miDiagnostics

What miDiagnostics does

miDiagnostics NV is a Belgian molecular diagnostics company, spun out of imec and Johns Hopkins University in 2015 and headquartered in Leuven, Belgium, with a manufacturing and warehouse facility in Wijgmaal. The company has developed a proprietary silicon chip-based nanoFluidic Processor that performs passive liquid processing via capillary forces and ultra-fast PCR (claimed at 20x the speed of classical PCR), embedded into single-use PCR Cards read by a compact portable Reader and accompanying Software with LIS integration. The platform delivers sample-to-result in under 30 minutes at the point of care, with reported clinical accuracy equivalent to central-lab PCR.

The commercial product portfolio currently centers on the CE-IVD certified ultra-fast COVID-19 PCR Test (launched May 2022) and the FDA 510(k) cleared HSV-1&2 Test for encephalitis and meningitis diagnosis (cleared October 2025). A higher-value sterility test for the BioPharma industry is in development, targeting CAR-T and cell/gene therapy manufacturing QC, with a strategic collaboration with Galapagos and a €30 million Series D led by Thermo Fisher Scientific (December 2024) explicitly funding this franchise.

The company monetizes through sales of single-use test cards/consumables and placement of reader instruments under enterprise contracts, supplemented by sterility testing services and technology licensing for pharma applications. Go-to-market is enterprise field sales targeting pharmaceutical manufacturers, healthcare providers and research institutions across Europe (CE-IVD) and the United States (FDA). Pricing is quote-based and not publicly disclosed; multi-year contracts are typical. Customers include Galapagos (CAR-T sterility), Johns Hopkins, UZ Leuven/KU Leuven, Hampshire Hospitals NHS, University of Liverpool, and TriCore Reference Laboratories. Total funding raised since inception is approximately €140 million plus a €20 million EIB loan, with strategic and financial backers including Thermo Fisher Scientific, Alychlo (Marc Coucke), VMF Invest (Urbain Vandeurzen), Pamica (Michel Akkermans), Smile Invest, imec, Johns Hopkins, PMV, and the EIB.

Name

miDiagnostics

Legal name

miDiagnostics NV

Website

https://midiagnostics.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

101–250 employees

Short description

miDiagnostics is a Leuven, Belgium-based molecular diagnostics company that has developed a proprietary silicon chip nanoFluidic Processor enabling ultra-fast point-of-care PCR testing, serving pharmaceutical manufacturers (sterility testing for CAR-T and cell therapies), healthcare providers, and research institutions across Europe and the United States.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516), Medical Laboratories (621511)

SIC

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

akta.pro primary industry

Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF)

akta.pro secondary industries

Analytical Testing & QC Release Services (potency, purity, sterility) (HLAAAKAG), Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL)

Keywords

• Molecular diagnostics
• Point-of-care PCR
• Pharmaceutical sterility testing
• Silicon nanofluidic chips
• Rapid PCR testing

Headquarters

HQ city

Leuven

HQ country

Belgium

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Test Kits and Consumables: Sale of single-use PCR cards/test cards and associated reagents for the diagnostic platform. These are disposable components required for each test run.
2. Diagnostic Instrument/Reader Systems: Sale or lease of the compact reader instrument used to process test cards and display results. The reader is a reusable multi-use device.
3. Pharma Services - Sterility Testing: Sterility testing and quality control testing services for pharmaceutical manufacturers, specifically for bio/pharma industry quality control including CAR-T and cell therapy manufacturing.
4. Technology Licensing: Licensing of proprietary silicon chip technology and platform to strategic partners for specific applications such as CAR-T manufacturing integration.

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels6 records

Core offering

miDiagnostics develops and sells a molecular diagnostic platform built around a proprietary silicon chip nanoFluidic Processor that performs passive liquid handling and ultra-fast PCR. Its commercial offerings include CE-IVD and FDA 510(k) cleared diagnostic tests (COVID-19 PCR, HSV-1&2), ultra-rapid sterility tests for bio/pharmaceutical manufacturers, and supporting Reader, Computer, and LIS-integrable Software components sold to hospitals, clinical labs, and pharma companies.

