ProBioQual

What ProBioQual does

ProBioQual (legal name L'association PRO.BIO.QUAL) is a non-profit association registered under French law 1901 with the Prefecture of Rhône (W691066392), founded in 1972 by hospital pharmacists from Lyon's hospitals specializing in clinical biology. The organization is headquartered at 7 Rue Antoine Lumière, 69008 Lyon, and is governed by a 10-member board of directors and a 5-member bureau, with operations supported by 16 staff and more than 30 volunteer expert biologists serving as program coordinators. It provides External Quality Assessment (EEQ) programs that enable French medical biology laboratories to meet NF EN ISO 15189 requirements, serving 1,329 laboratory sites in 2025.

The product portfolio centers on 67 EQA programs covering 370+ exam types across biochemistry, immunology, pharmacology-toxicology, hematology, hemostasis, infectious serology, bacteriology, and spermiology, of which 45 are accredited under COFRAC's ISO 17043 program (accreditation No. 1-5587, since 2014, current cycle 2025-2028). Statistical processing follows Algorithm A of ISO 13528:2022 with a proprietary Long Term CV method for measurement uncertainty, and the organization supports automated result transmission via HPRIM, HL7, MSSanté, and (from 2026) CDA formats. Complementary offerings include the HABI staff qualification assistance program and the PBQ-FC continuing education division (Qualiopi-certified since 2020, ANDPC-registered), and a digitized slide platform for cytology evaluation.

ProBioQual monetizes almost exclusively through recurring annual subscriptions, with program fees ranging from €140 to €1,500 depending on complexity and number of analytes, plus ancillary kit fees and a 5% volume discount for orders ≥€6,000 per site. Customer segments are private and public medical biology laboratories, medical biologists seeking DPC-funded continuing education, and laboratory technicians requiring qualification. The organization is independent, with stated no commercial policy and no ties to medical biology industrialists or financial groups, and is a member of EQALM and FAEEQ.

Name

ProBioQual

Legal name

L'association PRO.BIO.QUAL

Website

https://probioqual.com

Company type

Private

Founded year

1972

Operating status

Operating

Headcount range

11–50 employees

Short description

ProBioQual is a non-profit association founded in 1972 in Lyon, France, providing ISO 17043-accredited External Quality Assessment programs and continuing education to over 1,329 medical biology laboratory sites across France.

Ownership category

akta.pro rank

Product category

External Quality Assessment (Medical Laboratory Quality Control)

NAICS

Testing Laboratories and Services (54138)

SIC

Services-Testing Laboratories (8734)

akta.pro primary industry

Laboratory Quality & GLP/GCLP Compliance (HLAGAKAK)

Keywords

• External quality assessment
• Medical biology laboratory
• Proficiency testing programs
• Clinical laboratory quality control
• Medical laboratory accreditation

Headquarters

HQ city

Lyon

HQ country

France

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. EQA Program Subscriptions: Annual subscription fees for External Quality Assessment programs covering biochemistry, immunology, hematology, hemostasis, serology, bacteriology, and spermiology disciplines. Programs range from €140 to €1,500 per year depending on complexity and number of analytes.
2. Staff Empowerment Programs: Annual subscription fees for staff qualification assistance programs (HABILITATION), including cytology of hemogram and CSF, priced at €200 per tranche of 15 users
3. Continuing Education Training: Continuing education sessions for medical biologists and technicians, with potential DPC (Continuous Professional Development) funding from national healthcare agencies

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

ProBioQual provides External Quality Assessment (EEQ) programs for medical biology laboratories, comprising 67 programs (45 COFRAC-accredited under ISO 17043) covering more than 370 examinations across biochemistry, immunology, hematology, hemostasis, serology, bacteriology, and spermiology. The offering is complemented by staff qualification assistance (HABI) using digitized cytology slides and DPC-eligible continuing education (PBQ-FC) training days. Customers subscribe annually, submit results through a web application, and receive statistical reports within 15 days computed via ISO 13528:2022 Algorithm A.

