QuantuMDx receives UK approval for SARS-CoV-2 RT-PCR assay

QuantuMDx’s 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"). 

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 officer, 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."