Biomedica Diagnostics

What Biomedica Diagnostics does

BioMedica Diagnostics is a privately held specialty in vitro diagnostic (IVD) manufacturer focused on thrombosis and haemostasis, founded in 1999 and headquartered in Windsor, Nova Scotia, Canada. The company operates as a member of the Scotia Investments Family of Companies. Its product portfolio spans coagulation screening reagents (PT, APTT, fibrinogen, thrombin time under the QuikCoag brand), antiphospholipid syndrome diagnostics (DVVtest, DVVconfirm, ACTICLOT dPT), anticoagulant therapy monitoring assays (ACTICHROME Heparin Anti-FIIa and Anti-FXa), thrombotic risk markers, D-dimer/fibrinolysis tests, thrombotic thrombocytopenia purpura (TTP) diagnostics (ACTIFLUOR ADAMTS13, IMUBIND ADAMTS13), cancer prognosis ELISAs (FEMTELLE uPA/PAI-1), purified coagulation factors and antibodies for research, and chromogenic/fluorogenic substrates (SPECTROZYME, SPECTROFLUOR). Several products carry FDA 510(k), CE Mark, and/or Health Canada registrations, and the company documents assay precision metrics such as intra-assay CVs below 5.1% for its Heparin Anti-FXa assay and 4.1% for ADAMTS13 activity.

The company's underlying technology is grounded in classical diagnostic chemistries — chromogenic, fluorogenic, immunoassay (ELISA), and functional clotting assays — rather than computational or AI-based methods. BioMedica manufactures at a 49,000 sq ft ISO13485:2016 MDSAP-certified facility in Windsor with fully-automated manufacturing, dispensing, and freeze-drying capabilities.

BioMedica generates revenue through two primary streams: (1) one-time sale of branded diagnostic reagents, controls, calibrators, antibodies, and proteins to clinical laboratories and research institutions globally, sold directly and through a network of international distributors; and (2) contract manufacturing and OEM services offering bulk reagents, custom labeling, and private-label production to third-party diagnostic device manufacturers. The company is privately held under Scotia Investments, has not disclosed venture funding, and does not publish revenue figures. Its GTM motion is channel-partner-led, supported by trade show participation, a YouTube-based webinar series, and PDF product catalogs — with no public-facing API, SDK, or digital platform product.

Name

Biomedica Diagnostics

Legal name

BioMedica Diagnostics

Website

https://biomedicadiagnostics.com

Company type

Private

Founded year

1999

Operating status

Operating

Headcount range

11–50 employees

Short description

BioMedica Diagnostics is a private Canadian specialty IVD manufacturer of coagulation and thrombosis reagents, serving clinical laboratories, research institutions, and diagnostic OEMs via its ISO13485-certified facility, global distributor network, and multi-jurisdictional regulatory clearances.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics (Coagulation Reagents)

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Equipment and Supplies Manufacturing (3391)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841), Wholesale-Medical, Dental & Hospital Equipment & Supplies (5047)

akta.pro primary industry

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

akta.pro secondary industries

Hematology & Coagulation Diagnostics (HLAHAAAB), Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL), Laboratory Automation, Sample Prep & Liquid Handling (IVD Lab Diagnostics) (HLAHAAAN), Liquid Handling & Laboratory Automation (Pipettes, Robots, Workstations) (HLAGAIAD), Clinical Chemistry & Hematology Diagnostics (automated analyzers, blood testing) (HLAAALAH)

Keywords

• In vitro diagnostics reagents
• Thrombosis haemostasis assays
• Coagulation testing products
• Diagnostic contract manufacturing
• Anticoagulant therapy monitoring

Headquarters

HQ city

Windsor

HQ country

Canada

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Reagents and Assays: Sale of specialized in vitro diagnostic reagents for coagulation and thrombosis testing, including assays, controls, calibrators, antibodies, and proteins. Products are sold directly to laboratories and through distributor networks globally.
2. Contract Manufacturing and OEM: Custom manufacturing services including OEM and bulk materials for the diagnostics industry, leveraging their ISO13485:2016 MDSAP certified 49,000 square foot facility with fully-automated manufacturing, dispensing, and freeze-drying capabilities.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

BioMedica Diagnostics develops, manufactures, and sells in vitro diagnostic (IVD) reagents and research-use-only (RUO) assays for Thrombosis and Haemostasis testing, including chromogenic and fluorogenic substrates, functional clotting tests, ELISA immunoassays, controls and calibrators, purified coagulation factors, and antibodies. In parallel, the company provides custom and OEM contract manufacturing services leveraging its ISO 13485:2016 MDSAP-certified 49,000 sq ft facility with automated dispensing and freeze-drying capabilities.

