What ViennaLab Diagnostics does

ViennaLab Diagnostics GmbH is an Austrian in vitro diagnostics (IVD) company founded in 1990 in Vienna, developing, manufacturing, and distributing CE/IVD-labeled genetic testing assays for clinical laboratories. The company operates three proprietary technology platforms: StripAssays (lateral-flow assays for genetic disorders including Thalassemia, Cystic Fibrosis, Congenital Adrenal Hyperplasia, and Familial Mediterranean Fever), RealFast Assays (rapid PCR-based detection including HLA-B27 for seronegative spondyloarthropathies), and NGS Assays (next-generation sequencing solutions covering Hereditary Cancer, Somatic Mutations, Clinical Exome Sequencing, and 16S Microbiome with optional ITS fungal detection). The NGS product line is differentiated by an all-in-one workflow integrating library preparation, proprietary Genovesa bioinformatics, and automated variant report generation. Quality and regulatory posture is anchored by ISO 13485 certification and IVDR 2017/746 compliance, with multiple products having secured IVDR approval from TÜV Süd Notified Body.

The company serves five primary use case segments: genetic disorder testing, oncology and hereditary cancer testing, pharmacogenetics, genetic predispositions, and microbiome analysis. Customer base consists of clinical laboratories across more than 100 markets worldwide, accessed through an international distribution network of channel partners rather than direct sales. The revenue model is a one-time license per IVD kit sold, with pricing not publicly disclosed. ViennaLab has been a wholly integrated member of the BioVendor Group since 2020, a Czech-founded international IVD platform whose other brands include BioVendor R&D, TestLine, DiaSource, and Oxford BioSystems.

In 2025, BioVendor Group underwent an ownership change with healthcare-focused private equity firm ARCHIMED, paired with a major restructuring into three global divisions under a unified brand identity. Carlos Pascual, former CEO of Werfen, was appointed Chairman of BioVendor Group in 2025. ViennaLab participates in externally funded consortia including the Horizon 2020 MedPhab pilot line and the oncNGS consortium (with Euformatics and Oncompass Medicine) for liquid biopsy and Pan-cancer cfDNA test development, with Phase 2 funding secured in 2024. The company is led by CEO Christian Oberkanins and operates from its headquarters at Gaudenzdorfer Gürtel 43-45 in Vienna.

Name

ViennaLab Diagnostics

Legal name

ViennaLab Diagnostics GmbH

Website

https://viennalab.com

Company type

Private

Founded year

1990

Operating status

Operating

Headcount range

1–10 employees

Short description

ViennaLab Diagnostics GmbH is an Austrian IVD company founded in 1990, developing CE/IVD-labeled genetic testing assays including StripAssays, RealFast Assays, and NGS Assays for clinical laboratories in genetic disorders, oncology, pharmacogenetics, and microbiome applications worldwide.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics (Molecular Diagnostics for Human Genetic Testing)

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Genetic, Cytogenetic & Prenatal Screening IVD (HLAHAAAI)

akta.pro secondary industry

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

Keywords

• In vitro diagnostics
• Molecular diagnostic assays
• Genetic testing kits
• Next generation sequencing
• Clinical laboratory reagents

Headquarters

HQ city

Vienna

HQ country

Austria

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. IVD Diagnostic Products: Sale of in vitro diagnostic kits and assays for genetic testing across cancer, genetic disorders, microbiome, pharmacogenetics, and genetic predispositions

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

ViennaLab Diagnostics develops, manufactures, and distributes in vitro diagnostic (IVD) assay kits for human genetic testing under three technology platforms — StripAssay®, RealFast™, and NGS Assays — covering genetic disorders, hereditary cancer, somatic mutations, pharmacogenetics, genetic predispositions, and the human microbiome. The kits are CE/IVD labeled and many carry IVDR 2017/746 certification, and are sold globally to clinical and reference laboratories through BioVendor Group's distribution network.

