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Approval signals green light for COVID-19 test availability in UK
Jan 13 2022
Following approval in the UK under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) Regulations 2021 (“CTDA”) for its RIDA®GENE Flu & SARS-CoV-2 multiplex test (PG6825), international clinical diagnostics company R-Biopharm (Darmstadt) which has a significant Glasgow-based operation is now working to resume the sale of the product in the UK.
This multiplex real-time RT-PCR for the direct qualitative detection and differentiation of Flu A/Flu B and coronavirus (SARS-CoV-2) RNA in human nasal/throat swabs from persons with signs and symptoms of respiratory infection is able to detect the Omicron variant.
Intended for professional use in private and public laboratories, it targets the M gene/NP1 gene of the virus for Influenza A/B and the E gene and RdRp gene in all currently known variants and mutations of the COVID 19 virus, the company said.
Since October 2021 only validated products, or products on the temporary protocol, could be sold in the UK after 31 October 2021. Jason Baggaley, Sales Manager of R-Biopharm for Great Britain, said: “We are proud that our RIDA®GENE 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 Corona virus.”
Employing 60 people at its West of Scotland Science Park, the Glasgow company was awarded IIP’s (Investor in People) Platinum accreditation in summer 2021.
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