Since gaining access to the product, the ProAxsis team have continued to work closely with the team at AstraZeneca to modify the original prototype version of the assay, adapting various components and processes to create an easy-to-use, high-performance plasma-based assay for the identification of IgG antibodies raised against the COVID-19 virus for use in a clinical trial setting. Due to the nature of the coronavirus pandemic (increasing number of known variants, range of vaccines utilised globally, etc.), the assay development process is complex and time-consuming but the company has now run numerous samples, indicating that the assay is highly specific and sensitive for distinguishing between positive and negative samples.

In H1 2022, a World-renowned clinical partner who has supported multiple COVID-related assay development programmes, will conduct several of the required assay validation steps, which necessitates access to a cohort of very specific clinical samples, and which will provide key data for the dossier required to register the assay with a CE Mark. In parallel, the company continues to explore additional novel assay formats, and routes to market, for the product.

• Supported by Innovate UK, the company has successfully developed the first 2-plex protease multiplex panel, which is now being validated for use in a range of biological samples. This assay enables simultaneous measurement of two key proteases (neutrophil elastase and proteinase 3) which have been associated with COVID-19 symptom severity, utilising a widely available multiplex platform.  We are currently in discussion with potential commercialisation partners for this highly novel product and anticipate making a further announcement on the progress of this assay in due course.

These new products are forecast to contribute significant incremental sales in 2022.  Additionally, the company has continued to expand both its commercial and scientific teams, and expects to announce further news on its laboratory expansion plans during 2022.

David Ribeiro CEO