In the latest twist in a complex story, the Wetherby-based group said the regulatory submission was the responsibility of its partner, Mologic, a leading developer of lateral flow and rapid diagnostic technologies.
On May 10, Avacta announced that Mologic had submitted the Declaration of Conformity to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
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.
Avacta said 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 May 28.
In the meantime, Avacta has continued its discussions with distributors and customers for the AffiDX antigen test and said it 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 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.
Last week, Avacta denied rumours that its highly accurate Covid-19 test had been turned down by the MHRA.
As a result, the firm saw its shares plunge following Twitter speculation that the MHRA had rejected its application on May 20.
In an update to the market last Friday, Avacta said: “To date, neither Avacta nor Mologic have received any update from the MHRA. Avacta will update the market when it is in a position to do so.”
Today, Avacta confirmed that the SARS-CoV-2 test referenced in a social media post on May 27, 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.
Avacta stressed that it was not the Avacta AffiDX SARS-CoV-2 antigen lateral flow test that had been rejected, as purported in the social media post.
Avacta said it 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.