What I know is recently the FDA’s EUA rate has been around 18 new EUAs a month. This month they’ve had a slow start (for new ones), however I’d still expect circa 18 new ones. It’s lumpy.
We also know that Genedrive’s test fits the FDA’s priority list. I.e. fast through-put; saves on supplies.
This is just my opinion – conjecture:
If you entered into a partnership to sell a PCR test that would fly off the shelves due to it’s no prep-time, greatly help the in fight against the pandemic (and make a pile of cash to boot) - but the hold-up is the FDA approvals' are overloaded – what would you do?
We know the FDA are prioritising particular tests. How do you persuade the FDA to look at your test; one we know fits their priority-list?
Maybe send out samples to various labs and get them independently validated? Then add those cases-studies to your application?
I can’t think of a better way.
The 2 case studies we know about both stress fast through-put, high accuracy - and were both done in February. I know the FDA seem painfully slow - except they’re not. Not really. They’ve averaged more than 1 new test a day, every day for over a year.
You know this New Mexico study they did for the Genedrive test, that BC are using to market Genedrive’s tests? Well, they could also have used the same study to get the FDA to pay more attention to Genedrive's test.
“or would significantly increase testing capacity (e.g., tests that reduce reliance on test supplies and high-throughput, widely distributed tests).”
Also: the study is dated February. They must have done it the minute the samples were imported. And it’s probably what happened to the whole shipment: sent out to labs for independent verification. Then use that data to get the FDA's attention. I hope!
I still think t's because every testing diagnostics company on Earth saw this golden opportunity – at the same time – and they all went for it. Who the heck are Genedrive? Anyone heard of them, reckon they’ve got the best test on Earth – just like the other 1000’s.
But now BC are selling them. People have heard of BC. Beckman Coulter gives Genedrive cut-through, because if they’re selling them, there must be something to them. And BC have huge reach. A base of 270,000 Biomeks. Genedrive desperately needed BC, but – to their credit - they got them.
Aaah yes the EUA. I think Genedrive submitted end of May / beginning of June because they appear on the 360 site at that time. So we’re coming up on a year. We know they’ve got approvals for other tests and there’s no way BC haven’t checked.
At least the FDA are doing something, albeit at a snails pace. The WHO’s approval “progress” spreadsheet has had no changes to it in months. Every week it looks exactly the same.
BC are a $6 billion company. They got that big by selling masses and masses of stuff.
Also, remember BC have data-safety sheets for the Genedrive test on a 4th plate type. The only reference to it is on BC’s system, nothing on Genedrive. So, to me at least, it looks like it’s BC driven. Why would they bother, unless there was demand for it, or at least BC think there’s demand for it.
@doozy I did some pretty extensive analysis of that 360 page. I wouldn't put to much into the 27. I can explain in great detail if you wish, but the short version is the 27 is not really the queue. And if it were, Genedrive is within the top 11.
The vast majority of the entries on that page appear AFTER they get EUA. The "27" seem to notifications added by the testing-companies themselves, i.e. Genedrive added their entry to say they'd submitted theirs. The FDA only adds them after they get EUA.
One of the entries is a delayed one for April. Bringing April's tally for new EUAs up to 18. The recent average is around 18 new EUAs a month, so if the FDA keeps that up, the rest of May looks promising. :)
Reading the lab case studies is reassuring to say the least!
“Our assessment of the assay performance was very positive. A significant advantage of the Genedrive® 96 SARS-CoV-2 Kit is that the reagents are freeze dried in the plate. This allows for room temperature storage. In addition technical staff do not have to thaw and prepare the reagents, saving time. We will continue our collaboration with Genedrive and we are confident that we will be able to adopt this in our lab to provide sound results with significantly improved throughput.” Professor S. Young
Jaceorge Yep, tripled. And yes I feel a bit of a dope. I was looking for the top of the wave on the chart. But the signal never came because I did not know folk would ditch their shares before the trading update.
Lesson learned. I will not make that mistake again! Been caught out by people ditching on dividend days, too. Still learning, but don't screw up nearly as often.
Also, running the rollup stuff I did, but on this larger dataset, still shows the EUA rate increasing – but this dataset has bigger numbers. :)
2021 ---------- April - 17 March - 20 February - 13 January - 12
2020 ---------- December - 13 November - 8 October - 22 September - 30 August - 37 July - 38 June - 43 May - 38 April - 54 March - 23 February - 1
If anyone hasn't seen this before, it's the rate at which the FDA gives out NEW approvals for Covid tests (not reissues). You'll notice they had a bit of a break over winter. But since the $50bn Covid testing sign-off in March, the EUA approval rate does seem to be picking up. Remember I've filtered out the reissues - so just showing new EUAs.