What BAG Diagnostics does

BAG Diagnostics GmbH is a German specialty in-vitro diagnostics manufacturer headquartered in Lich, Germany, founded in 1947 and operating as a subsidiary of the privately held BAG Group. The company develops and sells CE/IVD and IVDR-certified diagnostic kits and automated platforms across four verticals: transplantation diagnostics (HLA typing and antibody detection for organ and stem cell transplantation), transfusion diagnostics (molecular genetic and serological blood group typing), human genetics (fetal Rhesus D typing and disease association testing), and infectiology (real-time PCR for SARS-CoV-2, influenza A/B, and RSV).

The technical portfolio is built on real-time PCR with TaqMan probe chemistry, sequence-specific primer (SSP) PCR, SSO hybridization, and microarray-based antibody detection, supported by the proprietary MR.SPOT automated pipetting platform and interpretation software (PlexTyper, HISTO MATCH). Flagship products include ERY Q for blood group typing (results in under 70 minutes), HISTO TYPE Rainbow for 11-gene HLA typing on a single 96-well plate (under 80 minutes), HISTO SPOT HLA AB for antibody detection, FastQ RHD fetal plus for non-invasive prenatal Rhesus D typing, and the ViroQ line of respiratory infectious disease PCR kits. The product range spans low-throughput confirmatory tests to fully automated 1-96 sample workflows validated against Bio-Rad CFX, Roche LightCycler 480 II, and Applied Biosystems QuantStudio 6 Flex systems.

BAG operates a sales-led, distributor-driven go-to-market, selling primarily through a global network of regional distributors complemented by direct enterprise sales (including bundled test system packages with hardware partners), inside-sales-driven quote and demo requests, and event-based demand generation at conferences such as EFI. Pricing is not publicly disclosed and is quote-based; revenue is generated through one-time sales of reagent kits, test systems, consumables, and instruments to hospital laboratories, blood donation services, specialist practices, and infectious disease testing laboratories. The company has 51-100 employees and operates without disclosed external funding, M&A activity, or named end-customer anchors.

Name

BAG Diagnostics

Legal name

BAG Diagnostics GmbH

Website

https://bag-diagnostics.com

Company type

Private

Founded year

1947

Operating status

Operating

Headcount range

51–100 employees

Short description

BAG Diagnostics is a German specialty in-vitro diagnostics manufacturer (founded 1947) selling CE/IVD-certified PCR, SSP, and microarray kits for HLA typing, blood group diagnostics, human genetics, and infectious disease testing to hospital laboratories, blood banks, and specialist practices globally through a distributor-led sales model.

Ownership category

akta.pro rank

Product category

In-vitro Diagnostics (Molecular and Serological Reagents)

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

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

akta.pro secondary industries

Hematology & Coagulation Diagnostics (HLAHAAAB), Genetic, Cytogenetic & Prenatal Screening IVD (HLAHAAAI), Clinical Chemistry & Hematology Diagnostics (automated analyzers, blood testing) (HLAAALAH)

Keywords

• In-vitro diagnostics
• Molecular genetic typing
• HLA diagnostics
• Blood group typing
• Transplant diagnostics

Headquarters

HQ city

Lich

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. In-vitro Diagnostic Products: Sale of IVD reagent kits, test systems, and consumables for transplantation diagnostics, transfusion diagnostics, human genetics, and infectiology. Products are sold globally through distributors and directly to laboratories, clinics, and blood donation services. Revenue is generated through repeat product orders and new customer acquisitions.

Go-to-market motion3 records

Distribution channels4 records

Marketing channels6 records

Core offering

BAG Diagnostics develops, manufactures and sells CE/IVD and IVDR-certified in-vitro diagnostic kits, reagents and automated systems for transplantation diagnostics (HLA typing, HLA antibody detection), transfusion diagnostics (blood group typing and serology), human genetics (disease association and fetal Rhesus D typing), and infectiology (SARS-CoV-2, influenza, RSV real-time PCR). The portfolio combines molecular-genetic and serological methods, the MR.SPOT® automated processor and PlexTyper®/HISTO MATCH interpretation software, sold globally through distributors and direct enterprise sales for use by hospital laboratories, blood banks and specialist practices.

