Medipan & GA Generic Assays

What Medipan & GA Generic Assays does

Medipan GmbH (founded 1992) and GA Generic Assays GmbH (founded 2002 by Professor Dr. Dirk Roggenbuck) operate as two sister, family-owned companies under a shared website and management, headquartered in Blankenfelde-Mahlow (south of Berlin) with an additional production office in Senftenberg. Together they develop, manufacture, and distribute immunodiagnostic test kits and automated systems for autoimmune and infectious disease diagnostics, distributing in over 70 countries through a direct international sales team and flagship trade shows (MEDICA, MedLab Middle East). The portfolio spans five core assay methods — ELISA, IFA, RIA/IRMA, LINE/Dot, and lateral-flow rapid tests — covering more than 20 autoimmune indications including thyroid disease, Type-1 Diabetes, rheumatoid arthritis, ANCA-associated vasculitis, antiphospholipid syndrome, celiac disease, Crohn's disease, and Myasthenia gravis.

The technical core consists of two proprietary platforms. First, the AKLIDES system (launched 2009 as the world's first commercial fully automated cell-based IFA evaluation platform), now extended by akiron NEO for automated IFA imaging and evaluation and DotDiver 2.0 for automated LINE/Dot processing. Second, the patented CytoBead technology, which combines cell-based immunofluorescence for screening with antigen-coated microparticles for differentiation and confirmation in a single serum step, replacing conventional two-step workflows. A newer modular AI-supported fluorescence microscopy system is in development, funded in part by EFRE public subsidies, integrating intelligent control and evaluation software with high-performance optics for automated autoimmune diagnostics. All products are CE marked and positioned to comply with IVDR (EU) 2017/746.

The business model is a hybrid of consumables and capital equipment sales: one-time diagnostic kit sales and hardware sales of AKLIDES/akiron NEO/DotDiver 2.0 systems to medical laboratories, physicians, hospitals, and research institutes, supplemented by EU and Land Brandenburg public R&D funding (EFRE, GRW, JTF). Go-to-market is enterprise field sales via named international sales managers and regional trade-show presence rather than digital self-serve. Distribution is direct rather than channel-led, with co-development validation through academic partnerships (Charité Berlin, TU Dresden, BTU Cottbus). Pricing is not publicly disclosed and no enterprise customer concentration was identified in the source data.

Name

Medipan & GA Generic Assays

Legal name

Medipan GmbH | GA Generic Assays GmbH

Website

https://medipan.de

Company type

Private

Founded year

1992

Operating status

Operating

Headcount range

51–100 employees

Short description

Medipan & GA Generic Assays are sister family-owned German IVD companies developing and distributing ELISA, IFA, RIA, LINE/Dot, and rapid diagnostic test kits and automated systems (AKLIDES, akiron NEO, DotDiver 2.0, CytoBead) for autoimmune and infectious disease detection across 70+ countries.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics — Autoimmune Disease Diagnostics

NAICS

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

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)

akta.pro primary industry

Autoimmune, Allergy & Specialized Immunology Diagnostics (HLAHAAAK)

akta.pro secondary industries

Clinical Chemistry & Immunoassay Systems (HLAHAAAA), Immunoassay Diagnostics (ELISA, chemiluminescence, serology) (HLAAALAB)

Keywords

• Autoimmune diagnostics
• Immunoassay test kits
• Immunofluorescence assays
• ELISA diagnostic kits
• Rapid lateral flow tests

Headquarters

HQ city

Dahlewitz

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Test Kits: Manual and automatable medical test kits including ELISA, RIA, IFA, Rapid Tests, and LINE/Dot assays sold to medical laboratories, physicians, and research institutions globally.
2. Automated Diagnostic Systems: Sale of automated diagnostic systems including AKLIDES and related instruments for laboratory automation.
3. Public Funding for R&D: Development projects supported by European Regional Development Fund (EFRE), GRW market expansion funds, and Just Transition Fund (JTF) for SME investments.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

