What Mitogen Diagnostics Corporation does

Mitogen Diagnostics Corporation (MitogenDx) is a Calgary, Alberta-based clinical diagnostic laboratory that has provided specialized autoimmune and cytokine biomarker testing since 1984. The company operates four core immunoassay technology platforms — Simoa (Single Molecule Array) from Quanterix, Line Immunoassays (LIA), Cell-Based Assays using indirect immunofluorescence, and Luminex bead-based multiplex assays — enabling detection of over 500 autoantibodies and biomarker targets. Its test menu spans complement pathway panels, cytokine/chemokine/growth factor multiplex panels (up to 95-plex), disease-specific autoimmune panels for lupus, scleroderma, myositis, rheumatoid arthritis, vasculitis, antiphospholipid syndrome, neurological autoimmune disorders, liver and kidney disease, and emerging applications including Long COVID biomarker assessment and immune checkpoint profiling for cancer immunotherapy.

The business operates as a fee-for-service diagnostic laboratory serving three primary customer channels: referring laboratories, clinics and hospitals, and direct-to-patient self-referred clients. Samples are shipped to the Calgary lab globally; results are delivered electronically via Netcare/Millennium/SCM systems to Alberta-based providers and via fax to out-of-province referring labs. Pricing is quote-based and not publicly disclosed. MitogenDx holds dual accreditation from the College of Physicians and Surgeons of Alberta (CPSA) and the College of American Pathologists (CAP), and participates in international research consortia including the International Consensus on ANA Patterns (ICAP) and the Canadian Scleroderma Research Group. The company is founder-led, privately held, and operates with a headcount of 1-10 employees under Director Dr. Marvin J. Fritzler (50+ years) and Associate Director Dr. May Y. Choi.

Name

Mitogen Diagnostics Corporation

Legal name

Mitogen Diagnostics Corporation

Website

https://mitogendx.com

Company type

Private

Founded year

1984

Operating status

Operating

Headcount range

1–10 employees

Short description

Mitogen Diagnostics Corporation is a Calgary-based clinical diagnostic laboratory founded in 1984 that provides specialized autoimmune and cytokine biomarker testing across 500+ diagnostic targets, serving referring labs, clinics, hospitals, and direct-to-patient clients globally via four immunoassay platforms.

Ownership category

akta.pro rank

Product category

Clinical Diagnostic Laboratory Services (Autoimmune & Cytokine Biomarker Testing)

NAICS

Medical Laboratories (621511)

SIC

Services-Medical Laboratories (8071)

akta.pro primary industry

Clinical Chemistry & Immunoassay Laboratories (HLAFAMAB)

Keywords

• Autoimmune diagnostics
• Cytokine biomarker testing
• Clinical laboratory services
• Immunoassay testing
• Autoimmune disease testing

Headquarters

HQ city

Calgary

HQ country

Canada

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Diagnostic Testing Services: MitogenDx operates as a clinical diagnostic laboratory providing specialized autoimmune and cytokine immune biomarker testing services to healthcare providers, clinics, hospitals, and directly to patients. Tests are ordered via requisition forms and samples are sent to the Calgary laboratory for processing.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

Mitogen Diagnostics Corporation operates a clinical diagnostic laboratory that processes patient and provider-submitted samples for specialized autoimmune and cytokine immune biomarker testing. The laboratory offers more than 500 diagnostic targets across complement pathway, cytokine/chemokine, and disease-specific autoimmune panels using Simoa, Line Immunoassay, Cell-Based Assay, and Luminex immunoassay platforms, serving referring laboratories, clinics, hospitals, and self-referred patients globally.

Product overview

Mitogen Diagnostics Corporation (MitogenDx) is a diagnostic laboratory offering over 500 autoimmune and cytokine immune biomarker diagnostic tests since 1984. The company's product portfolio centers on four core technology platforms: Simoa™ (Single Molecule Array) for ultra-sensitive biomarker detection, Line Immunoassays (LIA) for multiplex antigen profiling, Cell Based Assays (CBA) using indirect immunofluorescence, and Luminex bead-based multiplex assays. The comprehensive test menu includes specialized panels across complement pathway testing (6 panels), cytokine/chemokine/growth factor panels (95-Plex, 15-Plex, 9-Plex Interferon Panel, 18-Plex Long COVID, 17-Plex Immune Checkpoint, 15-Plex Soluble Cytokine Receptor), and disease-specific autoimmune panels for conditions including systemic lupus erythematosus, scleroderma, Sjögren syndrome, myositis/autoimmune myopathy, rheumatoid arthritis, antiphospholipid syndrome, ANCA-vasculitis, neurological disorders (encephalitis, NMOSD, ALS, neuropathies), liver disease, kidney disease, skin diseases, and cancer. The technology platforms enable detection of autoantibodies, cytokines, and biomarkers from various sample types including blood, serum, plasma, cerebrospinal fluid, and urine.

