Pro-Lab Diagnostics
Pro-Lab Diagnostics is a Canadian manufacturer and global distributor of clinical microbiology test kits, cryopreservation systems, women's health point-of-care tests, and general laboratory supplies, serving an estimated 15,000 hospitals across 45 countries via direct sales and a 50+ distributor network.
- Company typePrivate
- Founded1974
- HeadquartersRichmond Hill, Canada
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Pro-Lab Diagnostics does
Pro-Lab Diagnostics is a Canadian manufacturer and global distributor of clinical diagnostic test kits and laboratory supplies, headquartered in Richmond Hill, Ontario and operating three wholly-owned regional offices in Canada (Richmond Hill), the United Kingdom (Bromborough, Wirral), and the United States (Georgetown, TX). Founded in 1974, the company sells under the Prolex™, Microbank®, Prolisa™, Proflow™, AmnioTest™, PRO•Mcomplete™, Envirobead™, Pro-Loops™, and Vision™ brands across four product categories: clinical microbiology (latex agglutination kits, ELISA assays, Salmonella and Shigella antisera, staining reagents, sputum digestant, and cryopreservation systems), women's health/obstetrics (point-of-care tests for rupture of fetal membranes), molecular diagnostics (exclusive Canadian distribution of OptiGene Genie® instruments), and general lab supplies (inoculation loops, McFarland standards, biosafety transport envelopes, and autoclave deodorants).
The underlying technology spans latex agglutination, ELISA microwell immunoassays, lateral flow immunoassays, cryopreservation with color-coded bead storage, and isothermal nucleic acid amplification. Pro-Lab holds ISO 13485:2016 (MDSAP) certification and is registered with Health Canada's Therapeutic Products Directorate and the US FDA, with additional credibility signals including Microbank® selection for the European Space Agency's 2016 ExoMars mission. Products reach 15,000 hospitals across 45 countries through a hybrid go-to-market of direct sales in core English-speaking markets and a network of 50+ regional distributors across the rest of the world, complemented by OEM/private-label manufacturing partnerships with major multinational IVD companies. Founder/family ownership (Rae family in Chairman and Senior Vice President roles), no disclosed funding rounds, and absence of M&A activity indicate a cash-generating, owner-operated specialty diagnostics business rather than a venture-backed growth company.
Pro-Lab Diagnostics firmographics
Firmographics- Name
- Pro-Lab Diagnostics
- Legal name
- Pro-Lab Diagnostics Inc.
- Website
- https://pro-lab.com
- Company type
- Private
- Founded year
- 1974
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Pro-Lab Diagnostics is a Canadian manufacturer and global distributor of clinical microbiology test kits, cryopreservation systems, women's health point-of-care tests, and general laboratory supplies, serving an estimated 15,000 hospitals across 45 countries via direct sales and a 50+ distributor network.
- Ownership category
- akta.pro rank
Pro-Lab Diagnostics industry classification
Industry- Product category
- Clinical Diagnostics / In Vitro Diagnostics (IVD)
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Medical Equipment and Supplies Manufacturing (3391)
- 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), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Sample Logistics, Biorepository & IVD Kit Management (Trial Support) (HLAGAEAI), Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL), Release Testing & Batch Certification (QC) (HLAGADAC)
Keywords
Where Pro-Lab Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Richmond Hill
- HQ country
- Canada
- HQ region
- North America
Offices3 records
Markets served
Pro-Lab Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Operations, Supply Chain, Personnel, Technology or R&D, Marketing or Sales
Revenue model
- Diagnostic Products Sales: Sale of clinical diagnostic test kits, laboratory reagents, and supplies including microbiology products, women's health tests, and general lab supplies to hospitals, labs, and healthcare facilities worldwide.
- OEM/Private Label Manufacturing: Customized manufacturing and branding solutions for diagnostic equipment, aligning with distinctive requirements of OEM partners and many of the largest multinational IVD companies globally.
- Supply Distribution: Distribution of innovative products sourced from leading companies worldwide, providing laboratories access to latest advancements and technologies.
Go-to-market motion2 records
Distribution channels5 records
Marketing channels6 records
Pro-Lab Diagnostics product offering
Product offeringCore offering
Pro-Lab Diagnostics designs, manufactures, and globally distributes clinical diagnostic test kits, microbiology reagents, and laboratory supplies for hospitals, clinical laboratories, research institutions, and OEM/private-label IVD partners. Its proprietary product lines span latex agglutination (Prolex™), ELISA (Prolisa™), lateral flow (Proflow™), cryopreservation (Microbank®), and point-of-care obstetrics tests (AmnioTest™, PRO•Mcomplete™), distributed through a network covering 45 countries and 15,000 hospitals.
