Abingdon Accelerates AffiDX Antibody Replacement11 Jan 2022 16:06
Yesterday we were made aware that Abingdon (and Avacta) scientists are working together on replacing the antibody, hence accelerating the process. The process will be further accelerated as aside from the antibody replacement, the test will otherwise remain the same i.e., as Abingdon optimised all processes and elements for mass manufacture previously (completed mid-December 2021), this should be an expedited process. Avacta also have a rapid turn-around for test evaluation (in Madrid) with Omicron taking approx. 1-2 weeks.
AffiDX still awaits approval under the CTDA regulatory process and as such sales in the UK were hindered. The US FDA places greater weighting to test accuracy and the FDA have in the past suggested that Innova tests are to be binned. Furthermore, Chinese tests that have poor accuracy are not being used in the US. Although the AffiDX test is effective at high viral loads, it is imperative that for test longevity, that the antibody is replaced so that the test is resilient as possible to any future mutations. In doing so Avacta would be able to apply to the US FDA/ NIH Rapid Acceleration of Diagnostics initiative (which they referenced in the last RNS).
I think that we will have positive news on the AffiDX soon and Avacta are right with their decision to pause sales. However, for the purpose of valuation, I would like to draw the attention to Trinity Delta (the Analysts) value the therapeutics side of Avacta at £2.27/share. Furthermore, we have news on AVA3996 and AVA6000 in the pipeline and top-level data is expected from the clinical trials that will validate the preCision platform. The market over-reacted to the news of AffiDX pausing sales (I have personally added based on my own research).
GLA
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Summary of 10/01/2022
1. AffiDX® antigen test is effective at identifying high viral loads of Omicron
2. Sensititivity of the test is reduced at lower viral loads (compared to with the sensitivity of the previous SARS-CoV-2 variants.
3. Affimer® reagent in the AffiDX® test detects the Omicron variant with the same sensitivity as the Delta variant
4. The paired commercially available antibody in the test have been affected by the Omicron mutations
5. Avacta has voluntarily paused sales
6. Avacta will replace the antibody in the test to generate the next generation antigen test that will be as resilient as possible to any future mutations
7. Abingdon completed the final technical transfer batches and shipped to Avacta in mid-December 2021
8. Abingdon scientists will work with Avacta to accelerate the process of replacing the antibody in the current assay format and complete the process of technology transfer with this new specification.
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