By Samuel Indyk
Investing.com – Novacyt (LON:NCYT) shares were trading higher on Friday morning after the company confirmed that its genesig COVID-19 real-time PCR test has been approved in the UK under the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) regulation.
The test is the first of Novacyt’s to be added to the CTDA register and the company now plans to resume the sale of the product in the UK.
The CTDA regulations came into effect at the beginning of the month and a number of companies had to withdraw products from sale as they had not received authorisation in time.
“I am delighted to announce that our genesig COVID-19 test has become the seventh product to be approved and added to the CTDA register,” said Novacyt CEO David Allmond. “With the associated resumption of the sale of this product in the UK, we look forward to ensuring our customers continue to have access to this market leading test during the winter season.”
When the regulations were enforced, Novacyt said that if no further products were added to the CTDA register, the impact on full year revenue for 2021 would be circa £3 million.
With this approval, the AIM-listed company said that the financial impact will be significantly lower as the genesig COVID test accounts for approximately 30% of the revenue shortfall.
The company also confirmed it is working to get other tests approved under the new regulations.
“We continue to engage with the UK Health Security Agency and look forward to further updates on our tests still under review,” Allmond added.
At 09:17GMT, shares in Novacyt were trading higher by 12.4% at 369.4 pence per share.