Novacyt flags possible £3m hit from Covid test regulations change

Clinical diagnostics specialist Novacyt updated the market on the availability of its Covid-19 tests in the UK on Tuesday, following the implementation of amendments to the UK Health Security Agency's coronavirus test device regulations, or ‘CTDA’.

The AIM-traded firm said the mandatory CTDA guidelines would require all suppliers of Covid-19 tests, including both polymerase chain reaction (PCR) and lateral flow tests, to submit data on the tests for a desktop validation if they wished to continue to sell them in the UK.

It said the legislation would not apply or affect any sales outside the UK.

On 20 October, the UK Health Security Agency issued a list of products on the CTDA register that had so far successfully completed such a desktop review and been approved.

A second list, the ‘temporary protocol’, was also issued, detailing products which could remain on the market while validation was being processed, with an extended deadline from 1 November to 28 February.

Only validated products, or products on the temporary protocol could be sold in the UK after 31 October.

The company said the UK Health Security Agency had committed to continuing its review of submitted tests, and updating the CTDA register accordingly.

“Novacyt submitted 11 products for review on time to meet the original CTDA submission deadline of 1 September,” the board said in its statement.

“To date, Novacyt's ‘Primerdesign PROmate’ Covid-19 test has been named on the temporary protocol,” it added, confirming that it encompassed both the PROmate 1 Gene q16 and q32 products.

It said the CTDA had not yet communicated the status of any of the remaining nine products.

“As a result, from 1 November, the company will only be selling the PROmate Covid-19 test in the UK until the UK Health Security Agency completes its review of the additional nine products submitted.

“If no further products are added to the CTDA register, the impact on full year revenues for 2021 will be around £3m.”

At 1227 GMT, shares in Novacyt were down 2.46% at 248p.