Gentian Diagnostics AB

What Gentian Diagnostics AB does

Gentian Diagnostics ASA is a Norwegian in vitro diagnostics company (OSE: GENT) headquartered in Moss, Norway, with operating subsidiaries in Sweden (Gentian Diagnostics AB), the United States (Gentian USA Inc.), and China. Founded in 2006, the company develops and manufactures turbidimetric immunoassays using proprietary Particle-Enhanced Turbidimetric Immunoassay (PETIA) technology built around avian antibodies (IgY) purified from chicken egg yolk, eliminating complement, HAMA, and rheumatoid factor interference common to mammalian antibody-based diagnostics. Its portfolio addresses kidney disease (Cystatin C), inflammation and infection (GCAL® Calprotectin, the first turbidimetric assay for circulating calprotectin), nutrition and renal assessment (Retinol-Binding Protein), and veterinary diagnostics (Canine CRP); an NT-proBNP cardiac assay development program was terminated in May 2026.

Products are designed as open-channel, instrument-independent reagents compatible with a broad range of automated clinical chemistry analyzers (including Beckman Coulter and Mindray platforms), enabling deployment without proprietary instrument lock-in. Revenue is generated through direct sales to hospitals and clinical laboratories, OEM/embedded partnerships with IVD platform vendors, and distribution agreements — most notably a long-term faecal calprotectin partnership with Bühlmann Laboratories in the Nordics and a Beckman Coulter collaboration launched in March 2025. An exclusive development partnership with a leading global IVD company, announced in January 2026, targets commercial launch in H2 2027. YTD 2025 revenue of NOK 129.9 million (+19% YoY) and 9-month EBITDA of NOK 24.1 million indicate a profitable, scaling reagent business with strong international momentum, particularly in the US market.

Name

Gentian Diagnostics AB

Legal name

Gentian Diagnostics ASA

Website

https://gentian.com

Company type

Public

Founded year

2006

Operating status

Operating

Headcount range

1–10 employees

Short description

Gentian Diagnostics ASA is a Norwegian in vitro diagnostics company that develops and manufactures PETIA turbidimetric immunoassays using avian antibodies for kidney disease, inflammation, and veterinary diagnostics, sold globally through direct sales and OEM partners.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics Reagents

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834), Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)

akta.pro primary industry

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

Keywords

• In vitro diagnostics
• Clinical chemistry reagents
• Turbidimetric immunoassays
• Diagnostic biomarker assays
• Veterinary diagnostics

Headquarters

HQ city

Stockholm

HQ country

Sweden

HQ region

Europe

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Reagent Sales: Sale of IVD diagnostic reagents including Cystatin C, GCAL® Calprotectin, RBP, and Canine CRP assays. Products sold directly and through OEM/distribution partners. Revenue generated from product sales to laboratories, hospitals, and veterinary clinics globally.
2. OEM/Distribution Partnerships: Products distributed through OEM partners and distributors including Bühlmann Laboratories AG (Nordics), Beckman Coulter (GCAL partnership), and other regional distributors. Revenue share or direct sales to partners.
3. Partnership Development Revenue: Exclusive partnership for novel diagnostic assay development with global IVD company. Project advanced in development phase with commercial launch targeted H2 2027. Revenue expected upon launch through partner's global distribution network.

Pricing tiers

Go-to-market motion4 records

Distribution channels6 records

Marketing channels7 records

Core offering

Gentian Diagnostics develops, manufactures, and sells in vitro diagnostic (IVD) reagents — specifically turbidimetric immunoassays based on PETIA technology using avian antibodies — for use on automated clinical chemistry analyzers. Core products include GCAL® Calprotectin (inflammation), Cystatin C (kidney function), Retinol-Binding Protein (nutrition/renal), and Canine CRP (veterinary inflammation). The company also distributes Bühlmann, Mindray, and Certest products in the Nordics and sells to laboratories, hospitals, and OEM partners globally.

Product overview

Gentian Diagnostics is a Norwegian in vitro diagnostics company specializing in development and manufacturing of turbidimetric immunoassays for clinical chemistry analysers. The core product portfolio consists of PETIA-based diagnostic tests using avian antibodies: GCAL® Calprotectin (inflammation/infection marker), Cystatin C Immunoassay (kidney function), Retinol-Binding Protein Immunoassay (nutrition/renal), and Canine CRP Immunoassay (veterinary). NT-proBNP is under development for cardiac diagnostics. Products integrate with a wide range of automated clinical chemistry platforms including Beckman Coulter and Mindray. The company also distributes BÜHLMANN, Mindray, and Certest products in the Nordics through distribution partnerships.

Differentiator

Problem solved

Functional benefit

Brands

• GCAL Calprotectin: Plasma and serum calprotectin immunoassay for detection and assessment of inflammation and inflammatory response to infections
• Cystatin C Immunoassay
• Retinol-Binding Protein (RBP) Immunoassay
• Canine CRP Immunoassay

