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For those interested, the FDA have today published transcripts for their last 2 round table events held 7/10 and 14/10.
https://www.fda.gov/media/143084/download - end of p24 beginning of p25 is interesting.
https://www.fda.gov/media/143085/download - Dr Stenzel about two thirds down page 25 is interesting.
Altogether these docs give a great insight into FDA thinking, and as far as AVCT is concerned, demonstrate how eager the FDA are to get a home use saliva based LFT. To date , the FDA have still not received any EUA application for such a test, despite it being a priority for them and despite the fact that the relevant FDA template has been available for ages.
Anyone saying we are late to this particular and important party is, I think, wrong. We may well be the star guest and the first to arrive.
I’m not surprised. They won’t approve any swab test for at home use, so it’ll be a while before at home tests start coming through. Not sure how they feel about lower nasal swabs, but the challenge there will be the S&S figures. Despite not pushing it as the volumes needed in the U.K. are so huge, we might end up throwing the LFD in to the FDA for a laugh and being the first
Realy appreciate you sharing the info @ Muck. Thanks. Thumbs up smiley face emoji
Muck, a lot of us will be interested please post when you can
Thanks
Have just finished listening live to the latest of these events held this PM. (anyone can do that btw).
TBH I did fall asleep for a lot of it, but was awake right at the end when the FDA were asked directly whether or not they have had any EUA applications for an “at home” molecular or antigen test. The FDA guy began to respond quite cagily about what he could or couldn’t say, then explained that he gets daily updates on this as a top priority, and then simply confirmed that the FDA have not as yet Received such an application.
Whilst that might have been his final answer, the way he answered it spoke volumes and it seemed clear to me that lots of conversations are likely going on behind the scenes preparatory to actual application(s)
The transcript should be available pretty soon, which I’ll post for those interested.
Thank you - good find
The latest published FDA round table transcript is here, for anyone interested. It’s dated 23 Sept, although there was another round table event today (transcript yet to be published)
https://www.fda.gov/media/142511/download
Of note are the clearly stated FDA priorities (page 3)
“ There remains a robust interest in pooling and in particular kit manufacturers who have pooling submissions that would allow those kit users in the labs that use that kit to immediately pool with minimal work and perhaps no bench work for their own lab. That obviously greatly amplifies our efforts around trying to promote the opportunities for pooling. So those would be priority.
And then point of care tests, especially those that are molecular in antigen remain high priorities. As to those that help us to expand testing further and that includes home collection, and home testing, especially for molecular diagnostics and antigen testing.”
Avacta can help with these I think..!
I had thought it might have been possible for Cytiva to have been delegated that job. FDA EUA application that is.
Just to follow up on this, here is an audio of the full 16/9 FDA round table event
https://www.youtube.com/watch?v=PfakNcEmaXs&feature=youtu.be
It’s interesting to hear FDA thinking on various matters surrounding Covid diagnostics, directly from the horses mouth. All of its relevant but I suppose the best bits start around 15.30 in, when it becomes clear they’ve not had any at home antigen EUA submissions, are really keen to get them, and will be flexible in dealing with those submissions.
Sorry, here is the link to all the transcripts
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-town-hall-series-immediately-effect-guidance-coronavirus-covid-19-diagnostic-tests-09232020
For some time now the FDA have been holding regular round table events to discuss and answer questions about their guidance on COVID diagnostic tests, which make interesting reading for those who have time. A transcript follows each event, all of which can be found here - https://www.fda.gov/media/142312/download
The latest one was from 16/9, and of particular note was the confirmation on page 7 that the FDA has not received a single EUA application for an at home test, despite having had their template guidance for them out for some time.
So, although we are hearing more and more about “competitor” tests, none of them it seems are any further forward than us and indeed I would think most are lagging some way behind.