, with a median survival of just 15 months after diagnosis. Today, MRI imaging is the only available tool to assess tumour progression and treatment response after surgery and radiotherapy.
But MRI has a critical clinical blind spot: pseudoprogression. In the months following treatment, scans can show apparent tumour growth that is actually treatment-induced inflammation — visually indistinguishable from true disease progression. This leads to premature treatment changes, patient distress, and misdirected resources at the most critical window in a patient's care.
BioMark's SSAT (Spermidine/Spermine N1-Acetyltransferase) assay is a liquid biopsy blood test that provides an objective biochemical measure of tumour velocity and treatment response in GBM — a quantitative signal that imaging alone cannot provide. The SSAT enzyme is upregulated in metabolically active tumour tissue, enabling serial monitoring through simple blood draws.
New clinical results and peer-reviewed publications are expected in the second half of 2026, further defining the assay's role in post-surgical GBM monitoring and treatment outcome assessment.
After GBM surgery and radiotherapy, MRI cannot reliably distinguish true tumour regrowth from treatment-induced inflammation. This ambiguity causes premature treatment changes and clinical misjudgement at the most consequential point in care. A biochemical blood marker that tracks real tumour activity could be life-saving for GBM patients.
SSAT enzyme levels in blood rise with metabolically active tumour tissue. Serial measurements post-surgery track whether the tumour is responding to treatment, stable, or progressing — independent of imaging artefacts and without additional radiation exposure to the patient.
The SSAT assay is designed to work alongside existing MRI protocols — not replace them. It gives oncologists a biochemical second opinion during the critical 3–6 month post-treatment window when pseudoprogression is most prevalent and when treatment decisions carry the highest stakes.
Multiple near-term data readouts, commercial launches, and publications define BioMark's trajectory through the end of 2026 and into 2027.
Seminal results from the multimodal lung cancer trial at 7 Quebec hospitals — integrating metabolomics, radiomics, polygenic risk scores, and EGFR status alongside BioMark's AI model. Patient recruitment commenced February 2022.
Laboratory accreditation underway to begin accepting commercial patient samples. CLIA CAP certification to follow in late 2026, enabling US market access and reimbursement eligibility.
Completion of Germany's 10,000-patient HANSE trial — the largest longitudinal lung cancer screening trial since NELSON 2013. Supported by AstraZeneca and the EUREKA Network. Results will strengthen global commercial positioning.
First commercial revenue from the early-detection lung cancer assay following ISO certification. US go-to-market strategy under development — lab partner location (beachhead), reimbursement pathway, and National Cancer Centre KOL engagement.
New clinical results from the SSAT GBM assay expected alongside a peer-reviewed publication — defining its role in post-surgical monitoring, tumour velocity tracking, and treatment response in Glioblastoma Multiforme.
Multiple peer-reviewed publications on AI/ML-enhanced diagnostic prediction in early cancer detection — lung, breast, and GBM. Plus conference presentations at CTS Research Forum (Calgary), SABCS, CARST (Saskatoon), and investor conferences.
BioMark and IUCPQ-UL received the Innovation Award at the 35th ADRIQ Gala, celebrating the collaboration between BioMark, AstraZeneca Canada, Pfizer Canada, Dr. Philippe Joubert, and Dr. Yohan Bossé. Recognised for completing the largest lung cancer studies in Canada.
BioMark's platform was the exclusive choice for Germany's largest lung cancer screening trial — 10,000 patients, supported by AstraZeneca and the EUREKA Network. Over 60 German radiologists and oncologists trained on BioMark's risk score index. The largest trial since NELSON 2013.
ASCO 2023 (lung cancer poster) · USCAP New Orleans 2023 (NETs) · SABCS 2023 & 2024 (breast cancer) · Cancers Journal Sept 2024 (NETs) · CTS Research Forum finalist April 2026 · CARST Saskatoon May 2026.
A global team of scientists, engineers, oncologists, and business leaders committed to this mission since 2014.
As of May 22, 2026 · All figures CDN$
BioMark is transitioning from development-stage to revenue-generating. With ISO lab certification underway, the HANSE trial completing June 2026, and the IUCPQ 6,000-patient data readout imminent, first commercial revenue is targeted Q4 2026. Strong Stage I & II data could be pivotal for biopharma partnership discussions.
Over 25 patents across 9 families. Collaborators include AstraZeneca, Siemens Healthineers, Pfizer, SCIEX, and leading cancer centres across North America and Europe. US lab operations and CLIA CAP certification targeted for 2026–27.
Warrants: 26.8M @ $0.45–$0.50 · Options: 7.24M @ $0.30–$0.40
Audited by MNP LLP · Legal: Cozen O'Connor (BC), Norton Rose Fulbright (QC) · Patent: ROBIC LLP (QC). This page is for informational purposes only and does not constitute investment advice or an offer to sell securities. All $ CDN.
Proteomics and metabolomics — it's really what drives biology and disease. This is going to be at least as important as genomic medicine, and in many areas can go far beyond what genomic medicine was able to deliver.
Clinicians, investors, research institutions, and patient advocates — we'd like to hear from you.
This page contains forward-looking statements. Actual results may differ materially. BioMark Diagnostics is listed on the Canadian Securities Exchange (CSE: BUX) and OTCQB (BMKDF). Audited by MNP LLP. Legal: Cozen O'Connor (BC), Norton Rose Fulbright Canada (QC), ROBIC LLP — patent (QC). All figures in Canadian dollars unless stated. This does not constitute an offer to sell or solicitation to buy securities. Refer to SEDAR filings for full risk factors.