What HiSS Diagnostics does

HiSS Diagnostics GmbH is a privately held German specialty distributor of in-vitro diagnostics (IVD) and life-science products, founded in 1989 and headquartered in Freiburg im Breisgau under Managing Director Georg Klopfer. The company distributes a portfolio organized across molecular pathology, liquid biopsy, extracellular vesicles, flow cytometry controls, infectious disease PCR, and quality control / reference materials, sourced from at least 17 globally established manufacturers including STRECK, Invivoscribe, LGC SeraCare, LGC Maine Standards, LGC Kova International, NGeneBio, Revvity, GeneFirst, Nonacus, CelLBxHealth, Cell Guidance Systems, iNtRON Biotechnology, PentaBase, GBD, TRUPCR Europe, DNA Diagnostic, TiterMax, and ZeptoMetrix. Substantively, HiSS serves as the German/Austrian market access layer for sophisticated diagnostic reagents, NGS panels (GALEAS, BRCAaccuPanel, HEMEaccuPanel, HLAaccuTest), PCR assays, flow cytometry controls (CD-Chex family), and emerging extracellular vesicle systems (EVlution). Many products are explicitly CE-IVD and IVDR-compliant.

The business model is straightforward B2B distribution: products are priced individually (ranging from approximately €79.50 for consumables such as STRECK's Cell-Free DNA BCT up to €14,406 for complex kits such as the GALEAS Bladder Cancer Panel), with standard 30-day net payment terms, flat shipping fees (€30 within Germany, €80 to Austria, plus refrigerated surcharges), and a no-return policy. Revenue is generated through direct e-commerce sales via the company's web shop and through traditional sales-led outreach to clinical diagnostic laboratories, universities, research institutions, and pharmaceutical/biotech customers across the DACH region. The company holds DIN EN ISO 13485 certification (issued by DQS) for medical device quality management, participates in the Der Gr\u00fcne Punkt dual recycling system, and markets an extensive technical webinar and conference program (including ISOBM, Bundeskongress Pathologie, and DGP events) to educate the market alongside its manufacturing partners.

Name

HiSS Diagnostics

Legal name

HiSS Diagnostics GmbH

Website

https://hiss-dx.de

Company type

Private

Founded year

1989

Operating status

Operating

Headcount range

11–50 employees

Short description

HiSS Diagnostics GmbH is a privately held German specialty distributor (founded 1989, Freiburg) that markets IVD and life-science products from 17+ manufacturers — including NGS panels, liquid biopsy, flow cytometry controls, PCR assays, and EV isolation systems — to clinical laboratories, universities, and pharma/biotech customers across the DACH region via direct e-commerce and sales-led channels.

Ownership category

akta.pro rank

Product category

In-Vitro Diagnostics Distribution

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical and Diagnostic Laboratories (6215), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122), Laboratory Analytical Instruments (3826)

akta.pro primary industry

Microbiology & Infectious Disease Diagnostics (culture, rapid antigen, syndromic panels) (HLAAALAC)

akta.pro secondary industries

Clinical Chemistry & Hematology Diagnostics (automated analyzers, blood testing) (HLAAALAH), Analytical Development & QC Testing (Release/Stability/Potency) (HLAGAGAF), Release Testing & Batch Certification (QC) (HLAGADAC)

Keywords

• Molecular pathology diagnostics
• In-vitro diagnostics distribution
• Next generation sequencing assays
• Polymerase chain reaction kits
• Flow cytometry quality controls

Headquarters

HQ city

Freiburg Im Breisgau

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Product Sales: Sale of IVD and Life-Science products including reagents, controls, instruments, and consumables to laboratories, universities, and pharma/biotech companies. Products range from individual items (€79-€5,000+) to multi-product kits.
2. E-commerce Sales: Direct-to-customer sales through their web shop platform, serving laboratories in Germany and Austria with shipping and handling services.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

HiSS Diagnostics is a German specialty distributor of in-vitro diagnostics (IVD) and life-science products, selling molecular pathology assays, liquid biopsy solutions, flow cytometry controls, PCR infectious disease kits, extracellular vesicle systems, and quality control/reference materials sourced from global manufacturers such as STRECK, Invivoscribe, LGC SeraCare, NGeneBio, Revvity, Nonacus, and GeneFirst. The company operates its own e-commerce storefront serving clinical laboratories, universities, research institutions, and pharmaceutical/biotech customers in Germany and Austria.

