QuantuMDx, a UK-based developer of transformational diagnostic technologies and Medilink member, has launched a SARS-CoV-2 assay which delivers results in approximately 70 minutes.
Working with a British manufacturing partner, Biofortuna Limited, the company has increased the production capability up to 2 million tests a week with the potential to scale up to 3 million tests per week by introducing further automation within the manufacturing process.
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.
The test has been evaluated using 90 pre-extracted residual samples from The Newcastle upon Tyne Hospitals NHS Foundation Trust, UK, to assess clinical performance against tests currently in use. It has shown 100% concordance with all positive and negative SARS-CoV-2 classifications.
An application has been made to the U.S FDA for use under Emergency Use Authorisation and QuantuMDx expects to attain CE-IVD mark by mid-May. In addition, QuantuMDx will apply for World Health Organization ‘Emergency Use Listing’ listing.
Jonathan O’Halloran, Co-founder and Chief Executive Officer of QuantuMDx said: “It is clear that tackling the COVID-19 pandemic requires the widespread availability of accurate and appropriate diagnostics. It’s a privilege for us at QuantuMDx to have been able to use our expertise in diagnostics to develop a SARS-CoV-2 Detection assay and contribute to the national and international efforts to tackle this disease. By securing the supply chain early, we have been able to achieve massive scale for our assay to supply the testing needs of countries around the world.”
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