Yorkshire Covid test will be the most sensitive lateral flow test available

Drug developer Avacta said that its Covid-19 test will be the most sensitive lateral flow test available on the market ahead of its commercial launch next month.

Dr Alastair Smith, chief executive of Avacta Group
Dr Alastair Smith, chief executive of Avacta Group

The Wetherby-based group is in talks with the Department of Health to roll out its test in the UK and it is also in active discussion with distributors in 25 EU markets.

Avacta said its AffiDX SARS-CoV-2 antigen lateral flow test shows "excellent" analytical sensitivity of 50 pg/ml of S1 spike protein with a read time of 20 minutes.

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The firm said: "As far as the group is aware and on the basis of laboratory testing to date, this is currently the most sensitive S1 spike lateral flow test available."

An initial clinical evaluation of its test using front nasal swab samples (30 positive and 26 negative samples) demonstrated a sensitivity of 96.7 per cent.

Earlier this week, the group announced the completion of the clinical validation of its AffiDX SARS-CoV-2 antigen lateral flow test with "excellent" performance data.

The study tested 98 positive samples. Avacta’s rapid antigen test identified 96 out of 98 of these correctly as positive within a 20 minutes read time, resulting in a clinical sensitivity of 98 per cent.

Out of a total of 102 negative samples tested with the lateral flow device, the test correctly identified 101 as negative, giving a clinical specificity of 99 per cent.

This is a vast improvement on the performance of many other lateral flow tests. The Innova test had a sensitivity of 79 per cent when used by laboratory scientists, meaning that 21 per cent, or one in five, would be false negatives.

Dr Alastair Smith, chief executive of Avacta Group, said: "We have seen 98 per cent sensitivity, so that its ability to detect positive cases within that patient range.

"That is higher than the vast majority of tests because we've taken a huge amount of care and effort in making sure that's the case.

"We've had to do a lot to build the plane as we've been flying it."

Avacta will have to find a distributor in the UK or it will go through the Department of Health's procurement systems.

"We are talking to the British Government. I can't say much more because of the confidentiality involved," said Dr Smith.

"We have an ongoing dialogue with the Department of Health. We obviously hope that will be fruitful and the British public will get access to this test though that route."

Dr Smith said that 2020 was a momentous year for Avacta.

"I am enormously proud of the entire team who have been instrumental in delivering this transformational growth and creating substantial commercial and clinical opportunities for the group for 2021 and beyond, despite the difficult working conditions imposed on laboratory working by the Covid-19 pandemic," he said.

"We are now very close to self-declaration of the CE mark of the AffiDX rapid antigen test for professional use and commercial launch in early May.

"We have made very good commercial progress with potential distributors, licensing partners and large scale end users and demand is strong.”

Analyst Mark Brewer at FinnCap said: "Full year results to December 31 contain few surprises following the February update, with year-end cash of £47.9m and a higher than expected adjusted net loss of £14.0m due largely to fully expensed R&D (research and development).

"Focus turns to the imminent CE marking and launch of its AffiDX SARS-CoV-2 antigen lateral flow test in May, following the recent clinical validation data.

"With this major de-risking event behind us and confirmation that GAD has manufactured batches at scale, we now look forward to commercial deals, given that Avacta is in active discussion with distributors in 25 EU markets.

"We remain very excited by the opportunities that exist in both businesses."

Analysts at Stifel said in a note: "Avacta remains on course for a breakthrough year in 2021.

"Having recently delivered impressive clinical validation data for its Affimer-based COVID antigen lateral flow test (AffiDx), Avacta aims to secure CE mark authorisation of the test in early May, paving the way for commercial roll-out in Europe.

"While the lateral flow test market opportunity is large and established, success will be determined by Avacta's ability to upscale its manufacturing capacity and secure substantial commercial contracts with governments and large corporates/organisations."