# Avacta Group significant progress made on SARS-CoV-2 rapid antigen test

- Link: https://www.directorstalkinterviews.com/avacta-group-significant-progress-made-on-sars-cov-2-rapid-antigen-test/412940566
- Published: 2020-11-23T07:22:47+00:00
- Author: Giles

**[Avacta](https://www.directorstalkinterviews.com/company/avacta-group-plc/avct.l)
Group plc** ([LON:AVCT](https://www.directorstalkinterviews.com/ftse-company/avacta-group-plc/avct.l)),
the developer of innovative cancer therapies and diagnostics based on its proprietary
Affimer^(®) and pre|CISION^(TM) platforms, has announced significant progress in
the development of a highly scalable manufacturing process for a lateral flow SARS-
CoV-2 antigen test being carried out with BBI Solutions, and that the lateral flow
test has very good analytical sensitivity with laboratory samples.

[You might also enjoy our interview with CEO Alastair Smith discussing todays news here.](https://www.directorstalkinterviews.com/avacta-group-make-significant-progress-with-its-highly-scalable-lateral-flow-test-interview/412940598)

Avacta is developing several coronavirus tests using Affimer binders that are highly
specific to the SARS-CoV-2 virus spike protein.

The development of an Affimer-based lateral flow antigen test that can be manufactured
at scale being carried out in partnership with BBI Solutions has made substantial
progress. A highly scalable test device using readily available components and routine
manufacturing processes has now been shown to have a sensitivity for coronavirus
spike protein in laboratory samples better than 300 pg/ml which is in the range 
expected for spike protein in clinical samples.

In preparation for clinical validation of the lateral flow test Avacta is working
on both saliva and anterior nasal swab samples. Anterior nasal swabs sample the 
easily accessible parts of the nose and are therefore painless and straightforward
to administer, unlike nasopharyngeal swabs which are generally regarded as painful
and unpleasant. Avacta and its partners will 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 performance of the test with clinical samples will 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. In parallel BBI Solutions is working to finalise
and validate the manufacturing process so that the Group can carry out a full clinical
validation on the final product to support the regulatory approval process.

> **Alastair Smith, Chief Executive Officer of Avacta Group, commented:**
> “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. 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^(TM) assay
> at several sites in the UK. We are in discussions with commercial partners to 
> establish the route to market for a CE marked BAMS COVID-19 test that can be deployed
> in hospitals in the UK and Europe and we continue to make good 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 ISO13485 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 pre|CISION^(TM) chemotherapy platform at several clinical trial 
> sites in the UK early in 2021.
> I will continue to update market on these programmes and other developments when
> key commercial and clinical milestones are met and I look forward to doing that
> in due course.”

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