What Microbix Biosystems does

Microbix Biosystems Inc. is a Canadian life-sciences company founded in 1985 and headquartered in Mississauga, Ontario, that develops biological products and technologies for the infectious disease diagnostics market. The company's core offerings fall into four buckets: (1) native viral, bacterial and parasitic antigens sold as raw materials to IVD manufacturers, vaccine R&D groups and research institutions; (2) Quality Assessment Products (QAPs) under the REDx (IVD) and PROCEEDx (RUO) brands, available as liquid and Copan FLOQSwab formulations across respiratory, HPV, STI, gastrointestinal, genital ulcer and other disease panels; (3) QUANTDx characterized, quantified reference materials used by assay developers to establish LOD, sensitivity and specificity benchmarks; and (4) the Kinlytic (urokinase) clot-dissolving biologic being modernized for sBLA re-submission with Sequel Pharma targeting a 2028 market re-entry. Supporting services include aseptic custom vial filling (up to ~60,000 vials/day on the new automated line) and diagnostic assay development support for IVD manufacturers.

The underlying technology is industrial-scale viral and bacterial culture with downstream processing, anchored in ISO 13485:2016-certified BSL-2+ facilities and complemented by in-house synthetic biology (armoured RNA, recombinant protein expression, large genetic sequence design). Microbix holds exclusive rights to manufacture external quality controls on Copan's FLOQSwabs and its products have been validated on the leading IVD platforms of Abbott (Alinity m HR HPV), BD (Onclarity HPV), Hologic (ThinPrep PreservCyt) and Seegene. Products are CE marked, FDA registered, TGA certified, UKCA marked and Health Canada licensed, and ship to more than 30 countries.

The business model is B2B, quote-based, and one-time-purchase oriented rather than subscription-based. Revenue is generated through direct sales to IVD manufacturers, clinical labs and EQA/proficiency-testing providers, complemented by a global distributor network and a contract aseptic filling service. The company serves more than 280 customers worldwide with a catalogue of 500+ products, and is publicly listed on the TSX (MBX) and OTCQX (MBXBF).

Name

Microbix Biosystems

Legal name

Microbix Biosystems Inc.

Website

https://microbix.com

Company type

Public

Founded year

1985

Operating status

Operating

Headcount range

101–250 employees

Short description

Microbix Biosystems is a Canadian life-sciences manufacturer founded in 1985 that supplies infectious disease antigens, quality assessment products (QAPs), and characterized reference materials to IVD manufacturers, clinical laboratories, and EQA providers in 30+ countries.

Ownership category

akta.pro rank

Product category

Infectious Disease Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Microbiology & Infectious Disease Diagnostics (culture, rapid antigen, syndromic panels) (HLAAALAC)

Keywords

• In vitro diagnostics
• Infectious disease antigens
• Quality assessment products
• Diagnostic reference materials
• Viral transport medium

Headquarters

HQ city

Toronto

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, Infrastructure, Marketing or Sales

Revenue model

1. Antigen Sales: Sale of native viral, bacterial, and parasitic antigens used as key ingredients for manufacturing diagnostic tests and external quality control materials. Antigens also serve vaccine R&D and applied research applications.
2. Quality Assessment Products (QAPs): Sale of external quality controls (QAPs) designed to emulate patient samples, including IVD (REDx) and RUO (PROCEEDx) product lines for quality control in diagnostic testing
3. Reference Materials (QUANTDx): Sale of quantified, traceable reference materials for assay development, validation, and performance benchmarking
4. Vial Filling Services: Aseptic custom filling services for liquids at pilot and commercial scale, accommodating various fill volumes with batch sizes up to approximately 60,000 vials
5. Kinlytic (Urokinase): Clot-dissolving drug being developed for market re-entry, working with Sequel Pharma and CDMO for manufacturing modernization and sBLA preparation

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

Microbix Biosystems develops and manufactures biological products for the infectious disease diagnostics market, producing native antigens, external quality assessment products (QAPs) under REDx and PROCEEDx brands, quantified reference materials (QUANTDx), and viral transport medium (DxTM). The company also offers aseptic custom vial filling services at pilot and commercial scales and is revitalizing Kinlytic (Urokinase), a clot-dissolving biologic drug, for market re-entry. Products are designed for IVD diagnostic manufacturers, clinical laboratories, EQA providers, and research institutions across more than 30 countries.