Product overview

BioMedica Diagnostics is a manufacturer of in vitro diagnostic reagents and research products for thrombosis and haemostasis testing. The company operates a 49,000 square foot ISO13485:2016 MDSAP-certified manufacturing facility and offers a comprehensive portfolio organized into distinct product lines: (1) Coagulation screening reagents including QuikCoag® brand PT, APTT, Fibrinogen, and Thrombin Time tests; (2) Antiphospholipid Syndrome diagnostics including DVVtest®, DVVconfirm®, and ACTICLOT® dPT™; (3) Anticoagulant monitoring assays under the ACTICHROME® brand for Heparin (Anti-FIIa and Anti-FXa); (4) Thrombotic risk marker assays including ACTICHROME® TF, TFPI, AT-III, and ACTICLOT® Protein C, Protein S, and C; (5) Cancer prognosis products including FEMTELLE™ uPA/PAI-1 ELISA and IMUBIND® tissue factor/PAI-1/uPA ELISAs; (6) TTP diagnostics including ACTIFLUOR™ ADAMTS13 Activity and IMUBIND® ADAMTS13 ELISA; (7) D-dimer/ fibrinolysis testing including DIMERTEST® Latex, ACTISCREEN™ XL-FDP, and IMUCLONE™ D-dimer ELISA; (8) Quality control products including QuikCoag® Controls and Special/Routine Coagulation Controls; (9) Research reagents including purified coagulation factors, antibodies, and SPECTROZYME®/SPECTROFLUOR™ chromogenic and fluorogenic substrates. The products are distributed with various regulatory clearances including CE Mark, FDA 510(k) clearance, and Health Canada registration.

Differentiator

Problem solved

Functional benefit

Products and services

• ACTICHROME Heparin (Anti-FIIa and Anti-FXa) Activity Assays Chromogenic assays for quantitative determination of therapeutic heparin in human plasma via measurement of Factor IIa (Anti-FIIa) or Factor Xa (Anti-FXa) activity. Intended for clinical laboratories performing anticoagulant therapy monitoring.
• DVVtest and DVVconfirm Lupus Anticoagulant Testing System Screening (DVVtest) and confirmatory (DVVconfirm) coagulation reagents for determination of Lupus Anticoagulants in human plasma, used as primary tests for Antiphospholipid Syndrome.
• LAtrol LA Control Plasmas Lyophilized Lupus Anticoagulant control plasmas (Abnormal and Normal) used in daily quality control procedures for LA testing.
• ACTICLOT dPT Dilute Prothrombin Time Test Fully integrated dilute prothrombin time test for screening and confirming the presence of phospholipid-dependent lupus anticoagulant autoantibodies.
• Special and Routine Coagulation Control Plasmas (Multi-Parameter) Lyophilized control plasmas for monitoring performance of coagulation assays across multiple parameters including PT, APTT, TT, fibrinogen, and various clotting factors at normal and abnormal levels.
• Factor Deficient Plasmas Deficient (immunodepleted) plasmas including Antithrombin III, Factor VIII, Protein C, Protein S, TFPI, and tPA/PAI-1 used as reagents in coagulation factor assays.
• QuikCoag Routine Coagulation Reagents (APTT-EA, PT-HS, Fibrinogen, Thrombin Time, Calcium Chloride, Imidazole Buffer) Routine coagulation screening reagents under the QuikCoag brand for performing one-stage PT, APTT, fibrinogen (Clauss), thrombin time, recalcification, and plasma dilution steps in clinical coagulation testing.
• FEMTELLE uPA/PAI-1 ELISA Quantitative ELISA for measurement of human uPA and PAI-1 in breast tumor tissue extracts, used for breast cancer prognosis and recurrence risk assessment.
• ACTICHROME Thrombotic Risk Marker Assays (TF, TFPI, PLG, AT-III) Chromogenic assays for quantitative measurement of thrombotic risk markers including Tissue Factor (TF) procoagulant activity, TFPI, plasminogen, and antithrombin III in human plasma or cell lysates.
• ACTICLOT Protein C, Protein S, and Protein C Resistance (Factor V Leiden) Assays Functional clotting assays for quantitative determination of Protein C activity, Protein S activity, and activated Protein C resistance caused by Factor V Leiden mutation in human plasma.
• IMUBIND ELISAs (Tissue PAI-1, Plasma PAI-1, Thrombomodulin, Tissue Factor, uPA) ELISA kits for quantitative measurement of human Plasminogen Activator Inhibitor Type-1 (in tissue and plasma), thrombomodulin, and tissue factor across plasma, tissue extracts, and cell culture supernatants.
• IMUCLONE ELISAs (FPA, Free Protein S, Total TAFI) and SPECTROLYSE PAI-1 ELISA and chromogenic assays for measurement of Fibrinopeptide A, Free Protein S, Total TAFI antigen, and PAI-1 activity in human plasma and biological fluids, For Research Use Only.
• ACTIFLUOR ADAMTS13 Activity Assay FRET-based fluorescence assay for measurement of ADAMTS13 activity in human plasma, used for the differential diagnosis of Thrombotic Thrombocytopenia Purpura.
• IMUBIND ADAMTS13 ELISA ELISA for measurement of ADAMTS13 antigen in human plasma for the differential diagnosis of Thrombotic Thrombocytopenia Purpura.
• D-dimer Testing Portfolio (DIMERTEST Latex, ACTISCREEN XL-FDP, IMUCLONE D-dimer ELISA) D-dimer testing portfolio combining latex agglutination and ELISA formats for qualitative or semi-quantitative measurement of cross-linked fibrin degradation products in human plasma.
• SPECTROZYME Chromogenic and SPECTROFLUOR Fluorogenic Substrates Chromogenic and fluorogenic enzyme substrates for amidolytic assay of coagulation enzymes including C1-esterase, Factor IXa, Factor Xa, Plasmin, Thrombin, and tPA.
• Purified Coagulation Factors and Proteins Purified coagulation factors and proteins including Factor Va, VIIa, IXa, X, Xa, XIa, XIIa, Kallikrein, Plasmin, Plasminogen, Thrombin, Thrombomodulin, Tissue Factor, TFPI, and von Willebrand Factor.
• Coagulation Antibodies (Monoclonal and Polyclonal) Monoclonal and polyclonal antibodies targeting FVIIa, Factor VIII, Fibrin, Tissue Factor, and Gla amino acid residues for use in immunohistochemistry, immunoprecipitation, Western blot, flow cytometry, and immunofluorescence assays.
• IMUBIND Factor VIIa ELISA ELISA for quantitation of activated human Factor VII (FVIIa) in plasma and cell culture supernatants, For Research Use Only.
• Contract Manufacturing and OEM Services for Diagnostic Reagents Contract manufacturing and OEM services for diagnostic reagents, including bulk materials, custom formulations, and private labeling using an ISO 13485:2016 MDSAP-certified facility with automated dispensing and lyophilization.

