(AOF) – Novacyt’s genesig Covid-19 real-time PCR test has been approved in the UK. This test is the first from medtech to be added to the British Medical Device Safety Agency (CTDA) register. Novacyt will now work on resuming sales of the product in the UK. The genesig test was launched on January 31, 2020 and was one of the world’s first tests available on the market.
As announced on November 2, 2021, the company has submitted 11 products for CTDA review in order to meet the initial submission deadline of September 1, 2021.
Following validation of its genesig test, the PROmate Covid-19 test remains on the temporary protocol and continues to be supplied to the UK.
The company is awaiting information on the other eight products submitted to the CTDA as part of its portfolio of Covid-19 tests. Note that only validated products, or products on the temporary protocol, can be sold in the United Kingdom after October 31, 2021.
On November 2, 2021, Novacyt had said that if no more products were added to the CTDA register, the impact on revenue for the year 2021 would be around £ 3million. With this approval, the financial impact in the year 2021 will be significantly lower as genesig’s Covid-19 test accounts for around 30% of the shortfall of around £ 3million.
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