Summer launch target for Avacta coronavirus diagnostic test
A transatlantic alliance between Avacta in Cambridge UK and Adeptrix in Massachusetts has accelerated progress of a new diagnostic test for coronavirus.
A BAMS™ (bead-assisted mass spectrometry) diagnostic test for the COVID-19 infection being developed by the partners has reached prototype stage. They say it can detect the coronavirus spike protein in model samples in the concentration range appropriate for a clinical diagnostic test.
The BAMS assay uses the Affimer reagents specific to the SARS-COV-2 virus recently developed by Avacta to capture the virus spike protein from the sample for rapid detection by mass spectrometry.
A prototype assay has been developed and evaluated by Adeptrix using model samples containing the coronavirus spike protein. The unique method breaks up the spike protein captured from the samples by Affimer coated beads and is able to identify fragments of the spike protein using mass spectrometry, at concentrations in the range found in patient samples generated from standard throat swabs.
The combination of the selectivity of the Affimer reagents used to capture the virus spike protein with the precision and accuracy of mass spectrometry detection provides for a very high degree of specificity in the assay.
The next step in the development of the final product to run on the installed base of mass spectrometers in clinical laboratories around the world is to evaluate and optimise the BAMS assay using patient samples at laboratory sites in the UK and US.
This will be done imminently before moving to manufacturing, clinical validation to quantify the sensitivity and specificity and CE/FDA approval for professional use in the summer.
Dr Alastair Smith, CEO of Avacta Group, said: “I am very pleased with the rapid progress made by our partners at Adeptrix and delighted that the Affimer reagents that we have developed to detect the SARS-COV-2 spike protein are working very well in the BAMS assay. This bodes well for all our COVID-19 antigen test development programmes.
“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.”