QuantuMDx SARS-CoV-2 Test gets EU approval

QuantuMDx has received EU approval for it SARS-CoV-2 real-time reverse transcriptase rtRT-PCR test through the CE-IVD marking, and is waiting for a response to its Emergency Use Authorisation application filed with the FDA. It is also registered with the MHRA.

The test was developed using advanced bioinformatics and targets three SARS-Cov-2 genomic loci: the S gene, N gene and Orf1 region. The assay has been designed to guarantee total coverage of all known SARS-CoV-2 sequences, and the reagents are lyophilised in a single vial, facilitating a longer period of validity and more expedient shipping. The company are currently producing 2 million reactions a week, which could increase to 3 million, and are confident they have the right supply chain partners and manufacturing partner (Biofortuna Ltd) to supply the quantities of the test required on a global scale.

QuantuMDx CEO, Jonathan O’Halloran, 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.”