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Avacta’s Covid-19 lateral flow test can be sold in UK after MHRA registration confirmed



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Avacta’s lateral flow test for Covid-19 can now be sold for professional use in the UK, after its registration was confirmed by the MHRA.

The Whittlesford-based company expects product registration within the EU to follow shortly.

Avacta has received MHRA registration for its AffiDX SARS-CoV-2 antigen lateral flow test
Avacta has received MHRA registration for its AffiDX SARS-CoV-2 antigen lateral flow test

The test is based on Avacta’s Affimer platform, which provides an alternative to antibodies.

Avacta Group CEO Dr Alastair Smith said: “I am delighted to receive confirmation of the registration of the AffiDX SARS-CoV-2 antigen test from the MHRA [Medicines and Healthcare products Regulatory Agency].

“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.

“The excellent results of the recent clinical evaluation of the test at a clinical site in Europe demonstrate the test has excellent sensitivity across a range of viral loads which would be considered infectious.

“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 are very excited by the potential of this high-quality SARS-CoV-2 rapid antigen test and by the interest it has already attracted from potential commercial partners and distributors. We will continue to focus on its commercial roll-out and manufacturing scale-up to meet demand.

“Lateral flow tests have a crucial role to play in helping our society and economy return to normal, and I am confident that the AffiDX test will now play a significant part in this process.”

Avacta has received MHRA registration for its AffiDX SARS-CoV-2 antigen lateral flow test
Avacta has received MHRA registration for its AffiDX SARS-CoV-2 antigen lateral flow test

In trials, the AffiDX test demonstrated 100 per cent sensitivity for identifying infectious individuals with viral loads, measured by PCR, in which the cycle threshold (Ct) was less than 27.

The Ct is the thermal cycle number at which the fluorescent signal exceeds that of the background, meaning it passes the threshold for positivity. Higher numbers indicates a low concentration of viral genetic material, which is typically associated with lower risk of infectivity.

For comparison, typical PCR tests - which are more sensitive than lateral flow tests - have a Ct of 40.

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

The company was highly commended in the Covid-19 Response Award category at the Cambridge Independent Science and Technology Awards in April.

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