Products and services

• GCAL® Calprotectin Immunoassay Particle-Enhanced Turbidimetric Immunoassay (PETIA) for quantitative determination of calprotectin in plasma and serum, designed for automated clinical chemistry analyzers. Used for detection and assessment of inflammation and inflammatory response to infections. CE-marked and IVDR certified.
• Cystatin C Immunoassay Particle-Enhanced Turbidimetric Immunoassay using avian antibodies for automated determination of cystatin C in serum and plasma on clinical chemistry analyzers. Used for kidney function assessment and GFR estimation. ERM-DA471/IFCC standardized, FDA 510(k) cleared, IVDR certified.
• Retinol-Binding Protein (RBP) Immunoassay Turbidimetric assay for quantitative determination of retinol-binding protein in plasma and serum, with measuring range 7.8–139 mg/L and CV below 5%. Instrument-independent, FDA Exempt, CE-marked and UKCA-marked. Used for vitamin A status assessment, nutritional screening, renal health, and diabetes evaluation.
• Canine CRP Immunoassay Open channel turbidimetric assay for quantitative determination of canine C-reactive protein (CRP) in dog plasma and serum using canine-specific avian antibodies for high specificity. Validated across a broad range of clinical chemistry analyzers with measuring range up to 300 mg/L. FDA Exempt. Used by veterinary diagnostic laboratories, hospitals, and reference labs.
• Bühlmann Distributed Products (Nordics) Distribution of Bühlmann Laboratories AG products in Nordic markets including fCAL® turbo (faecal calprotectin), fPELA® turbo (pancreatic elastase), ACE Kinetic, GanglioCombi ELISA, anti-MAG Antibodies ELISA, and Flow CAST basophil activation test. Long-term partnership renewed April 2026.
• Mindray Distributed Laboratory Solutions (Nordics) Distribution of Mindray laboratory solutions for chemistry, chemiluminescence immunoassay, and haematology to customers across the Nordics through Gentian's distribution network.
• Certest Distributed Immunodiagnostic Products (Nordics) Distribution of Certest quantitative immunodiagnostic FOB and transferrin turbilatex methods to customers across the Nordics through Gentian's distribution network.

Quantifiable outcome

• 73% increase in Cystatin C sales in Q3 2025 vs Q3 2024
• +4 more outcomes

Named customers3 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

Feature6 records

Partnerships

Six partnerships are on record, tiered core and minor.

• Bühlmann Laboratories AGcoreChannel Partner/ Reseller/ Distributor · 20 April 2026Long-term faecal calprotectin partnership renewal. Bühlmann distributes Gentian's faecal calprotectin products. In Nordics, Gentian also distributes Bühlmann products including fCAL® turbo, fPELA® turbo, and other Bühlmann immunoassays.
• Leading Global IVD CompanycoreStrategic or Co-development Partner · 7 January 2026Exclusive cooperation agreement for development and manufacturing of novel diagnostic assay to be integrated on widely used clinical chemistry analyser platform. Project advanced in development with current activities focused on assay performance optimization and system integration. Target commercial launch H2 2027. Assay will be distributed through partner's global sales and distribution network.
• Beckman Coulter DiagnosticscoreTechnology or Integration · 10 March 2025Partnership to launch Gentian GCAL® Calprotectin Immunoassay on Beckman Coulter clinical chemistry platforms. This partnership brings innovative calprotectin biomarker to broad audience and ensures easy and fast routine access for laboratories and clinicians through Beckman Coulter's distribution network.
• ESSANGE REAGENTSminorStrategic or Co-development PartnerCollaboration agreement announced June 24, 2026. Details of collaboration not specified in available sources.
• MindrayminorChannel Partner/ Reseller/ DistributorGentian distributes Mindray laboratory solutions (chemistry, chemiluminescence immunoassay, haematology) to customers across Nordics. Mindray provides robust, cost-efficient, and easy-to-use laboratory solutions.
• CertestminorChannel Partner/ Reseller/ DistributorGentian distributes Certest quantitative immunodiagnostic FOB- and transferrin turbilatex methods to customers across Nordics.

Scale indicators12 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• DiaSys Diagnostic Systems: German-headquartered developer and manufacturer of turbidimetric and clinical chemistry reagents for automated analyzers; the closest direct comparable to Gentian's PETIA-based immunoassay portfolio and open-channel clinical chemistry strategy.
• Bühlmann Laboratories AG: Swiss specialty IVD company focused on calprotectin (fCAL) and related turbidimetric immunoassays for clinical chemistry analyzers; both partner and direct competitor to Gentian in fecal calprotectin, sharing the same clinical chemistry channels.
• Sentinel Diagnostics: Italian clinical diagnostics reagent manufacturer specializing in turbidimetric and immunoturbidimetric assays (including Cystatin C) for open-channel clinical chemistry platforms; directly comparable technology and channel strategy to Gentian.
• R-Biopharm AG: German clinical diagnostics company developing and distributing immunoassays and clinical chemistry reagents, including veterinary diagnostics; competes with Gentian in OEM and clinical laboratory channels and shares a similar SME IVD profile.

Broad incumbents

• Sekisui Diagnostics: Global IVD subsidiary of Sekisui Chemical offering clinical chemistry and immunoassay reagents across many disease areas; broad incumbent portfolio that overlaps Gentian's clinical chemistry and OEM go-to-market, though not focused on calprotectin/cystatin C niches.
• DiaSorin: Italy-headquartered global IVD company spanning immunoassay and molecular diagnostics with a public market listing; relevant broader incumbent competitor in specialty biomarkers and clinical chemistry adjacencies.
• Tosoh Bioscience: Division of Tosoh Corporation producing clinical chemistry analyzers, immunoassay reagents (including HLC and glycated hemoglobin) and dedicated clinical chemistry systems; competes broadly in the same laboratory channel as Gentian.
• FUJIFILM Wako Pure Chemical: Japanese IVD and life science reagent manufacturer with established clinical chemistry and diagnostic reagent lines; comparable as a broader incumbent in open-channel clinical chemistry reagents globally.

Emerging players

• Kamiya Biomedical Company: US-based specialty developer of veterinary and human immunoassays, including canine CRP and inflammation biomarkers; directly comparable emerging player in the canine CRP veterinary segment where Gentian competes.
• Diazyme Laboratories: US specialty IVD manufacturer offering clinical chemistry reagents (including cystatin C and inflammation biomarkers) for automated analyzers; emerging niche peer overlapping Gentian's biomarker portfolio with focus on open-channel reagents.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/GentianDiagnost

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries3 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 Gentian Diagnostics AB