Shares in international diagnostics specialist Novacyt (NCYT:AIM) jumped 20% on Friday to 396.6p after the company’s real time genesig Covid-19 PCR test was added to the approved list of products under new CTDA (Covid Testing Devices Authorisation) regulations.

Novacyt said the approval will ‘significantly’ lower the financial impact that it previously quantified as £3 million of lost revenues in the current 2021 financial year had none of its products been added to the CTDA register.

The genesig Covid-19 assay was the first commercially available Covid-19 test, launched on 31 January 2020, and accounts for around 30% of the lost revenues identified. The test continues to be able to detect all known variants and has so far analysed over 4.5 million sequences.

The news today of a potentially new variant of concern in South Africa throws into sharp relief the importance of having high quality and up to date diagnostic technologies to help fight the pandemic.


The company had submitted 11 products for review under CTDA regulations before the deadline of 1 September 2021 and today’s approval is the first to make the list which means sales of the test kit can now restart.

The company said its Primerdesign Ltd PROmate Covid-19 test which comprises two test kits remains on the temporary protocol and continued to be supplied to the NHS.

This leaves eight products across the firm’s Covid-19 testing portfolio for which it is awaiting an update from the authorities.

Chief executive David Allmond commented: ‘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.

‘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.


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Issue Date: 26 Nov 2021