Product overview

Microbix Biosystems is a life sciences company founded in 1985, offering a portfolio of infectious disease diagnostic products and biological solutions. The core product offering comprises four main categories: (1) Antigens — native viral, bacterial, and parasitic antigens for immunoassay development, organized into panels including ToRCH, Childhood Disease, Dengue, Respiratory, STI, and Other Infectious Disease antigens; (2) External Quality Controls (QAPs) under the REDx (IVD) and PROCEEDx (RUO) brands, available as liquid and Copan FLOQSwab formulations across panels including Respiratory Viral/Bacterial, STI, HPV, Gastrointestinal, Genital Ulcer, and Vaginal Infection; (3) QUANTDx Reference Materials — quantified, traceable reference materials for assay development and validation across Fungal, Respiratory, STI, HPV, Gastrointestinal, Meningitis, and Sample Process Control panels; and (4) Kinlytic (Urokinase) — a clot-dissolving biologic drug being revitalized for market re-entry. Supporting services include Aseptic Custom Vial Filling (pilot and commercial scale up to 60,000 vials/day), Diagnostic Assay Development Services for IVD manufacturers, and ONBOARDx onboarding kits. The DxTM Viral Transport Medium and Control Elution Buffer round out the product ecosystem. The company holds ISO 13485:2016 and ISO 9001:2015 certifications and ships to 30+ countries.

Differentiator

Problem solved

Functional benefit

Brands

• QAPs™: Quality Assessment Products for external quality controls in diagnostic testing
• QUANTDx™
• REDx™
• PROCEEDx™
• ONBOARDx™
• DxTM™
• Kinlytic (Urokinase)

Products and services

• Antigens One of the industry's most extensive portfolios of infectious disease antigens covering viral, bacterial, and parasitic products for diagnostic assay manufacturing, vaccine R&D, and applied research. Antigens are purified and inactivated to eliminate infectivity while maintaining antigenicity, available in panels including ToRCH, Childhood Disease, Dengue, Respiratory, STI, and Other Infectious Diseases.
• External Quality Controls (QAPs) - REDx (IVD) and PROCEEDx (RUO) brands Quality Assessment Products (QAPs) designed to emulate patient samples using native pathogens or synthetic genomes, available in ready-to-use liquid and swab (Copan FLOQSwab) formulations. The REDx IVD brand is CE marked for ongoing QC, operator training, and end-to-end workflow evaluation, while the PROCEEDx RUO brand supports assay verification, validation, training, and R&D applications. Products span Respiratory Viral/Bacterial, STI, HPV, Gastrointestinal, Genital Ulcer, and Vaginal Infection panels.
• QUANTDx Reference Materials Characterized reference materials formulated with highly concentrated, quantified, and traceable inactivated pathogens. Ideal for benchmarking assay performance during development and establishing analytical metrics such as LOD, sensitivity, and specificity. Majority quantified using digital PCR. Spans Fungal, Respiratory, STI, HPV, Gastrointestinal, Meningitis, and Sample Process Control panels.
• DxTM Viral Transport Medium IVD medical device designed for the secure collection and transport of specimens. Only available for sale in Canada.
• Control Elution Buffer Stable sample elution buffer used as an intermediate step for preparing control swab formulations in validation/verification protocols, including the swab sample elution step.
• Kinlytic (Urokinase) Clot-dissolving drug (urokinase) undergoing manufacturing modernization and supplemental Biologics License Application (sBLA) preparation for market re-entry targeted in 2028, in collaboration with Sequel Pharma and a contract development organization.
• Aseptic Custom Vial Filling Services Aseptic custom filling services for pilot and commercial scale, offering two production lines: a development/pilot scale line (10,000 vials per day, semi-automated, flexible) and a commercial scale line (60,000 vials per day, fully automated, includes capping and labelling). Batch sizes range from hundreds to approximately 10,000 vials.
• Diagnostic Assay Development Services End-to-end solutions for IVD manufacturers supporting assay development from R&D through commercialization, including characterized raw materials, custom-developed controls (white-label), analytical and clinical validation support, assay manufacturing scale-up, and commercial launch support via ONBOARDx kits and external quality controls.

Quantifiable outcome

• Products stable at ambient temperature for two years
• +3 more outcomes

Named customers8 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration5 records

Feature5 records

Partnerships

Eight partnerships are on record, tiered minor, core and major.