Medipan GmbH and GA Generic Assays GmbH manufacture and distribute in vitro diagnostic test kits and automated instruments for the detection of autoimmune and infectious diseases. Their portfolio covers five assay methods — ELISA, IFA, RIA, LINE/Dot, and Rapid Lateral Flow — together with automated evaluation systems (akiron NEO, DotDiver 2.0) and proprietary CytoBead single-step serum testing technology. Products are sold to medical laboratories, physicians, and research institutions in 70+ countries, targeting indications such as thyroid disease, Type-1 diabetes, rheumatoid arthritis, vasculitis, gastroenterology, and infectious diseases.

Product overview

Medipan GmbH and GA Generic Assays GmbH offer a comprehensive portfolio of autoimmune diagnostic solutions spanning five core assay methods: ELISA, IFA (Immunofluorescence Assays), RIA (Radioimmunoassays), LINE/Dot Assays, and Rapid Tests/Lateral Flow Tests. The portfolio includes manual test kits and automated systems such as akiron NEO for automated IFA imaging and evaluation, and DotDiver 2.0 for automated LINE/Dot processing. The companies have developed the innovative CytoBead technology platform that combines cell-based immunofluorescence screening with antigen-coated microparticles for simultaneous differentiation and confirmation of antibody specificity. Their rapid tests include products for inflammatory markers (CRP, calprotectin), infectious diseases (influenza, H. pylori, rotavirus/adenovirus), and rheumatoid factor. Additional products target specific autoimmune conditions including thyroid diseases, inflammatory bowel disease, and neurological disorders.

Differentiator

Problem solved

Functional benefit

Brands

• CytoBead Technology: A revolutionary combination of cell-based immunofluorescence for screening and antigen-coated microparticles for differentiation and confirmation of antibody specificity
• AKLIDES System
• Anti-Ganglioside Dot
• Glycoprotein 2 (GP2)

Products and services

• ELISA Test Kits Enzyme-linked immunosorbent assay (ELISA) test kits for detecting antibodies and antigens in clinical samples, including products such as Medizym T.R.A. human (3505), Anti-ASGPR (3900), and Anti-Faktor H (4067). Sold to medical laboratories and research institutions for autoimmune disease diagnostics.
• IFA (Immunofluorescence Assays) Cell-based immunofluorescence tests for autoimmune disease diagnosis, available in manual kits and automated formats (e.g., Anti-MuSK IFA 8049). Used by medical laboratories for screening and confirmation of autoantibodies.
• RIA (Radioimmunoassays) Radioimmunoassay (RIA/IRMA) test kits for detection of specific antibodies and antigens using radioactive labeling. Sold to medical laboratories for sensitive quantification in thyroid, reproductive, and other autoimmune endocrine diagnostics.
• LINE & Dot Assays Line and dot blot immunoassays for antibody detection (e.g., Anti-Phospholipid 10 Dot 5012), available in manual kits and automated DotDiver 2.0 format. Sold to laboratories for multi-parameter autoantibody profiling.
• Rapid Lateral Flow Tests Lateral flow point-of-care diagnostic tests delivering rapid visual results for various biomarkers, including Calprotectin Rapid (6118/6119), Helicobacter Antigen Quick (6110), Influenza Antigen Quick (6109), Rotadeno Antigen Quick (6103), CRP Latex (4095), and RF Latex (4096). Sold to clinicians and laboratories for point-of-care testing of inflammatory, infectious, and autoimmune markers.
• akiron NEO System Automated IFA imaging and evaluation system providing standardized, objective immunofluorescence analysis for autoimmune diagnostics. Sold to medical laboratories seeking to eliminate inter-observer variability and automate cell-based IFA workflows.
• DotDiver 2.0 System Automated processing and evaluation system for LINE/Dot assays, enabling walk-away incubation, image capture, and result interpretation. Sold to laboratories adopting automated multi-parameter line and dot blot autoimmune testing.
• CytoBead Technology Platform Proprietary combination of cell-based immunofluorescence for screening and antigen-coated microparticles for differentiation and confirmation of antibody specificity, enabling single-step serum testing. Commercialized through products such as CytoBead ANCA (8063). Sold to medical laboratories for differential autoimmune diagnostics.

