London, 4th September 2024 – Fast MDx, the developers of the world’s first low‑cost, high‑throughput molecular diagnostic test system, today 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.”

 

ENDS

 

 

About Fast MDx

 

Fast MDx is a registered Social Enterprise with the ambition to bring low-cost, high-throughput, ultra-rapid, molecular diagnostic testing to greater numbers, across geographic boundaries.

 

Fast MDx aims to provide clinicians with more detailed results earlier, allowing each patient to receive a faster and better developed, personalised clinical pathway.

 

Fast MDx was established by BJS Company, which since 1991 has been involved in PCR thermal cycling and today, supplies Tier 1 thermal cycler manufacturers

with fast, accurate, silver heat exchange blocks.

 

All manufacturing is carried out under an ISO 13485 Quality Management System.

 

About NGX 124

Jointly designed and developed by Fast MDx and industry leading, automation specialist Festo, the NGX 124 platform can be used to test high volume patient samples for:

▪ Contracted Diseases: NGX 124 provides high-throughput ultra-rapid routine testing for bacterial, fungal and viral infections.

Case study example: NGX 124 can be used with validated assays to test for Human papillomavirus (HPV), using urine samples, taken at home by patients, making it more convenient,

easier, accessible, and significantly less distressing for women, compared with clinician-taken cervical samples.

▪ Screening Programs: NGX 124 can be used to test for biomarkers within the patient’s DNA, that indicate a predisposition toward disease, allowing patients to make lifestyle changes

or for surgical intervention to prevent cancer.

▪ Liquid Biopsy: NGX 124 is designed to be used with validated tests to diagnose and monitor cancers from simple blood samples.

▪ Preparedness in the fight against future pandemics: NGX 124 can be quickly adjusted as required, from routine day-to-day testing requirements to tests for highly infectious diseases,

enabling governments to bolster their preparedness against future pandemics. NGX 124 can be calibrated to accommodate tests for diseases like Mpox and Avian flu.

 

Advantages of Fast MDx’s NGX 124 over existing competitor platforms:

▪ Low-cost testing: Each NGX 124 platform is offered free of charge, with a subscription service for tests only. One Fast MDx platform and technician provide the same testing capability as

five biomedical scientists in a traditional, centralised bio-secure laboratory.

▪ Open: NGX 124’s open architecture allows Laboratory Developed Tests (LDT), Research Use Only (RUO) assays and assays bought directly from independent manufacturers to be run on the platform.

NGX 124 enhances operational flexibility for users, with the aim to decrease costs for labs through greater assay choice.

▪ Mobile: A mobile platform, NGX 124 can be run locally and can complete automated testing in comparable volumes to those processed in complex, centralised laboratories relying on slower,

expensive semi-automated platforms.

Media Contact:

press@fastmdx.com

+44 (0)203 021 3751

Callum Alexander, Communications Director, Fast MDx