What Lionex Diagnostics & Therapeutics does

LIONEX Diagnostics & Therapeutics GmbH is a privately held German biotech company headquartered in Braunschweig that develops and manufactures in-vitro diagnostic (IVD) products, research reagents and OEM lateral flow assays, with its strategic centre of gravity in tuberculosis (TB) and adjacent infectious disease and cancer biomarker detection. The company operates ISO 13485-certified manufacturing facilities (re-certified December 2024 by TÜV Rheinland) including CAT-I and CAT-II molecular biology laboratories with CAT-III access, and produces highly purified, endotoxin-free recombinant proteins using multiple expression systems (E. coli, insect cells, B. subtilis, Lactococcus lactis, M. smegmatis). Its flagship proprietary assets are the LIOFeron TB/LTBI Interferon Gamma Release Assay (IGRA) — featuring a unique antigen cocktail including alanine dehydrogenase for CD8+ T-cell stimulation — the LIODetect rapid lateral flow family (TB-ST, CRP, D-Dimer, Troponin I, COVID-19 IgG/IgM/Ag), and the patented LIOSpot TB ELISPOT test that differentiates latent from active TB. The company also holds exclusive global manufacturing and distribution rights to the EndoTrap family of endotoxin removal resins (acquired when Hyglos discontinued in December 2017) and offers EndoGrade endotoxin-free ovalbumin for vaccine research.

LIONEX monetizes through four distinct revenue streams: (1) one-time sale of branded IVD kits to hospitals and diagnostic companies; (2) OEM contract manufacturing of lateral flow tests (CRP, D-Dimer, Troponin I, plus Vitamin D and bladder cancer tests in development) under ISO 13485; (3) supply of mycobacterial antigens, recombinant proteins and endotoxin removal resins to research institutions and biopharma; and (4) licensing-style exclusive distribution of EndoTrap products globally. Pricing is quotation-based across all channels ([email protected]) and is not publicly disclosed. Customer segments span large diagnostic companies, distributors, research institutions, universities and hospitals across all continents, with named distributors including Thermo Fisher/PRIONICS in Switzerland and NPO NanoChimSyntez in Russia.

The company is led by founder Prof. Dr. Mahavir Singh as Executive Director and operates as a tightly held GmbH with no disclosed institutional investors, no parent company, no subsidiaries, and no disclosed funding rounds. Its non-dilutive growth capital comes from participation in at least 14 EU-funded research consortia (EMI-TB, EURIPRED, RAPP-ID with Janssen, POCKET with Ghent/IMEC, TRANSVAC, BactiVax, TESTOMETIC, DIPROMON, IP4Plasma, KeimOUT, Multi-WAP, FluoResYst, NANOKANAL and others) coordinated by the European Commission, WHO, FIND, BMBF and BMWi, which simultaneously generate IP, talent, publications and commercial pipeline assets.

Name

Lionex Diagnostics & Therapeutics

Legal name

LIONEX GmbH

Website

https://lionex.de

Company type

Private

Operating status

Operating

Headcount range

11–50 employees

Short description

LIONEX is a private German biotech (Braunschweig) that develops and manufactures ISO 13485-certified IVD kits, recombinant antigens and OEM lateral flow tests, anchored by the LIOFeron TB/LTBI IGRA, LIODetect rapid tests and exclusive EndoTrap endotoxin removal resins. It sells globally via direct B2B to diagnostic companies, hospitals, universities and research institutions.

Ownership category

akta.pro rank

Product category

In-Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Equipment and Supplies Manufacturing (3391)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

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

akta.pro secondary industry

Reference Laboratory Testing (Clinical Pathology & Chemistry) (HLAMADAA)

Keywords

• In-vitro diagnostics
• Tuberculosis diagnostics
• Endotoxin removal
• Recombinant antigens
• Lateral flow tests

Headquarters

HQ city

Braunschweig

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. IVD Products Sales: Sale of In-Vitro Diagnostic products including LIOFeron TB/LTBI IGRA kits, LIODetect rapid tests (CRP, D-Dimer, Troponin I, TB-ST), COVID-19 tests, and other diagnostic kits for professional use.
2. OEM Manufacturing: Contract manufacturing of lateral flow tests for partner companies. Products include CRP tests, D-Dimer tests, Troponin I tests, Vitamin D tests (in development), and urinary bladder cancer tests. All manufacturing done in Germany under ISO 13485 conditions.
3. Research Products: Sale of research-use recombinant proteins, mycobacterial antigens, and endotoxin removal products (EndoTrap, EndoGrade Ovalbumin) to research institutions and companies worldwide.
4. Endotoxin Removal Products: Sale of EndoTrap family products (EndoTrap HD, EndoTrap red) and EndoGrade Ovalbumin for endotoxin removal from proteins, antibodies, vaccines, nucleic acids, and other biological samples.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

Lionex develops, manufactures, and sells in-vitro diagnostic (IVD) kits (primarily tuberculosis and infectious disease rapid and ELISA tests), endotoxin removal affinity resins (EndoTrap), recombinant mycobacterial antigens and research proteins, and provides OEM contract manufacturing of lateral flow tests. The company also offers a standalone software for automated ELISA result analysis. All products are manufactured in Germany under ISO 13485 certified conditions.

