QuantuMDx, a UK-based molecular diagnostics company, has announced its SARS-CoV-2 detection assay has been CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC).

QuantuMDx has now registered the test with the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA). The company has also applied to the US Food and Drug Administration (FDA) for Emergency Use Authorisation.

Jonathan O’Halloran, Chief Executive of QuantuMDx, said: “Gaining CE-IVD marking now enables us to sell our SARS-CoV-2 detection assay directly into the European Union, as well as other territories worldwide that adhere to its regulations. This is another exciting step forward for QuantuMDx as we commercialise, join the international testing effort and support governments in their test, track and trace strategies.”

QuantuMDx’s SARS-CoV-2 assay is a real-time reverse transcriptase rtRT-PCR test that has been developed using bioinformatics. The assay has been designed with up-to-date sequence information aiming to ensure 100% coverage of all known SARS-CoV-2 sequences.

The sensitive test targets three SARS-Cov-2 genomic loci: The S gene, N gene and Orf1 region. The assay can run on multiple open PCR platforms, both high and low throughput, removing the tie into proprietary reagent supply constraints. The assay reagents are lyophilised in a single vial, eliminating the master mix formulation step, and enabling convenient shipping and a longer shelf life.

Working with British manufacturing partner Biofortuna, QuantuMDx has scaled up production capability to initially 2 million reactions per week and with the potential to scale up to 3 million reactions per week. QuantuMDx has stress tested its supply chains and aims to supply significant volumes of tests worldwide.