Product overview
Pro-Lab Diagnostics is a Canadian manufacturer and global distributor of clinical diagnostic products and laboratory supplies serving laboratories, hospitals, and research institutions. The product portfolio spans four main categories: Clinical Microbiology (Prolex™ latex agglutination kits, Prolisa™ ELISA assays, Microbank® cryopreservation system, Salmonella/Shigella antisera, Proflow™ lateral flow tests, Pro-Stains™, Mucolyse™, and Rabbit Coagulase Plasma), Women's Health (AmnioTest™ and PRO•Mcomplete™ for obstetrics/detection of fetal membrane rupture), Molecular Diagnostics (OptiGene instruments for isothermal nucleic acid detection), and General Lab Supplies (Pro-Loops™, McFarland Standards, Envirobead™, TransVelopes™, ProRax™). The company also offers private labeling/OEM manufacturing services and point-of-care training programs. Products are distributed to 45 countries serving 15,000 hospitals worldwide.
Differentiator
Problem solved
Functional benefit
Brands
- Prolex™: Latex agglutination kits and reagents for clinical microbiology including streptococcal grouping, staphylococci identification, Legionella detection, and E. coli diagnostics
- Microbank®
- Prolisa™
- Proflow™
- AmnioTest™
- PRO•Mcomplete™
- OptiGene
- Envirobead™
- Pro-Loops™
- McFarland Standards
- TransVelopes™
- ProRax™
- Vision™
- Mucolyse™
- Pro-Stains™
- TestOxidase™
Products and services
- Prolex™ Latex Agglutination A comprehensive suite of latex agglutination kits for bacterial identification including Streptococcal Grouping (groups A, B, C, D, F, G), Staphylococci identification, Legionella detection, and Enterohemorrhagic E. coli (O157 and non-O157 serotypes). Uses modified acid extraction reagents and colored carboxylated latex particles for rapid results. Used by clinical microbiology laboratories.
- Microbank® Ready-to-use cryopreservation system for storage and retrieval of bacterial and fungal cultures. Features specially formulated preservative for prolonged survival of fastidious cultures, color-coded beads in five colors for species/strain identification, and now available with 2D barcoding. Standard presentation includes 80 vials per box with up to 25 years of reliable storage. Used by clinical microbiology laboratories, research institutions, and even space missions (ISS, ESA ExoMars).
- Prolisa™ ELISA Assays (C. difficile GDH) Microwell enzyme immunoassay for qualitative detection of Clostridium difficile glutamate dehydrogenase (GDH) in fecal specimens, used as an aid in C. difficile infection diagnosis. Kit includes 96 tests per plate. Targeted at clinical microbiology laboratories performing CDI screening.
- Prolisa™ Quantitative Anti-SARS-CoV-2 IgG EIA Quantitative enzyme immunoassay for detection of human IgG antibodies against SARS-CoV-2 in serum and plasma (K2-EDTA, lithium heparin, citrate). Aids in identifying adaptive immune response indicating infection or vaccination. Kit contains 96 tests with IgG standards S1-S8. Targeted at clinical and reference laboratories performing COVID-19 serology.
- Proflow™ Lateral Flow Test Rapid, qualitative lateral flow immunoassay for detection of GDH antigen in stool specimens. Uses antibodies specific to GDH coated on membrane with gold particle conjugation for visual test line detection. Targeted at clinical microbiology laboratories performing C. difficile screening.
- Vision™ Salmonella Antisera Specialized reagents for identifying and classifying different strains of Salmonella bacteria. Includes Vision™ Polyvalent and Monovalent Somatic antisera, and Polyvalent/Monovalent Flagella antisera. Produced to World Health Organization guidelines for slide agglutination testing. Used by clinical microbiology and public health laboratories.
- Shigella Antisera Comprehensive range of Shigella antisera for slide agglutination testing. Includes Vision™ Polyvalent Shigella slide antisera for Sonnei, Flexneri, Dysenteriae, and Boydii strains. Produced to W.H.O. guidelines with long shelf life and certified reference center performance. Used by clinical microbiology and public health laboratories.
