@Nostra. No, it hasn't been added to the 'no trade' list. It occasionally goes 'closing only' on IG CDF/SB (last time it lasted 3 weeks). I expect it will go 'opening' again in the not too distant.
Just thinking about the timing of the FDA announcement. The FDA inspections of Innova's manufacturing facilities were ongoing between 15th Mar 21 - 9th April 21. On 23rd April 21, Innova did their voluntary Class 1 recall of the test. So, the question is why now?
The MHRA and the FDA are possibly the two most respected health regulatory authorities in the world. The head of both organisations will doubtless have a reasonably close professional relationship. So, despite their stated misgivings about the Innova test, the MHRA will have felt under enormous pressure to renew Innova's EUA authorisation, given the dire consequences for the UK govt, should they not renew it (just think of the enormous vested interest the UK govt have in ongoing Innova EUA, with millions of tests stockpiled for T&T and 'home use' purposes, not to mention the embarrassment at not having an 'at hand' replacement test if the EUA was cancelled).
With that in mind, I think it entirely conceivable that Dr. June Raine (head of MHRA) would have been on the blower with the head of the FDA to request a favor. No skin off the FDA's nose to publish this report in a timely fashion for Dr Raine, since they are obviously no fan of the Innova organisation anyway. This report gives MHRA the exact cover/excuse they need to cancel EUA. I'd say we're looking good.
This govt will just brass neck it out, like they always do. There is no such thing as accountability these days, there is only sacrificial lamb..ism. Handjob is on death row, awaiting the right moment for him to be thrown to the wolves.
The govt knew what they were buying in Nov 2020. They haven’t been tricked by Innova. The real crime is that the UK govt didn’t throw huge resource into the UK diagnostics industry way back in Apr/May/Jun last year.
Porton Down Phase 4 (‘real world’) - Innova results Nov 2020
Test conducted by:
- laboratory scientists 79.2% sensitivity
- trained healthcare-workers 73.0% sensitivity
- self-trained members of the public 57.5% sensitivity
Why, oh why, in these interviews, doesn't anybody ever say there are (or will be) better tests available soon. Don't these journalists know anything about the lateral flow test market? It's enough to drive you crackers listening to a piece like that and nobody ever mentions the alternatives...absolutely crazy.
Sorry AgentB, I too feel a little disappointed with Sonia. Our relationship was only one email old, but I felt we were really bonding. And now that spoilsport Ndn says I’m not allowed to see her anymore, something about her being an enima friend…another deeply penetrating judgement by him. Still, if I had a chance to educate her about anything, I could think of more exciting subjects than asymptomatic testing, lovely looking lady that she is :-)
Talk Radio - Discussion on Innova/FDA about to start 4:35pm
My new bezza, Sonia, discussing Innova/FDA on Talk Radio today at 4:35pm
Just to emphasise the point, the results of PD phase 4 evaluation of Innova:
Test conducted by laboratory scientists 79.2% sensitivity
Test conducted trained healthcare-workers 73.0% sensitivity
Test conducted by self-trained members of the public 57.5% sensitivity
Bear in mind these results are based on optimal NP sampling (as per test design), so will be significantly lower when using AN sample, especially now it is being used as self-test AN sample.
Compare that to Affidx specifically designed as AN test - 100% sensitivity at ct<27.
"But the innova test was still tested in Porton down, and UK government had results. Etc"
Yes, @Scarabbeatle, and these were the PD phase 4 results:
Phase 4 evaluation
A further series of individuals were recruited from consecutive cases from COVID19 Testing centres with tests
performed by self-trained individuals and the results were compared to the Phase 3b shown above. Performance
was optimal when the LFD was used by laboratory scientists (156/197 LFDs positive [79.2%, 95% CI: 72.8-84.6%])]
versus trained healthcare-workers (92/126 LFDs positive [73.0%, 95% CI: 64.3-80.5%]) and self-trained members
of the public given a protocol (214/372 LFDs positive [57.5%, 95% CI:52.3-62.6%]; p<0.0001 chi2(2)=30.1) (Figure 3)
In other words, very poor.
Why would UK this, UK that, and UK the other be a massive selling point in Europe - the UK and EU are at daggers drawn right now.
He's just basically listed everything the UK govt have asked for and now he's saying "do you want it or not?"
- Excellent performance
- ease of nasal sampling
- developed in the UK, is
- based on UK technology
- manufactured in the UK
This is a definite "the balls in your court" statement from AS to UK gov.
Old Smiffy is a very clever man!
"This excellent performance and ease of nasal sampling, coupled with the fact that the AffiDX test is has been developed in the UK, is based on UK technology and is manufactured in the UK, are huge selling points for customers in Europe."
Lovely sideswipe at the UK govt. He may as well have "...are huge selling points for customers in Europe, but not for the UK apparently." Love it!
"As part of the study the same clinical samples were tested with two leading, commercially available lateral flow antigen tests, and the data show that the AffiDx® test has superior clinical sensitivity across the range of samples and in particular at lower viral loads."
Was thinking about this last night @Timster. I was asking myself why AS chose to do this. If they haven't published the details of the 'other' tests, then why bother doing it at all? It occurred to me that AS has done this to persuade a third party (UK govt) that despite Affidx not being suitable for PD validation (frozen samples etc.), we are in fact better than other tests that have been through PD. I think this could be an AS masterstroke.
With the MHRA already having reservations about the Innova EUA, you have to think they would be extremely reluctant to renew it after this FDA decision. Their reputation is on the line with this one. Would they really want to set themselves up for a potentially major embarrassment.
I notice that Porton Down 3b study gets a mention in the FDA Innova complaint letter.
"This PPA (Positive Percentage Agreement) for the 7T Configuration devices does not appear to align with the PPA observed in the phase 3b prospective clinical study conducted in the United Kingdom. Accordingly, the clinical performance estimates reported in the labeling of the 25T Configuration and 7T Configurations devices are false or misleading as they do not accurately reflect the performance estimates observed during the clinical studies of your devices."