Product overview

miDiagnostics offers a portfolio of molecular diagnostic products centered on its proprietary silicon chip technology platform. The core offering consists of the nanoFluidic Processor embedded in single-use PCR Cards, read by a compact Reader device, all supported by proprietary Software. The company provides specific diagnostic tests including the Ultra-Fast COVID-19 PCR Test, the FDA-cleared HSV-1&2 Test, and Sterility Tests for the BioPharma industry. The system delivers lab-quality results in under 30 minutes at point of care, using capillary-driven passive liquid processing without requiring pumps or valves.

Differentiator

Problem solved

Functional benefit

Products and services

• miDiagnostics Molecular Diagnostic Platform Integrated point-of-care molecular diagnostic platform combining a single-use PCR Card (embedded with a proprietary silicon chip nanoFluidic Processor), a multi-use compact Reader with thermal and optical processing, a touchscreen Computer with barcode scanner, and LIS-integrable software for sample-to-answer traceability. Delivers lab-quality PCR results in under 30 minutes for hospitals, clinical labs, and point-of-care settings.
• Ultra-Fast COVID-19 PCR Test CE-IVD certified point-of-care molecular diagnostic test for COVID-19 using nasopharyngeal swabs processed through PCR Cards on the compact Reader. Delivers PCR-accurate results in under 30 minutes and was validated in a Brussels Airport pilot of ~600 passengers demonstrating turnaround under 20 minutes with accuracy equivalent to traditional PCR.
• HSV-1&2 Test FDA 510(k) cleared point-of-care test for rapid diagnosis of encephalitis and meningitis caused by herpes simplex virus types 1 and 2. Delivers fast and accurate results in under 30 minutes at point of care with ultra-high sensitivity, including full system validation across assay, cartridge, instrument, software, and cybersecurity/quality controls.
• Sterility Test for BioPharma Ultra-fast PCR-based sterility test for bio/pharmaceutical manufacturers delivering results in under two hours versus several days for traditional methods. Enables pharmaceutical manufacturers to accelerate delivery of advanced immunotherapies including CAR-T cancer treatments and supports decentralized, point-of-care manufacturing of cell and gene therapies.
• Pharma Sterility Testing Services Sterility testing and quality control services for pharmaceutical manufacturers using miDiagnostics' ultra-fast PCR platform, including the Galapagos partnership for closed-flow CAR-T batch release and integration with Lonza Cocoon manufacturing platform and xCellit workflow management. Targeted at bio/pharma industry quality control including CAR-T and cell therapy manufacturing.

Quantifiable outcome

• Sterility test results in under 2 hours compared to several days for traditional methods, enabling faster CAR-T treatment delivery
• +3 more outcomes

Named customers7 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

AI capability1 record

Feature6 records

Partnerships

Ten partnerships are on record, tiered core, notable and minor.

