Avacta Group Share News (AVCT)

(Sharecast News) - Cancer therapies and diagnostics developer Avacta Group announced "significant progress" in the development of a scalable manufacturing process for a lateral flow SARS-CoV-2 antigen test being carried out with BBI Solutions on Monday.


The AIM-traded firm said the test had "very good" analytical sensitivity with laboratory samples.

It said it was developing several Covid-19 tests using Affimer binders that were "highly specific" to the SARS-CoV-2 virus spike protein.

A test device using readily-available components and routine manufacturing processes had now been shown to have a sensitivity for coronavirus spike protein in laboratory samples better than 300 pg/ml, the board reported, which was in the range expected for spike protein in clinical samples.

In preparation for clinical validation of the lateral flow test, Avacta said it was working on both saliva and anterior nasal swab samples.

Anterior nasal swabs sample the easily-accessible parts of the nose, and were therefore painless and straightforward to administer, unlike nasopharyngeal swabs, which were generally regarded as painful and unpleasant.

Avacta and its partners would continue to develop both sampling methods in parallel, in order to bring high performance Covid-19 tests to market quickly to suit a range of use cases, the board explained.

The performance of the test with clinical samples would now be evaluated as a precursor to a much larger clinical study with Covid-19 patients of known viral load, to determine the clinical sensitivity of the test.

At the same time, BBI Solutions was working to finalise and validate the manufacturing process so that the group could carry out a full clinical validation on the final product to support the regulatory approval process.

"I am delighted with the excellent progress that has been made with BBI Solutions in developing a scalable version of a lateral flow rapid SARS-CoV-2 antigen test with sensitivity in the expected clinical range for spike protein," said chief executive officer Alastair Smith.

"BBI Solutions is an excellent development partner and I am particularly pleased at how well the teams are working together to shorten the timeline as much as possible without compromising quality.

"In addition to the excellent progress made with the lateral flow antigen test we are also currently carrying out a clinical evaluation of the 'BAMS' assay at several sites in the UK."

Smith said the company was in discussions with commercial partners to establish the route-to-market for a CE-marked BAMS Covid-19 test that could be deployed in hospitals in the UK and Europe, adding that it was making progress towards establishing a commercial partner for the research 'ELISA'.

"The diagnostic business unit has also made good progress on a number of other non-Covid-19 commercial opportunities and on putting in place an ISO 13485-accredited quality system to support the future growth.

"Furthermore, we remain on track to submit the UK regulatory application, or CTA, for AVA6000 pro-doxorubicin before the end of the year to allow first-in-human trials of the 'preCISION' chemotherapy platform at several clinical trial sites in the UK early in 2021."

At 1230 GMT, shares in Avacta Group were down 17.9% at 111.25p.