Quantifiable outcome

• First commercially available system worldwide for fully automated, objective evaluation of cell-based immunofluorescence tests (2009)
• +1 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Three partnerships are on record, tiered core.

• Charité BerlincoreStrategic or Co-development PartnerAcademic partnership for diagnostic development and validation. Charité Berlin collaborates with GA Generic Assays on innovative product development in autoimmune diagnostics.
• Technische Universität DresdencoreStrategic or Co-development PartnerAcademic partnership for research collaboration in diagnostic technologies and product development.
• Brandenburgische Technische Universität (BTU)coreStrategic or Co-development PartnerAcademic partnership for diagnostic development and validation, contributing to the innovation capabilities of GA Generic Assays.

Scale indicators2 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• INOVA Diagnostics (Werfen): Specialty autoimmune diagnostics company owned by Werfen, offering ELISA, IFA, and multiplex assays for autoimmune disease detection. Directly competes in the same autoimmune IFA/ELISA product categories targeting clinical laboratories with similar customer profiles.
• EUROIMMUN (PerkinElmer): Direct competitor specializing in autoimmune diagnostics with comprehensive immunoassay portfolio (ELISA, IFA, blot assays). EUROIMMUN is the largest pure-play autoimmune diagnostics specialist globally and was acquired by PerkinElmer, now part of Revvity. Highly comparable in target market, product offering, and channel approach.
• AESKU Diagnostics: German-based specialty autoimmune diagnostics company offering ELISA, IFA, and line immunoassays. Comparable niche focus on autoimmune disease testing, similar product portfolio composition, and overlapping customer base of clinical laboratories and hospitals in European and international markets.
• Orgentec Diagnostika: German specialty diagnostics company focused on autoimmune disease testing with ELISA and blot assay products. Highly comparable as a German-based mid-size autoimmune diagnostics specialist serving clinical laboratories and hospitals with similar product portfolio composition.
• DIESSE Diagnostica Senese: Italian specialty IVD manufacturer offering ELISA, immunofluorescence, and rapid tests for autoimmune and infectious disease diagnostics. Similar mid-size European specialty diagnostics positioning with comparable product breadth and target customer segments.

Broad incumbents

• Thermo Fisher Scientific (Diagnostics): Global IVD giant including the Binding Site specialty diagnostics franchise. Competes in autoimmune and specialty immunodiagnostics as part of a much broader diagnostics portfolio, with overlapping technologies in immunoassays and laboratory automation.
• Abbott Diagnostics: Global IVD leader offering broad autoimmune testing through immunoassay platforms. While not specialized like Medipan/GA, Abbott competes for autoimmune testing volume in large hospital and reference laboratory accounts with high-throughput automated systems.
• DiaSorin: Italian specialty diagnostics company with strong autoimmune and infectious disease menu using CLIA and ELISA technologies. Comparable mid-size European IVD player focused on specialty testing segments, competing in similar clinical laboratory channels.
• Bio-Rad Laboratories: Major IVD player with significant autoimmune diagnostics portfolio including IFA and ELISA products. Competes with Medipan/GA across multiple assay methods and serves the same clinical laboratory customer base, though Bio-Rad operates across much broader diagnostic categories.
• Roche Diagnostics: World's largest IVD company with extensive autoimmune testing menu on cobas and Elecsys platforms. Represents the dominant competitive threat in automated autoimmune diagnostics, particularly for high-volume laboratory accounts that prioritize workflow consolidation.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCFTKVg_v7n57CG7i9rPv-NQ
• Facebookfacebook.com/profile.php?id=61554278093963
• LinkedInde.linkedin.com/company/medipan-generic-assays-gmbh
• Xx.com/medipan

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries2 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 Medipan & GA Generic Assays