Yourgene gets UK approval for 'Clarigene' Covid-19 test

Molecular diagnostic company Yourgene has received confirmation from the UK Health Security Agency that the ‘Clarigene’ SARS-CoV-2 test has been approved under the requirements set out in the Coronavirus Test Device Approvals regulations, it announced on Thursday.

The AIM-traded firm said the product would be included on the register of products approved under the Medical Devices Regulations 2002 in due course.

Yourgene said its primary source of Covid-19 revenues, PCR testing and sequencing services, were unaffected by the extended time taken to receive the approval under the newly-introduced UK regulations, as they were not reliant on selling Clarigene, or Clarigene achieving approval.

“Following approval under CTDA regulations, Yourgene can now actively market the Clarigene test to new UK customers to meet the needs of continued seasonal PCR testing,” the board said in its statement.

“Clarigene will be one of a small number of UK manufacturers with Covid-19 testing products currently approved for sale in the UK.

“Having recently provided upgraded guidance for the current financial year on 17 January, Yourgene intends to provide a further progress update on trading following the March year-end.”

At 1419 GMT, shares in Yourgene Health were down 1.36% at 9.03p.