Affinity Diagnostics

What Affinity Diagnostics does

Affinity Diagnostics Corp is a privately held Canadian distributor of clinical diagnostic testing products headquartered in Toronto, Ontario. Founded in 2006, the company sources a catalog of more than 200 assay products spanning eight specialty categories — Bone & Mineral Metabolism, Therapeutic Drug Monitoring, Endocrinology, Gastroenterology, Infectious Disease, Neuroscience, Oxidative Stress, and Specialty Products — from two core manufacturer partners: Immundiagnostik AG (Germany) and Tecan/IBL International GmbH (Switzerland). Its offerings consist of enzyme immunoassays (ELISA), HPLC assays, LC-MS/MS assays, radioimmunoassays (RIA), photometric assays, calibrator/control sets, stool preparation consumables, research proteins (including HMGB1 variants), and antibodies, all third-party manufactured and resold to Canadian clinical laboratories and research institutions.

The company's customers are primarily clinical laboratories, with showcase reference relationships displayed on its website including large Canadian healthcare systems and reference labs such as University Health Network (UHN), Hospital for Sick Children (SickKids), Mount Sinai Hospital, LifeLabs, Dynacare, Hamilton Health Sciences, Alberta Health, as well as international logos (Cleveland Clinic, Amgen). The business operates on a quote-based B2B pricing model with no public price lists, supported by direct sales, a product inquiry workflow, and a content marketing strategy built around health-education articles on gut health, mental health, hormonal balance, and neurotransmitter function. The company is incorporated in Ontario, Canada, with 1-10 employees, no external funding rounds, no M&A history, and no disclosed certifications, patents, or regulatory clearances of its own.

Name

Affinity Diagnostics

Legal name

Affinity Diagnostics Corp

Website

https://affinitydiagnostics.ca

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

1–10 employees

Short description

Affinity Diagnostics is a privately held Toronto-based distributor, founded in 2006, that resells clinical diagnostic assay kits (ELISA, HPLC, LC-MS/MS, RIA) sourced from Immundiagnostik AG and Tecan/IBL International to Canadian clinical laboratories and research institutions across eight specialty categories.

Ownership category

akta.pro rank

Product category

Clinical Diagnostics Distribution

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers (423450)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

akta.pro secondary industries

Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI), Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL)

Keywords

• Clinical diagnostics distribution
• Diagnostic assay kits
• ELISA test kits
• LC-MS/MS assays
• Laboratory testing products

Headquarters

HQ city

Toronto

HQ country

Canada

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Supply Chain, Operations, Personnel, Marketing or Sales, Infrastructure

Revenue model

1. Diagnostic Testing Products: Revenue generated from sale of clinical diagnostic assay kits, ELISA products, HPLC assays, LC-MS/MS assays, and related laboratory testing products to clinical laboratories and healthcare institutions. Products sourced from partner manufacturers including Immundiagnostik AG and Tecan/IBL International GmbH.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Affinity Diagnostics distributes and supplies clinical diagnostic assay kits and research-based testing material sourced from top-tier manufacturers (Immundiagnostik AG and Tecan/IBL International GmbH) to clinical laboratories across Canada. Its portfolio spans ELISA, HPLC, LC-MS/MS, and RIA technologies covering bone & mineral metabolism, therapeutic drug monitoring, endocrinology, gastroenterology, infectious disease, neuroscience, oxidative stress, and specialty products. The company emphasizes a relationship-based service model in which customer support continues beyond product shipment.

