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R-Biopharm receives approval of COVID-19 test in the UK under CTDA legislation
R-Biopharm, an international specialist in clinical diagnostics, announces that the company’s RIDA®GENE Flu & SARS-CoV-2 multiplex test (PG6825) has been approved in the UK under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) Regulations 2021 (“CTDA”).
R-Biopharm, which has a significant operation in Glasgow, will now work to resume the sale of the product in the UK.
RIDA®GENE Flu & SARS-CoV-2 test is a 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. The testing is able to detect the Omicron variant.
The product is intended for professional use in, for example, hospital laboratories, reference laboratories, private laboratories, or public laboratories. The RIDA®GENE Flu & SARS-CoV-2 multiplex test 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.
Only validated products, or products on the temporary protocol, can be sold in the UK after 31 October 2021. Jason Baggaley, Sales Manager of R-Biopharm for Great Britain, commented: “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.”
R-Biopharm AG develops technologies, products and solutions in the areas of clinical diagnostics, nutrition care and food and feed analysis.
The global business is headquartered in Darmstadt, Germany, and has a Glasgow operation which employs 60 people at its West of Scotland Science Park base in the north west of the city. It is one of the UK’s most successful exporters in its field, selling more than 70 per cent of its output to major international companies outside the UK.
Founded in 1988, the family-owned company employs a total of around 1,200 people worldwide (660 at its headquarters in Darmstadt) and is present in more than 120 countries - by 28 subsidiaries and 120 distributors.
In summer 2021, the Glasgow company secured IIP’s (Investor in People) Platinum accreditation.