Product overview

ViennaLab Diagnostics develops, manufactures, and distributes in vitro diagnostic (IVD) products for human genetic testing. Their product portfolio consists of three core technology platforms: StripAssays (lateral flow-based assays for genetic disorders such as Thalassemia, Cystic Fibrosis, CAH, and FMF), RealFast Assays (rapid detection assays including HLA-B27), and NGS Assays (next-generation sequencing solutions including Hereditary Cancer, Somatic Mutations, Clinical Exome Sequencing, and 16S Microbiome assays). The company operates as part of the BioVendor Group and serves international markets through a distribution network, with products CE/IVD labeled and compliant with EU IVDR 2017/746 regulations.

Differentiator

Problem solved

Functional benefit

Products and services

• RealFast Assays Easy-to-use IVD real-time PCR assays for rapid detection of genetic variants, including HLA-B27 for seronegative spondyloarthropathies, sold to clinical laboratories through distribution partners.
• StripAssays CE/IVD labeled diagnostic assays using reverse-hybridization strip technology for detection of genetic disorders including Thalassemia, Cystic Fibrosis (CF), Congenital Adrenal Hyperplasia (CAH), and Familial Mediterranean Fever (FMF).
• NGS Assays Next Generation Sequencing assays for comprehensive genetic variant analysis, providing an all-in-one solution with library preparation, bioinformatic analysis via Genovesa, and genetic variant report generation for clinical laboratories.
• Hereditary Cancer NGS Assay NGS-based IVD assay for detecting hereditary cancer-associated genetic variants as part of the NGS product line, targeted at clinical molecular diagnostics laboratories.
• Somatic Mutations NGS Assay NGS IVD assay designed for detection of somatic mutations in cancer diagnostics, used by clinical laboratories for tumor profiling.
• Clinical Exome Sequencing (CES) NGS Assay Comprehensive clinical exome sequencing NGS assay for broad genetic analysis in clinical settings, supporting differential diagnosis of complex genetic conditions.
• 16S Microbiome + ITS NGS Assay Comprehensive intestinal microbiome NGS assay enabling simultaneous detection of both bacterial and fungal species in a single sample, with primers for fungal detection supplied as an add-on; used by research and clinical laboratories for gut microbiome analysis.
• 16S Microbiome NGS Assay (Improved) Updated version of the 16S Microbiome NGS Assay with a faster 2-step library preparation protocol, improved sequencing quality, and reduced per-sample cost compared to the prior version.
• HLA-B27 RealFast Assay IVDR CE0123 certified real-time PCR assay for characterizing HLA-B*27 subtypes associated with seronegative spondyloarthropathies such as Morbus Bechterew (ankylosing spondylitis), available in 100 rxn and 32 rxn kit configurations.
• FMF StripAssay IVDR certified StripAssay for detecting pathogenic MEFV variants in Familial Mediterranean Fever patients, supplied as REF 4-230 for 20 tests per kit.
• FMF-SAA1 StripAssay IVDR certified StripAssay for detecting MEFV variants and assessing risk for AA amyloidosis in Familial Mediterranean Fever patients, supplied as REF 4-390 for 20 tests per kit.

Segments4 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Seven partnerships are on record, tiered core, major and minor.

• BioVendor GroupcoreOthers · 1 January 2020BioVendor Group is the parent company of ViennaLab Diagnostics. Founded in 1992 in the Czech Republic, BioVendor Group is an international group of biotechnology companies with expertise in immunodiagnostics, molecular diagnostics, and radio-immunodiagnostics. ViennaLab became a full member of the BioVendor Group family in 2020.
• HVD Vertriebs GmbHmajorChannel Partner/ Reseller/ DistributorLong-term distribution partner in Austria. HVD Life Science Vertriebs GmbH represents ViennaLab at industry exhibitions and trade shows in the Austrian market.
• EuformaticsmajorStrategic or Co-development PartnerPartnership in oncNGS consortium for development of liquid biopsy solutions. Euformatics provides bioinformatics expertise for Pan-cancer cfDNA test development.
• Oncompass MedicinemajorStrategic or Co-development PartnerPartnership in oncNGS consortium for development of liquid biopsy solutions. Oncompass Medicine provides AI expertise for cancer detection technology.
• MedPhab ConsortiumminorStrategic or Co-development PartnerHorizon 2020 funded European consortium dedicated to manufacturing, testing, validation and up-scaling of new photonics technologies for medical diagnostics. ViennaLab is part of this pilot production line for diagnostic devices.
• oncNGS ConsortiummajorStrategic or Co-development PartnerPartnership with Alleanza Contro il Cancro, Institut Curie, Charité - Universitätsmedizin Berlin, and Institut Jules Bordet for liquid biopsy and cancer detection development. Phase 2 secured for Pan-cancer cfDNA test development.
• Goffin Molecular TechnologiesminorChannel Partner/ Reseller/ DistributorLocal distribution partner representing ViennaLab at European Molecular Diagnostics conferences and exhibitions.

