What Lyme Diagnostics does

Lyme Diagnostics Ltd. is a Hungary-based private diagnostics company that develops and commercializes DualDur, a proprietary cell technology medium for the laboratory diagnosis of Lyme borreliosis. DualDur conserves patient blood or CSF samples for 2-3 weeks, concentrates Borrelia spirochetes by at least 1,000x, and enables direct visualization of live, motile spirochetes via dark-field microscopy, optionally augmented with an automated AI-based microscopy module for image analysis. The method bypasses immune-response-based serology and genetic-detection methods, which are unreliable in early-stage infection, and has demonstrated 93% sensitivity, 89% specificity, and 96% Positive Predictive Value in clinical trials.

The company serves three primary B2B segments: general practitioners, clinics and laboratories, and trained Lyme disease specialists, with theoretical and practical training delivered as part of the offering. Its go-to-market is enterprise field sales directed at European laboratory and clinic networks, supplemented by the dualdur.com platform for international sample submission from 30+ countries. Revenue is generated through laboratory diagnostic testing services (DualDur investigation, Western-blot confirmation, and clinical symptom assessment) performed at partner facilities. The core technology was developed by Dr. Béla Pál Bózsik over ~30 years, achieved IVD CE registration in 2020 after the largest prospective clinical trial in Europe for Lyme diagnostics (400 subjects, 8 sites, 6 countries), and was cited in the 2018 EU Parliament Lyme Resolution. Non-dilutive funding has come from the EU Horizon 2020 programme (grant agreement No. 805609) and related EISMEA awards.

Name

Lyme Diagnostics

Legal name

Lyme Diagnostics Ltd.

Website

https://lymediagnostics.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

11–50 employees

Short description

Lyme Diagnostics Ltd. is a Budapest-based diagnostics company that sells DualDur, an IVD CE-registered cell technology medium and direct-detection method for Lyme borreliosis, serving European GPs, clinics, laboratories, and Lyme disease specialists across 30+ countries.

Ownership category

akta.pro rank

Product category

In-Vitro Diagnostics for Infectious Disease

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Laboratory Developed Tests (LDTs) & Specialized Clinical Lab Assays (HLAAALAN)

akta.pro secondary industry

Central Laboratory & Clinical Trial Testing CROs (HLAGAAAE)

Keywords

• Lyme disease diagnostics
• In-vitro diagnostic devices
• Dark-field microscopy
• Borrelia spirochete detection
• Clinical laboratory testing

Headquarters

HQ city

Budapest

HQ country

Hungary

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Others

Revenue model

1. Laboratory Diagnostic Testing Services: The company provides laboratory diagnostic services for Lyme borreliosis using the DualDur method, including clinical symptoms assessment, DualDur investigation, and Western-blot confirmation. Tests are performed at partner laboratories and sent samples from 30+ countries.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Lyme Diagnostics Ltd. sells the DualDur cell-technology medium and IVD CE-registered preparation method for laboratory diagnosis of Lyme borreliosis, which conserves and 1,000x-concentrates live Borrelia spirochetes from patient blood for direct visualization via dark-field microscopy. The company bundles this with clinical symptoms assessment, DualDur investigation services, Western-blot confirmation, and theoretical/practical training and continuous support for Lyme specialists at partner laboratories and clinics in Europe.

Product overview

Lyme Diagnostics Ltd. offers DualDur as its core in-vitro diagnostic product - a cell technology medium and preparation method for Lyme borreliosis diagnosis. This is supplemented by diagnostic services including clinical symptoms assessment (via questionnaire), DualDur dark-field microscopy investigation, and Western-blot testing for enhanced specificity. The company also provides training and support services for Lyme specialists. DualDur with automated AI microscopy represents their technologically advanced offering, achieving 96% PPV in clinical trials and IVD CE registration for the European market.

Differentiator

Problem solved

Functional benefit

Brands

• DualDur: Cell technology medium and preparation method for direct detection of Borrelia burgdorferi sensu lato spirochetes through dark-field microscopy; available as IVD CE registered medical device

Products and services

• DualDur Cell Technology Medium (DualDur diagnostic method) IVD CE-registered cell technology medium and preparation method that conserves and 1,000x-concentrates live Borrelia spirochetes from a patient's blood sample (or CSF) for direct visualization via dark-field microscopy, enabling Lyme borreliosis diagnosis at any disease stage independent of immune response.
• Clinical Symptoms Assessment Questionnaire-based service in which a trained professional records the clinical symptoms reported by the patient to support Lyme borreliosis diagnosis alongside DualDur and Western-blot testing.
• Western-blot Confirmation Testing Standard and modified Western-blot tests performed to enhance specificity and confirm the type of spirochete, helping prescribe appropriate treatment.
• Lyme Specialist Training and Support Theoretical and practical training program for Lyme specialists on how to use the DualDur system for best diagnosis, supplemented by continuous support from Lyme Diagnostics.

