miDiagnostics
miDiagnostics is dedicated to revolutionizing healthcare by developing innovative silicon chip technology for rapid, reliable, and high-quality molecular diagnostic tests. Their solutions support healthcare professionals in delivering fast and accurate diagnostics, ultimately improving patient care worldwide. The company is actively involved in developing ultra-fast PCR tests for COVID-19, including CE-IVD certified solutions and pilot testing at Brussels Airport, as well as collaborations with leading research institutions and biotech companies to advance decentralized and point-of-care diagnostics.
Industries
Nr. of Employees
medium (51-250)
miDiagnostics
Leuven, Vlaams-Brabant, Belgium, Europe
Products
Ultra-fast point-of-care SARS‑CoV‑2 PCR test (CE‑IVD; peer-reviewed performance)
A rapid RT-qPCR workflow for nasopharyngeal/nasal swabs validated in independent clinical studies with reported equivalence to central-lab RT-PCR; designed for decentralized settings with sample-to-result times under 30 minutes and real-time PCR components under 15 minutes.
CSF PCR test for HSV-1/2 (development)
An ultra-fast PCR test designed to detect HSV-1 and HSV-2 in cerebrospinal fluid with low sample volume requirements and closed-chamber cartridge format to reduce contamination; intended to shorten time to diagnosis in encephalitis/meningitis workflows.
Disposable silicon-based PCR cartridge
Single-use cartridge embedding a silicon microfluidic processor for sample and reagent handling, with barcode/QR traceability and integrated assay controls for point-of-care amplification.
Portable PCR reader (reusable thermocycler + optical detection)
Reusable, compact reader that accepts disposable cartridges, performs ultra-fast thermocycling and fluorescence detection, and provides wired/wireless connectivity for data transfer to workstations or LIS.
Integrated diagnostic workstation (computer + UI)
On-site workstation with barcode scanning, touchscreen UI, secure access controls and data archiving for device management, result review and reporting.
Diagnostic software (LIS integration and remote diagnostics)
Device software that supports common laboratory information system protocols, remote updates, device diagnostics and secure export/archival of results.
Ultra-fast point-of-care SARS‑CoV‑2 PCR test (CE‑IVD; peer-reviewed performance)
A rapid RT-qPCR workflow for nasopharyngeal/nasal swabs validated in independent clinical studies with reported equivalence to central-lab RT-PCR; designed for decentralized settings with sample-to-result times under 30 minutes and real-time PCR components under 15 minutes.
CSF PCR test for HSV-1/2 (development)
An ultra-fast PCR test designed to detect HSV-1 and HSV-2 in cerebrospinal fluid with low sample volume requirements and closed-chamber cartridge format to reduce contamination; intended to shorten time to diagnosis in encephalitis/meningitis workflows.
Disposable silicon-based PCR cartridge
Single-use cartridge embedding a silicon microfluidic processor for sample and reagent handling, with barcode/QR traceability and integrated assay controls for point-of-care amplification.
Portable PCR reader (reusable thermocycler + optical detection)
Reusable, compact reader that accepts disposable cartridges, performs ultra-fast thermocycling and fluorescence detection, and provides wired/wireless connectivity for data transfer to workstations or LIS.
Integrated diagnostic workstation (computer + UI)
On-site workstation with barcode scanning, touchscreen UI, secure access controls and data archiving for device management, result review and reporting.
Diagnostic software (LIS integration and remote diagnostics)
Device software that supports common laboratory information system protocols, remote updates, device diagnostics and secure export/archival of results.
Services
Pharma sterility testing services (PCR-based)
Rapid PCR-based sterility testing solutions adapted for decentralized biopharma manufacturing and CAR-T batch release, with closed-flow automation, regulatory-aligned QC workflows and integration support.
Assay development and clinical validation support
Collaborative development and optimization of molecular diagnostic assays for infectious diseases and QC applications, plus execution of clinical performance studies and peer-reviewed validation to support regulatory submissions and deployment.
Deployment and pilot implementation support
Operational and logistical support for point-of-care deployment, including workflow optimization, pilot studies in high-throughput environments (e.g., airports) and coordination with on-site lab operators and logistics partners.
Breath-sampling pilot integration
Evaluation and integration of breath/aerosol sampling modules for non-invasive specimen collection and compatibility testing with on-chip molecular detection workflows in pilot settings.
Pharma sterility testing services (PCR-based)
Rapid PCR-based sterility testing solutions adapted for decentralized biopharma manufacturing and CAR-T batch release, with closed-flow automation, regulatory-aligned QC workflows and integration support.
Assay development and clinical validation support
Collaborative development and optimization of molecular diagnostic assays for infectious diseases and QC applications, plus execution of clinical performance studies and peer-reviewed validation to support regulatory submissions and deployment.
Deployment and pilot implementation support
Operational and logistical support for point-of-care deployment, including workflow optimization, pilot studies in high-throughput environments (e.g., airports) and coordination with on-site lab operators and logistics partners.
Breath-sampling pilot integration
Evaluation and integration of breath/aerosol sampling modules for non-invasive specimen collection and compatibility testing with on-chip molecular detection workflows in pilot settings.
Expertise Areas
- Point-of-care molecular diagnostics
- Assay development and clinical validation (including peer-reviewed studies)
- Nano/microfluidics and silicon chip development
- Ultra-fast thermocycling and on-chip PCR
Key Technologies
- Silicon-based micro/nanofluidic processors
- Capillary-driven passive microfluidics
- On-chip ultra-fast real-time qPCR
- Single-use microfluidic PCR cartridges