Scale indicators2 records

Recent moves9 records

Expansion highlights6 records

Direct peers

• QIAGEN: QIAGEN is a global leader in molecular diagnostics and sample-preparation technologies, offering IVD kits and assays for genetic and infectious disease testing. Directly comparable to ViennaLab as both sell IVD molecular diagnostic kits (PCR-based, NGS panels) to clinical labs worldwide.
• Bio-Rad Laboratories: Bio-Rad manufactures clinical diagnostics products including IVD kits, quality controls, and genetic testing reagents. Highly comparable to ViennaLab's StripAssay and RealFast product lines, both targeting genetic and inherited disease testing in clinical laboratories.
• Cepheid (Danaher): Cepheid makes GeneXpert molecular diagnostic systems and IVD tests for healthcare-associated infections, sexual health, and oncology. Directly comparable as a molecular IVD kit maker, though Cepheid sells closed-cartridge tests on its proprietary instrument whereas ViennaLab sells kits usable on standard lab equipment.
• ELITech Group: ELITech develops and distributes IVD reagents and instruments for clinical chemistry, molecular diagnostics, and microbiology, with a strong European presence. Comparable to ViennaLab as a European-headquartered IVD kit manufacturer serving molecular diagnostics and genetic testing markets.
• Hologic: Hologic's molecular diagnostics division develops IVD assays for women's health, infectious disease, and oncology on automated Panther platforms. Comparable to ViennaLab in selling molecular IVD kits to clinical labs, though ViennaLab focuses more on genetic disorders vs. Hologic's broader infectious disease and cytology focus.

Broad incumbents

• Thermo Fisher Scientific: Thermo Fisher's Specialty Diagnostics segment provides IVD kits, reagents, and instruments for clinical and genetic testing. Comparable to ViennaLab in molecular IVD offerings but with substantially broader portfolio, including instruments, software, and global commercial infrastructure.
• Roche Diagnostics: Roche Diagnostics is the world's largest IVD company, offering comprehensive molecular, clinical chemistry, and tissue diagnostics portfolios. Overlaps with ViennaLab across genetic testing and oncology IVD, but operates at far greater scale and with proprietary instruments plus a much broader menu.
• Illumina: Illumina is the dominant NGS platform provider with expanding IVD kits through its Illumina Connected Diagnostics business. Relevant as ViennaLab's NGS Assays run on Illumina sequencers and Illumina's growing menu of clinical IVD kits competes directly in oncology and hereditary disease testing.

Emerging players

• Devyser: Devyser is a Swedish molecular diagnostics company specializing in IVD kits for hereditary disease, oncology, and post-transplant monitoring. Closely comparable to ViennaLab in product scope (genetic IVD kits) and European origin, but smaller and earlier-stage commercially.
• Yourgene Health (Novogene): Yourgene Health (now part of Novogene) develops molecular IVD kits for reproductive health, NIPT, and oncology. Comparable to ViennaLab in genetic IVD focus, with overlapping oncology and hereditary disease assays, but with stronger NIPT specialization.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/channel/UCVOdfqLSzdGPQmTMow4-iLQ
• LinkedInlinkedin.com/company/viennalab-diagnostics-gmbh

Compliance3 records

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 ViennaLab Diagnostics