Avacta Group says CE mark submission for antigen test delayed due to error

© Reuters

By Samuel Indyk

Investing.com – AIM-listed Avacta Group (LON:) has provided an update on the submission of its Declaration of Conformity for CE mark of its AffiDX SARS-CoV-2 antigen lateral flow test for professional use.

The company previously announced that the Declaration of Conformity was submitted on 10th May to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, with the regulatory submissions to the MHRA and a Competent Authority in an EU member state subcontracted to an independent regulatory consulting agency.

An error made by that agency, for which it was solely responsible, meant a delay to the MHRA submission which was finally made on 28th May.

Following the delay, it is anticipated that confirmation of registration of the AffiDX test for the UK market from the MHRA will be received shortly.

In the meantime, Avacta said it has continued discussions with distributors and customers and does not anticipate the error will cause a delay to first commercial sales of the product.

Social media rumours

The company also reiterated its stance regarding a social media post that gained attention last week. The post alleged that the MHRA had rejected Avacta’s filing of a Declaration of Conformity for its test. However, Avacta said this was related to a different test from the Group’s partner, Mologic.

“It was not the Avacta AffiDX SARS-CoV-2 antigen lateral flow test as purported in the social media post,” Avacta Group said in a statement.

At 09:53BST, shares in Avacta Group were trading higher by 0.4% at 238.00 pence per share.

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