Biotech firm says error will not delay covid test commercialisation
Biotech business Avacta Group has said it is still on track for commercial sales of its AffiDX® SARS-CoV-2 antigen lateral flow test for Covid-19, despite an “error” made in a submission to gain a CE mark for the test.
As previously announced by Wetherby-based Avacta, this regulatory submission was the responsibility of the Group’s partner, Mologic Limited, a developer of lateral flow and rapid diagnostic technologies, products and services.
On 10 May, Avacta said 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 says 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.
It adds: “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 Mologic will receive confirmation of registration of the AffiDX® test for the UK market from the MHRA shortly.
“The company can confirm 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.”
As reported by TheBusinessDesk.com last week, a Twitter user, @StickyStock81, published an e-mail that appeared to be from the MHRA which said the CE mark application for this Covid test had been rejected on May 20, leading to a share sell-off.
The shared e-mail explained the rejection was because of the documents filed for the application, and that this apparent administrative error meant the application would need to be resubmitted.
But Avacta has today responded: “Avacta can confirm the SARS-CoV-2 test referenced in a social media post on 27 May, highlighting an e-mail 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.”