Product overview

HiSS Diagnostics is a German distributor of State-of-the-Art IVD and Life Science products, operating for over 36 years as a reliable provider of laboratory diagnostic products from globally renowned manufacturers. The company offers a comprehensive portfolio organized across multiple categories: Molecular Pathology products including Next Generation Sequencing (NGS) assays such as the GALEAS™ tumor and hereditary panels, BRCAaccuPanel™ and BRCAaccuTest™ for BRCA analysis, HEMEaccuPanel™ for hematological malignancies, and LymphoTrack® for immunoglobulin gene rearrangement analysis; Liquid Biopsy solutions including Cell-Free DNA BCT® collection tubes and chemagic™ cfDNA extraction kits; Flow Cytometry controls including CD-Chex Plus® and related CD marker controls from STRECK; Extracellular Vesicle products including the EVlution™ System and Exo-spin™ kits from Cell Guidance Systems; Infectious Disease diagnostics featuring PCR assays from TRUPCR® Europe, Papilloplex® HR-HPV kits from GeneFirst, Optitrol NAT controls, and AccuPlex™ reference materials; Molecular Biology & Cell Culture reagents including growth factors, cytokines, small molecules, and enzymes; and comprehensive Control & Reference Materials for quality assurance. The company serves clinics, private laboratories, universities, and pharmaceutical/biotech companies primarily in Germany and Austria.