• Seegene CanadaminorGTM or Marketing Partner · 20 April 2026Featured guest on Microbix's 'Diagnostics: Beyond the Lab' Season 2 podcast discussing diagnostic technology adoption in Canada.
• EMQN (UK)minorGTM or Marketing Partner · 20 April 2026Featured guest on Microbix's 'Diagnostics: Beyond the Lab' Season 2 podcast discussing quality assessment for genetic testing in the UK.
• Kirby Institute (Australia)minorGTM or Marketing Partner · 20 April 2026Featured guest on Microbix's 'Diagnostics: Beyond the Lab' Season 2 podcast discussing community health outreach initiatives in Australia.
• Sequel PharmacoreStrategic or Co-development Partner · 10 March 2026Microbix works with Sequel Pharma to advance its Kinlytic clot-dissolving drug, modernizing manufacturing methods and preparing for a supplemental biologics license application (sBLA) submission targeting market re-entry in 2028.
• College of American Pathologists (CAP)coreStrategic or Co-development Partner · 10 February 2026Microbix has been selected by CAP to supply quality assessment products (QAPs) for CAP's clinical laboratory proficiency-testing programs. Multiple SKUs of Microbix's QAPs have been provided to CAP and are now being used at subscriber clinical laboratories, with plans to expand offerings throughout fiscal 2026. CAP is the world's largest association of board-certified pathologists with approximately 20,000 members.
• Seegene MexicomajorStrategic or Co-development Partner · 3 December 2025Microbix and Seegene Mexico announced a collaboration to support the clinical use of their molecular HPV detection assays through quality assessment products. The partnership aims to improve HPV screening and cervical cancer prevention efforts in Mexico and other regions.
• SEKISUI DiagnosticscoreStrategic or Co-development Partner · 12 November 2025Microbix is supporting SEKISUI Diagnostics' U.S. commercialization of a COVID/Flu molecular test with its REDxFLOQ QAPs, which help ensure test accuracy and compliance. The test detects SARS-CoV-2, Influenza A, and Influenza B within 20 minutes using the Metrix platform.
• CopancoreTechnology or IntegrationExclusive partnership where Copan's FLOQSwabs are used exclusively in Microbix's growing line of swab-formatted QAPs. Products are desiccated on FLOQSwabs for room-temperature stability and wide storage range (2-30°C).

Scale indicators11 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• ZeptoMetrix (Antylia Scientific): Specializes in infectious disease antigens, inactivated viruses, and quality controls for IVD manufacturers — directly overlapping with Microbix's antigen and QAP portfolio across respiratory, STI, and ToRCH panels.
• The Native Antigen Company (LGC Group): Supplies native and recombinant viral and bacterial antigens for diagnostic assay development, vaccine research, and immunoassay manufacturing — a direct competitor in the infectious disease antigen market.
• SeraCare (LGC Group): Provides reference materials, serology QC controls, and proficiency testing materials for IVD manufacturers and clinical labs — closely comparable to Microbix's QUANTDx reference materials and QAP lines.
• Maine Molecular Quality Controls (MMQC): Develops molecular quality controls and proficiency testing samples for infectious disease assays, overlapping with Microbix's PROCEEDx RUO controls and laboratory proficiency testing panels.
• Vircell: Spanish manufacturer of infectious disease antigens, controls, and molecular diagnostics reagents for clinical labs and IVD manufacturers — directly comparable in size, focus, and product mix to Microbix.
• Sino Biological: Major Asian supplier of recombinant antigens, antibodies, and QC reagents for diagnostic and research use — competes with Microbix in antigen catalogs and reference materials across infectious disease panels.

Broad incumbents

• Bio-Rad Laboratories: Global life sciences leader with extensive infectious disease QC, molecular diagnostics controls, and clinical lab products — a broad incumbent whose Unity QC and molecular controls overlap with Microbix's QAPs and reference materials.
• QuidelOrtho: Large diagnostics company offering immunoassay and molecular infectious disease tests, plus associated QC controls across its Triage, Sofia, and Savanna platforms — broader portfolio than Microbix but overlapping in QC consumables.
• LGC Group: Life sciences measurement and testing company that has consolidated the QC and antigen market through acquisitions of SeraCare and Native Antigen Company — a scaled incumbent competing head-to-head with Microbix.
• Bio-Techne: Diversified life sciences tools and diagnostics company whose proteins, antibodies, and assay reagents overlap with Microbix's antigen and reference material offerings for infectious disease and immunology research.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/microbix
• Facebookfacebook.com/microbixbiosystems
• LinkedInlinkedin.com/company/342321

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds7 records

Investors2 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 Microbix Biosystems