Differentiator

Problem solved

Functional benefit

Products and services

• Simoa™ Based Assays Single Molecule Array (Simoa™) immunoassay platform from Quanterix Corporation enabling highly sensitive detection and quantification of biomarkers at femtogram concentrations across autoimmunity, inflammation, infectious disease, neurology, cardiology, and oncology disciplines; supports blood, serum, plasma, CSF, urine, BAL, cell culture supernatant, and cell lysate sample types in single and multiplex formats.
• Line Immunoassays (LIA) Line blot immunoassays in which multiple antigens are individually adsorbed in parallel on a single nylon test strip, providing high-specificity differentiation of antibody reactivity and comprehensive qualitative and semi-quantitative antibody profiles in one test run.
• Cell Based Assays (CBA) Indirect immunofluorescence (IIF) assays using transfected cells that overexpress specific antigen cDNA, preserving conformational epitopes through proper folding and post-translational modifications, with cellular array multiplexing for simultaneous detection of multiple antigen-specific antibodies.
• Luminex Assays Microsphere (bead)-based immunoassays detecting multiple analytes within a single sample using dual laser flow detection to differentiate bead populations by spectral signature and quantify antibody binding for high-throughput, high-accuracy multiplex bioanalysis.
• Complement Pathway Panel Tests Six complement pathway test panels covering deficiency screening (12-plex), nephritis, classical pathway activation, angioedema, thrombotic microangiopathy (TMA), and complement system activation for diagnosis of cytokine and complement-mediated diseases.
• Cytokine, Chemokine Growth Factor 95-Plex Panel Comprehensive 95-plex panel detecting cytokines, chemokines, and growth factors including APRIL, BAFF, IFN variants, interleukins (IL-1α through IL-35), TNF family members, and VEGF for inflammatory and immune disease profiling.
• Focused Cytokine, Chemokine, Growth Factor 15-Plex Panel Focused 15-plex panel detecting GM-CSF, IFNγ, IL-1β, IL-1RA, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12(p40), IL-12(p70), IL-13, MCP-1, and TNF-α for routine cytokine profiling.
• Interferon Panel (9-Plex) 9-plex panel detecting IFNα2, IFNβ, IFNγ, IFNγR1, IFNε, IFNλ1, IFNλ2, IFNλ3, and IFNω for interferon pathway assessment.
• Long COVID Angiogenesis & Cardiovascular Biomarker Panel (18-Plex) 18-plex panel for Long COVID assessment detecting ADAMTS13, Angiopoietin-2, BMP-9, D-Dimer, Endoglin, Endothelin-1, FGF-1, Follistatin, HB-EGF, HGF, Leptin, PLGF, SAA, sICAM-1, sP-Selectin, sVCAM-1, VEGF-C, and VEGF-D.
• Circulating Immune Checkpoint Biomarker 17-Plex Panel 17-plex panel investigating T cell activation and exhaustion to assess suitability of checkpoint inhibitor therapies in cancer and autoimmune conditions; detects BTLA, CD27, CD28, CD40, CD80/B7-1, CD86/B7-2, CTLA-4, GITR, GITRL, HVEM, ICOS, LAG-3, PD-1, PD-L1, PD-L2, TIM-3, and TLR-2.
• Autoimmune Myopathy / Myositis Panel PLUS Comprehensive myositis profile using Line Immunoassay (LIA) and CIA methods to detect autoantibodies to Jo-1, Mi2-α, Mi2-β, MDA5, NXP2, TIF1γ, PL7, PL12, PM/Scl75, PM/Scl100, Ku, SRP, EJ, OJ, Ro52/TRIM21, SAE1, HMGCR, and cN-1A/Mup44 for autoimmune myopathy diagnosis.
• Anti-SMN Complex Test (Laboratory Developed Test) Laboratory Developed Test using Addressable LASER Bead Immunoassay (ALBIA) to detect autoantibodies to SMN1, Gemin 3, RuvBL1, and RuvBL2 for necrotizing autoimmune myopathy and SLE/autoimmune myositis overlap syndrome.
• Arthritis Panel Rheumatoid arthritis panel measuring six autoantibodies including RF-human FC (IgM), RF-animal FC (IgM), and four citrullinated peptides (HCP1, HCP2, VCP1, VCP2) for improved RA diagnosis sensitivity over conventional ACPA testing.
• Anti-Acetylcholine Receptor (AChR) / Myasthenia Gravis Test ELISA-based semi-quantitative test detecting autoantibodies to acetylcholine receptor associated with myasthenia gravis; reference ranges Negative <0.4 nmol/l, Borderline 0.40–0.50 nmol/l, Positive ≥0.50 nmol/l.