Quantifiable outcome

• DVVtest/DVVconfirm lupus anticoagulant testing achieves 100% sensitivity and 97.9% specificity
• +2 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators2 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Diagnostica Stago: Global leader in hemostasis IVD with both reagents and automated analyzers (STA line). Most directly comparable specialty coagulation competitor to BioMedica's reagent portfolio, particularly in chromogenic and clotting-based assays.
• Siemens Healthineers: Offers the Atellica/BCS coagulation analyzer platform with proprietary reagents covering routine and specialty coagulation. Competes with BioMedica for hospital and reference lab reagent procurement.
• Sysmex Corporation: Hemostasis product line (CS-series analyzers plus reagents) targets the same clinical laboratory customers and assay menu (PT, APTT, D-dimer, lupus anticoagulant) that BioMedica serves with its QuikCoag and DVVtest lines.
• Precision BioLogic: Canadian specialty coagulation diagnostics company (Nova Scotia-based) focused on reagents for hemostasis, including cryocheck controls. Highly comparable in geography, therapeutic focus, and product mix.
• Roche Diagnostics: cobas t-series coagulation analyzers and accompanying reagent menu (PT, APTT, fibrinogen, D-dimer, factors). Large installed base in hospital labs creates bundled competition for BioMedica's standalone reagents.
• Werfen (Instrumentation Laboratory): Specialty hemostasis and acute care diagnostics through IL and ACL Elite product lines. Comparable to BioMedica in its deep focus on coagulation testing reagents and analyzer-reagent systems.
• Sekisui Diagnostics: Provides coagulation and specialty clinical chemistry reagents and controls globally. Comparable to BioMedica in supplying OEM-grade specialty IVD reagents and controls.
• Helena Laboratories: Specialty coagulation and hemostasis reagent manufacturer with focus on electrophoresis and clotting assays. Closely comparable in size and product-category focus to BioMedica.
• Trinity Biotech: Specialty IVD company focused on hemostasis reagents and diabetes diagnostics. Comparable in size and product overlap with BioMedica's coagulation franchise.
• Abbott Diagnostics: Provides coagulation reagents for use with Architect and other platforms. Competes in the routine and specialty coagulation reagent market that BioMedica serves.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@BiomedicaDiagnosticsInc
• Xx.com/biomedica_ns
• LinkedInlinkedin.com/company/biomedica-diagnostics-inc.

Compliance4 records

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 Biomedica Diagnostics