Avacta enters commercial partnership with Mologic

Biotherapeutics developer Avacta Group has entered into a commercial partnership with Mologic, it announced on Monday, to accelerate to market its ‘AffiDX’ SARS-CoV-2 lateral flow rapid antigen test.

The AIM-traded firm said it would also support antigen testing in low and middle income countries by providing access to its spike antigen test through Mologic.

It said the partnership would provide a faster route-to-market for Avacta's rapid antigen test by CE-marking it for professional use under Mologic's existing ISO13485 quality system.

The CE mark would then be transferred to Avacta when it receives ISO13485 accreditation, which was expected by the end of March.

Avacta said the partnership would also immediately provide it with additional manufacturing capacity through Mologic and its partners, including Global Access Diagnostics (GAD), in addition to the scaled-up manufacturing capacity being built with BBI and Abingdon Health.

Combined, those manufacturing partnerships would deliver “several millions” of tests per month, and potentially much higher with further investment.

Avacta said it was also continuing its discussions with other manufacturers in the UK and overseas to access additional capacity to meet demand.

Clinical evaluation of the lateral flow test was currently being carried out at a hospital in mainland Europe, and the company said it would shortly initiate further clinical validation studies in the UK and abroad.

The partnership between Avacta and Mologic also provided a framework agreement for the future development of a pipeline of tests in a range of disease areas, the board said.

It added that the possibility of combining Avacta's spike antigen test with Mologic's nucleocapsid antigen-based technology in a single lateral flow device was already being explored.

A hybrid antigen test such as that was expected to be a “world first”, the company said, and would have the potential to deliver an “extremely sensitive” lateral flow coronavirus antigen test.

“The partnership provides Avacta with a low risk route to CE-marking our rapid antigen test during the first quarter ahead of achieving our own ISO13485 accreditation,” said chief executive officer Dr Alastair Smith.

“The longer-term collaboration with Mologic, on a range of diagnostic tests, offers a significant potential opportunity for the group.

“The combination of our technologies to generate a world-leading second generation antigen test for SARS-CoV-2 is an exciting possibility.”

Dr Smith said the critical next step was to demonstrate that the outstanding laboratory performance of our rapid spike antigen test is reflected in its clinical performance.

“Customs issues following the UK's departure from the EU caused delays to the tests being delivered to our clinical partner in Europe, but the clinical evaluation is now progressing.

“We have also identified UK clinical groups outside of the FALCON/CONDOR programmes whose data can be used for CE marking.

“Therefore, if the clinical evaluation in Europe is positive, we are ready to move quickly into full clinical validation in Europe and the UK, and subsequent CE-marking through Mologic.”

Dr Smith said that with that approach, it was possible to bring the test to market around the end of the first quarter.

At 1106 GMT, shares in Avacta Group were up 9.57% at 139.7p.