Liverpool School of Tropical Medicine to validate Avacta’s saliva-based Covid-19 test
Avacta Group has continued its summer of intense activity by announcing a partner to clinically validate the rapid saliva-based coronavirus test it is developing with Cytiva, and a manufacturer to produce it.
The Liverpool School of Tropical Medicine (LSTM) will carry out on the validation of the test in its category three laboratories on patient samples.
The antigen test strip is being evaluated under the government’s CONDOR programme, meaning there is access to samples from the UK.
But LSTM also has good access to samples from patients in Africa and South America, where Covid-19 is prevalent, potentially speeding up the validation process.
The clinical validation will establish the sensitivity and specificity performance parameters used to define the performance of a diagnostic test.
As a precursor to the full study, LSTM is evaluating the performance of prototype lateral flow tests provided by the multinational Cytiva - formerly GE Healthcare Life Sciences - alongside Whittlesford-based Avacta’s ELISA laboratory test using SARS-CoV-2 coronavirus samples.
Dr Lisa Baldwin, business development manager at LSTM, said:: “The partnership between Avacta and LSTM exemplifies the role of the LSTM in translational work to advance products to market and we are pleased to be working with Avacta on this coronavirus antigen test.”
The test uses Affimer reagents that detect the SARS-CoV-2 virus spike protein.
Meanwhile, Kent-based BBI Solutions, which has manufacturing sites in five countries across four continents, has been appointed as the manufacturing partner for the test.
The deal offers the potential for millions of tests to be created per month.
Avacta, Cytiva and BBI are engaged in the technology transfer of the prototype and manufacturing procedures for the saliva-based rapid SARS-CoV-2 antigen test from Cytiva to BBI.
The clinical validation can begin once the first pilot batches are generated.
The companies will then work on the technical documentation required for CE marking the final product.
Avacta CEO Dr Alastair Smith said: “BBI has been excellent to work with to define a highly compressed product development timeline that will allow us to get the product to market as quickly as possible.
“We anticipate very high demand for the Covid-19 rapid test and will be working with our preferred manufacturing partners at BBI to satisfy that demand.
“We are actively continuing our discussions with other manufacturing partners to ensure that we have access to additional manufacturing capacity to address the global need for SARS-CoV-2 antigen testing both now, and in the next few years.
“As we set out in the use of proceeds at the recent fundraising, we have now expanded our product development team with the appointment of an experienced in-vitro diagnostic product development manager, and we are expanding the protein production facilities in order to meet the expected demand for Affimer proteins for the Covid-19 tests and future diagnostic tests in the pipeline.
“The diagnostics business has also been working at a rapid pace towards ISO13485 accreditation, which will streamline CE marking and other regulatory approval processes.
“I am immensely proud of what has been achieved by Avacta’s diagnostics team. Their progress in just a few months would have been challenging under normal circumstances, but with the additional restrictions imposed by Covid-19, it has been an outstanding example of hard work, ingenuity and commitment from a world-class team.
Dr Mario Gualano, chief executive of BBI Group, said: “BBI are delighted to have been appointed to lead the manufacture of Avacta’s rapid coronavirus antigen test, and to be able to further extend our lateral flow expertise to addressing the global challenges presented by Covid-19.
“Our ability to respond rapidly to Avacta’s needs is testament to our team’s diagnostic expertise and the supporting manufacturing and quality systems we have implemented at our ISO13485 accredited facility.”
Avacta has previously announced a distribution partner, Medusa19, for the test.