• GalapagoscoreStrategic or Co-development Partner · 10 November 2023Collaboration to develop closed-flow, ultra-rapid PCR sterility test for CAR-T batch release in decentralized manufacturing setting. miDiagnostics will adapt its platform for fully automated sterility testing at point-of-care integrated with Galapagos' xCellit workflow management and Lonza Cocoon manufacturing platform. Supports 7-day vein-to-vein time for fresh CAR-T therapies.
• imeccoreTechnology or IntegrationTechnology licensing partner. miDiagnostics' nanoFluidic Processor technology was initially developed by imec, the world-leading R&D and innovation hub in nanoelectronics and digital technologies. Silicon chip technology licensed from imec enables high-precision liquid control and ultra-fast PCR through miniaturization.
• Johns Hopkins UniversitycoreTechnology or IntegrationResearch collaboration partner. Developed in close collaboration with Johns Hopkins University, the leading US research and medical centre. Technology licensed through imec/Johns Hopkins partnership. Multiple clinical trials conducted with Johns Hopkins investigators (Heba Mostafa as PI for HSV clinical trial).
• Brussels Airport CompanynotableStrategic or Co-development PartnerPilot study partner for ultra-fast COVID-19 PCR testing at Brussels Airport. Nearly 600 passengers participated over 2 months. Demonstrated turnaround times under 20 minutes with accuracy equivalent to traditional PCR. CEO Arnaud Feist noted confidence in technology for airport testing services.
• EcolognotableStrategic or Co-development PartnerCOVID-19 screening and diagnostics logistics partner for Brussels Airport pilot. Leading global provider of COVID-19 screening infrastructure responsible for passenger registration and sampling workflow at airport test centre.
• Eurofins Labo Van PouckenotableStrategic or Co-development PartnerClinical diagnostics partner performing standard PCR tests as benchmark in Brussels Airport pilot study. Provided comparison testing to validate miDiagnostics' ultra-fast PCR accuracy against traditional lab methods.
• KU Leuven / UZ LeuvencoreStrategic or Co-development PartnerClinical performance evaluation partner. Published study in ASM Journal of Clinical Microbiology demonstrating excellent diagnostic performance. Prof. Jan Verbakel served as Principal Investigator; Prof. Katrien Lagrou and Dr. David Bos were key collaborators. Study of 766 subjects confirmed accuracy comparable to central lab PCR.
• BSI (Netherlands)notableImplementation/ SI/ Consulting PartnerPartnership with BSI as Notified Body to assess and certify miDiagnostics Quality Systems to ISO 13485 (2016) in preparation for CE marking and FDA 510(k) clearance of diagnostic devices.
• Leuven MindGateminorOthersAssociate member of Leuven MindGate, a regional organization positioning Leuven as a top destination in health, high-tech and creativity. Provides access to member activities, content, and opportunities to participate in local and international projects and trade fairs.
• LonzanotableStrategic or Co-development PartnerProvider of Cocoon Platform for cell therapy manufacturing. Galapagos partnership utilizes Lonza's functionally closed, automated manufacturing platform for decentralized CAR-T production, with miDiagnostics providing integrated sterility testing.

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Qiagen:
• Cepheid (Danaher): Cepheid is the market leader in rapid molecular diagnostics with its GeneXpert platform, deployed across hospitals and POC settings globally. Directly comparable to miDiagnostics' PCR-based reader + cartridge architecture, but with vastly larger installed base, broader test menu, and parent Danaher's commercial scale.
• bioMérieux (BioFire): BioFire FilmArray is a leading syndromic and rapid molecular diagnostic platform for POC and clinical lab use. Comparable to miDiagnostics' rapid PCR architecture and sterility testing portfolio (via bioMérieux Industrial Microbiology), with established global distribution and strong hospital presence.
• Roche Diagnostics: Roche cobas is the dominant automated PCR/molecular diagnostic platform globally, used in central labs and hospital POC settings. Comparable in core technology (PCR) and test menu, with materially greater scale, broader regulatory clearances, and reimbursement coverage than miDiagnostics.

Direct peers

• Talis Biomedical: Talis developed a rapid point-of-care molecular diagnostic platform (Talis One) targeting decentralized infectious disease testing with single-use cartridges. Highly comparable to miDiagnostics in technology approach (cartridge + reader PCR), target markets (POC infectious disease, COVID/RSV/STI), and even leadership (miDiagnostics CSO Betty Wu and SVP David Morrow are ex-Talis).
• NeuMoDx Molecular (Qiagen): NeuMoDx developed fully automated, rapid molecular diagnostic systems for hospital and reference lab use, now part of Qiagen. Directly comparable platform architecture to miDiagnostics' reader + cartridge PCR model, with overlapping customer base (clinical labs, hospitals). miDiagnostics' CSO led assay development at NeuMoDx.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xtwitter.com/miDIAGNOSTICS
• Facebookfacebook.com/miDIAGNOSTICS-164818897697630
• LinkedInlinkedin.com/company/midiagnostics

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds5 records

Investors6 records

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 miDiagnostics