What LionDx does

LionDx srl is an Italian molecular diagnostics company headquartered in Pordenone that designs, markets, and distributes diagnostic kits and sequencing systems for clinical and research laboratories. The company's portfolio spans CE-IVD marked Real-Time PCR kits for fungi, viruses, bacteria, and parasites — including unique proprietary assays for Candida auris (direct-from-swab without DNA extraction), a 6-species Candida multiplex from serum/plasma, Acanthamoeba, and Tick-Borne Encephalitis / West Nile viruses — together with ß-D-Glucan testing via the Fungitell STAT system for invasive fungal infection screening.

The product surface also includes distributed next-generation sequencing platforms from Element Biosciences, namely the AVITI and AVITI24 benchtop systems (the latter extending into single-cell, spatial, and multiomics workflows) and the VITARI high-volume NGS system, complemented by the ChapterDx MLSTnext strain-typing platform and the 1928 bioinformatics software for data interpretation. The company positions itself as an expert-led specialty distributor with 25 years of molecular diagnostics experience rather than a broadline catalog reseller, emphasizing unique kits and validated CE-IVD clinical workflows.

Commercially, LionDx operates a direct-to-customer model via its website and direct engagement with laboratories and healthcare facilities, with quote-based pricing and no public price list. Revenue is generated through one-time sales of diagnostic kits and consumables, hardware sales of NGS systems, and ongoing reagent replenishment. The company reports 1.5 million products sold in one year and 10x growth in the last year, though no revenue, headcount, or financial figures are disclosed. Ownership is private under Italian srl form, with no disclosed parent company, institutional investors, or management team beyond founder and president Michael Johansen.

Name

LionDx

Legal name

LionDx srl

Website

https://liondx.it

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

1–10 employees

Short description

LionDx srl is an Italian molecular diagnostics company that sells CE-IVD marked PCR kits for fungi, viruses, bacteria, and parasites and distributes Element Biosciences NGS systems to clinical and research laboratories across global markets.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)

akta.pro primary industry

Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA)

akta.pro secondary industries

Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD), Microbiology & Infectious Disease Diagnostics (Culture/ID/AST) (HLAHAAAC), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)

Keywords

• Molecular diagnostics
• Fungal diagnostics
• PCR test kits
• Next generation sequencing
• In vitro diagnostics

Headquarters

HQ city

Pordenone

HQ country

Italy

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Molecular Diagnostic Kits: Sale of CE-IVD marked diagnostic kits for fungi, viruses, bacteria, and parasites including Real Time PCR tests and rapid tests. One-time reagent sales with consumable replenishment.
2. NGS Instruments and Consumables: Sale and distribution of Element Biosciences AVITI™ and AVITI24™ NGS systems along with associated consumables and reagents for sequencing operations.
3. ß-D-Glucan Testing: Sale of Fungitell STAT® system for rapid screening of invasive fungal infections, utilizing disposable format with compact size.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

LionDx develops and distributes molecular diagnostic kits and laboratory products with a specialization in fungal diagnostics. The company offers Real-Time PCR kits, ß-D-Glucan testing systems, and Next Generation Sequencing (NGS) platforms for detection of pathogens including Candida species, viruses, bacteria, and parasites. It also distributes Element Biosciences AVITI and AVITI24 NGS benchtop sequencing systems in its market.

Product overview

LionDx is a molecular diagnostics company specializing in fungal diagnostics, offering a diverse portfolio of unique diagnostic kits and NGS solutions. The product portfolio includes: (1) Real-time PCR kits for fungi, viruses, bacteria, and parasites including unique products like the Candida multiplex (discriminates 6 species), Candida auris (direct from swab without DNA extraction), and Acanthamoeba tests; (2) Next-generation sequencing solutions including Element Biosciences AVITI™ and AVITI24™ systems, and VITARI™ for high-volume applications; (3) ß-D-Glucan analysis (Fungitell STAT) for invasive fungal infection screening; (4) MLSTnext ChapterDx for genomic typing of bacterial and fungal strains; and (5) 1928 Bioinformatics Platform for data analysis. Many products carry CE IVD certification. The company distributes Element Biosciences sequencing platforms alongside its proprietary molecular diagnostic assays, combining a range of PCR-based tests with advanced NGS capabilities.

