RefLab

What RefLab does

RefLab ApS is a privately held Danish biotechnology laboratory headquartered in Hvidovre, Denmark, operating since 1991 with approximately 11 team members across leadership, scientific, technical, and administrative functions. The company operates two integrated business lines: a Service Laboratory that performs diagnostic testing for clinicians using the proprietary Basophil Histamine Release Assay (BHRA), and a Contract Research Organization (CRO) that provides preclinical and clinical research services to biotech and pharmaceutical companies. RefLab is a member of the R-Biopharm Group, a larger diagnostic network.

The core technology is the BHRA platform, delivered in two accredited variants: the allergen-induced BHRA (a-BHRA, marketed as HR-Test) for identifying specific allergens causing allergic symptoms, and the serum-induced BHRA (s-BHRA, marketed as HR-Urticaria Test) for detecting autoantibodies against IgE and the IgE receptor in patients with chronic spontaneous urticaria (CSU). For CRO work, RefLab deploys a proprietary human ex vivo skin model that enables prediction of first-in-human immune and adverse immune responses, including pseudo-allergic reactions, supporting investigations into dermal drug delivery, hypersensitivity reactions, and local metabolism. Both BHRA variants are accredited by DANAK under ISO/IEC 17025:2017, and the company holds ISO 13485:2016 certification enabling CE-labeled in vitro diagnostic (IVD) product manufacturing in compliance with EU IVDR.

RefLab monetizes through three revenue streams: (1) pay-as-you-go service laboratory testing fees from healthcare professionals who submit patient serum samples with requisition forms, with pricing set at requisition time and VAT-exempt for most services; (2) tailored contract research project fees from biotech and pharmaceutical clients, with each study scoped to regulatory and scientific requirements; and (3) one-time sales of CE-labeled IVD reagent kits and accessories (buffers, calibration plates, stop reagent, IL-3) for laboratory use. Customers include hospitals, allergy and immunology specialists, private companies requiring diagnostic testing, and pharma/biotech firms requiring translational human models for drug development. The company is dual-led by Co-CEOs Katrine Baumann (CSO) and Gert Pynt (CCO), with founder Per Stahl Skov continuing as Scientific Advisor.

Name

RefLab

Legal name

RefLab ApS

Website

https://reflab.dk

Company type

Private

Founded year

1991

Operating status

Operating

Headcount range

1–10 employees

Short description

RefLab is a Danish private laboratory operating as a specialty diagnostics service lab and CRO. Using its proprietary Basophil Histamine Release Assay (BHRA) and human ex vivo skin model, it serves clinicians diagnosing allergy and chronic urticaria, and biotech/pharma clients running preclinical research.

Ownership category

akta.pro rank

Product category

Allergy and Urticaria Diagnostic Laboratory Services

NAICS

Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Central Laboratory & Clinical Trial Testing CROs (HLAGAAAE)

akta.pro secondary industry

Preclinical CROs (Discovery/Pharmacology/DMPK) (HLAGAAAB)

Keywords

• Allergy diagnostics testing
• Urticaria diagnostic assays
• Contract research services
• Preclinical safety testing
• In vitro diagnostics

Headquarters

HQ city

Copenhagen

HQ country

Denmark

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Service Laboratory Testing: RefLab operates a service laboratory providing diagnostic testing for allergy and chronic spontaneous urticaria. Healthcare professionals submit patient samples (blood/serum) along with requisition forms. RefLab performs the basophil histamine release assay (BHRA) and returns results through a secure mail system. Pricing is exclusive of VAT for most services.
2. Contract Research Services: CRO services for biotech and pharmaceutical companies including preclinical screening packages, clinical testing, and biological standardization of allergens. Each study is tailored to meet scientific and regulatory requirements. Services cover dermal drug delivery, hypersensitivity reactions, and local metabolism investigations.
3. In Vitro Diagnostic Products: RefLab develops and manufactures CE-labeled in vitro diagnostic products compliant with IVDD and IVDR. Products include reagent kits, buffers, calibration plates, and accessories for the BHRA testing system. Certified under DS/EN ISO 13485:2016.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

RefLab operates a diagnostic service laboratory performing the proprietary Basophil Histamine Release Assay (BHRA) in two variants — allergen-induced (a-BHRA / HR-Test) for allergy diagnosis and serum-induced (s-BHRA / HR-Urticaria Test) for chronic spontaneous urticaria — processing patient blood/serum samples submitted by clinicians. It also runs a contract research organization (CRO) offering preclinical and clinical testing services built on human ex vivo skin models and the BHRA, supporting biotech and pharmaceutical drug development. The company additionally manufactures and sells CE-labeled in vitro diagnostic reagent kits for performing BHRA testing.

Product overview

RefLab offers two distinct service lines: a Service Laboratory providing diagnostic testing using the basophil histamine release assay (BHRA), and a Contract Research Organization (CRO) providing preclinical research services. The BHRA platform comes in two variants: a-BHRA (HR-Test) for allergy diagnosis and s-BHRA (HR-Urticaria Test) for chronic spontaneous urticaria diagnosis. RefLab also manufactures and sells CE-labeled in vitro diagnostic reagent kits (Pipes Buffer, Wash Buffer, OPA Disc, Diluent, Stop Reagent, IL-3, Calibration Plate, and Reagent Kit) for laboratory use. The CRO services leverage the same human ex vivo models for preclinical drug development.

