What Orgentec Diagnostika does

Orgentec Diagnostika GmbH is a Mainz, Germany-headquartered in-vitro diagnostics (IVD) company founded in 1988 that develops, manufactures, and markets test systems for laboratory diagnostics, with particular depth in autoimmune and infectious disease testing. Its core product platform is the Alegria® family of random-access ELISA analyzers, including the next-generation Alegria® 2, which runs proprietary SMC® (Sensotronic Memorized Calibration) Monotest strips containing complete reagent sets with barcode-encoded lot-specific calibration, cut-off controls, and expiration data. The company complements the automated Alegria platform with over 200 manual ELISA kits, immunofluorescence (IFT/IFA) assays using HEp-2 cells and tissue substrates, and branded specialty tests including Anti-MCV® and Anti-CCP hs® for rheumatoid arthritis, Anti-dsDNA for SLE, fecal calprotectin for IBD/IBS differentiation, and 25-OH Vitamin D3/D2. The full portfolio exceeds 300 laboratory tests across rheumatology, thrombosis, vasculitis, gastroenterology, thyroid, diabetes, and infectious serology.

The business model is B2B sale of IVD reagents, kits, and analyzers to medical laboratories in more than 100 countries. Distribution is hybrid: direct sales via own employees or branches in Germany, Austria, Hungary, France, and Switzerland, with an established distributor network in other international markets. Post the September 2021 acquisition by Sebia Group — a French IVD leader in protein electrophoresis — Orgentec operates as a wholly-owned subsidiary and Sebia legal entity aligned with the parent brand as of 2024, while remaining the legal manufacturer of its products from Mainz. Quality management is certified to ISO 13485, all IVD products carry CE marking, and the company participates in external proficiency programs (INSTAND, UK NEQUAS, RCPA, ÖQUASTA). Customer base is fragmented across clinical and medical diagnostic laboratories, served in part via the myAlegria technician/distributor portal and supported by literature services and conference presence at events such as the International Congress on Autoimmunity.

Name

Orgentec Diagnostika

Legal name

ORGENTEC Diagnostika GmbH

Website

https://orgentec.com

Company type

Private

Founded year

1988

Operating status

Operating

Headcount range

11–50 employees

Short description

Orgentec Diagnostika is a Mainz, Germany-based in-vitro diagnostics company developing automated ELISA analyzers (Alegria®) and over 300 autoimmune and infectious disease tests, serving medical laboratories in 100+ countries as a wholly-owned subsidiary of Sebia Group since 2021.

Ownership category

akta.pro rank

Product category

Clinical Diagnostics Reagents

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Autoimmune, Allergy & Specialized Immunology Diagnostics (HLAHAAAK)

akta.pro secondary industries

Immunoassay Diagnostics (ELISA, chemiluminescence, serology) (HLAAALAB), Microbiology & Infectious Disease Diagnostics (culture, rapid antigen, syndromic panels) (HLAAALAC)

Keywords

• Autoimmune diagnostics
• Infectious disease testing
• ELISA test systems
• Immunofluorescence assays
• Automated immunoassay analyzers

Headquarters

HQ city

Mainz

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. In-vitro Diagnostic Products: Sale of diagnostic test systems including ELISA test kits, immunofluorescence tests, automated analyzers (Alegria®), and reagents. Products are sold directly to medical laboratories and through distribution partners.
2. Quality Control Reagents: Sale of control reagents for monitoring Alegria® system performance, including multi-parameter specific serum controls for daily internal quality control in autoimmune laboratories.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels4 records

Core offering

Orgentec Diagnostika develops, manufactures, and markets in-vitro diagnostic test systems and reagents for clinical laboratories. Its portfolio centers on autoimmune and infectious disease diagnostics, delivered through ELISA microplate tests, immunofluorescence assays, and the fully automated Alegria® random-access analyzer platform based on its proprietary SMC® technology.

Product overview

Orgentec Diagnostika offers a comprehensive portfolio of in vitro diagnostic products for autoimmune and infectious disease testing. The core platform is the Alegria® automated laboratory system, available in two generations (Alegria® and Alegria® 2), which uses proprietary SMC® Technology with Monotest strips for flexible, random-access testing. Supporting this platform are over 200 manual ELISA test systems and immunofluorescence (IFT/IFA) assays covering rheumatology, thrombosis, vasculitis, gastroenterology, thyroid, and diabetes diagnostics. The company also provides stool diagnostics (calprotectin), bone metabolism tests (Vitamin D), infectious disease serology panels, and autoimmune quality controls. All products are manufactured at the Mainz facility and distributed to laboratories in over 100 countries.