Differentiator

Problem solved

Functional benefit

Products and services

• Cell-Free DNA BCT Blood collection tube for stabilization and preservation of cell-free DNA in blood samples, designed for liquid biopsy applications. Distributed by HiSS Diagnostics under its STRECK partnership for clinical laboratories.
• CD-Chex Plus Flow Cytometry Controls Quality control materials for flow cytometry analysis of hematologic malignancies, including the CD-Chex Plus, CD-Chex CD34, CD-Chex CD103 Plus, CD-Chex CD117 Plus, CD-Chex TdT Plus, and CD-Chex Daily variants. Distributed by HiSS Diagnostics under its STRECK partnership.
• LymphoTrack NGS Assays Research Use Only NGS assays for identification and detection of B-cell immunoglobulin heavy chain (IGH) gene rearrangements in the FR1 region and related clonality testing, designed for Thermo Fisher Scientific Ion S5 or Ion PGM platforms. Distributed by HiSS Diagnostics under its Invivoscribe partnership.
• LeukoStrat FLT3 ITD MRD Assay and LeukoStrat NPM1 MRD Assay Assays for detection of FLT3 ITD (Internal Tandem Duplication) mutations and NPM1 mutations plus minimal residual disease (MRD) monitoring in hematological malignancies, distributed by HiSS Diagnostics under its Invivoscribe partnership.
• GALEAS NGS Panels (Bladder, HereditaryPlus, Tumor) Next-generation sequencing panels for detection of biomarkers in bladder cancer analysis, hereditary cancer panels, and tumor biomarker analysis and characterization. Distributed by HiSS Diagnostics under its Nonacus partnership.
• BRCAaccuPanel HRD and BRCAaccuTest PLUS Comprehensive NGS panels for homologous recombination deficiency (HRD) analysis and targeted BRCA1/2 gene testing in hereditary breast and ovarian cancer. Distributed by HiSS Diagnostics under its NGeneBio partnership.
• HEMEaccuPanel and HEMEaccuTest NGS Hematology Assays Targeted NGS panels and tests covering DNA-based and RNA-based biomarkers for hematological malignancies. Distributed by HiSS Diagnostics under its NGeneBio partnership.
• HLAaccuTest All NGS Typing Assay Comprehensive NGS assay for HLA (Human Leukocyte Antigen) typing and analysis. Distributed by HiSS Diagnostics under its NGeneBio partnership.
• EVlution Extracellular Vesicle Systems Extracellular vesicle isolation and analysis systems including the EVlution System, EVlution Digital System, and EVlution Filter Cartridges (260cm² and 94cm²) for EV/analyte separation, concentration, and characterization. Distributed by HiSS Diagnostics under its Cell Guidance Systems partnership.
• Exo-spin 96 Extracellular Vesicle Isolation Kit 96-well plate format kit for extracellular vesicle isolation from various sample types. Distributed by HiSS Diagnostics under its Cell Guidance Systems partnership.
• chemagic cfDNA Extraction Kits and Magnetic Stands Magnetic bead-based extraction kit for cell-free DNA isolation from blood samples and magnetic separation stands for automated nucleic acid extraction workflows. Distributed by HiSS Diagnostics under its Revvity partnership.
• Papilloplex HR-HPV E6/E7 DNA Kit Real-time PCR test for qualitative screening of 14 high-risk HPV types in cervical samples using GeneFirst MPA technology. Distributed by HiSS Diagnostics under its GeneFirst partnership.
• Papilloplex HR-HPV E6/E7 mRNA Kit RT-PCR assay for screening of oncogenic E6/E7 mRNA transcripts from 14 high-risk HPV types for cervical cancer risk assessment. Distributed by HiSS Diagnostics under its GeneFirst partnership.
• TRUPCR SARS-CoV-2 RT-qPCR Kit and Respiratory Viral Pathogen Panel Real-time PCR kit for detection of SARS-CoV-2 viral RNA and multiplex PCR panel for detection of respiratory viral pathogens. Distributed by HiSS Diagnostics under its TRUPCR Europe partnership.
• TRUPCR Meningitis, HIV, HBV, and HCV Detection Kits Multiplex PCR panel for detection of bacterial and fungal pathogens causing meningitis, and real-time PCR kits for detection and differentiation of HIV-1 and HIV-2, quantification of Hepatitis B virus DNA, and detection/genotyping of Hepatitis C virus. Distributed by HiSS Diagnostics under its TRUPCR Europe partnership.
• TRUPCR HSV1/2 Detection Kit Real-time PCR kit for qualitative detection and differentiation of Herpes simplex virus 1 and 2. Distributed by HiSS Diagnostics under its TRUPCR Europe partnership.
• Optitrol NAT Quality Controls Ready-to-use quality controls for infectious disease testing systems including HIV, HBV, HCV, and CMV, compatible with Abbott ARCHITECT, DiaSorin LIAISON, and Roche Elecsys platforms. Distributed by HiSS Diagnostics.
• AccuPlex SARS-CoV-2 Reference Materials Reference material kit containing positive and negative controls for SARS-CoV-2 assay development and quality control. Distributed by HiSS Diagnostics under its LGC SeraCare partnership.
• ACCURUN Serology Controls Series of external controls for serological in vitro assays including hepatitis, HIV, Lyme disease, and other infectious disease markers. Distributed by HiSS Diagnostics under its LGC SeraCare partnership.
• ZeptoMetrix Inactivated Viral Culture Fluids Heat-inactivated viral culture fluids for infectious disease assay development and quality control, including Zika, West Nile, Yellow Fever, VZV, SARS-CoV-2, Influenza, and other pathogens. Distributed by HiSS Diagnostics under its ZeptoMetrix partnership.
• e-Myco Mycoplasma PCR Detection Kit PCR-based detection kit for Mycoplasma contamination in cell culture and biological samples. Distributed by HiSS Diagnostics under its iNtRON Biotechnology partnership.
• DNA-spin Plasmid DNA Purification Kit Kit for plasmid DNA purification from bacterial cultures. Distributed by HiSS Diagnostics under its iNtRON Biotechnology partnership.
• easy-spin Total RNA Extraction Kit Kit for total RNA extraction from various biological samples. Distributed by HiSS Diagnostics under its iNtRON Biotechnology partnership.
• ARM-D Antibiotic Resistance PCR Kits PCR kits for detection of antibiotic resistance genes including ampC, OXA, TEM, SHV, GES, and beta-lactamase markers. Distributed by HiSS Diagnostics under its STRECK partnership.
• LymphoQuant B-cell and T-cell Internal Controls Internal controls for B-cell and T-cell flow cytometry analysis. Distributed by HiSS Diagnostics under its Invivoscribe partnership.
• Cell Guidance Systems Growth Factors, Cytokines, and PODS Portfolio of growth factors, cytokines, and PODS (protein-based sustained release) for cell culture and research applications. Distributed by HiSS Diagnostics under its Cell Guidance Systems partnership.
• Bovine Serum Albumin (BSA), Reagent Grade High-purity BSA for use as diluent in assay development, ELISA blocking, and cell culture applications. Distributed by HiSS Diagnostics under its LGC SeraCare partnership.
• GEN3P Parsortix Cleaning Cassette Microfluidic cassette for cleaning procedure of the Parsortix PR1 instrument used for circulating tumor cell (CTC) enrichment. Distributed by HiSS Diagnostics under its CelLBxHealth partnership.
• MGMT Methylation qPCR Assay qPCR assay for MGMT (O⁶-methylguanine-DNA methyltransferase) promoter methylation detection used as a cancer biomarker. Launched in 2025 by HiSS Diagnostics for clinical and research laboratories.
• Sensiscreen Product Line 2025 product launch related to molecular pathology solutions and diagnostic products. Distributed by HiSS Diagnostics under the Sensiscreen brand.
• Streck Cell Preservative and Cyto-Chex BCT Liquid preservative for white blood cell integrity enabling CD marker measurement via flow cytometry (stabilizing samples for up to 7 days) and blood collection tube for cell stabilization and preservation for flow cytometry analysis. Distributed by HiSS Diagnostics under its STRECK partnership.

