QuantuMDx has announced that its Q-POC SARS-CoV-2, Flu A/B & RSV Assay, has been approved for sale in the UK under The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (“CTDA”) as reviewed by the UK Health Security Agency (UKHSA).
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This is the latest product offered by QuantuMDx to receive CTDA approval, following the announcement of CTDA approval for the Q-POC SARS-COV-2 assay on 22 February 2022. Both assays, alongside the Q-POC system, are commercially available in the UK and across Europe. Q-POC is CE-IVD marked under the In Vitro Diagnostic Regulation (2017/746) and both tests are CE-IVD marked under the In Vitro Diagnostic Directive (98/79/EC).
Jonathan O’Halloran, chief executive officer, QuantuMDx, said: “Our Q-POC SARS-CoV-2, Flu A/B & RSV Assay is one of only a handful of multiplex respiratory panel tests to be approved by CTDA on sample-to-answer and Point of Care platforms. It is our first multiplex rapid molecular test on our Q-POC device and will allow for rapid diagnosis of what virus is causing a patient’s respiratory symptoms. We are seeing high numbers of Flu and RSV this winter and it is important to quickly and effectively triage patients to keep them and our frontline healthcare workers safe. Doing this on our Q-POC device, rather than sending these tests to the lab, will mean this can be done quickly.”
Q-POC is an automated sample-to-answer instrument designed to qualitatively detect target nucleic acid sequences by fluorescence-based Polymerase Chain Reaction (PCR). Intended for use by healthcare professionals for near-patient testing, the Q-POC has been designed for use in a range of settings, such as hospitals, clinics, pharmacies, and workplace testing providing PCR results at the Point of Need.
The Q-POC SARS-CoV-2, Flu A/B & RSV Assay is a single-use disposable test cassette for the detection and differentiation of SARS-CoV-2, influenza A, influenza B and RSV genomic RNA from either nasal mid-turbinate, or nose and throat specimens collected from individuals suspected of respiratory viral infection by their healthcare provider. The assay targets well conserved regions of the viruses and has been developed using advanced bioinformatics, including mapping to the most up to date sequences to ensure 100% coverage of all known SARS-COV-2 variants.
The Company plans to expand the portfolio of tests for Q-POC and will add a sexually transmitted infections assay, amongst others, to the current respiratory assays.
