Clarity required please17 Sep 2020 11:08
1. BAMS - where are you?
On June 6th, Sir Al said;
We are now looking forward to testing the prototype BAMS assay with patient samples in the UK very soon, whilst Adeptrix does the same at a site in the US. This will keep us on track for launch of a product for professional use in the summer.
Almost 4 months have passed since SIr Al shared the above. As above, where are you BAMS?
2. What is the role of LSTM? We were told they had been signed up to clinically validate performance of the LFD? If ELISA was validated with results shared, where are the LFD results?
Note the following from the RNS;
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.
Avacta aims to begin clinical validation of the test as soon as possible by using the first pilot batches generated as part of the technology transfer process for these studies. In parallel with these clinical validation studies, which will be run within the UK government's CONDOR programme and potentially with other collaborators globally, BBI will work with Avacta and Cytiva to produce the additional technical documentation that is required for CE marking of the final product.
Who is validating clinical performance? Are LSTM still doing so?
3. Tech transfer to BBI started on Aug 6th. Where are we now with this process and what is the expected completion date? If LSTM is no longer validating clinical performance, I assume the process will not start until tech transfer and pilot production is complete and passed to CONDOR?
Thanks
Wiggly
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