Avacta appoints BBI as it prepares to launch millions of Covid-19 tests

The deal will see the accelerated development and validation of a scaled-up manufacturing process that has the potential to ramp up production to millions of tests per month.

Wetherby-based Avacta said BBI is a leading global developer and manufacturer of raw materials and finished test products for the in-vitro diagnostics market, with manufacturing sites in five different countries, spanning four continents.

Avacta, Cytiva and BBI will transfer the prototype technology for the saliva-based, rapid SARS-CoV-2 antigen test from Cytiva to BBI.

Avacta aims to begin clinical validation of the test as soon as possible by using the first pilot batches for these studies.

In parallel with these clinical validation studies, which will be run within the UK government’s CONDOR programme and potentially with other collaborators globally, BBI will work with Avacta and Cytiva to produce the additional technical documentation that is required for CE marking of the final product.

Dr Alastair Smith, chief executive of Avacta, said: “I am delighted to be working with BBI to manufacture the rapid Covid-19 test. 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."

Avacta said it has expanded its product development team with the appointment of an experienced, in-vitro diagnostic product development manager.

The diagnostics business has also been working at a rapid pace towards ISO13485 accreditation, which will streamline CE marking and other regulatory approval processes.

Dr Smith said: "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.

"I look forward to further updating the market as we go through the next stages of manufacturing scale-up, clinical validation, regulatory approval and product launch.”

Dr Mario Gualano, chief executive of BBI Group, added: “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.”

Analyst Mark Brewer at FinnCap said the appointment of BBI Solutions as Avacta’s manufacturing partner for the rapid SARS-CoV-2 antigen test shows "clear and rapid progress towards commercialisation".

Mr Brewer said: "Given the increasing acceptance that the virus will remain in the community into 2021 and beyond, and that many infections are thought to be asymptomatic, regular screening using rapid, low cost point-of-care tests is likely to be widely adopted."