Product overview

Affinity Diagnostics is a Canadian distributor of clinical diagnostic testing solutions, offering a comprehensive portfolio of testing products across eight specialized categories: Bone & Mineral Metabolism, Therapeutic Drug Monitoring, Endocrinology, Gastroenterology, Infectious Disease, Neuroscience, Oxidative Stress, and Specialty Products. The company's offerings primarily consist of enzyme immunoassays (ELISA), HPLC assays, LC-MS/MS assays, and radioimmunoassays (RIA) sourced from top-tier manufacturers including Immundiagnostik AG, IBL International GmbH, and TECAN. Their product line includes diagnostic assays for biomarkers such as calprotectin, CRP, zonulin, vitamin D, TNFα, and hepcidin; research proteins including HMGB1 variants (BoxA, BoxB, Fully reduced, Disulfide forms); antibodies; calibrator and control sets (Tec-Trace™); and stool preparation consumables (IDK Extract®). These products serve clinical laboratories for patient diagnostics as well as research institutions conducting biomedical research.

Differentiator

Problem solved

Functional benefit

Products and services

• Calprotectin ELISA Enzyme immunoassay for quantitative determination of calprotectin (MRP 8/14, S100A8/A9) in plasma and serum samples, used by clinical laboratories for inflammatory bowel disease and related diagnostic testing.
• C-Reactive Protein (CRP) ELISA Enzyme immunoassay for quantitative determination of C-reactive protein in plasma, serum, stool, dried blood spot, and urine samples for clinical diagnostics.
• Zonulin ELISA Enzyme immunoassay for quantitative determination of zonulin family peptides in serum samples, used to assess intestinal permeability and gut barrier function.
• 25-Hydroxy (25-OH) Vitamin D3/D2 RP-HPLC Assay RP-HPLC assay for quantitative determination of 25-hydroxy vitamin D3 and D2 in serum and plasma for bone and mineral metabolism testing.
• Vitamin C HPLC Assay HPLC assay for quantitative determination of vitamin C (ascorbic acid) in plasma samples for oxidative stress and nutritional status assessment.
• Tumor Necrosis Factor (TNFα) ELISA Enzyme immunoassay for quantitative determination of TNFα in plasma, serum, stool, and cell culture supernatant for assessment of inflammatory conditions.
• Hepcidin 25 LC-MS/MS Assay LC-MS/MS assay for quantitative determination of hepcidin-25, used by clinical laboratories to differentiate iron deficiency anemia from anemia of chronic disease.
• PerOx (TOS/TOC) Photometric Assay Photometric assay for quantitative determination of total oxidative status/capacity in serum, plasma, and cell culture supernatant for oxidative stress testing.
• HMGB1 Express ELISA Enzyme immunoassay for quantitative determination of HMGB1, a biomarker for tissue damage, inflammation, and drug-induced liver failure.
• cAMP RIA Radioimmunoassay for quantitative determination of cyclic adenosin-3',5'-monophosphate (cAMP) in plasma and urine for parathyroid function assessment.
• BoxA from HMGB1 (Various Sizes) Recombinant BoxA protein derived from HMGB1, supplied LPS-free, used in research related to HMGB1 signaling of tissue damage and regeneration.
• BoxB from HMGB1 (Various Sizes) BoxB DNA binding domain of HMGB1 that recapitulates cytokine activity and activates macrophages to release TNF and proinflammatory cytokines, for research use.
• Fully reduced HMGB1 (Various Sizes) Fully reduced HMGB1 protein with chemoattractant activity for inflammatory cells and tissue repair, supplied LPS-free for research use.
• Disulfide HMGB1 (Various Sizes) Disulfide HMGB1 containing a disulfide bond between C23 and C45 that induces cytokine and chemokine production in inflammatory cells, for research use.
• Anti-HMGB1 [DPH1.1] Monoclonal Antibody Monoclonal antibody targeting HMGB1, used in research to block HMGB1-elicited cell migration.
• Tec-Trace Calibration and Control Sets Calibrator and control sets for LC-MS/MS assays including vitamins, methylmalonic acid, metanephrines, cortisol, and cortisone, distributed under the Tecan/IBL International brand.
• IDK Extract Stool Preparation Tubes Stool preparation system using a proprietary Universal Extraction Buffer for extraction of stool samples, enabling determination of multiple parameters from a single extraction.
• Myostatin ELISA Enzyme immunoassay for quantitative determination of myostatin in serum and plasma for muscle metabolism research and bone-related biomarker studies.
• Triiodothyronine (T3) ELISA Enzyme immunoassay for quantitative determination of triiodothyronine (T3) in serum for thyroid dysfunction diagnosis.
• Symmetric Dimethylarginine (SDMA) ELISA Enzyme immunoassay for quantitative determination of symmetric dimethylarginine (SDMA), a biomarker of renal dysfunction.

