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Saliva was always my preferred method and would have done an acceptable job but for PD not really understanding the R rate and pandemic control at that less than one. Surely I can have a moan at the idiot boffins to ruin their Christmas. Not to mention the probable vested interests in the Innova test and vaccine rollout.
Is this a wind up. It certainly is for AVCT who ditched the saliva test for mid-turbinate on UK preferred method now almost at market however a switch to saliva now advisable. Maybe Meduflow will not be needed as Medusa have their RSPT though as an antibody test maybe that won't work either. Can AVCT resurrect the saliva test at Cytiva?
Hi Eastside, Merry Christmas! I do agree with you but the £s speak quite loudly for them.
If the EU conformity list shows the commercial name as Meduflow I am assuming Medusa will be the manufacturer but still guesses for me. I am referring back to Mologic/GAD who seem to have hightailed it with their affimer test for low cost manufacturing on the back of their ISO so assume Medusa can do with Meduflow what they like but will be sharing the profit in 50/50 partnership.
The diagnostic team at AVCT I see as having great potential and brains and the IP but Gates/Kamani knowing how to leverage it. AVCT with the new commercial appointments might build the retail up in the future but I don't see them as enjoying a huge logistic/distribution business to distract from the science.
If it was not for the rspt the Medusa team would not have been up to speed and have the contacts in Spain and aswell as that they will likely have many different tests to sell if their business expands just like bioserve. They are a fully integrated business; biotech to manufacture to retail with their rspt which is more than AVCT can claim. The recent rns reads as Medusa being the senior partner in many respects. AVCT do not dictate to Medusa.
I have posted before that HUA is a box to be ticked in the evaluation and note the 'Completed validation studies' column is the equivalent in the EU and notes at 2 show that the Paul Ehrlich Institut do them. The Germans have a compliant population largely and have been super efficient with their processes. https://ec.europa.eu/health/sites/default/files/preparedness_response/docs/covid-19_rat_common-list_en.pdf
So AVCT have that box ticked but unsure what will appear in the 'Completed validation studies' column and whether Medusa's lay studies provided this data. It is confusing things when AS uses validation in a different context https://www.lse.co.uk/rns/AVCT/clinical-validation-of-affidx-lateral-flow-test-cq0zbg851uwxx1a.html . This column 'Clinical performance As reported by independent validation studies' in the ' A common list of COVID-19 rapid antigen tests ' link above refers to 'In Vitro Characterization and Clinical Evaluation of the Diagnostic Accuracy of a New
Antigen Test for SARS-COV-2 Detection' and the column should be headed 'evaliation studies' https://www.iomcworld.org/articles/in-vitro-characterization-and-clinical-evaluation-of-the-diagnostic-accuracy-of-a-new-antigen-test-for-sarscov2-detectio.pdf
It all just shows how the regulators don't understand what they are doing and contrive to confuse issues and the EU are probably worse than UK. Generally speaking the whole pharma industry needs to be made intelligible as all good science is life enhancing and inspirational, not confusing.
Evaluation and device ID yet to be delivered I think, last update just missed 21/12/21 https://ec.europa.eu/health/sites/default/files/preparedness_response/docs/covid-19_rat_common-list_en.pdf
The nominated authority (in Spain/Carlos 111 hospital?) has validated the test and it is for professional sale in the EU
We still await being on https://ec.europa.eu/health/sites/default/files/preparedness_response/docs/covid-19_rat_common-list_en.pdf but now fit for retail sale in the context of the tests usability until 1/1/23 https://www.gov.uk/guidance/using-the-ukca-marking
AVCT have only recently completed a commercial team for diagnostics and I expect the groundwork is being laid for when there are more tests to sell. The leadership team is bigger too and AS is based at Wetherby so more hands on/physical presence/team interaction I imagine than with the therapeutic side.
It has been a 'testing' year for AVCT but I wish them all the best for the new year and a Happy Christmas maybe like most with restraint on mixing . The state covid has reduced us to it is a subdued celebration.
Fingers crossed for a US opening Wiggly. It couldn't have been worse for AS with Brexit and covid gumming up the political works in the EU and UK and the regulators have been exposed for deficient process through imo an entrenched uneven playing field to suit dubious decision takers whose decisions should have been open to debate before actioning. All AS can do is resort to academic lectures to inform decision makers; it was not his fault the playing field favoured the opposition- fleet of foot business with ministerial ear combined with poor science and regulatory process not attuned to pandemics except where 'success' is perceived (astra zeneca vaccine)
The problems with government involvement is the communication of the departments and suggest transparency is required leading to increased efficiency and accountability. Matters such as Innova purchases and ABDX ginolis need to be open to public input and subsequent investment decision making. Post Brexit the country needs to work together not be mutually destructive within its borders.
I have used it to diversify Apre and am up with the new choice though I do think the AVCT adjustment is a nod to a maturing AVCT market which is good. I did not want to use the margin however to up the risk exposure to AVCT.
It is not a priority to get the R rate down because any LFT is unlikely to affect spread of omicron and Boris prefers people stay at work with a false negative test I should imagine as the jabs keep them mobile. I am hopeful for hua in the UK and EU even if only to save the regulators from repercussions of not awarding it.
https://www.nibsc.org/about_us/mission_and_values.aspx
https://www.nibsc.org/about_us/scientific_advisory_committee.aspx
As our servants it looks like the advisory committee should be pressured to do something about procedures and COBAS 6800/8800 systems perhaps not favourable to the spike protein/whole virus detection with affimer binder/reagent. Can imagine no proactive work here though, just fees taken for advice for MHRA to keep noses clean. They were set up to be a positive force of their own but merged with MHRA on 1/4/13 https://www.nibsc.org/about_us/latest_news/nibsc_merges_with_the_mhra.aspx