FinnCap note £3.1016 Feb 2021 08:19
“Avacta (AVCT): Corp
Positive initial data for SARS-CoV-2 lateral flow test
Highly encouraging positive initial clinical data from 56 PCR-confirmed clinical samples indicate 96.7% sensitivity and 100% specificity in patient samples where levels of virus (viral load) are considered would be infectious. These data significantly de-risk the lateral flow antigen test development programme, bringing closer the prospect of significant revenues in 2021 and helping to accelerate commercial discussions regarding the roll-out of the test when it is approved for professional use (targeted by end Q1 2021). Avacta will now move into the full clinical validation of the test, manufactured at scale, at clinical trial sites already identified in the UK and Europe. We reiterate our 310p SOTP target price.”
“Avacta*
Positive initial data for SARS-CoV-2 lateral flow test
Highly encouraging positive initial clinical data from 56 PCR-confirmed clinical samples indicate 96.7% sensitivity and 100% specificity in patient samples where levels of virus (viral load) are considered would be infectious. These data significantly de-risk the lateral flow antigen test development programme, bringing closer the prospect of significant revenues in 2021 and helping to accelerate commercial discussions regarding the roll-out of the test when it is approved for professional use (targeted by end Q1 2021). Avacta will now move into the full clinical validation of the test, manufactured at scale, at clinical trial sites already identified in the UK and Europe. We reiterate our 310p SOTP target price.
?Newsflow. The initial evaluation of Avacta’s lateral flow rapid antigen test (AffiDXTM) with clinical samples (30 positive and 26 negative for SARS-CoV-2 virus) has been released. Undertaken at two sites in Europe and the UK, using patient samples with viral loads confirmed by PCR, the results indicate excellent performance, which will now lead to a validation study for the purposes of CE marking for professional use.
?Results: The lateral flow test identified 29/30 positive samples correctly as positive, indicating a clinical sensitivity of 96.7%. This was in samples with a Ct (Cycle Threshold – semi-quantitative indication of viral load in a patient measured by PCR) value below 26 with half in the Ct range 22-26 – levels where patients are deemed to be more infectious. Importantly, AffiDX correctly identified all 26 negative samples as negative, giving a clinical specificity of 100%.
?Implications: High specificity is critical for a lateral flow test for mass screening so that large numbers of false positives are not generated, which creates a major burden on follow-on testing resources, and results in a significant socio-economic cost of unnecessarily isolating people. The LFT shows very good sensitivity in the infectious range of viral loads including at the lower infectious loads with Ct values of 23-26 (the higher the number – the lower the viral load and infectivity). ...”
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