Avacta suspends UK Covid test sales while it waits for new approval

Alastair Smith, CEO of Avacta GroupAlastair Smith, CEO of Avacta Group
Alastair Smith, CEO of Avacta Group
Drug developer Avacta has suspended UK sales of its Covid-19 test while it waits for the UK Health Security Agency to complete its evaluation of the test.

The Wetherby-based group, which has said that its coronavirus test is the most sensitive lateral flow test available, said that new regulations came into force yesterday which means that it has to wait until the ongoing desktop evaluation of the test has been successfully completed.

When this happens, the test will be put on the Coronavirus Test Device Approvals (CTDA) register for approved products.

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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 Avacta's AffiDX test with the MHRA which was announced in June.

Avacta said that the impact of the UK sales suspension as a result of the CTDA regulations coming into force will not have a material impact on its 2021 financial results.

The firm is now focusing on opportunities outside the UK for the sale and marketing of its AffiDX SARS-CoV-2 Lateral Flow Rapid Antigen Test including markets in Europe and further afield.

The new CTDA regulations stipulate 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.

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As of yesterday, there were only three products for which the agency had completed its desktop review listed on the CTDA register for approved products.

Additionally, the UK Health Security Agency has published a temporary protocol which lists 48 tests (both PCR and antigen based), which passed the Public Health England validation process at Porton Down earlier in the year, that can remain available for sale in the UK whilst their validation is completed until a cut-off date of the end of February.

Avacta said that it submitted, ahead of the September 1 deadline, all the information required for its AffiDX test to be validated under these regulations by the UK Health Security Agency, and it has paid the required fee.

The firm said that it 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.

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