Product overview

BAG Diagnostics develops and manufactures in-vitro diagnostic products for transplantation diagnostics, transfusion diagnostics, human genetics, and infectiology. The portfolio is organized into four product groups: (1) Transplantation Diagnostics encompassing HLA typing products including HISTO TYPE Rainbow (real-time PCR), HISTO SPOT® SSO (automated SSO), HISTO TYPE SSP (sequence-specific primer PCR), HISTO TRAY (serology), and HLA antibody diagnostics including HISTO SPOT® HLA AB (microarray) and SeraScreen Abs (LCT); (2) Transfusion Diagnostics including ERY Q® (real-time PCR blood group typing), BAGene SSP (sequence-specific primer PCR), and Test Sera and Reagents (serology); (3) Human Genetics including FastQ® product line for disease association testing (B*27, celiac disease) and FastQ® RHD fetal for fetal rhesus typing; (4) Infectiology including ViroQ® SARS-CoV-2, ViroQ® SC2 Variant, and ViroQ® SARS-FluA/B-RSV multiplex PCR tests. Supporting platforms include MR.SPOT® Processor automation and PlexTyper®/HISTO MATCH interpretation software.

Differentiator

Problem solved

Functional benefit

Brands

• ViroQ®: Real-time PCR product line for infectious disease detection including SARS-CoV-2, influenza, and RSV diagnostics.
• ERY Q®
• BAGene
• FastQ®
• HISTO SPOT®
• HISTO TYPE
• HISTO TRAY
• SeraScreen Abs
• MR.SPOT® Processor
• PlexTyper®
• HISTO MATCH

