Technology

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, mobile Molecular Diagnostic (MDx) test platform and incorporates Fast MDx’s latest, ultra-fast, “NGx2” 4-Channel qPCR thermal cycler and Reverse Transcription “RT” block technology.

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 can just as easily be used in a test centre, a hospital environment or a pathology laboratory.

The Fast MDx platform will have both UKCA and CE-IVDr regulatory approvals when launched.

All instrumentation is 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 offers the opportunity for laboratories accredited to ISO 15189 to use their Laboratory Developed Tests (LDT), Research Use Only (RUO) assays and, following validation, any existing CE-IVD approved assays that they use.

To keep testing costs down, laboratories can buy their assays and reagents directly from the manufacturers.

Fast MDx will impose no on-costs and will help laboratories adapt their assays to the high-throughput protocols, to ensure minimisation of dead volumes and optimal assay performance.

An open platform will create more competition by allowing for the first time, small and medium sized assay manufacturers, access to a high-throughput automated MDx platform.

Greater competition and economies of scale in assay manufacture will drive down the cost of assays and reagents.

Fast MDx is built under an 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.