Product overview

Lionex Diagnostics & Therapeutics is a German biotech company offering a diversified portfolio of in vitro diagnostic products and research reagents. The core offerings include: (1) LIOFeron® TB/LTBI, a novel IGRA test for tuberculosis diagnosis; (2) the LIODetect® family of rapid lateral flow tests including TB-ST, CRP, D-Dimer, Troponin I, and COVID-19 tests; (3) EndoTrap® HD and EndoTrap® red endotoxin removal resins for biomanufacturing; (4) TUB IgG/IgA ELISA kits; (5) mycobacterial antigens and recombinant proteins for research; and (6) OEM manufacturing of lateral flow tests. The company also offers the LIOFeron® stand-alone software for ELISA result analysis. Products are manufactured under ISO 13485 certification at the company's Braunschweig, Germany facility.

Differentiator

Problem solved

Functional benefit

Brands

• LIOFeron: IGRA (Interferon Gamma Release Assay) diagnostic test for diagnosing Latent TB Infection (LTBI)/TB, consisting of human blood stimulation tubes and human IFN-gamma ELISA kit.
• LIODetect
• EndoTrap
• EndoGrade

Products and services

• LIOFeron TB/LTBI IGRA Test A 2-component Interferon Gamma Release Assay (IGRA) kit for diagnosing Latent Tuberculosis Infection (LTBI) and TB, consisting of Human Blood Stimulation Tubes containing proprietary TB antigens (ESAT6, CFP10, TB 7.7) and Human IFN-γ ELISA for quantifying the interferon-gamma response. Intended for professional in vitro diagnostic use.
• LIODetect TB-ST Tuberculosis Rapid Test Rapid lateral flow test for qualitative detection of IgG, IgA and IgM antibodies to Mycobacterium tuberculosis in serum, plasma or whole blood with results within 20 minutes; demonstrates approximately 98% specificity and 65% sensitivity.
• LIODetect CRP Rapid Tests Semi-quantitative rapid tests for detection of C-reactive protein (CRP) in serum, plasma or whole blood within 5-10 minutes, available in two variants (CRP 10-30 and CRP 10-60). For professional in vitro diagnostic use.
• LIODetect D-Dimer Rapid Test Rapid visual test for qualitative detection of D-dimer in plasma or whole blood within 10-15 minutes, intended to aid in the diagnosis of thrombotic events. For professional in vitro diagnostic use.
• LIODetect Troponin I Rapid Test Visual rapid test for qualitative detection of Troponin I in whole blood, plasma and serum samples within 10-15 minutes, intended to support diagnosis of acute myocardial infarction (AMI). For professional in vitro diagnostic use.
• COVID-19 Rapid Tests Series of rapid tests for SARS-CoV-2 including IgG antibody detection, IgM antibody detection, and antigen detection (LD COVID-19 IgG, LD COVID-19 IgM, COVID-19 Ag Rapid Test). For professional in vitro diagnostic use.
• EndoTrap HD Affinity chromatography resin for endotoxin (LPS) removal from proteins, antibodies, vaccines, nucleic acids and other biological samples; usable in column or batch mode, with >5,000,000 EU/ml binding capacity, >99.99% LPS removal, >95% sample recovery, and reusable up to 10 times.
• EndoTrap red Affinity matrix for endotoxin removal from proteins, antibodies, cell extracts and nucleic acids; compatible with buffers containing calcium chelators, with >2,000,000 EU/ml binding capacity and reusable at least 3 times.
• EndoGrade Ovalbumin Endotoxin-free ovalbumin product intended for use in vaccine development and immunological research.
• TUB IgG ELISA Microtiter plate-based enzyme immunoassay for quantitative detection of human IgG antibodies to Mycobacterium tuberculosis in serum, plasma or CSF within 100 minutes. For professional in vitro diagnostic use.
• TUB IgA ELISA Microtiter plate-based enzyme immunoassay for quantitative detection of human IgA antibodies to Mycobacterium tuberculosis in serum, plasma or CSF within 100 minutes. For professional in vitro diagnostic use.
• TUB IgM ELISA Microtiter plate-based enzyme immunoassay for the detection of IgM antibodies to Mycobacterium tuberculosis, evidenced by downloadable product manuals on the LIONEX website. For professional in vitro diagnostic use.
• Mycobacterial Antigens (Research Catalog) Large catalog of highly purified, endotoxin-free recombinant and native antigens of Mycobacterium tuberculosis (including ESAT6, CFP10, Ag85B, 16kD, ALADH, HSP70, HSP65, MPT64, LAM and others) for use in TB and mycobacterial disease research and vaccine development.
• LIOSpot TB human ELISPOT test capable of differentiating between latent TB infection (LTBI) and active TB, protected by international patents of LIONEX.
• LIOFeron Software Stand-alone software for automatic analysis of LIOFeron TB/LTBI ELISA results, with options for direct import of raw data from various ELISA readers (including the DS2 automated platform) in .csv/.txt formats.
• Detect-Clostridium perfringens Beta 2-Toxin Test Membrane-based rapid test for detection of Clostridium perfringens Beta 2-Toxin in culture supernatants, intended for research use only.
• OEM Lateral Flow Test Manufacturing Contract (OEM) manufacturing of lateral flow rapid tests for partner companies, including CRP, D-Dimer, Troponin I, Vitamin D and urinary bladder cancer tests, produced under ISO 13485 conditions in Germany.

