BioMark Diagnostics

What BioMark Diagnostics does

BioMark Diagnostics Inc. is a Canadian clinical-stage diagnostics company developing a metabolomics-based liquid biopsy platform for early-stage cancer detection, with an initial commercial focus on lung cancer and pipeline expansion into breast, pancreatic, thyroid, and glioblastoma indications. The core technology combines mass spectrometry analysis of metabolites (including proprietary polyamine and SSAT1-related biomarkers, with the FDA-approved drug amantadine used as an amplifying agent) in blood and urine samples with machine learning models, including a proprietary Graph Neural Network (N-GNN) architecture co-developed with Harrisburg University and published in Frontiers in Oncology. The company operates a wholly-owned Quebec subsidiary (BioMark Diagnostic Solutions Inc., BDS) where its ISO 15189-accreditation-pending laboratory is located, with additional R&D operations in Winnipeg (glioblastoma research with the University of Manitoba) and a US market-entry office in Baltimore, Maryland. BioMark has built a substantial validation dataset — more than 15,000 blood samples across Quebec, France, and Germany, plus a 7,000-patient Canadian lung cancer study and a 5,400-subject, 7-hospital validation under IUCPQ — and is currently the exclusive partner in the 10,000-patient HANSE lung cancer screening trial.

The business model is a hybrid of direct laboratory diagnostic services (processing samples in its own Quebec lab for healthcare providers), companion diagnostic testing for treatment response monitoring, and an emerging international licensing and partnership revenue stream targeting US, European, and South Asian health systems. The company is pre-commercial in revenue terms — pricing is not publicly disclosed, ISO 15189/CLIA/CAP certifications are still in process, and Health Canada and Bangladesh Ministry of Health approvals are pending — but is investing in enterprise go-to-market infrastructure (reference lab partnerships, hospital channel relationships, point-of-care prototype development) ahead of commercial launch. BioMark funds its operations primarily through a mix of equity private placements (cumulative CAD ~$6M from late-2023 through April 2026), US strategic investment (USD $2M in March 2025), and non-dilutive government and foundation grants (cumulatively exceeding CAD $5.5M, including a C$4.42M collaborative grant with AstraZeneca Canada and Pfizer Canada). Management is led by founder and CEO Rashid Ahmed Maula Bux, CSO Jean François Haince, and a recently expanded board/ advisory bench adding AI/ML and US commercialization expertise.

BioMark's strategic posture is a deliberate transition from R&D to commercialization: it is pursuing regulatory accreditation across multiple jurisdictions, filing and securing patents in major markets (Canada, US, Europe, Japan, Asia), and aligning with marquee pharmaceutical and academic partners — AstraZeneca, Pfizer, Ohio State, TMIC, Phytronix — to de-risk both the science and the commercial channel. The principal go-to-market is enterprise field sales to healthcare systems, hospitals, and reference laboratories, paired with multi-channel scientific credibility-building through peer-reviewed publications and conference presentations at ESMO, USCAP, ASCO, and SABCS.

Name

BioMark Diagnostics

Legal name

BioMark Diagnostics Inc.

Website

https://biomarkdiagnostics.com

Company type

Public

Founded year

2006

Operating status

Operating

Headcount range

1–10 employees

Short description

BioMark Diagnostics is a Canadian clinical-stage company developing a metabolomics-based liquid biopsy platform with AI/ML for early-stage cancer detection, initially focused on lung cancer and expanding into breast, pancreatic, thyroid, and glioblastoma indications, serving healthcare providers, oncologists, and underserved screening populations.

Ownership category

akta.pro rank

Product category

Cancer Diagnostics / Liquid Biopsy

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Liquid Biopsy Biomarkers (ctDNA/ctRNA/CTCs/exosomes) (HLAAAMAH)

akta.pro secondary industries

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Biomarker Discovery & Validation (omics, assay feasibility, clinical validation) (HLAAAMAA), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC), Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing (HLAAANAG), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• Liquid biopsy diagnostics
• Metabolomics cancer detection
• Early cancer screening
• Companion diagnostics
• Oncology diagnostic tests

Headquarters

HQ city

Richmond

HQ country

Canada

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Laboratory Diagnostic Testing Services: BioMark operates clinical laboratories providing liquid biopsy tests for cancer detection. Revenue generated from processing patient samples and providing diagnostic results to healthcare providers and patients.
2. Companion Diagnostics (CDX): Response to treatment monitoring tests for cancer patients undergoing therapy. Used to measure patient response following lung cancer resection and chemotherapy treatment.
3. Licensing and International Partnerships: Plans to pursue international partnerships and licensing agreements with global health systems as part of commercialization strategy for its liquid biopsy technology platform.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels6 records

Core offering

BioMark Diagnostics develops and provides non-invasive liquid biopsy diagnostic tests for early-stage cancer detection using metabolomics and machine learning. The company operates its own clinical laboratory in Quebec (pursuing ISO 15189 and CLIA/CAP certifications) to process blood and urine samples, with a primary focus on lung cancer detection and plans for expansion into breast, prostate, pancreatic, thyroid, and glioblastoma cancers. Its offerings include companion diagnostics for treatment response monitoring and screening solutions for high-risk populations.

