Avacta Stock Up On MHRA Registration Of AffiDX SARS-CoV-2 Antigen Lateral Flow Test

Shares of Avacta Group plc (AVCT.L) were gaining around 4 percent in the morning trade in London after the company announced that the MHRA has confirmed registration of its AffiDX SARS-CoV-2 antigen lateral flow test. The company can now place the product on the market in the UK for professional use. The Company expects product registration from a Competent Authority within the EU to follow shortly.

The developer of diagnostics and innovative cancer therapies based on its proprietary Affimer and pre|CISION platforms noted that lateral flow antigen tests are intended to provide a cost effective and rapid means of identifying individuals with a high viral load that means they are more likely to infect others.

The clinical data for Avacta’s AffiDX SARS-CoV-2 antigen lateral flow test reported in April demonstrated 100% sensitivity for identifying infectious individuals with viral loads measured by PCR of Ct<27.

Avacta said it continues with multiple commercial discussions with distributors and end user customers in countries that accept the CE mark for in vitro diagnostic products.

Alastair Smith, Chief Executive Officer of Avacta, said, “It is a transformative milestone for Avacta’s Diagnostics Division being the first CE marked product powered by the Affimer platform that has been brought to market. …As part of the study the same clinical samples were tested with two leading, commercially available lateral flow antigen tests, and the data show that the AffiDx test has superior clinical sensitivity across the range of samples and in particular at lower viral loads… We will continue to focus on its commercial roll-out and manufacturing scale-up to meet demand.”

In London, Avacta shares were trading at 249 pence, up 4.2 percent.

Source: Read Full Article