Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer® and pre|CISION™ platforms, today releases an update on the submission of the Declaration of Conformity for CE mark of its AffiDX® SARS-CoV-2 antigen lateral flow test for professional use. As previously announced, this regulatory submission was the responsibility of the Group’s partner, Mologic Limited (“Mologic”), a leading developer of lateral flow and rapid diagnostic technologies, products and services.
On 10 May, Avacta announced that Mologic had submitted the Declaration of Conformity to the Medicines and Healthcare products Regulatory Agency (“MHRA”) in the UK at that date. The regulatory submissions to both the MHRA and to a Competent Authority in a European Union member state were sub-contracted 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. 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 is anticipated that Mologic will 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 a European Union member state to enable marketing and sale of the AffiDX® SARS-CoV-2 antigen lateral flow test in the EU.
Avacta can also confirm 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 Company looks forward to updating the market shortly on the responses from the Competent Authorities in the UK and EU and on commercial progress for its AffiDX® SARS-CoV-2 antigen lateral flow test.