Avacta Group has announced that the first Affimer-based rapid test strips to detect SARS-COV-2 spike protein have been developed and evaluated by partners at Cytiva (formerly GE Healthcare Life Sciences) and show positive initial performance data.
In mid-May Avacta provided Affimer reagents that are specific to the SARS-COV-2 spike protein to Cytiva which has now developed the first lateral flow test strips using these reagents and generated initial performance data using coronavirus spike protein.
These data show that the test strips detect the spike protein in model samples at concentrations within the clinical range found in saliva of patients with COVID-19. Work continues now to refine the test strip design, optimise its performance and get the best detection limit possible in order to generate the highest sensitivity in the final rapid test product.
Following the optimisation of the lateral flow test by Cytiva the design will then be transferred to manufacturing partners in the UK that are currently being put in place by Avacta. The company is working with these manufacturers to compress the normal manufacturing, clinical validation and regulatory timelines in order to bring a product to market as quickly as possible.
Dr. Alastair Smith, Chief Executive of Avacta Group commented: “I am delighted with the progress made by our partners at Cytiva and very encouraged by the positive data from the first test devices. We now need to optimise the test performance to achieve the best possible limit of detection as this will ultimately play a significant factor in determining the clinical sensitivity of the test.
This is a really positive step and we aim to have completed the optimisation very soon so that we can begin the transfer to manufacturers. I will be updating the market on progress in due course.”
Klaus Hochleitner, Global Lead, Technology Product Specialist at Cytiva, commented: “I am pleased that the test development has progressed from a working initial design to now focussing on optimising the test as much as possible. The Affimer reagents have worked well in lateral flow test strips and we are very encouraged by the initial data.”