inno-train Diagnostik GmbH - Global Leader in HLA & Molecular Blood Group Diagnostics

Company Profile (Updated April 2026)

inno-train Diagnostik GmbH is a global leader in HLA (Human LeUKocyte Antigen) diagnostics and molecular blood group typing, headquartered in Kronberg im Taunus, Hessen, Germany, near Frankfurt/Main. Founded in 1998, the company has pioneered the commercialization of molecular blood group typing and built a comprehensive portfolio spanning serology, SSP-PCR, real-time PCR, and next-generation sequencing (NGS) for transfusion medicine and immunohematology.

Development History:

- 1998: Founded in Germany with the mission to integrate innovative products into transfusion medicine and immunohematology

- 1998: Became the world's first commercial supplier of molecular blood group typing systems

- 2018: Established North American division in Clinton, New York, USA, expanding direct sales and technical support across the Americas

- 2021: Expanded worldwide headquarters in Kronberg, Germany, to support growing global demand

- 2024: HLA-PCR product lines (HLA-Ready Gene, HLA-FluoGene) and FluoGene software (HLA part) officially certified under EU IVDR 2017/746, demonstrating long-standing commitment to quality standards

- 2025: Launched RBC-NGS type CORE system for next-generation sequencing of blood group systems (ABO, Rhesus, Kell, Kidd, Duffy)

- Jan 2026: Controlling stake acquired by Sansure Biotech Inc. (688289.SH); became Sansure's strategic bridgehead in Europe and global markets

Core Mission: To develop and market state-of-the-art in vitro diagnostics that ensure smooth laboratory workflows and quickly deliver reliAble diagnoses for patients, with a genuine passion for innovation and scientific exchange.

Corporate Honors & Certifications

inno-train maintains the highest quality and regulatory standards in the IVD industry:

- DIN EN ISO 13485:2016: Quality management system certification for medical devices

- EU IVDR 2017/746 Certification: HLA-Ready Gene, HLA-FluoGene product lines and FluoGene software (HLA part) officially certified under the new EU In Vitro Diagnostic Regulation

- "Innovative through Research" Award: Granted by the German Stifterverband for sustained research excellence

- CE IVD Certification: All transfusion diagnostic products meet highest safety standards and are CE IVD certified (outside USA & Canada)

Core Technologies & Methodologies

Unique Technology Positioning

inno-train is the only provider worldwide offering the complete method range for blood group and HLA diagnostics:

- Serology: Classical immunohematological methods including reagents and gel card tests

- SSP-PCR (Sequence-Specific Primer PCR): Robust, well-established molecular typing platform

- Real-Time PCR (qPCR / TaqMan-based SSP): High-throughput, automated molecular typing with FluoGene technology

- NGS (Next-Generation Sequencing): High-resolution HLA and blood group genotyping on Illumina and Oxford Nanopore platforms

- Bioinformatics & Software: Proprietary FluoGene software and interactive data analysis tools for qPCR and sequencing data interpretation

Core Products & Solutions

HLA Diagnostics

HLA typing is critical for organ transplant compatibility, transfusion safety, and autoimmune disease diagnosis. inno-train offers comprehensive HLA diagnostic solutions:

- HLA-Ready Gene (SSP-PCR): Sequence-specific primer PCR kits for HLA-A, -B, -C, -DRB1, -DQB1, and other loci

- HLA-FluoGene (Real-Time PCR): TaqMan-based real-time PCR kits for Rapid, automated HLA typing

- FluoGene Software (HLA Module): Automated result evaluation and reporting software integrated with real-time PCR instruments

- HLA-Disease Association Kits: Specialized kits for HLA-associated disease risk assessment

- IVDR 2017/746 Certified: Full HLA-PCR product lines officially certified under the new EU regulation

Transfusion Diagnostics - Molecular Blood Group Typing

inno-train provides innovative product ranges for detecting blood group characteristics to ensure safe transfusion of blood products including erythrocytes, platelets, granulocytes, and therapeutic plasma:

- RBC-Ready Gene (SSP-PCR): Molecular detection of ABO, Rhesus (RHD/RHCE), Kell, Kidd, Duffy, MNS, Dombrock, and other blood group systems

- RBC-FluoGene Q (Real-Time PCR): Rapid molecular RBC typing including:

- RBC-FluoGene fetal RHD Q: Non-invasive fetal RHD genotyping from maternal plasma for prenatal management of RhD alloimmunization

- RBC-FluoGene RHD Zygosity Q: Determination of RHD zygosity status

- FluoGene D weak Screen Q: Detection of weak and partial D variants

- RBC-Ready Gene RHCE Variants: Specialized analysis of RHCE alleles (C, c, E, e, Cw) and variant expressions for anomalous serological typings and unexpected RH antibodies

- RBC-Ready Gene vERYfy: Combined parallel analysis of RHD, RHCE, MNS, Kell, Kidd, Duffy, and Dombrock systems for polytransfused patients and allo-/auto-antibody producers

- RBC-NGS type CORE: Next-generation sequencing solution covering ABO, Rhesus, Kell, Kidd, and Duffy blood group systems with high-resolution genotyping

Human Platelet Antigen (HPA) Typing

- HPA-Ready Gene: Molecular HPA typing kits for platelet transfusion compatibility and neonatal alloimmune thrombocytopenia (NAIT) prevention

Serology & Auxiliary Products

- DaraEx: Reagent for neutralization of therapeutic anti-CD38 antibodies (e.g., Daratumumab) that interfere with serological blood group testing by antigen masking. Easier and faster than conventional DTT treatment with no undesired side effects

- Recombinant Blood Group Antigens (rBGA): Specific inhibition of antibodies in gel card tests, minimizing risk of incompatible blood transfusions

- imusyn Serological Products: Exclusive worldwide distribution partnership with German company imusyn for serological diagnostics

Transplant Diagnostics & Post-Transplant Monitoring

- Chimerism Analysis: Monitoring donor/recipient cell ratios after hematopoietic stem cell transplantation for early detection of graft rejection or relapse

Instruments & Automation

- FluoQube / FluoQube384: Real-time PCR instruments supporting molecular HLA, RBC, and HPA typing. Combines FluoGene method (TaqMan-based SSP) with real-time PCR, enabling automated amplification and fluorescence reADINg with integrated FluoGene software result evaluation

- BEXS 12 Bead Extraction System: Automated DNA isolation system for streamlined workflow

- Pipetting Unit PiU 1: Automated PCR setup unit for high-throughput laboratories

- Complete Workflow Automation: From automated DNA extraction to automated PCR setup and real-time detection

Sansure Biotech Acquisition (January 2026)

Transaction Overview

On January 29, 2026, Sansure Biotech Inc. (688289.SH) announced the completion of a controlling stake acquisition of inno-train Diagnostik GmbH, marking a landmark cross-border transaction in the global IVD industry.

Strategic Rationale:

- For Sansure: Strengthens global layout in high-end blood molecular diagnostics; enhances competitiveness in transfusion safety and organ transplantation—two high-threshold segments in china; accelerates internationalization through inno-train's European channels

- For inno-train: Gains access to Sansure's global platform, automation technology advantages, and China market channels; expands international coverage under Sansure's ecosystem

Post-Acquisition Structure:

- inno-train maintains independent operations as a German subsidiary

- Joint international R&D center established to integrate Sansure's molecular diagnostic and gene sequencing platforms with inno-train's FluoGene and ReadyGene product lines

- inno-train serves as Sansure's "bridgehead" in Europe and global markets, providing real-time technical support, personnel training, and after-sales maintenance for global customers

- Sansure's infection, oncology, and other advantage products will leverage inno-train's mature logistics, warehousing, and direct sales networks to efficiently distribute across Europe and North America

Technology Synergy: PCR and NGS platforms combined to create full-scenario diagnostic solutions, driving blood diagnostics toward greater efficiency and intelligence

Market Opportunity

Global HLA Typing Market

According to Grand View Research and industry analysis:

- Global Market Size: Projected to grow from approximately USD 1.6 billion in 2024 to USD 3.1 billion by 2034, representing a CAGR of 6.8%

- China Market: Estimated at RMB 1.26-1.48 billion in 2023, projected to exceed RMB 4.5 billion by 2030

- Key Growth Drivers: Aging population, increasing organ transplant demand, rising autoimmune disease incidence (3-5% annual growth globally), and precision medicine policy support

- Clinical Applications: Organ transplant matching, hematopoietic stem cell transplantation, transfusion safety, autoimmune disease diagnosis, tumor immunotherapy companion diagnostics

Global Health Context: WHO data indicates over 2 million patients worldwide await organ transplant surgery annually. HLA precise matching can improve donor utilization, shorten patient waiting times, reduce postoperative rejection risk, and enhance 10-year survival rates.

Company Information & Leadership

Corporate Overview

Company Full Name: inno-train Diagnostik GmbH

Founded: 1998

Headquarters: Niederhoechstaedter Str. 62, Kronberg im Taunus, Hessen 61476, Germany

North American Office: Clinton, New York, USA (established 2018)

Parent Company: Sansure Biotech Inc. (688289.SH) - controlling stake acquired January 2026

Company Type: Private company (now subsidiary of Sansure Biotech)

Industry: In Vitro Diagnostics (IVD) / Transfusion Medicine / Immunohematology / HLA Diagnostics

Global Presence: Products distributed in 50+ countries

Certifications: DIN EN ISO 13485:2016, EU IVDR 2017/746, CE IVD

Leadership Team

Co-Founder: Dr. Rainer Frank

- Commented on the acquisition: "Joining the Sansure ecosystem will allow inno-train to leverage Sansure's global network, automation technology advantages, and China market channels to further expand international coverage."

Head of Innovative Product Development: Dr. Stephan Jacobs

- Contact: s.jacobs@inno-train.de; Tel: +49 6173 6079 30

Scientific Engagement & Education

Molecular Blood Group Forum

inno-train regularly organizes the Molecular Blood Group Forum, an international scientific conference promoting scientific exchange among immunohematology experts. The 12th Blood Group Forum is scheduled for November 2-3, 2026 in Frankfurt, featuring high-level international speakers.

Practical Workshops

- May 20-21, 2026: RBC-FluoGene practical workshop (English)

- June 16-17, 2026: HLA-FluoGene practical workshop including NGS (German)

These workshops provide hands-on training for laboratory professionals to safely use FluoGene products and learn expert tips.

2026 Outlook & Strategic Focus

Post-Acquisition Development Priorities

- China Market Entry: Accelerate landing of advanced HLA typing and safe transfusion solutions in the Chinese market, addressing the rapidly growing domestic demand

- Technology Integration: Combine Sansure's molecular diagnostic and gene sequencing platforms with inno-train's FluoGene and ReadyGene product lines to create PCR + NGS full-scenario diagnostic solutions

- European Distribution Hub: Leverage inno-train's established European brand, logistics, warehousing, and direct sales channels to distribute Sansure's infection, oncology, and other products across Europe and North America

- Global R&D Center: Establish Germany-based international R&D center to incubate innovative diagnostic projects and drive technology upgrades

- AI + Diagnostics: Explore integration of AI technologies into blood group and HLA diagnostic workflows for enhanced efficiency and intelligence

- NGS Expansion: Expand next-generation sequencing applications in HLA and blood group genotyping with higher resolution and throughput

Contact Information

Germany Headquarters

Address: Niederhoechstaedter Str. 62, 61476 Kronberg im Taunus, Germany
   Telephone: +49 6173 6079 30
   Fax: +49 6173 6079 50
   Email: info@inno-train.de
   Website: www.inno-train.de

USA Office

Address: Clinton, New York, USA
   Established: 2018

Parent Company Contact

Sansure Biotech Inc.
   Stock Exchange: Shanghai Stock Exchange STAR Market
   Ticker: 688289
   Website: www.sansureglobal.com

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