Differentiator

Problem solved

Functional benefit

Brands

• HR-Test: Allergen-induced basophil histamine release assay (a-BHRA) for diagnosing patients with allergy.
• HR-Urticaria Test

Products and services

• BHRA Service Laboratory Testing (Allergy and CSU) Diagnostic service laboratory in which clinicians submit patient blood or serum samples with requisition forms for RefLab to perform the Basophil Histamine Release Assay (BHRA); results are returned through a secure mail system. Used by hospitals, allergy/immunology specialists, and clinical laboratories for allergy and chronic spontaneous urticaria diagnosis.
• Allergen-induced BHRA (a-BHRA / HR-Test) Variant of the BHRA service used to diagnose patients with allergies by detecting allergen-specific IgE-mediated reactions through basophil histamine release. Targeted at clinicians needing identification of specific allergens suspected of eliciting allergic symptoms.
• Serum-induced BHRA (s-BHRA / HR-Urticaria Test) Variant of the BHRA service used to diagnose patients with chronic spontaneous urticaria (CSU) by detecting autoantibodies directed against IgE and the IgE receptor. Targeted at allergists, dermatologists, and immunologists managing CSU patients.
• Contract Research Services (CRO) CRO services built on RefLab's human ex vivo skin model and BHRA, enabling prediction of first-in-human immune and adverse immune responses (including pseudo-allergic reactions) for new therapeutics. Each study is tailored to meet the scientific and regulatory requirements of biotech and pharmaceutical clients across dermal drug delivery, hypersensitivity reactions, and local metabolism investigations.
• Preclinical Screening Package Defined CRO service package using human ex vivo models to investigate allergic side effects of new therapeutics, dermal drug delivery, local pharmacodynamic effects, and local metabolism in the preclinical phase. Targeted at biotech and pharmaceutical R&D teams.
• BHRA Reagent Kit (CE-labeled IVD) CE-labeled in vitro diagnostic product comprising reagents (calibration plate, diluent, wash buffers, stop reagent, IL-3 components) for performing the basophil histamine release assay. Manufactured under DS/EN ISO 13485:2016 and marketed in compliance with IVDD and IVDR.

Quantifiable outcome

• Accurate diagnosis of chronic spontaneous urticaria using serum-induced BHRA
• +1 more outcomes

Named customers3 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

Feature4 records

Partnerships

One partnership is on record.

• R-Biopharm GroupcoreOthersRefLab is a member of R-Biopharm Group, a diagnostic company network. This membership provides RefLab with association to a larger diagnostic company group while maintaining independent operations as a specialized allergy and urticaria testing laboratory and CRO.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• ICON plc: Global CRO and clinical services organization supporting pharma/biotech development across all phases. Comparable to RefLab via its clinical research services and central laboratory operations, though operating at vastly larger scale and broader therapeutic coverage.
• Thermo Fisher Scientific: Diversified life sciences tools and CRO services provider through PPD and Thermo Fisher Clinical Diagnostics. Comparable to RefLab via its clinical diagnostics and contract research services portfolios, including allergy/IgE testing on much larger scale.
• Charles River Laboratories: Global CRO providing preclinical and clinical laboratory services to pharmaceutical and biotechnology companies. Comparable to RefLab's CRO arm offering preclinical safety and translational research, though at vastly larger scale across many therapeutic areas.
• IQVIA: Global CRO and clinical research services provider with extensive laboratory and bioservices capabilities. Comparable to RefLab's contract research and clinical testing work as part of a comprehensive clinical development offering for pharma/biotech sponsors.
• Eurofins Scientific: Global leader in bioanalytical testing and contract laboratory services across pharma, food, and clinical diagnostics. Comparable to RefLab as a reference laboratory and CRO serving biotech/pharma with allergy and immunology-adjacent assays as part of a much broader testing portfolio.

Emerging players

• Inotiv: Preclinical CRO specializing in toxicology, safety assessment, and translational research models. Comparable to RefLab's preclinical CRO services offering around hypersensitivity and predictive immunology models, though with broader therapeutic and model coverage.
• Celerion: Specialty CRO focused on early-phase clinical pharmacology and bioanalytical services. Comparable to RefLab's clinical testing arm and translational research services for biotech/pharma sponsors requiring specialized assay capabilities.

Direct peers

• Omega Diagnostics: UK-based diagnostics company developing IVD kits for food intolerance, allergy, and infectious disease. Comparable to RefLab's IVD reagent business given overlapping allergy/intolerance focus, clinical laboratory channel, and CE-marked product commercialization.
• Bühlmann Laboratories: Swiss-based specialty diagnostic company focused on allergy and gastroenterology IVD kits (e.g., CALPROTECTIN, Allergen-specific IgE). Directly comparable to RefLab as a niche allergy-diagnostics manufacturer with proprietary assays and CE-marked products serving clinical labs.
• Stallergenes Greer: Global allergy diagnostics and immunotherapy company that develops and commercializes allergy tests and therapeutics. Directly comparable to RefLab in the allergy diagnostics space, with overlapping focus on allergen identification and physician-facing diagnostic tools.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/reflab-aps/?viewAsMember=true

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 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 RefLab