Avacta confident despite filing delay for Covid-19 antigen test

(Sharecast News) - Diagnostics and cancer therapies developer Avacta Group updated the market on its CE-mark submission for its 'AffiDX' SARS-CoV-2 antigen lateral flow test for professional use.
The AIM-traded firm said the submission was the responsibility of its partner Mologic, which submitted the declaration of conformity to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK on 10 May.

It said the regulatory submissions to both the MHRA and to a 'competent authority' in a European Union member state were subcontracted by Mologic to an independent regulatory consulting agency.

"An error made by that agency, for which it was solely responsible, resulted in a delay to the MHRA submission which was finally made on 28 May," Avacta said in its statement.

"In the meantime, the company has continued its discussions with distributors and customers for the AffiDX antigen test and does not anticipate that the error will cause a delay to first commercial sales of the product."

Following the delayed MHRA submission, it said it expected Mologic to receive confirmation of registration of the AffiDX test for the UK market from the MHRA "shortly".

"The company can confirm that the submission of the declaration of conformity has also been made to a competent authority in an EU member state, to enable marketing and sale of the AffiDX SARS-CoV-2 antigen lateral flow test in the EU."

Avacta also confirmed that the SARS-CoV-2 test referenced in a social media post on 27 May, highlighting an email that had been obtained from the MHRA reporting rejection of a filing of a declaration of conformity of a SARS-CoV-2 antigen test from Mologic, was an "unrelated" Mologic antigen test.

"It was not the Avacta AffiDX SARS-CoV-2 antigen lateral flow test, as purported in the social media post," the board said.

At 1056 BST, shares in Avacta Group were down 0.74% at 235.26p.