Product overview

BioMark Diagnostics offers a unified liquid biopsy platform for early-stage cancer detection focused on metabolomics. The core products include the Liquid Biopsy SSAT1 Assay (a general cancer 'red alert' tool using FDA-approved amantadine) and the Liquid Biopsy Metabolic Panel (a specialized lung cancer early detection test). Both products leverage the same underlying metabolomics platform technology that combines mass spectrometry analysis with machine learning algorithms to detect amplified cancer biomarkers. The platform also supports companion diagnostics for treatment response monitoring and cancer survivor monitoring. Current focus is on lung cancer, with expansion plans for breast, pancreatic, thyroid, and glioblastoma cancers.

Differentiator

Problem solved

Functional benefit

Products and services

• Liquid Biopsy SSAT1 Assay A non-invasive liquid biopsy test that detects elevated Spermidine/Spermine N-Acetyltransferase (SSAT1) enzyme levels using FDA-approved amantadine drug. The assay identifies cancer through over-expressed enzyme activity that produces amplified metabolites detectable in urine samples. It targets lung, breast, prostate, melanoma, and GI cancers, serving as a general cancer 'red alert' tool for oncologists and healthcare providers.
• Liquid Biopsy Metabolic Panel A high-powered metabolic panel assay validated for early detection of lung cancer, particularly stage 1 and 2. Uses urine and serum samples with clinically demonstrated superior detection capabilities compared to traditional LDCT screening, dramatically reducing false positive rates. Validated across more than 15,000 blood samples from Quebec, France, and Germany. Designed to complement Low Dose CT screening for high-risk populations.
• Urine-Based Lung Cancer Test A method of detecting lung cancer using urine samples with five clinical applications: detection and diagnosis, staging, non-invasive screening, treatment response assessment, and drug efficacy evaluation. Uses proprietary panel of polyamine metabolites and other critical analytes for ease of use and implementation.
• Companion Diagnostics (CDX) Response to treatment monitoring tests for cancer patients undergoing therapy. Used to measure patient response following lung cancer resection and chemotherapy treatment. Provides healthcare providers with diagnostic information to evaluate treatment efficacy and adjust therapy plans.

Quantifiable outcome

• False positive rates reduced dramatically compared to current LDCT screening (which has 30-55% false positive rates)
• +3 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature5 records

Partnerships

14 partnerships are on record, tiered flagship, core and minor.

• AstraZeneca CanadaflagshipStrategic or Co-development Partner · 3 December 2025Strategic collaboration for multimodal blood test development using AI to predict lung cancer risk. Established biobank with blood samples and imaging data from over 3,000 subjects. Part of $4.42 million collaborative lung cancer screening project awarded Innovation Award.
• Pfizer CanadaflagshipStrategic or Co-development Partner · 3 December 2025Collaborative partner in lung cancer screening project valued at $4.42 million, supporting development of AI-integrated blood biopsy tool for lung cancer detection.
• Research ManitobacoreStrategic or Co-development Partner · 9 April 2024Received over $290,000 in collaborative research funding with Mitacs for glioblastoma cancer treatment development using nanoparticle-based drug delivery platform to improve radiation responses. Project led by Dr. Donald Miller at University of Manitoba.
• MitacscoreStrategic or Co-development Partner · 9 April 2024Co-funding partner with Research Manitoba for glioblastoma research project developing drug delivery platform for improved radiation and chemotherapy responses in brain and other cancers.
• Theresa PetersonminorStrategic or Co-development Partner · 26 February 2024Joined advisory team to support company's strategic initiatives and commercialization efforts.
• Dr. W. Randolph FordminorStrategic or Co-development Partner · 14 November 2023Ph.D. joined advisory team to support integration of artificial intelligence and machine learning capabilities for early cancer detection platform.
• Kevin J. CosgriffminorStrategic or Co-development Partner · 30 August 2023Vice Admiral Kevin Cosgriff joined advisory team to support innovation and investment strategy, leveraging experience and connections to expand US clinical research collaborations.
• Harrisburg UniversitycoreTechnology or Integration · 30 August 2023US-based academic institution with exceptional AI/ML capabilities collaborating to optimize algorithms for diagnostic assays. Collaboration yielded promising data on breast cancer studies and successfully amplified overall accuracy of lung cancer assay.
• Phytronix TechnologiescoreTechnology or IntegrationPartnership with Phytronix Canada for patented laser diode thermal desorption technology that complements mass spectrometry analysis for metabolomics. Phytronix hosted BioMark for presentation at Annual Symposium on Disruptive Technologies.
• TMIC (The Metabolomics Innovation Centre)coreStrategic or Co-development PartnerPartnership with Dr. Wishart's TMIC to develop high-performance lung cancer metabolic fingerprints, leading to assay revalidation and proprietary customized kit development.
• RUBIX LSminorStrategic or Co-development PartnerPartnership to advance blood-based cancer screening in underserved communities, focusing on improving access for rural, northern, and Indigenous populations.
• Arthur G. James Comprehensive Cancer Center (Ohio State University)coreStrategic or Co-development PartnerCDA signed for joint research on early lung cancer detection using multi-omics approach. Dr. Christian Rolfo leading group preparing NIH applications for clinical validation and Point-of-Care studies targeting early 2025 submission.
• Siemens HealthineersminorStrategic or Co-development PartnerSelected following Eureka Investment Readiness Programme for deeper discussions under 2-way NDA regarding potential synergistic diagnostic and ML projects.
• IUCPQ (Institut Universitaire de Cardiologie et de Pneumologie de Quebec)coreStrategic or Co-development PartnerMajor Quebec research institution conducting large-scale early lung cancer multimodal study (5,400+ patients) across 7 hospitals, measuring response to immunotherapy for advanced-stage lung cancer trials under Dr. Joubert.