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

18 partnerships are on record, tiered core.

• STRECKcoreTechnology or IntegrationLong-term distribution partnership for STRECK products including Cell-Free DNA BCT, Cyto-Chex BCT, CD-Chex controls, and ARM-D antibiotic resistance detection kits. Products are CE-IVD and IVDR compliant.
• InvivoscribecoreTechnology or IntegrationDistribution partner for LymphoTrack NGS assays, LeukoStrat FLT3 ITD MRD Assay, LymphoQuant controls for hematology and oncology applications.
• LGC SeraCarecoreTechnology or IntegrationDistribution of ACCURUN serology controls, SeraCon diluents, and diagnostic grade serum proteins including Human Serum Albumin and Gamma Globulin.
• LGC Maine StandardscoreTechnology or IntegrationDistribution partner for standard reference materials for clinical chemistry and diagnostic quality assurance.
• NGeneBiocoreTechnology or IntegrationDistribution of NGeneBio NGS assays including BRCAaccuPanel HRD, HEMEaccuPanel, and HLAaccuTest for molecular diagnostics.
• RevvitycoreTechnology or IntegrationDistribution of chemagic nucleic acid extraction kits and related sample preparation products for NGS workflows.
• ZeptoMetrixcoreTechnology or IntegrationDistribution of inactivated viral culture fluids and reference materials including SARS-CoV-2, Influenza, and other infectious disease pathogens.
• GeneFirstcoreTechnology or IntegrationDistribution of Papilloplex HPV detection kits including E6/E7 DNA and mRNA assays for cervical cancer screening.
• NonacuscoreTechnology or IntegrationDistribution of GALEAS bladder cancer panels and Cell3 Xtract DNA extraction products for liquid biopsy applications.
• Cell Guidance SystemscoreTechnology or IntegrationDistribution of EVlution extracellular vesicle isolation systems, Exo-spin products, and growth factors for cell biology research.
• iNtRON BiotechnologycoreTechnology or IntegrationDistribution of molecular biology products including DNA-spin plasmid purification kits and e-Myco Mycoplasma detection PCR kits.
• PentaBasecoreTechnology or IntegrationDistribution partner for PentaBase molecular diagnostic products and SensiScreen assays.
• GBDcoreTechnology or IntegrationDistribution partner for GBD infectious disease diagnostic products.
• TRUPCR EuropecoreTechnology or IntegrationDistribution of TRUPCR molecular diagnostic kits for infectious diseases including bacterial, viral, and fungal pathogen detection.
• CelLBxHealthcoreTechnology or IntegrationDistribution partner for CelLBxHealth Parsortix CTC enrichment systems and related products.
• DNA DiagnosticcoreTechnology or IntegrationDistribution partner for DNA Diagnostic molecular biology products.
• TiterMaxcoreTechnology or IntegrationDistribution partner for TiterMax immunological reagents and controls for research applications.
• LGC Kova InternationalcoreTechnology or IntegrationDistribution partner for LGC Kova quality control and reference materials.