Quantifiable outcome

• LIODetect TB-ST showed ~98% specificity and ~65% sensitivity in clinical studies
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature6 records

Partnerships

20 partnerships are on record, tiered core and minor.

• Ghent University – Photonic GroupcoreStrategic or Co-development PartnerPartner in POCKET project for development of low-cost point-of-care TB sensor using silicon nitride chip technology. LIONEX responsible for antibody and antigen development.
• IMECcoreStrategic or Co-development PartnerPartner in POCKET project for chip fabrication of TB detection sensor.
• European Vaccine Initiative (EVI)coreStrategic or Co-development PartnerPartner in TRANSVAC project coordinated by EVI for accelerating vaccine development through European vaccine research infrastructure.
• IIT MadrascoreStrategic or Co-development PartnerPartner in Multi-WAP and DEMO-Multi-WAP projects for multiplexed fiber optic biosensor for waterborne pathogen detection. IIT responsible for sensor array development.
• Spinverse LtdminorStrategic or Co-development PartnerPartner in IP4Plasma project for coordination, valorisation, and market studies in atmospheric pressure plasma technology for medical diagnostics.
• Fraunhofer Institute for Surface Engineering and Thin Films ISTminorStrategic or Co-development PartnerPartner in IP4Plasma project for RTD performance of plasma processes development.
• Max Planck Institute for Biophysical ChemistryminorStrategic or Co-development PartnerPartner in KeimOUT project developing rapid detection technology for multi-resistant hospital germs.
• Kings College LondoncoreStrategic or Co-development PartnerCollaborator in HIV vaccine development with candidate vaccine ready for Phase II trials. LIONEX contributes to research in infectious diseases and cancer therapeutics.
• Karolinska InstitutetminorStrategic or Co-development PartnerAcademic research partner in Sweden for TB and infectious disease research collaborations.
• Universidade Eduardo MondlaneminorStrategic or Co-development PartnerAcademic partner in Mozambique for TB research collaborations.
• NPO NanoChimSyntezminorChannel Partner/ Reseller/ DistributorPartner in Russian Federation for distribution of LIONEX products.
• Locus BiosciencesminorStrategic or Co-development PartnerPartner/客户关系展示 on LIONEX website.
• SOFTAL Corona & Plasma GmbHminorStrategic or Co-development PartnerPartner in IP4Plasma project for plasma system manufacturing.
• Microfluidic ChipShopminorStrategic or Co-development PartnerPartner in POCKET and FluoResYst projects for microfluidic chip development.
• Life Technologies (Thermo Fisher Scientific/PRIONICS AG)coreChannel Partner/ Reseller/ DistributorPartner/distributor in Switzerland for diagnostics products.
• University College DublinminorStrategic or Co-development PartnerPartner in BactiVax innovative training network for anti-bacterial vaccine development.
• University of SurreycoreStrategic or Co-development PartnerCoordinator of DIPROMON project for bladder cancer biomarkers. LIONEX discovers, characterises and produces purified biomarkers.
• AegirbiominorStrategic or Co-development PartnerPartner in TESTOMETIC project for next generation COVID-19 PoC diagnostic test development.
• Janssen Research & DevelopmentcoreStrategic or Co-development PartnerRAPP-ID project coordinator for rapid detection of bacteria, mycobacteria, fungi and viruses. LIONEX participates in TB-related research within this consortium.
• Stiftung Tierärztliche Hochschule HannoverminorStrategic or Co-development PartnerPartner in Sero-FaSt-Myho project for Mycoplasma hyopneumoniae serological test development.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Market position

Competitive moat6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/lionex

Compliance2 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 Lionex Diagnostics & Therapeutics