Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer® and pre|CISIONTM platforms, is pleased to announce significant progress in the development of a highly scalable manufacturing process for a lateral flow SARS-CoV-2 antigen test being carried out with BBI Solutions, and that the lateral flow test has very good analytical sensitivity with laboratory samples.
Avacta is developing several coronavirus tests using Affimer binders that are highly specific to the SARS-CoV-2 virus spike protein.
The development of an Affimer-based lateral flow antigen test that can be manufactured at scale being carried out in partnership with BBI Solutions has made substantial progress. A highly scalable test device using readily available components and routine manufacturing processes has now been shown to have a sensitivity for coronavirus spike protein in laboratory samples better than 300 pg/ml which is in the range expected for spike protein in clinical samples.
In preparation for clinical validation of the lateral flow test Avacta is working on both saliva and anterior nasal swab samples. Anterior nasal swabs sample the easily accessible parts of the nose and are therefore painless and straightforward to administer, unlike nasopharyngeal swabs which are generally regarded as painful and unpleasant. Avacta and its partners will continue to develop both sampling methods in parallel in order to bring high performance COVID-19 tests to market quickly to suit a range of use cases.
The performance of the test with clinical samples will now be evaluated as a precursor to a much larger clinical study with COVID-19 patients of known viral load to determine the clinical sensitivity of the test. In parallel BBI Solutions is working to finalise and validate the manufacturing process so that the Group can carry out a full clinical validation on the final product to support the regulatory approval process.
Alastair Smith, Chief Executive Officer of Avacta Group, commented:
“I am delighted with the excellent progress that has been made with BBI Solutions in developing a scalable version of a lateral flow rapid SARS-CoV-2 antigen test with sensitivity in the expected clinical range for spike protein. BBI Solutions is an excellent development partner and I am particularly pleased at how well the teams are working together to shorten the timeline as much as possible without compromising quality.
In addition to the excellent progress made with the lateral flow antigen test we are also currently carrying out a clinical evaluation of the BAMSTM assay at several sites in the UK. We are in discussions with commercial partners to establish the route to market for a CE marked BAMS COVID-19 test that can be deployed in hospitals in the UK and Europe and we continue to make good progress towards establishing a commercial partner for the research ELISA. The diagnostic business unit has also made good progress on a number of other non-COVID-19 commercial opportunities and on putting in place an ISO13485 accredited quality system to support the future growth.
Furthermore, we remain on track to submit the UK regulatory application, or CTA, for AVA6000 pro-doxorubicin before the end of the year to allow first-in-human trials of the pre|CISIONTM chemotherapy platform at several clinical trial sites in the UK early in 2021.
I will continue to update market on these programmes and other developments when key commercial and clinical milestones are met and I look forward to doing that in due course.”