Company Profile
inno-train Diagnostik GmbH is a Germany-based manufacturer of in-vitro diagnostic reagents and systems for transfusion medicine and immunohematology, headquartered in Kronberg im Taunus, Hessen. Founded in 1998 in Frankfurt/Main and relocated to Kronberg in 2000, the privately held company is registered under HRB 5256 at the Register Court of Königstein/Taunus. In January 2026, the company was acquired by Sansure Biotech Inc. through a controlling stake purchase. The company employs approximately 30 people and is led by Managing Directors Dipl. Biol. Dr. Rainer Frank and Dipl. Kfm. Alexander Keck.
Core Products ＆ Technologies
HLA Typing Systems
• HLA-Ready Gene: SSP-PCR system for HLA-A, -B, -C, -DR, -DQ, and -DP typing via classic gel electrophoresis
• HLA-FluoGene / FluoGene Software: TaqMan-based fluorescence PCR system combining SSP-PCR with endpoint fluorescence detection; supported by FluoQube real-time PCR instrument and automated analysis software
• HLA-FluoGene384 / FluoGeneNX: High-throughput and accelerated HLA typing formats with automatic data import and evaluation
Blood Group ＆ Transfusion Diagnostics
• RBC-ReadyGene: PCR-SSP assay for molecular blood group typing including ABO, Rhesus, Kell, Kidd, and Duffy systems
• RBC-FluoGene: TaqMan-based SSP assay for RBC antigen genotyping
• RBC-NGS type / BloodSeq: Next-generation sequencing platform for comprehensive blood group system analysis; EU ERDF co-funded innovation project as of March 2026
• HPA Typing: Human platelet antigen genotyping assays
Transplant ＆ Disease Association Diagnostics
• Transplant Diagnostics Portfolio: Complete range from serology to NGS for organ and hematopoietic stem cell transplantation safety
• HLA Disease Association Kits: HLA-B27 (ankylosing spondylitis), HLA-B57 (abacavir hypersensitivity), and coeliac disease association testing
• KIR Ready Gene: Killer cell immunoglobulin-like receptor genotyping for transplant and disease research
Automation ＆ Software
• FluoQube / FluoQube384: Real-time PCR instruments integrating amplification and fluorescence reading with automated result import into FluoGene Software
• BEXS 12 Bead Extraction System: Automated DNA isolation unit
• PiU 1 Pipetting Unit: Automated PCR setup workstation
Market Position ＆ Certifications
inno-train holds a specialized leadership position in molecular transfusion and transplant diagnostics, competing with Immucor, Grifols, Omixon, and BAG Diagnostics. Key strengths include:
• 27+ years of diagnostic innovation heritage
• Methodology completeness: The only provider worldwide covering the full method range of serology, SSP, real-time PCR, and NGS for HLA and blood group diagnostics
• First-mover advantage: The first international provider of molecular-biological IVD test systems for blood group determination
• Regulatory compliance: CE IVD certified; DIN EN ISO 13485:2016 certified for design, manufacture, and sale of in-vitro diagnostics since September 2003; HLA-PCR product lines IVDR 2017/746 certified as of February 2026
• Global distribution: Direct presence in Germany and USA (Clinton, NY, established 2018), with distribution partners across Europe, North America, South America, and Asia
Corporate Timeline
1998 — Founded in Frankfurt/Main, Germany
2000 — Relocated headquarters to Kronberg im Taunus
2003 — Achieved DIN EN ISO 13485 certification for IVD design and manufacturing
2018 — Established North American division in Clinton, New York, USA
2021 — Expanded worldwide headquarters facility in Kronberg
2025 — Presented at MEDICA Healthcare Brokerage Event; Horizon Europe partnership seeking for molecular biological diagnostics projects
2026 — HLA-PCR kits (HLA-Ready Gene, HLA-FluoGene, FluoGene Software) received IVDR 2017/746 certification; RBC-NGS BloodSeq project awarded EU ERDF co-financing; acquired by Sansure Biotech Inc. (China) in January
Target Markets ＆ Applications
• Transfusion Medicine: Molecular blood group typing for donor-recipient compatibility and antibody identification
• Organ Transplantation: HLA typing and cross-matching for kidney, liver, heart, and lung transplant programs
• Hematopoietic Stem Cell Transplantation: HLA matching and post-transplant monitoring
• Pharmacogenomics: HLA-B57 screening for abacavir hypersensitivity and HLA-associated drug reaction testing
• Autoimmune Disease Screening: HLA-B27 testing for ankylosing spondylitis and related spondyloarthropathies
• Research ＆ Reference Laboratories: NGS-based extended blood group and HLA genotyping for research and rare phenotype identification
Contact Information
Global Headquarters
Address: Niederhöchstädter Str. 62, 61476 Kronberg, Germany
Phone: +49 6173 6079 30
Email: info@inno-train.de
Website: www.inno-train.de
North American Division
inno-train Diagnostik, Inc.
Address: 108 Utica Street, Clinton, NY 13323, USA
Phone: +1 (888) 352 2196
