May 1, 2020 @ 10:11 by Richard Dawson
Global life sciences and diagnostics developer, QuantuMDx has today (May 1) launched a COVID-19 test for laboratory use, which delivers results in approximately 70 minutes.
The Newcastle-headquartered company is working with Biofortuna as manufacturing partner to scale up production capacity.
Initially, the scheme will have capacity for 2 million tests per week with the potential to scale up to 3 million by introducing further automation within the manufacturing process.
The company is ready to start shipping assays (tests) from today and has rigorously stress tested its supply chains worldwide to be able to withstand significant volumes.
QuantuMDx’s SARS-CoV-2 assay is a real-time test that has been developed using advanced bioinformatics to maximise performance.
It has been designed with the most up-to-date sequence information to ensure 100 per cent coverage of all known SARS-CoV-2 sequences.
The accuracy of the test has been validated using 90 pre-extracted residual samples from Newcastle upon Tyne Hospitals NHS Foundation Trust.
It has been shown to be clinically equivalent to the comparator assay presently used in NHS hospitals, with 100 per cent concordance with all positive and negative coronavirus classifications.
An application has been made to the US FDA for use under Emergency Use Authorisation and QuantuMDx expects to attain CE-IVD accreditation by mid-May.
The company, which has offices in the US and Singapore, will also apply for the World Health Organisation’s ‘Emergency Use Listing.’
In response to the shortage of extraction kits in the current market, QuantuMDx is validating the use of the test without the need for RNA extraction, running the RT-PCR test direct from swabs. The company is also looking at tests on other specimen types, such as saliva samples.
Sanjeev Krishna, professor of molecular parasitology and medicine at St George’s, University of London, is working closely with QuantuMDx on its diagnostic test.
She 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, added: “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.”