Quantifiable outcome

• Committed to positive impact on patient care through laboratory success
• +1 more outcomes

Named customers9 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• Immundiagnostik AGcoreTechnology or IntegrationManufacturer partner providing diagnostic assay products distributed by Affinity Diagnostics. Products include IDK Extract stool preparation systems, ID-Vit vitamin assays, and various ELISA kits. Immundiagnostik AG is a German biotech company specializing in clinical diagnostic assays.
• Tecan/IBL International GmbHcoreTechnology or IntegrationManufacturer partner supplying Tec-Trace calibration and control products, LC-MS/MS assays, and specialty diagnostic products. Tecan is a Swiss instrumentation company with IBL International as diagnostic division.

Scale indicators2 records

Recent moves4 records

Expansion highlights4 records

Direct peers

• Calbiotech: Calbiotech is a specialty manufacturer/distributor of ELISA kits and immunoassays for clinical and research labs, with a comparable specialty-assay distribution model and shared customer profile with Affinity.
• ALPCO: ALPCO is a US-based specialty distributor/manufacturer of ELISA and immunoassay kits targeting clinical and research endocrinology, metabolism, and inflammation testing — directly comparable to Affinity's specialty IVD kit distribution model across overlapping therapeutic areas.
• MyBioSource: MyBioSource is a distributor/manufacturer of ELISA kits, antibodies, and clinical diagnostic reagents serving research and clinical labs — directly comparable as a specialty diagnostic product distributor with similar catalog breadth.
• Cayman Chemical: Cayman Chemical supplies ELISA kits, assay reagents, and specialty biochemicals to clinical and biomedical research laboratories, overlapping Affinity's specialty assay portfolio across oxidative stress, inflammation, and metabolism areas.
• DRG International: DRG International manufactures and distributes ELISA and RIA diagnostic kits for endocrinology, infectious disease, and autoimmunity — directly comparable specialty IVD catalog targeting clinical laboratories.
• Eagle BioSciences: Eagle BioSciences manufactures and distributes niche ELISA, RIA, and clinical chemistry assay kits to clinical and research laboratories — closely comparable in scale, product category, and customer profile to Affinity Diagnostics.

Broad incumbents

• Tecan (IBL International): Tecan, through its IBL International diagnostics division, is a manufacturer and global distributor of immunoassays, ELISA/RIA kits, and calibrators for clinical labs — overlapping Affinity's specialty catalog, and is also a direct supplier to Affinity, making it both a partner and competitor.
• Bio-Rad Laboratories: Bio-Rad is a major life science and clinical diagnostics manufacturer and distributor with broad IVD and specialty assay portfolios — overlapping with Affinity across immunoassay and clinical chemistry categories but at much larger scale.
• Thermo Fisher Scientific: Thermo Fisher operates broad life sciences, reagents, and clinical diagnostics divisions serving clinical and research laboratories globally — a much larger incumbent with overlapping SKU categories including ELISA kits, calibrators, and specialty immunoassays.
• Bio-Techne (R&D Systems): Bio-Techne, through its R&D Systems brand, is a large established manufacturer and distributor of ELISA kits, reagents, and proteins for life-science and clinical customers — overlapping product categories across multiple Affinity therapeutic segments at materially greater scale and breadth.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat2 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/affinity-diagnostics-corp

Revenue estimate

Valuation estimate

Number of profiles

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 Affinity Diagnostics