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.

READ  BHP, Rio, Vale launch contest to cut haul truck emissions
Disclaimer: Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. All CFDs (stocks, indexes, futures) and Forex prices are not provided by exchanges but rather by market makers, and so prices may not be accurate and may differ from the actual market price, meaning prices are indicative and not appropriate for trading purposes. Therefore Fusion Media doesn`t bear any responsibility for any trading losses you might incur as a result of using this data.

Fusion Media or anyone involved with Fusion Media will not accept any liability for loss or damage as a result of reliance on the information including data, quotes, charts and buy/sell signals contained within this website. Please be fully informed regarding the risks and costs associated with trading the financial markets, it is one of the riskiest investment forms possible.





READ SOURCE

LEAVE A REPLY

Please enter your comment!
Please enter your name here