QuantuMDx obtains U.K. approval for first multiplex assay on point-of-care molecular system

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QuantuMDx said on Tuesday that its Q-POC SARS-CoV-2, Flu A/B & RSV Assay has been approved for sale in the U.K. under the Medical Devices Coronavirus Test Device Approvals (CTDA) Amendment Regulations 2021.

The firm said the assay is its latest to receive CTDA approval, following the announcement of CTDA approval for the Q-POC SARS-CoV-2 assay in February.

Both assays, alongside the Q-POC system, are commercially available in the U.K. and across the EU.

Q-POC is a rapid, portable, and automated sample-to-answer instrument that qualitatively detects target nucleic acid sequences by fluorescence-based polymerase chain reaction (PCR). The system has been designed for use by healthcare professionals in a wide range of settings, such as hospitals, clinics, pharmacies, and the workplace, providing PCR test results at the point of need.

“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,” Jonathan O’Halloran, CEO of QuantuMDx, said in a statement. “It is our first multiplex rapid molecular test on our Q-POC device and will allow for rapid diagnosis of [a virus] causing a patient’s respiratory symptoms.”

Specifically, 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 respiratory syncytial virus (RSV) genomic RNA. Measurements are made using either nasal mid-turbinate, or nose and throat specimens collected from individuals suspected by their healthcare provider of respiratory viral infection.

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, QuantuMDx said.

The company added that it plans to expand the portfolio of tests for Q-POC and will add a sexually transmitted infections assay and others to the current respiratory assays.

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