Breaking news: Newcastle business has today launched its sensitive SARS-CoV-2 test, which delivers a result in approx 70 minutes
QuantuMDx Group Limited is an ambitious North East business, dedicated to making diagnostic technologies so that diseases can be detected and treated earlier, and transmission eradicated.
Teaming up with British manufacturing partner Biofortuna Limited, QuantuMDx has been able to scale-up production capability to initially 2 million tests per week and with the potential to scale up to 3 million tests per week by introducing further automation within the manufacturing process.
The company is ready to start shipping the tests from today. In addition, QuantuMDx has rigorously stress-tested its supply chains and is confident in its ability to supply significant volumes of tests worldwide.
The test has been designed with the most up-to-date sequence information to ensure 100% coverage of all known SARS-CoV-2 sequences. The company’s test has been evaluated using 90 pre-extracted residual samples from The Newcastle-upon-Tyne Hospitals NHS Foundation Trust, to assess clinical performance against tests currently in use.
It has been shown to be clinically equivalent to the comparator test presently used in NHS hospitals, with 100% concordance with all positive and negative SARS-CoV-2 classifications.
An application has been made to the United States FDA (Food and Drug Administration) for use under Emergency Use Authorisation and QuantuMDx expects to attain CE-IVD mark (the approved CE marking to meet EU requirements) by mid-May.
In addition, QuantuMDx will apply for World Health Organization ‘Emergency Use Listing’.
In response to the shortage of extraction kits in the current market, QuantuMDx is also validating the use of the test without the need for RNA extraction, running the RT-PCR test direct from swabs. Furthermore, the company is validating the test on other specimen types, such as saliva samples.
Sanjeev Krishna, Professor of Molecular Parasitology and Medicine at St George’s, University of London, said: “It’s universally acknowledged that one of the most urgent needs to help us control and hopefully eliminate the COVID-19 pandemic are good diagnostic tests. We need a test that can diagnose the disease quickly and accurately while being available and affordable for all healthcare systems. This test is very much aiming to address those needs so we can control the infection with greater precision.”
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.”
In addition to developing this test for laboratories, QuantuMDx continues preparations for scale-up and manufacture of its Q-POCTM rapid point-of-care testing device.
The company is currently translating both its SARS-CoV-2 detection test and its proprietary respiratory panel on to the Q-POCTM platform. Using swab samples, a Q-POCTM test could provide a result in a targeted 15-20 minutes at the patient’s side whether in a hospital, pharmacy, care home, school or even immigration zones.