Avacta Group has announced progress in the development of a scalable manufacturing process for a lateral flow SARS-CoV-2 antigen test being carried out with BBI Solutions, and that the test has “very good” analytical sensitivity with laboratory samples.
A 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.
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 clinical validation on the final product to support the regulatory approval process.
Alastair Smith, CEO of Avacta Group, said: “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 BAMS 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.”
