Avacta suspends UK Covid test sales ahead of new approval
By Michele Maatouk
Date: Tuesday 02 Nov 2021
(Sharecast News) - Avacta said on Tuesday that it has suspended sales of its AffiDX Covid latest flow rapid antigen tests in the UK while it awaits new approval.
The company said new regulations from the UK Health Security Agency came into effect on Monday and it now has to wait until an evaluation has been completed and the test has been approved.
"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," it explained.
The new regulation stipulates that all suppliers of Covid-19 tests must submit information regarding their products for desktop review if they wish to remain on sale in the UK. Avacta said it has submitted all the information required for its AffiDX test to be validated by the UKHSA and paid the required fee.
The company said the suspension of sales will not have a material impact on its anticipated financial outturn for the year ending 31 December.
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