A test that can detect the Omicron variant of COVID-19 has been approved by the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) Regulations 2021 (CTDA), giving it the green light for use in the UK.

The RIDAGENE Flu & SARS-CoV-2 multiplex test (PG6825), developed by clinical diagnostics specialist R-Biopharm, can detect and differentiate between Flu A/Flu B and COVID-19 in nasal and throat swabs from people displaying symptoms or other signs of respiratory infection

The test is designed for professional use in setting such as private or public laboratories, hospital labs and reference labs. The test targets the M gene/NP1 gene of the Influenza A/B virus and, for all currently-known strains of COVID-19, works by targeting both the E gene and the RdRp gene.

Jason Baggaley, sales manager of R-Biopharm for Great Britain, said: “We are proud that our RIDAGENE Flu & SARS-CoV-2 test was approved and added to the CTDA register and our customers will continue to be able to distinguish between the flu and an infection with the Coronavirus.”

R-Biopharm, which operates in the UK via a significant presence in Glasgow, will now focus on resuming sales of the RIDAGENE Flu & SARS-CoV-2 multiplex test within the UK. As of October 31 2021, only validated products or those on the temporary protocol, are able to be sold in the UK.

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