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Regional players

• Sarstedt AG & Co. KG: German manufacturer and distributor of laboratory consumables, blood collection tubes, and sample handling products. Comparable on the sample-collection/stabilization side (cfDNA BCT, Cyto-Chex BCT distribution) and on German-market reach, though vertically integrated as a manufacturer.
• Carl Roth GmbH + Co. KG: German distributor and manufacturer of laboratory chemicals, life-science reagents, and molecular biology consumables. Comparable on molecular biology reagents and B2B distribution to German-speaking research labs, though with broader catalog and direct manufacturing.

Others

• STRECK: US-based manufacturer of cell stabilization and molecular diagnostics products — a key manufacturing partner of HiSS (Cell-Free DNA BCT, CD-Chex controls). Comparable as an upstream supplier in HiSS's value chain and as an adjacent competitor in stabilization products.
• Invivoscribe: US-based developer of NGS assays and controls for hematology and oncology — also a key manufacturing partner of HiSS (LymphoTrack, LeukoStrat, LymphoQuant). Comparable as an upstream supplier and as a competing assay developer in hematology NGS.

Broad incumbents

• Bio-Rad Laboratories: Global life-science and clinical diagnostics company with overlapping product lines in PCR/qPCR reagents, quality controls, digital PCR, and flow cytometry. Comparable as both a competing supplier and a manufacturer of QC materials distributed by HiSS peers.
• Thermo Fisher Scientific: World's largest life-science tools provider; supplies many of the same categories (NGS, PCR, qPCR, clinical chemistry, sample preparation) directly or through its Fisher Scientific distribution channel. Directly competes with HiSS in nearly every product vertical.
• Merck KGaA (MilliporeSigma Life Science): Global life-science tools and reagents business serving the same clinical and research laboratory customers with overlapping products (PCR reagents, nucleic acid extraction, QC materials, flow cytometry antibodies). Comparable as a competitor and adjacent supplier for HiSS customers.

Direct peers

• Dunn Labortechnik GmbH: German distributor of life-science and diagnostic consumables, reagents, and instruments to research and clinical labs. Comparable in GTM (B2B distribution in Germany), product breadth (reagents, plastics, instruments), and target customers (academic and clinical labs).
• Amplimmun AG: German distributor specialized in immunology, cell biology, and molecular diagnostics products. Comparable niche focus on immunology-related IVD and life-science tools for German-speaking research and clinical markets.
• Zytomed Systems GmbH: German specialized distributor of pathology, molecular diagnostics, and immunohistochemistry products for clinical and research laboratories. Closest comparable to HiSS in terms of size, customer base (German pathology/molecular labs), and exclusive regional distribution model.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights5 records

Customer concentration

• Xx.com/HiSSDiagnostics

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

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 HiSS Diagnostics