Product overview

ProBioQual is a non-profit association (French law 1901) founded in 1972, offering a comprehensive portfolio of External Quality Assessment (EEQ) programs for medical biology laboratories. The core offering consists of 67 EQA programs covering 370+ examinations across eight disciplines: Biochemistry, Immunology, Pharmacology-Toxicology, Hematology, Hemostasis, Infectious Serology, Bacteriology, and Spermiology. Of these, 45 programs are COFRAC-accredited under ISO 17043. Complementing the EQA portfolio are two staff empowerment (HABI) programs for personnel qualification in cytology, and continuing education (PBQ-FC) training days for medical biologists and technicians. The organization operates under a platform model where laboratories access programs through a web application for result entry, statistical processing via ISO 13528:2022 methods, and report retrieval. Results can be transmitted automatically via HPRIM/HL7/MSSanté/CDA standards.

Differentiator

Problem solved

Functional benefit

Brands

• ProBioQual-FC: Continuing Education in Clinical Biology division of ProBioQual, offering professional development training for medical biologists and laboratory technicians.

Products and services

• EEQ - Évaluation Externe de la Qualité (External Quality Assessment Programs) Core External Quality Assessment programs providing proficiency testing for medical biology laboratories. Includes 67 programs (45 accredited) covering biochemistry, immunology, pharmacology-toxicology, hematology, hemostasis, serology, bacteriology, and spermiology disciplines. Each program offers statistical analysis, expert biologist commentary, z-scores, and measurement uncertainty calculations. Used by private and public medical biology laboratories to meet NF EN ISO 15189 and French regulatory requirements.
• HABI - Aide à l'Habilitation du Personnel (Staff Qualification Assistance) Staff empowerment assistance programs providing personnel qualification support for biologists, technicians, and medical residents. Includes digitized slide evaluation with clinical context, reference values, acceptable limits, and nominative result extraction for administrators. Covers cytology of blood count (HCHF) and cerebrospinal fluid (HCLCR) at €200 per tranche of 15 users. Used by laboratories to support staff habilitation and inter-operator comparability assessment.
• PBQ-FC - Formation Continue en Biologie Médicale (Continuing Education in Medical Biology) Continuing education in medical biology for private and public medical biologists and laboratory technicians. Full-day training sessions covering bacteriology, biochemistry, hematology, immunology, virology, quality assurance, informatics, instrumentation, and legislation topics to meet DPC requirements. Delivered at venues including Hôtel Mercure Lyon and Palais des Congrès de Paris.
• CQH - Biochimie Sérique (Serum Biochemistry) Serum biochemistry quality control program covering 62 analytes across chemistry, lipids, and proteins. Includes neonatal bilirubin evaluation. Features 22 surveys per year with 18-31 analytes per survey, priced at €550/year. Adapted to all analyzers measuring serum indices.
• HMPO - Hémostase (Hemostasis) Hemostasis quality control program for common hemostasis and thrombosis examinations. Covers prothrombin time, activated cephalin time, fibrinogen, factors, antithrombin, proteins C and S, and thrombin time across 10 surveys with 20 samples annually.
• NUM - Numération Sang stabilisé (Complete Blood Count) Complete blood count quality assessment using stabilized blood samples. Evaluates leukocytes, erythrocytes, hemoglobin, hematocrit, platelets, and reticulocytes with inter-laboratory comparison by peer groups. Priced at €350 per year.
• CIMD - Marqueurs Tumoraux et Hormonologie Générale (Tumor Markers and General Hormonology) Tumor markers and general hormonology quality control program covering ACE, CA markers, cardiac markers, hormones (cortisol, estradiol, FSH, LH, testosterone, TSH), and vitamins. First kit priced at €520 per year, additional kit at €250.
• HIL - Indices Sériques (Serum Indices) Serum indices quality assessment for hemolysis, icterus, and lipemia interference evaluation. Adapted to all analyzers measuring serum indices across chemistry, hemostasis, and serology instruments.
• New EEQ Programs 2025 (HELI, ETG, ARGA, BDDI) Four new EQA programs introduced in 2025: HELI (13C urea breath test for H. pylori), ETG (Urinary Ethylglucuronide), ARGA (Argatroban), and BDDI (Decentralized Biology - D-Dimers option). Each program extends the EEQ portfolio into new examination types within ProBioQual's existing disciplines.
• TIH and PDF Programs (2023) Two new hemostasis EQA programs introduced in 2023: TIH (Anti-PF4 Antibodies for heparin-induced thrombocytopenia diagnosis) and PDF (Fibrin and Fibrinogen Degradation Products). Each program provides inter-laboratory comparison for specialized hemostasis examinations.
• MONO - Fibrin Monomers Program (2020) MONO Fibrin Monomers EQA program introduced in 2020, providing inter-laboratory comparison for fibrin monomer measurement within the hemostasis discipline.

