RE: Nothing has changed1 Sep 2020 10:22
Just a reminder on what we officially know:
LFD we were told 7th August:
Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that it has entered into a collaboration with the Liverpool School of Tropical Medicine ("LSTM") to clinically validate the rapid, saliva-based coronavirus antigen test that Avacta is developing with Cytiva.
Under the terms of the collaboration, LSTM will carry out the clinical validation of the Avacta COVID-19 antigen rapid saliva test in their category 3 laboratories on patient samples. In addition to working with the UK government's CONDOR programme to provide Avacta with access to patient samples in the UK, the partnership with LSTM also provides the opportunity to access patient samples in Africa and South America. The higher prevalence of the disease in those regions means that samples for prospective clinical validation studies are more readily available which, if necessary, could be used to speed up the validation process.
Clinical validation is the process of evaluating the performance of a diagnostic test using real patient samples. Clinical validation generates the sensitivity and specificity performance parameters which are most often used to define the performance of a diagnostic test.
LSTM is currently evaluating the performance of prototype lateral flow tests provided by Cytiva alongside Avacta's ELISA laboratory test using SARS-CoV-2 coronavirus samples, as a precursor to full clinical validation studies.
BAMS we were told 22nd July:
Avacta to begin clinical validation of the high throughput COVID-19 laboratory test in collaboration with the UK government CONDOR programme
Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that it has begun work with the UK government's CONDOR programme to evaluate and clinically validate the high throughput COVID-19 bead-assisted mass spectrometry ("BAMSTM") laboratory assay developed with Adeptrix (Beverly, MA, USA).
Through the collaboration with the CONDOR scheme, Avacta will be provided access to patient samples and collaborators in UK hospitals to evaluate the performance of the prototype BAMS assay and to conduct the clinical validation study.
The work with the CONDOR programme will commence immediately to evaluate the test performance using real patient samples and will quickly progress to full clinical validation.
I don't think there is an NDA just noting to report while the process continues.... But I think we should be relatively close now to an update.
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