SARS-CoV-2 RT-PCR Detection Assay receives CTDA legislation approval

A box full of small medical jars with white lids

by QuantuMDx Team March 10, 2022

NEWCASTLE UPON TYNE, UK, 10 MARCH 2022. QuantuMDx Group Limited (“QuantuMDx”), today announces that its SARS-CoV-2 RT -PCR detection assay, has been approved in the UK under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (“CTDA”).

The QuantuMDx SARS-CoV-2 RT-PCR Detection Assay has proven robust detection of SARS-CoV-2 across 5 external validation sites, as detailed in its clinical performance publication. QuantuMDx has also released a publication on rapid extraction-free methodology for detection of SARS-CoV-2 using the QuantuMDx SARS-CoV-2 RT-PCR Detection Assay for use in the screening of single/pooled saliva samples and findings on preliminary evaluation of SARS-CoV-2 RT-PCR assay as novel technology

This is the latest product offered by QuantuMDx to receive CTDA approval, following the announcement of CTDA approval for the Q-POC™ SARS-CoV-2 assay on 22 February 2022. Both assays, alongside the Q-POC™ system, are commercially available in the UK, as well as across Europe.

QuantuMDx’s SARS-CoV-2 assay is a real-time reverse transcriptase RT-PCR test that has been developed using advanced bioinformatics to maximise performance. The assay has been designed with the most up-to-date sequence information to ensure 100% coverage of all known SARS-CoV-2 sequences.

Jonathan O’Halloran, Chief Executive, QuantuMDx, said: “Our mission is to make transformative, quality diagnostic technologies accessible to everyone, so that diseases can be detected and treated earlier. This latest CTDA approval from the UK Health Security Agency is another endorsement of the high quality of QuantuMDx’s diagnostics products and follows on from the recent approval of the Q-POC™ SARS-CoV-2 assay in February 2022.”

“It is pleasing to see that our product range of diagnostic devices are being approved in our domestic market and we are highly excited to be able to provide the UK with QuantuMDx’s suite of testing devices and tests as we move to the next stage of the pandemic.”

Notes to editor:

About QuantuMDx:

QuantuMDx is a progressive MedTech company passionate about empowering the world to control disease and reduce suffering. QuantuMDx solves real-world diagnostic problems by creating multiplex molecular solutions for the Point of Need, for anyone, anywhere.

QuantuMDx has global operations and strategic partnerships – keeping it at the forefront of molecular diagnostics.

Q-POC™ is a rapid, simple to use, portable, sample to answer PCR device and has been designed for use in a wide range of settings, such as hospitals, clinics, pharmacies, and workplace testing providing accurate PCR results at the Point of Need. Q-POC™ and its first test, a SARS-CoV-2 multiplex detection assay, are CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC), enabling use within Europe. It tests multiple targets of the disease for a future proof COVID-19 testing solution at the Point of Need.

QuantuMDx plans to launch a range of syndromic multiplex testing assays over the coming months and years.

For more information about QuantuMDx and Q-POC™, its rapid PCR point of care system, go to: www.quantumdx.com.