2nd Nov 2021 11:25
(Alliance News) - Avacta Group PLC and Novacyt SA on Tuesday said they have pulled some Covid-19 testing products off sale in the UK, as new regulatory measures come into force.
Under UK Health Security Agency rules which came into effect on Monday, all suppliers of Covid-19 tests must submit data on their products for desktop validation. The legislation only applies to sales made inside in the UK.
A desktop review is an assessment of evidence submitted by the company against a minimum required data set, according to the UK Department of Health & Social Care website. The purpose of the desktop review is to prevent tests that are below expected standards from progressing to a technical validation in a laboratory.
Shares in Wetherby, England-based biotechnology Avacta Group were down 8.9% at 110.09 pence each in London on Tuesday morning. Novacyt, a Surrey-based biotechnology group focused on clinical diagnostics, was trading 2.6% lower at 247.74p.
Avacta explained sales of its AffiDX SARS-CoV-2 lateral flow rapid antigen test in the UK have been suspended until an ongoing desktop evaluation is completed.
"This is a new requirement for the supply of any Covid-19 test in the UK and is over and above the CE mark and successful registration of company's AffiDX test with the MHRA which was announced on 7 June 2021," Avacta said.
Avacta said it submitted all data, and also paid a relevant fee, before a regulatory cut-off date of September 1.
"The company awaits further notification from the UK Health Security Agency when it completes its review of the information supplied for the AffiDX SARS-CoV-2 lateral flow rapid antigen test," the company added.
Avacta said the suspension of sales will not have a "material impact" on its 2021 earnings. The AIM listing said it is continuing to focus on opportunities outside of the UK.
Novacyt said it submitted 11 products for approval ahead of the deadline. Two of its products have been included in a temporary sale protocol, however, watchdogs are yet to deliver a verdict on the status of Novacyt's other nine tests.
If no further products are approved, Novacyt said its full-year 2021 revenue will take a GBP3 million hit.
By Eric Cunha; [email protected]
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