• Scleroderma / Systemic Sclerosis Panel Comprehensive scleroderma panel using Line Immunoassay (LIA) detecting anti-CENP A+B, Topo-I/Scl-70, RNA polymerase III, fibrillarin/U3RNP, Th/To/hPOP1, Ku, PDGFR, Ro52/TRIM21, PM/Scl-75, PM/Scl-100, and NOR90/Hubf for systemic sclerosis diagnosis and characterization.
• Bullous & Autoimmune Skin Disease Panel Autoimmune skin disease panel detecting anti-BP180, BP230, Desmoglein-1, and Desmoglein-3 antibodies for diagnosis of bullous pemphigoid, pemphigus vulgaris, and pemphigus foliaceus.
• Systemic Lupus Erythematosus (SLE) Panel SLE-specific panel detecting anti-Sm, U1RNP, Ro52/TRIM21, SSA/Ro60, SSB/La, PCNA, dsDNA, Ku, Ribosomal-P, and Chromatin antibodies.
• Sjögren Syndrome Panel Sjögren syndrome panel detecting anti-SSA/Ro, SSB/La, and Ro52/TRIM21 antibodies.
• Advanced ANA – Anti-Cellular Antibodies Advanced ANA testing using HEp-2 IFA detecting atypical nuclear, cytoplasmic, and cellular cycle patterns for comprehensive autoantibody screening.
• Neuromyelitis Optica Spectrum Disorder (NMOSD) Test Cell-based immunofluorescence assay detecting anti-Aquaporin 4 (AQP4/NMO) and anti-Myelin Oligodendrocyte Glycoprotein (MOG) antibodies for NMOSD diagnosis.
• Encephalitis Antibody Panels Multiple encephalitis tests including anti-VGKC (LGI1/CASPR2), anti-DPPX, anti-AMPA receptor, anti-GABAB receptor, and anti-NMDA receptor (NR1) for autoimmune encephalitis diagnosis.
• ANCA (PR3, MPO) Test Anti-neutrophil cytoplasmic antibodies test detecting perinuclear ANCA (MPO) and cytoplasmic ANCA (PR3) for ANCA-associated vasculitis diagnosis.
• Antiphospholipid Syndrome Tests APS diagnostic panel including anti-beta-2 glycoprotein 1 domain 1 (D1 β2GP1), anti-cardiolipin (IgG+IgM), and anti-phosphatidylserine/prothrombin complex (PS/PT) tests.
• Soluble Cytokine Receptor 15-Plex Soluble cytokine receptor panel detecting sCD30, sCD163, sEGFR, sgp130, sIL-1RI, sIL-1RII, sIL-2Rα, sIL-4R, sIL-6R, sRAGE, sTNF RI, sTNF RII, sVEGF R1, sVEGF R2, and sVEGF R3.
• ADAMTS-13 Activity & Anti-ADAMTS-13 Test ADAMTS13 activity level and autoantibody/inhibition testing for atypical HUS, TTP, and thrombotic microangiopathy assessment.
• High-Sensitivity Neurofilament Tests Neurofilament light chain (pNf-L) and phosphorylated neurofilament heavy chain (pNf-H) tests for ALS and neurological disease diagnostics.
• Ganglioside Autoantibody Panel Neurological disease panel detecting anti-GM1, GM2, GM3, GD1a, GD1b, GT1b, and GQ1b ganglioside antibodies for Guillain-Barré syndrome and related neuropathies.
• Paraneoplastic Disease Panel PLUS Comprehensive paraneoplastic panel detecting anti-Amphiphysine, Ri (NOVA-1), Yo, Hu, PNMA2 (Ma2/Ta), CV2.1, Recoverin, SOX1, Titin, Zic4, GAD65, and Tr (DNER) antibodies.
• Cancer-Associated Autoantibody Panel Panel detecting anti-CENP-F1, CENP-F4, and p53 autoantibodies associated with cancer.
• Interstitial Lung Disease (ILD) Antibody Panel Comprehensive ILD panel detecting 22 autoantibodies including anti-CENP A+B, Topo-I/Scl-70, RNA polymerase III, fibrillarin, Th/To/hPOP1, Jo-1, Mi2 variants, MDA5, NXP2, TIF1γ, and SRP for myositis-associated ILD assessment.
• Autoimmune Liver Disease Panel PLUS Liver disease panel detecting anti-AMA-M2, M2-3EBPO, LKM, SLA, SP100, gp210, PML, LC-1, Ro52/TRIM21, SSA/Ro60, Scl-70, Centromere A, Centromere B, and PGDH antibodies.
• Anti-DFS70 Test Dense Fine Speckled 70 (DFS70/LEDGF) antibody test for distinguishing true autoimmune disease from non-specific ANA positivity.
• Anti-DS DNA Test Quantitative anti-double-stranded DNA (dsDNA) IgG test for SLE disease activity monitoring.
• Anti-GAD 65 Test Anti-glutamate decarboxylase (GAD65) test for Type 1 diabetes and autoimmune neurological conditions; present in 70–90% of Type 1 diabetes patients.
• Anti-PLA2R Tests Anti-phospholipase A2 receptor (PLA2R) quantitative ELISA and standard tests for primary membranous nephropathy diagnosis.
• ASCA Test (Inflammatory Bowel Disease) Anti-Saccharomyces cerevisiae (ASCA IgG/IgA) test for inflammatory bowel disease, particularly Crohn's disease diagnosis.
• Sleep Disorder Test (Anti-IgLON5) Test for anti-IgLON5 antibodies associated with IgLON5 syndrome and sleep disorders.