- Pro-Stains™ & Immersion Oil Microbiological staining solutions including Gram stains (Crystal Violet, Gram's Iodine, Safranin, Neutral Red), Acid Fast stains for Mycobacteria (ZN Carbol Fuchsin, Methylene Blue, Malachite Green, Auramine Phenol), Trichomonas stains, and immersion oil. Available in concentrated (x10) and ready-to-use formats. Used by clinical microbiology laboratories.
- Mucolyse™ Sputum Digestant Effective sputum digestant containing lyophilized Dithiothreitol and Phosphate Buffer. Each vial reconstitutes with 10 ml sterile water and dilutes to 100 ml active digestant solution. Supplied in packs of 10 vials. Used by clinical microbiology laboratories for respiratory sample preparation.
- Rabbit Coagulase Plasma Standard citrated and lyophilized product for detecting coagulase enzymes produced by Staphylococcus aureus. Available in multiple sizes (10 ml, 20 ml, 30 ml, and 10x3.0 ml pack). Used by clinical microbiology laboratories for S. aureus identification.
- AmnioTest™ Point-of-care diagnostic test for detecting rupture of fetal membranes using nitrazine yellow dye. The sterile swab detects elevation of vaginal pH consistent with amniotic fluid leakage. Provides results in approximately 15 seconds with up to 3-year shelf life. Targeted at obstetricians, midwives, and OB nurses for PROM/PPROM diagnosis.
- PRO•Mcomplete™ Diagnostic tool for detecting premature rupture of fetal membranes through identification of IGFBP-1 (Insulin-like Growth Factor-Binding Protein-1) and AFP (Alpha-Feto Protein) from amniotic fluid in vaginal swab samples. Targeted at obstetric care providers for PROM/PPROM diagnosis.
- OptiGene Genie® Molecular Diagnostic Instruments Molecular diagnostic instruments enabling rapid nucleic acid target detection without isolation. Includes Genie® II, Genie® III, and Genie® HT (high-throughput, competing with high-end PCR analyzers), supported by test strips and enzyme options including Isothermal Mastermixes, DNA polymerases, and Reverse Transcriptase. Pro-Lab is the exclusive Canadian distributor. Used by clinical and research laboratories.
- Pro-Loops™ Inoculation Tools Complete range of inoculation tools including calibrated nichrome wire loops with insulated handles, sterile disposable plastic loops and spreaders for laboratory specimen handling. Used by microbiology laboratories.
- McFarland Standards Turbidity standards used to adjust the density of bacterial suspensions. Supplied in protective carrying cases with up to two-year shelf life from date of manufacture. Used by clinical microbiology laboratories.
- Envirobead™ Autoclave Deodorant
Quantifiable outcome
- Products used in 45 countries serving 15,000 hospitals
- +2 more outcomes
Companies that use Pro-Lab Diagnostics
Customer profileNamed customers3 records
Segments5 records
Ideal customer profiles5 records
Pro-Lab Diagnostics technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature7 records
Pro-Lab Diagnostics partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core and notable.
- OptiGenecorePro-Lab is the exclusive Canadian distributor for OptiGene, offering their Genie® II, III, and HT instruments for rapid nucleic acid target detection without isolation, along with test strips and enzyme options including Isothermal Mastermixes, DNA polymerases, and Reverse Transcriptase.
- ESA (European Space Agency)notableESA's ExoMars Mission 2016 trusted the Pro-Lab Microbank® to store aliquots from pure cultures, demonstrating the product's reliability in extreme conditions and space environments.
- Universities worldwidecorePro-Lab partners with universities globally to supply medical devices required to support their R&D efforts, contributing to high-quality employment and medical advancement revenue.
Scale indicators3 records
Recent moves6 records
Expansion highlights5 records
Pro-Lab Diagnostics competitors and assessment
Company assessmentBroad incumbents
- bioMérieux: Global IVD leader with deep clinical microbiology, immunoassay, and molecular diagnostics franchises. Overlaps with Pro-Lab across nearly the full product portfolio and represents the dominant incumbent in hospital microbiology.
- Bio-Rad Laboratories: Global life science and clinical diagnostics company with a clinical microbiology and immunoassay portfolio that directly overlaps Pro-Lab's Prolex™ latex agglutination and Prolisa™ ELISA offerings. Represents the larger, listed incumbent competing in Pro-Lab's core segments.
- Thermo Fisher Scientific: Global life sciences leader offering diagnostic reagents, microbiology consumables (Oxoid, Remel), and analytical instruments. Its microbiology segment directly competes with Pro-Lab, and Thermo is also a likely OEM customer counterpart.