Differentiator

Problem solved

Functional benefit

Brands

• Alegria®: Fully automated laboratory diagnostic system using monotest technology for autoimmune diagnostics and infectious serology.
• Alegria® 2
• SMC® Technology (Sensotronic Memorized Calibration)

Products and services

• Alegria® Random-Access Analyzer Fully automated, random-access bench-top immunoassay analyzer that processes SMC®-based single-test strips for autoimmune and infectious serology. Designed for mid-volume clinical and hospital laboratories seeking walk-away automation.
• Alegria® 2 Analyzer Next-generation version of the Alegria® analyzer offering higher throughput and connectivity features for routine autoimmune and infectious disease testing in clinical laboratories.
• ELISA Test Systems Microplate-based enzyme-linked immunosorbent assay kits used by clinical laboratories for the qualitative and quantitative detection of autoantibodies and infectious-disease markers in patient samples.
• Immunofluorescence Assays (IFA) Substrate slides and配套 reagents for indirect immunofluorescence detection of autoantibodies, used by specialized immunology laboratories for confirmatory testing.
• Autoimmune Diagnostic Reagents Broad menu of test kits covering autoimmune markers such as ANA, ANCA, ENA, dsDNA, and other disease-specific autoantibodies, available across ELISA, IFA, and Alegria® SMC® strip formats.
• Infectious Disease Diagnostic Reagents Serology kits for infectious disease markers including borreliosis (Lyme disease), EBV, Helicobacter pylori, and other pathogens, offered in ELISA and Alegria® SMC® formats for clinical labs.
• OrgSys Software Laboratory middleware software for controlling Alegria® analyzers, managing test orders, processing results, and supporting laboratory information system workflows.

Quantifiable outcome

• More than 60 million Alegria® tests performed in over 80 countries
• +4 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature4 records

Scale indicators8 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• EUROIMMUN (PerkinElmer): EUROIMMUN, now part of Revvity/PerkinElmer, is one of the world's leading manufacturers of autoimmune diagnostics with a broad ELISA, immunofluorescence, and blot test portfolio. It is the most direct comparable to ORGENTEC in autoimmune IVD product mix and target customer (medical laboratories).
• Trinity Biotech: Trinity Biotech offers a portfolio of autoimmune and infectious disease diagnostic tests, with ELISA and immunofluorescence products. It serves clinical laboratories globally and overlaps with ORGENTEC in autoimmune serology and infectious disease diagnostics.
• Inova Diagnostics (Werfen): Inova Diagnostics, owned by Werfen, specializes in autoimmune disease diagnostics including ELISA, immunofluorescence, and multiplex assays. It directly competes with ORGENTEC in rheumatology, vasculitis, and connective tissue disease serology panels served to clinical laboratories.
• AESKU Diagnostics: AESKU Diagnostics develops and markets autoimmune diagnostic test systems including ELISA and immunofluorescence products. It is a niche-focused direct peer to ORGENTEC with comparable target customers (clinical laboratories) and overlapping autoimmune test menus.
• ZEUS Scientific: ZEUS Scientific manufactures ELISA and immunofluorescence test systems focused on autoimmune and infectious disease diagnostics. It is a direct peer to ORGENTEC in product format (manual ELISA kits, IFA substrates) and customer base (specialty clinical labs).

Others

• Tecan: Tecan is a leading manufacturer of laboratory automation instruments and OEM platforms for IVD companies. It is comparable to ORGENTEC as a provider of automated analyzer hardware used in clinical labs, though Tecan operates as an enabler and instrument supplier rather than a direct autoimmune diagnostics competitor.

Broad incumbents

• Roche Diagnostics: Roche Diagnostics is the world's largest IVD manufacturer with cobas and Elecsys immunoassay platforms covering a comprehensive autoimmune and infectious serology menu. It competes with ORGENTEC for hospital laboratory budgets but as a broad-line incumbent offering full laboratory automation.
• Thermo Fisher Scientific (Phadia): Thermo Fisher Scientific, through its Phadia / ImmunoCAP allergy and autoimmune franchise, is a major broad-line IVD player in autoimmune diagnostics. It overlaps with ORGENTEC in autoimmune testing but serves a much larger customer base via fully automated high-throughput platforms.
• Abbott Diagnostics: Abbott Diagnostics operates a broad IVD portfolio including Architect and Alinity immunoassay systems that include autoimmune and specialty serology panels. It competes with ORGENTEC in clinical laboratories but as a diversified diagnostics incumbent rather than an autoimmune specialist.
• Bio-Rad Laboratories: Bio-Rad Laboratories is a broad life science and clinical diagnostics company with a meaningful autoimmune and infectious disease testing portfolio, including the BioPlex 2200 multiplex system. It competes with ORGENTEC in specialty autoimmune serology but as part of a much wider IVD and research product portfolio.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/ORGENTEC
• YouTubeyoutube.com/user/ORGENTECMainz
• LinkedInlinkedin.com/company/orgentec-diagnostika-gmbh

Compliance2 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&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Orgentec Diagnostika