Quantifiable outcome

• 93% sensitivity in detecting Lyme borreliosis
• +3 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature5 records

Partnerships

Four partnerships are on record, tiered core and major.

• Clinical Trial Sites (Hungary, Austria, Czechia, Germany, Poland, Slovakia)coreStrategic or Co-development Partner · 1 January 2019Multi-country clinical trial conducted at 8 sites across 6 Central European countries: Hungary (Istenhegyi Genetic Diagnostics Centre), Austria (MedUni Vienna), Czechia (FORBELI s.r.o.), Germany (Praxis Dr.med Reinhardt), Poland (St. Luke's Clinic, Centrum Dr. Ozimek), Slovakia (Borélia centrum Bratislava, BCB Clinic). Laboratory investigations were carried out at Synlab laboratories in Hungary.
• OGYÉI (National Institute of Pharmacy and Nutrition)coreStrategic or Co-development PartnerThe Hungarian competent authority that managed the IVD CE registration and clinical research of DualDur, including performance assessment through in-vitro studies, clinical trials for stability and detectability, and artifact generation studies.
• Synlab Laboratories HungarycoreStrategic or Co-development PartnerPartner laboratory that carried out the laboratory investigations for the EU clinical trial of DualDur, processing samples from multiple clinical sites across Central Europe.
• dualdur.commajorChannel Partner/ Reseller/ DistributorDistribution partner platform through which DualDur testing services are made available to customers internationally, expanding access beyond the European laboratory network.

Scale indicators10 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• bioMérieux: Global IVD leader offering Vidas and BioBall serology panels for Lyme disease. Comparable as an established diagnostics player serving European clinical laboratories with Lyme tests, though bioMérieux's offering is serology-based rather than direct detection.
• DiaSorin: Specialty IVD company with the Liaison platform for infectious disease serology including Lyme. Comparable as a European-headquartered diagnostics manufacturer selling Lyme immunoassays into the same lab channel that Lyme Diagnostics targets.
• EUROIMMUN (PerkinElmer): Major European specialty serology provider including comprehensive Lyme Western blot and ELISA menus. Comparable as a competitor in the Lyme diagnostics workflow at the same clinical laboratory channel, backed by PerkinElmer's broader life sciences platform.
• QIAGEN: Global molecular diagnostics and sample-preparation leader with PCR-based Lyme and tick-borne disease tests. Comparable as a competing modality (molecular vs. microscopy) for direct Lyme detection, serving the same reference lab customer base.
• Roche Diagnostics: Cobas/Elecsys-based Lyme serology is widely deployed across European hospital networks. Comparable as the entrenched standard-of-care serology incumbent that Lyme Diagnostics' direct-detection method is positioned to complement or displace for ambiguous cases.
• Abbott Diagnostics: Architect and Alinity platforms include Lyme serology assays deployed across European laboratories. Comparable as a deep-pocketed established IVD competitor serving the same clinical lab and hospital channel.

Direct peers

• IGeneX: US-based specialty reference laboratory offering PCR and immunoblot-based Lyme and tick-borne disease testing. Comparable as a specialized Lyme diagnostics lab targeting complex and chronic-Lyme cases, competing for the same physician-referred testing volume through direct sample shipment.

Emerging players

• Galaxy Diagnostics: Specialty reference lab focused on Bartonella and tick-borne disease direct detection using culture and PCR. Comparable as a niche direct-detection player in the same Lyme and co-infection specialty testing market that Lyme Diagnostics addresses.
• Ceres Nanosciences: Developer of Nanotrap antigen-detection technology for Lyme and other infectious diseases. Comparable as an emerging direct-detection Lyme diagnostics company pursuing a different concentration/capture technology (nanoparticles vs. DualDur medium) but serving the same unmet clinical need.
• Oxford Immunotec: T cell-based specialty diagnostics company expanding into Lyme after T-SPOT tuberculosis franchise. Comparable as a specialty immunodiagnostics player with European regulatory footprint targeting infectious disease direct-detection use cases overlapping with Lyme Diagnostics.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/lymediagnostics
• LinkedInlinkedin.com/company/lyme-diagnostics-ltd
• Instagraminstagram.com/lymediagnosticsltd

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds2 records

Investors1 record

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 Lyme Diagnostics