- Becton, Dickinson and Company (BD): Major medical technology company with a Diagnostic Systems segment spanning microbiology, molecular, and lab consumables. BD's MAX System, Phoenix M50, and culture media lines overlap with Pro-Lab's clinical microbiology offering.
- QuidelOrtho: Specialized IVD company focused on immunoassays, rapid diagnostics, and specialty clinical tests. Comparable to Pro-Lab's lateral flow (Proflow™) and ELISA (Prolisa™) franchises, though at significantly larger scale.
- Abbott Diagnostics: Global IVD giant spanning immunoassays, clinical chemistry, molecular, and POC diagnostics. Competes with Pro-Lab across hospital labs and women's health testing where Abbott's i-STAT and Alinity platforms are widely deployed.
Others
- OptiGene: UK-based molecular diagnostics developer of isothermal nucleic acid detection instruments (Genie® II/III/HT). Currently a channel partner whose Genie® instruments Pro-Lab exclusively distributes in Canada, but a potential future competitor as isothermal molecular platforms encroach on Pro-Lab's traditional immunoassay niches.
Direct peers
- EKF Diagnostics: UK-headquartered point-of-care and clinical diagnostics company of comparable size to Pro-Lab. EKF's portfolio of clinical chemistry, hematology, and infectious disease rapid tests overlaps with Pro-Lab's POC obstetrics and microbiology offerings.
- Hardy Diagnostics: California-based manufacturer of clinical microbiology products including culture media, reagents, and diagnostic kits. Directly comparable to Pro-Lab's clinical microbiology and lab consumables portfolio with similar mid-size, privately-held positioning.
- Rosco Diagnostica: Danish manufacturer of clinical microbiology products including antimicrobial susceptibility testing and IVD reagents. Rosco is also listed among Pro-Lab's distribution partners, but operates a directly comparable product portfolio in the same clinical microbiology niche.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
Pro-Lab Diagnostics social profiles
Digital presencePro-Lab Diagnostics compliance and trust
Trust signalCompliance1 record
Pro-Lab Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Pro-Lab Diagnostics leadership team
Management profileNumber of profiles
Profiles7 records
Pro-Lab Diagnostics subsidiaries and ownership
Company hierarchySubsidiaries2 records
Pro-Lab Diagnostics funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Pro-Lab Diagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Pro-Lab Diagnostics
What does Pro-Lab Diagnostics do?
Pro-Lab Diagnostics designs, manufactures, and globally distributes clinical diagnostic test kits, microbiology reagents, and laboratory supplies for hospitals, clinical laboratories, research institutions, and OEM/private-label IVD partners. Its proprietary product lines span latex agglutination (Prolex™), ELISA (Prolisa™), lateral flow (Proflow™), cryopreservation (Microbank®), and point-of-care obstetrics tests (AmnioTest™, PRO•Mcomplete™), distributed through a network covering 45 countries and 15,000 hospitals.
Is Pro-Lab Diagnostics a public or private company?
Pro-Lab Diagnostics is a private company. It is classified as family owned and is currently operating.
When was Pro-Lab Diagnostics founded?
Pro-Lab Diagnostics was founded in 1974. It employs 11 to 50 people.
Where is Pro-Lab Diagnostics based?
Pro-Lab Diagnostics is headquartered in Richmond Hill, Canada, in the North America region.
How does Pro-Lab Diagnostics make money?
Three revenue lines are on record. Diagnostic Products Sales are the primary driver. The others are OEM/Private Label Manufacturing and supply Distribution.
Who are Pro-Lab Diagnostics's main competitors?
Broad incumbents on record are bioMérieux, Bio-Rad Laboratories, Thermo Fisher Scientific, Becton, Dickinson and Company (BD), QuidelOrtho and Abbott Diagnostics. OptiGene is listed as an others. Direct peers are EKF Diagnostics, Hardy Diagnostics and Rosco Diagnostica.
Does Pro-Lab Diagnostics have an API?
No public API is recorded for Pro-Lab Diagnostics.
What industry is Pro-Lab Diagnostics in?
Pro-Lab Diagnostics's product category is Clinical Diagnostics / In Vitro Diagnostics (IVD). Its primary akta.pro industry code is HLAHAAAM, IVD Reagents, Assay Kits & Consumables (Non-instrument), with a secondary code of HLAGAIAI, Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes). Its NAICS code is 325413 and its SIC code is 2835.