Quantifiable outcome

• Over 500 diagnostic targets available for autoimmune and cytokine biomarker testing
• +1 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

Integration3 records

Feature4 records

Partnerships

Four partnerships are on record, tiered core.

• Choi LabcoreStrategic or Co-development PartnerChoi Lab appears as a research partner, likely associated with Dr. May Y. Choi, Associate Director of MitogenDx, who brings expertise from Brigham and Women's Hospital and Harvard Medical School in lupus research and biomarker discovery.
• Eve TechnologiescoreTechnology or IntegrationEve Technologies is listed as a partner, providing technology collaboration for biomarker and cytokine testing services. Eve Technologies specializes in multiplex immunoassay platforms.
• International Consensus on ANA Patterns (ICAP)coreStrategic or Co-development PartnerICAP is an international consensus initiative establishing standards for antinuclear antibody (ANA) pattern interpretation. MitogenDx participates in ICAP as part of its research leadership and commitment to standardized autoantibody diagnostics.
• Quanterix CorporationcoreTechnology or IntegrationQuanterix Corporation manufactures and services the Simoa™ (Single Molecule Array) technology platform used by MitogenDx for highly sensitive biomarker detection at femtogram concentrations.

Scale indicators3 records

Recent moves6 records

Expansion highlights4 records

Broad incumbents

• Quest Diagnostics: Large commercial clinical laboratory offering a broad autoimmune and immunology test menu. Comparable to MitogenDx as a competitor for autoimmune test orders, but operates at vastly larger scale and across many specialties.
• Sonic Healthcare: International clinical laboratory network (including Lifelabs in Canada) offering autoimmune and specialty testing. Comparable in serving Canadian clinicians and accepting samples globally, though at much larger scale.
• Labcorp: Major global clinical laboratory network with significant autoimmune and specialty testing capabilities. A broad incumbent competitor that overlaps with MitogenDx on autoimmune diagnostics, though it serves a much wider test menu.

Direct peers

• EUROIMMUN (PerkinElmer): Specializes in autoimmune diagnostics with line immunoassays, IIF, and ELISA platforms. Highly comparable to MitogenDx's technology stack and test menu, and frequently competes for autoimmune testing contracts internationally.
• ARUP Laboratories: A nonprofit reference laboratory at the University of Utah offering highly specialized autoimmune and immunology diagnostics. Directly comparable to MitogenDx in serving complex esoteric test menus for hospital systems and clinicians, though at much larger scale.
• Mayo Clinic Laboratories: Reference laboratory offering extensive autoimmune, neurologic, and specialty test menus with global shipping. Comparable to MitogenDx in serving specialized autoimmune diagnostics, with much broader scale and academic research ties.
• Inova Diagnostics: Specialty diagnostics company with a deep autoimmune menu including connective tissue disease, vasculitis, and celiac panels. Directly comparable to MitogenDx in autoimmune specialty testing, with a stronger US commercial footprint.

Regional players

• Athena Diagnostics (Quest): Specialty neurology and autoimmune reference laboratory under Quest Diagnostics. Comparable to MitogenDx's neurological autoimmune testing (encephalitis, NMOSD, neuropathies), with stronger US payor relationships.

Emerging players

• Exagen Inc. Specialty diagnostics company focused on autoimmune diseases (especially lupus and rheumatoid arthritis) with proprietary testing. Comparable to MitogenDx's autoimmune niche, with a stronger commercial focus on rheumatology.
• ImmunoConcepts: Specialty manufacturer and laboratory focused on autoimmune diagnostics including ANA testing and line immunoassays. Comparable to MitogenDx in autoimmune test menu and IIF-based technologies, with a more product-focused model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/mitogen-diagnostics

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

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 Mitogen Diagnostics Corporation