The Fast MDx Platform
The Fast MDx platform aspirates the sample through the cap of Fast MDx’s patented Pathtubes® and so requires no manual sample handling or preparation steps.
Jointly designed and developed by Fast MDx and Festo, the Fast MDx platform is the first fully automated, high-throughput, Near-Patient mobile Molecular Diagnostic (MDx) test platform and incorporates Fast MDx’s latest, ultra-fast, NGx2 qPCR thermal cycler and Reverse Transcription block technology.
Location and Use
Easily moved through any standard doorways or elevator, the platform glides on 4 rugged, lockable casters.
Requiring only one operator to process over 1,000 patients samples in an 8 hour shift and being Near-Patient, can just as easily be used in a test centre, a hospital environment or a pathology laboratory.
All tests and instrumentation will be UKCA and CE-IVDr approved.
Safety and Electrical Approvals
All instrumentation will be CE marked, having been tested and proved to comply with IEC 61010‐1:2010, Edition 3 – Safety & Electrical Compliance of medical laboratory equipment, published by The International Electrotechnical Commission (IEC).
Fast MDx Test Menu
Fast MDx will launch in June 2023, with the opportunity of laboratories accredited to ISO 15189 to us etheir own assays and well as with a CE-IVD approved, high-throughput, syndromic, respiratory test for flu A, flu B, RSV A, RSV B and COVID-19.
Future additions to the test menu
Healthcare Acquired Infections (HAI)
Testing for Central Line-associated Bloodstream Infections (CLABSIs), Catheter-associated Urinary Tract Infections (CAUTI), Surgical Site Infections (SSI) and Ventilator-associated Pneumonia (VAP).
Using PCR to amplify and detect gyrB, parE and mecA genes of 47+ bacterial species.
Cyber Secure LIMS Integration
Built with advanced cyber security, the Fast MDx platform seamlessly integrates into all major Laboratory Information Management Systems (LIMS).
Built with ISO13485 Quality Management System
Fast MDx will be built under a ISO13485 Quality Management System and has been designed to be manufactured initially with UKCA and CE-IVDr regulatory approvals and subsequently with FDA regulatory approval.