Products and services

• ERY Q® Real-Time PCR Blood Group Typing Real-time PCR kits for molecular-genetic blood group diagnostics covering ABO, ABO variant, Rhesus (RH), Weak D, Partial D, KKD/MNS, HNA, HPA and rare blood groups. All kits run under a single PCR programme and can be combined in one run, with results in under 70 minutes using gel-free, pre-dried primers/probes and Hot Start Taq polymerase. For blood banks, transfusion services and clinical laboratories.
• BAGene SSP Blood Group Typing Sequence-specific primer (SSP) PCR kits for blood group diagnostics including ABO-TYPE, RH-TYPE, KKD-TYPE, MNS-TYPE, HNA-TYPE, HPA-TYPE, Partial D-TYPE, Rare-TYPE and Weak D-TYPE. Ready-to-use, pre-aliquoted reaction mixes with CE/IVD-certified Taq polymerase, including rare blood group variants. For blood banks and immunohaematology laboratories.
• Test Sera and Reagents Ready-to-use polyclonal and monoclonal test sera and reagents for serological blood group typing, including ABO grouping reagents, Rhesus reagents, rare blood group reagents and anti-human globulin (Coombs) products. For blood donation centres and transfusion services.
• HISTO TYPE Rainbow HLA Real-Time PCR Typing Real-time PCR kit typing all 11 relevant HLA genes on one 96-well plate, with results in 80 minutes and automated PlexTyper® interpretation. For HLA laboratories in transplant centres and clinical diagnostics.
• HISTO SPOT® SSO HLA Typing Automated HLA SSO typing solution with individually combinable kits (4D, Xtend, On-call formats) for high and low throughput at low-to-medium resolution, processed on the MR.SPOT® Processor with HISTO MATCH software evaluation. For HLA typing laboratories.
• HISTO TYPE SSP HLA Typing Sequence-specific primer (SSP) PCR kits for fast HLA typing at low resolution, including locus-specific kits (A, B, C, DR, DQB) and disease-association kits (B*57:01, B27, Coeliac Disease, Narcolepsy), validated with CE-certified Taq polymerase. For HLA laboratories and specialist practices.
• HISTO TRAY HLA Serology Ready-to-use microtest plates with pre-dropped anti-HLA sera and rabbit complement for microlymphocytotoxicity testing (MLCT) of HLA antigens, providing rapid and cost-efficient HLA-ABC typing. For HLA serology laboratories.
• HISTO SPOT® HLA AB Microarray Antibody Detection Fully automated microarray-based system for detection and identification of HLA antibodies using recombinant single antigens for HLA Class I and II; processes 1–96 samples per run from 2–10 µl serum, automated on the MR.SPOT® platform and evaluated via HISTO MATCH software. For transplant immunology laboratories.
• SeraScreen Abs HLA Antibody LCT Ready-to-use microtest plates with pre-dried peripheral lymphocytes from different donors for lymphocytotoxicity testing (LCT) of HLA antibodies, supplied with rabbit complement. For transplant immunology and HLA laboratories.
• FastQ® RHD fetal (Fetal Rhesus D Typing) Non-invasive prenatal real-time PCR kit typing 3 exons (5, 7 and 10) of the RHD gene from maternal blood using optimised multiplexing and TaqMan probes; the FastQ RHD fetal plus variant is IVDR-certified. Enables targeted anti-D immunoglobulin prophylaxis. Results in approximately 105 minutes. For obstetrics laboratories and human genetics labs.
• FastQ® Human Genetics Real-Time PCR Real-time PCR product line for typing disease associations including FastQ® B*27 (ankylosing spondylitis/Morbus Bechterew) and FastQ® CD (coeliac disease), available in both DNA and direct whole-blood formats. For human genetics laboratories and specialist practices.
• ViroQ® SARS-CoV-2 Real-Time PCR CE-IVD-certified real-time PCR tests for specific detection of SARS-CoV-2 viral RNA (E gene and RdRP gene) in respiratory samples, with a built-in cell-material check to prevent false negatives; transportable uncooled. Available as standard (90 min) and Rapid (60 min) formats. For respiratory / infectious disease testing laboratories.
• ViroQ® SC2 Variant SARS-CoV-2 Differentiation Kit Real-time PCR differentiation kit for SARS-CoV-2 variants (Alpha, Beta, Gamma, Delta, Omicron BA.1/3, BA.2) via point-mutation detection, returning variant results in 60 minutes versus approximately 30 hours for gene sequencing. For public health and infectious disease laboratories.
• ViroQ® SARS-FluA/B-RSV Multiplex Respiratory Panel Multiplex real-time PCR assay for simultaneous detection of SARS-CoV-2, Influenza A, Influenza B and RSV in a single test run with results in approximately 60 minutes, including a cell-material check for sample quality control. For respiratory / infectious disease testing laboratories.
• MR.SPOT® Processor (Automated Pipetting Platform) Fully automated pipetting processing platform that handles 1–96 samples per run for HLA antibody detection (HISTO SPOT® HLA AB) and SSO typing workflows. Automates incubation through detection; the MR.SPOT 2.0 does not require daily calibration. For HLA diagnostics and blood group / antibody testing laboratories.
• PlexTyper® Interpretation Software User-friendly software for automated interpretation of real-time PCR data from ERY Q®, FastQ® and HISTO TYPE Rainbow kits, with worklist function via Excel and intuitive editing tools. Compatible with Bio-Rad CFX systems and other cyclers. For laboratories using BAG real-time PCR kits.
• HISTO MATCH Evaluation Software Evaluation and documentation software for HLA typing and antibody detection results, with a user-friendly interface for processing data from HISTO SPOT® and HISTO TYPE product lines. For HLA diagnostics laboratories.

Quantifiable outcome

• Results available in under 70 minutes for ERY Q blood group typing
• +4 more outcomes

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature9 records

Partnerships

Five partnerships are on record, tiered core and minor.

