Fast MDx, the developers of the world’s first low-cost, high-throughput molecular diagnostic test system, has announced CE-IVDr marking for its flagship NGX 124 platform, following the signing of a Declaration of Conformity to the IVD Regulation 2017/746.
CE-IVDr marking represents the latest milestone in the on-going development of NGX 124 and
paves the way for an official launch in Autumn 2024.
Jointly designed and developed by Fast MDx and German automation specialists 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.
Richard Lewis, Fast MDx Founder and CEO said: “Applying the CE-IVDr mark for the NGX 124
platform is a significant milestone in our work to develop the world’s first low cost, high
throughput molecular diagnostic test system. As a social enterprise, we pride ourselves on our
aim to bring sustainable, molecular diagnostic testing to billions worldwide, regardless of
geographic location. Providing clinicians quickly with accurate test results will enable them to
treat their patients faster and more appropriately than ever before, resulting in better patient
outcomes and a large reduction in the use and expense of critical care facilities.”
Ana Fernandez, Fast MDx Chief Scientific Officer said: Fast MDx offers the opportunity for
laboratories accredited to ISO 15189 to automate testing of their Laboratory Developed Tests
(LDT), Research Use Only (RUO) assays and any existing CE-IVDd approved assays that they use.
The European Commission’s CE-IVDr mark embodies Fast MDx’s commitment to technical
excellence and demonstrates that the NGX 124 is performing as expected and will rapidly provide
accurate diagnostic results, electronically to clinicians.”