Quantifiable outcome

• 1,329 laboratory sites participate in programs in 2025
• +3 more outcomes

Named customers2 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

Integration4 records

Feature3 records

Partnerships

Three partnerships are on record, tiered core and minor.

• EQALMcoreOthersProBioQual is a member of EQALM (European Organization for External Quality Assurance Schemes in Laboratory Medicine), contributing to European quality assurance standards and collaboration.
• FAEEQ (Fédération des Associations d'EEQ)coreOthersProBioQual is a member of FAEEQ, the Federation of EQA Associations, coordinating with 5 other non-profit associations (Asqualab, Association de Biologie Praticienne, Biologie Prospective, CTCB, GBMHM) to offer standardized EQA programs under the FAEEQ umbrella.
• ARBRE (Association Rhônalpine des Biologistes de la Reproduction)minorStrategic or Co-development PartnerProBioQual collaborated with ARBRE to create the Spermiology (SPE) EQA program, combining expertise in reproductive biology quality control.

Scale indicators8 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Biologie Prospective: FAEEQ-aggregated French EQA association providing proficiency testing schemes across clinical biology disciplines. Overlaps directly with ProBioQual's subscription-based program portfolio.
• Asqualab: French non-profit EQA provider and fellow FAEEQ member offering inter-laboratory comparisons for medical biology labs in France. Direct competitor to ProBioQual on overlapping hematology, biochemistry, and serology proficiency testing programs.
• GBMHM: French medical biology association offering inter-laboratory comparisons and continuing education. Competes with ProBioQual for laboratory accreditation support and biologist CPD.
• Association de Biologie Praticienne: French EQA association grouped under FAEEQ umbrella with accredited inter-laboratory comparison programs for medical biology laboratories. Competes head-to-head for the same French laboratory customer base.
• CTCB (Centre Toulousain de Contrôle de Qualité): FAEEQ member offering quality control programs for French medical biology laboratories. Direct domestic peer covering similar ISO 17043-accredited proficiency testing in overlapping disciplines.

Emerging players

• Labquality: Finnish-based commercial EQA provider (formerly Labquality) extending accredited proficiency testing and digital platforms across Europe. Comparable ISO 17043 portfolio but with a commercial, scaling delivery model.

Regional players

• WEQAS: Welsh EQA provider serving UK and some international markets with clinical chemistry and hematology proficiency testing. Comparable non-profit model and program scope but UK-centric.

Broad incumbents

• Referenzinstitut für Bioanalytik (RfB): German reference institute for bioanalytics running extensive proficiency testing schemes used internationally. Comparable ISO 17043 scope to ProBioQual, focused on clinical chemistry and immunology.
• INSTAND e.V. German non-profit promoting quality assurance in medical laboratories with broad international EQA reach. Comparable scope to ProBioQual but operating cross-border across multiple European countries.
• UK NEQAS: Largest UK-based EQA provider offering hundreds of accredited proficiency testing programs globally. International incumbent with deeper program breadth and global footprint than ProBioQual.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/probioqual

Compliance6 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 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 ProBioQual