Differentiator

Problem solved

Functional benefit

Products and services

• Candida auris Test qPCR (AurisID) Unique qPCR kit for the detection of Candida auris directly from swab without DNA extraction. CE IVD marked and optimized for surveillance of Candida auris in healthcare settings. Targeted at clinical and hospital laboratories.
• Candida Test multiplex qPCR (Cand*ID) Unique multiplex qPCR kit that discriminates 6 species of Candida from serum and plasma samples. CE IVD marked. Targeted at clinical laboratories performing invasive candidiasis diagnostics.
• Acanthamoeba Test Real-Time PCR Unique CE IVD marked Real-Time PCR test for detection of Acanthamoeba, a parasitic pathogen. Targeted at clinical microbiology laboratories.
• TBE virus and West Nile virus Test qPCR Multiplex qPCR assay for simultaneous detection of Tick-Borne Encephalitis virus and West Nile virus. CE IVD marked. Targeted at clinical laboratories performing vector-borne virus diagnostics.
• Fungitell STAT — ß-D-Glucan Analysis Rapid screening system for invasive fungal infections using ß-D-Glucan analysis. A highly flexible system due to its compact size and disposable format. Targeted at clinical laboratories performing invasive fungal infection screening.
• SEPTI-LOOP Rapid Sepsis Test Rapid molecular test for sepsis detection enabling faster clinical decision-making. Targeted at clinical and hospital laboratories and emergency settings.
• AVITI™ and AVITI LT™ NGS Systems Benchtop next-generation sequencing system from Element Biosciences featuring dual flow cells and Q40+ accuracy. The only Q40+ benchtop sequencer available. Distributed by LionDx for research and clinical laboratories.
• AVITI24™ Multiomics and NGS Advanced Element Biosciences sequencing system combining single-cell analysis, spatial genomics, and multiomics capabilities. Distributed by LionDx for advanced genomic research and clinical applications.
• VITARI™ High Volume NGS High-volume next-generation sequencing solution designed for large-scale genomic research and clinical applications. Targeted at laboratories with high-throughput sequencing requirements.
• MLSTnext ChapterDx Innovative genomic sequencing and typing platform for bacterial and fungal strain identification and characterization. Distributed by LionDx for research and clinical laboratories performing epidemiological typing.
• 1928 Bioinformatics Platform Bioinformatics analysis platform for processing and interpreting molecular diagnostic and NGS data. Targeted at laboratories using LionDx NGS systems for genomic data analysis.

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature8 records

Partnerships

Two partnerships are on record, tiered core.

• Element BiosciencescoreTechnology or IntegrationLionDx distributes Element Biosciences AVITI™ and AVITI24™ NGS systems in their market. These benchtop sequencing systems represent core products in their portfolio, with LionDx promoting them as revolutionary in Next Generation Sequencing with dual flow cells and Q40+ accuracy.
• Fungitell (Associated Partners)coreTechnology or IntegrationLionDx distributes the Fungitell STAT® system for ß-D-Glucan analysis, which is highlighted as a highly flexible and quick system due to its compact size and disposable format. Rapid screening for invasive fungal infections is a key application.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• bioMérieux: Global leader in microbiology and molecular diagnostics with a strong portfolio of PCR and NGS-based infectious disease tests, including fungal diagnostics and blood culture identification. Closely comparable to LionDx's microbiology/molecular diagnostics focus.
• Cepheid (Danaher): Operates the GeneXpert molecular diagnostic platform widely used in clinical labs for infectious disease testing including fungal and bacterial pathogens. Directly comparable in target customer (clinical/hospital labs) and core molecular diagnostic technology.
• QIAGEN: Major molecular diagnostics and sample-preparation company with PCR and NGS workflows for infectious disease detection. Comparable to LionDx's PCR kit business and its role as an enabler of molecular testing in research and clinical labs.
• ELITech Group: European-headquartered molecular diagnostics company specializing in infectious disease PCR kits for clinical laboratories. Closely comparable to LionDx in geography, customer base, and infectious-disease PCR product focus.
• Hologic: Operates the Panther molecular diagnostic system with a broad infectious disease menu. Comparable to LionDx in providing PCR-based molecular tests for pathogens to clinical labs.
• Bruker: Provides microbiology diagnostics including MALDI-TOF identification and molecular solutions for fungal and bacterial pathogens. Comparable to LionDx's microbiology and fungal identification focus.
• Seegene: Molecular diagnostics company with multiplex qPCR syndromic assays for infectious diseases including respiratory and hospital-acquired pathogens. Comparable to LionDx's multiplex PCR approach (e.g., 6-species Candida kit).

Emerging players

• T2 Biosystems: Specializes in rapid molecular detection of invasive fungal infections (T2Candida) and sepsis directly from whole blood. Highly comparable to LionDx's fungal diagnostics and rapid sepsis portfolio, though focused on a narrower set of indications.
• Molzym: European molecular diagnostics company focused on rapid pathogen detection from sterile sites, including sepsis and fungal bloodstream infections. Comparable niche overlap with LionDx's fungal and sepsis rapid test portfolio.

Broad incumbents

• Element Biosciences: Developer of the AVITI benchtop NGS sequencer, which LionDx distributes. Element is the upstream technology provider whose platform powers LionDx's NGS offering, making it a key ecosystem partner and broad incumbent in the sequencing category.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights5 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

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 LionDx