NEW YORK ─ Point-of-care molecular diagnostics firm QuantuMDx said on Monday that it has received the CE-IVD mark for its SARS-CoV-2 detection assay, enabling its use within the European Union and other countries that accept the designation.
Newcastle Upon Tyne, UK-based QuantuMDx said it has registered the rtRT-PCR test with the UK’s Medicines & Healthcare Products Regulatory Agency and has applied to the US Food and Drug Administration for Emergency Use Authorization.
QuantuMDx CEO Jonathan O'Halloran said in a statement that gaining CE-IVD marking enables the firm to "join the international testing effort and support governments in their test, track, and trace strategies."
QuantuMDx’s SARS-CoV-2 assay has been designed with the most up-to-date sequence information to ensure full coverage of all known SARS-CoV-2 sequences, the firm said. The test targets three SARS-Cov-2 genomic loci ─ the S gene, N gene, and Orf1 region.
The company said its assay can run on multiple open, low- and high-throughput PCR platforms, removing proprietary reagent supply constraints. Assay reagents are lyophilized in a single vial, eliminating the master mix formulation step and enabling convenient shipping and a longer shelf life, QuantuMDx said.
Working with British manufacturing partner Biofortuna, QuantuMDx has scaled up production capability to 2 million reactions per week and has the potential to scale up to 3 million reactions per week.