• BAG GroupcoreOthersBAG Diagnostics GmbH is a subsidiary of the BAG Group (BAG Holding GmbH), which encompasses multiple healthcare companies including BAG Health Care GmbH. The group operates with a shared spirit focused on customer success, sharing resources such as IT infrastructure, HR (centralized at BAG Holding GmbH), and a common brand identity. BAG Diagnostics is part of a group of companies that together are described as 'unbeatable.'
• Bio-Rad LaboratoriescoreTechnology or IntegrationBAG Diagnostics has validated its real-time PCR test kits (ERY Q, HISTO TYPE Rainbow, FastQ, ViroQ) specifically for use with Bio-Rad CFX 96 and CFX Opus 96 real-time PCR systems. The companies offer bundled product packages where BAG test kits and Bio-Rad cyclers are sold together from a single supplier at attractive conditions, including installation and initial instruction.
• Universities and Research InstitutesminorStrategic or Co-development PartnerBAG Diagnostics cooperates with universities, research institutes, and other companies in dialog-driven innovation processes. Customer requirements and scientific discourse with colleagues worldwide drive targeted research for product development. Several peer-reviewed publications involve academic co-authorship.
• Federal Ministry for Economic Affairs and Energy (BMWi) / ZIM ProgrammeminorOthersThe development project for HISTO TYPE Rainbow was funded by the Federal Ministry for Economic Affairs and Energy (BMWi) as part of the Central Innovation Programme for SMEs (ZIM). This represents a public research funding partnership supporting BAG's R&D activities.
• Applied Biosystems (Thermo Fisher Scientific)coreTechnology or IntegrationBAG's FastQ RHD fetal plus kit is specifically designed for the QuantStudio 6 Flex System (Applied Biosystems) real-time cycler, combining detection of 3 RHD exons, internal amplification control, and cff control in a 5-plex mix format compatible with this platform.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Immucor: Specializes in transfusion and transplantation diagnostics, offering serological and molecular blood bank reagents that directly overlap with BAG's transfusion and HLA antibody product lines.
• Thermo Fisher Scientific (One Lambda): One Lambda, a Thermo Fisher subsidiary, is the dominant HLA typing and antibody diagnostics franchise globally and competes head-to-head with BAG's HISTO TYPE and HISTO SPOT product lines.
• GenDx: Specialty molecular diagnostics company focused on HLA and transplant diagnostics via NGS and Sanger-based kits — directly comparable to BAG's HISTO TYPE and BAGene SSP transplant diagnostic offerings.
• Grifols: Diagnostic division provides blood-bank serology reagents and molecular immunohematology products overlapping with BAG's transfusion diagnostics (ERY Q, BAGene SSP, test sera) portfolio.
• Quotient Limited: Focused transfusion diagnostics company offering serological and molecular blood-grouping reagents, directly comparable to BAG's transfusion diagnostics portfolio.

Broad incumbents

• Bio-Rad Laboratories: Broad life-science and clinical diagnostics company that sells HLA typing products (via its acquired DiaMed and Bio-Rad platforms) and supplies the CFX real-time PCR cyclers for which BAG's kits are validated.
• Hologic: Molecular diagnostics leader with Panther / Aptima systems for infectious disease and women's health, competing broadly in the PCR-based clinical diagnostics space where BAG's ViroQ kits are positioned.
• DiaSorin: Specialty IVD manufacturer with a strong immunodiagnostics and molecular infectious disease portfolio that overlaps with BAG's ViroQ respiratory pathogen and HLA disease-association testing offerings.
• Qiagen: Broad molecular diagnostics player with sample-preparation and PCR workflows used in HLA typing, infectious disease, and human genetics applications — overlapping with BAG's molecular diagnostic kit portfolio.
• Cepheid (Danaher): Molecular diagnostics platform (GeneXpert) with extensive infectious-disease menu including SARS-CoV-2 and respiratory pathogens, competing with BAG's ViroQ product line in hospital and reference laboratories.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/bag-diagnostics-gmbh

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 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 BAG Diagnostics