QuantuMDx diagnostic test for SARS-CoV-2 remains suitable for the detection of all discovered variants, including VUI-202012/01
NEWCASTLE UPON TYNE, UK, 22 December 2020. QuantuMDx Group Limited (“QuantuMDx”), a UK-based life sciences company developing transformational point-of-care molecular diagnostics, today confirms its diagnostic assay for SARS-CoV-2 remains suitable for detecting all available virus strains, following the identification of a new strain of SARS-CoV-2.
The UK COVID Genomics Consortium and Public Health England have identified a new strain of SARS-CoV-2 which is characterised by multiple spike gene variants. The new strain known as VUI-202012/01 or lineage B.1.1.7 appears to be significantly more transmissible than other circulating linages and there are reports that some diagnostic tests may be affected.
QuantuMDx continually monitors genomic sequences deposited to the NCBI and GISAID databases as part of post market surveillance. Analysis of VUI-202012/01 genomes shows that none of the variants interfere with QuantuMDx’s three target QMDx SARS-CoV-2 test.
The high performance QuantuMDx SARS-CoV-2 assay has been proven against seven separate sample cohorts including independent evaluations from FIND, several hospitals and UK Department of Health and Social Care. Aggregated across cohorts, totalling over 800 samples, clinical sensitivity was shown to be 98.9% and specificity 99.8%.
Jonathan O’Halloran, Chief Executive, QuantuMDx, said:
“At the start of the outbreak, we anticipated the emergence of new strains as the pandemic progressed and designed our assay to target three different genomic regions of SARS-CoV-2. We can confirm that this new strain of virus will not affect our assay which maintains its high level of sensitivity in the UK and worldwide. We continue to work with regional, national, and international health authorities as we continue efforts to deliver high quality diagnostics for COVID-19.
“Q-POCTM, our 30 min swab to result PCR point-of-care device, is nearing launch and will run an assay targeting the same three loci as the QuantuMDx SARS-CoV-2 RT-PCR Detection Assay. We are already experiencing great demand for this incredibly powerful device and want to assure our customers that our test will work across all strains represented in the online SARS-CoV-2 genome databases.”
QuantuMDx Group is an ambitious company with a global vision of empowering the world to control and eradicate disease by making transformative, quality point-of-care diagnostic technologies universally accessible. QuantuMDx has operations and strategic partnerships in the United States, Asia, Australasia, Europe and Africa – keeping it at the forefront of molecular diagnostics. For more information go to: www.quantumdx.com
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