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Avacta Group (LON: AVCT) said on Tuesday morning that it has received the first data for its SARS-CoV 2 rapid antigen test from ongoing clinical studies in Europe and the UK.
“These data show excellent performance of the test in identifying patients with an infectious viral load and no false positive results,” Avacta revealed in its statement.
The initial evaluation of Avacta’s lateral flow rapid antigen test with clinical samples has been carried out at two sites, one in the EU and one in the UK, using patient samples with viral loads confirmed by PCR tests.
30 positive samples were tested with the lateral flow test, identifying 29 out of 30 correctly as positive, indicating a clinical sensitivity of 96.7% for samples with cycle threshold value below 26.
Out of 26 negative samples tested, the test identified all 26 correctly, giving a clinical specificity of 100%.
There have been many questions regarding false-positive rates among coronavirus tests, and Avacta said a high specificity is critical for a lateral flow test for mass screening so that large numbers of false positives are not generated which would create a burden on follow-on testing resources, and result in the isolation of people unnecessarily.
The company said it will now progress to a full clinical validation with a larger number of patients samples to CE test for professional use, aiming to bring the test market in Europe around the end of the first quarter of this year.
“These data from the first clinical studies will allow us to quickly progress with confidence into the full clinical validation of the test, manufactured at scale, at our clinical trial sites in the UK and the EU,” said Dr Alastair Smith, chief executive officer of Avacta.
“I am confident that these data will accelerate our commercial discussions regarding the roll-out of the test when it is approved for professional use,” Dr Smith added.
The company's shares are trading over 19% higher following the news at 184p.
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