Scale indicators11 records

Recent moves7 records

Expansion highlights7 records

Emerging players

• VolitionRx: VolitionRx is developing blood-based cancer diagnostics using nucleosome biomarkers. As a small-cap publicly-traded liquid biopsy company, it is comparable to BioMark in scale, regulatory stage, and focus on novel biomarker-based cancer detection.
• Freenome: Freenome is developing a multiomics blood test for early cancer detection combining genomics, proteomics, and methylomics. As an emerging liquid biopsy peer, Freenome shares BioMark's focus on multi-analyte early detection but with different core biomarker chemistry.
• Personalis: Personalis offers NeXT Personal, a tumor-informed MRD liquid biopsy test. It represents an emerging peer in cancer MRD and treatment monitoring, similar to BioMark's planned companion diagnostics offerings.

Direct peers

• Guardant Health: Guardant Health is a leading liquid biopsy company offering blood-based oncology tests for therapy selection and monitoring. BioMark and Guardant both compete in blood-based cancer detection using novel biomarker chemistries, though BioMark focuses on metabolomics vs Guardant's ctDNA approach.
• GRAIL: GRAIL developed the Galleri multi-cancer early detection test using methylation-based liquid biopsy. BioMark competes directly with GRAIL in the early cancer detection market, though using metabolomics/Ssat1 chemistry rather than methylation sequencing.
• Natera: Natera offers Signatera, a tumor-informed ctDNA test for MRD and recurrence monitoring in cancer patients. BioMark's planned companion diagnostics for treatment response monitoring competes with Natera's MRD franchise in oncology liquid biopsy.

Broad incumbents

• NeoGenomics: NeoGenomics is a clinical laboratory services company offering oncology diagnostics including liquid biopsy and molecular testing. As an established lab services peer, it parallels BioMark's laboratory services business model and oncology test menu.
• Foundation Medicine: Foundation Medicine, a Roche subsidiary, provides FoundationOne CDx and FoundationOne Liquid CDx for comprehensive genomic profiling. BioMark competes in oncology diagnostics but takes a metabolomics rather than genomics approach to cancer detection.
• Exact Sciences: Exact Sciences commercializes Cologuard for colorectal cancer screening and is developing oncoguard tests for multiple cancers. As an established publicly-traded diagnostics incumbent, it represents a major scaled competitor to BioMark's cancer screening ambitions.

Regional players

• Burning Rock Biotech: Burning Rock Biotech is a China-based liquid biopsy company offering cancer therapy selection and monitoring tests. It represents a regional peer with similar next-generation sequencing-based oncology diagnostics, though primarily serving the China market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xtwitter.com/biomarkdx?lang=en
• YouTubeyoutube.com/channel/UCkAFM6HLmH2T3NclBZcf7Rg
• Facebookfacebook.com/pages/category/Biotechnology-Company/BioMark-Diagnostics-1442084389396301
• LinkedInlinkedin.com/company/biomark-diagnostics-inc

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

Funding overview

Funding rounds7 records

Investors7 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about BioMark Diagnostics