| 21 May 2024, Tuesday |

Two UK COVID test makers pull devices due to new review

Two COVID-19 test makers in the United Kingdom announced on Tuesday that they have withdrawn some of their tests from the market following the implementation of a new review mechanism that has yet to obtain certification for their previously approved goods.

Suppliers of COVID-19 tests, according to Avacta, were required to submit information on their products for desktop assessment under the new system if they wanted to remain on the market in the United Kingdom. It stated it had submitted its information ahead of the September 1 deadline but had yet to receive a response.

As a result it has suspended further sales of its AffiDX SARS-CoV-2 Lateral Flow Rapid Antigen Test in the UK. Its shares were trading down 8% in early morning deals on Tuesday.

France-based Novacyt said it had submitted 11 products for review before the deadline. Two have appeared on a temporary UK list that can continue to be sold, but it is waiting for an update on the additional nine products.

Its shares fell 3%.

Avacta said the new review system was “over and above” the European Union’s CE health and safety mark and the successful registration with the UK’s health regulator which it had previously achieved. No one at the UK Health Security Agency was immediately available to comment.

The two companies said only three products had been fully approved while a temporary list allows 48 tests, both PCR and antigen based, to remain on sale.

Britain is carrying out higher levels of testing than many other countries in Europe, and is currently seeing around 40,000 cases of COVID-19 a day.

  • Reuters