Member Info for JimiHendrix

Cake is getting bigger maestro! New cases worldwide have nearly doubled over the last 30 days, from approx 400k to 800k.

There are no guarantees in life Maestro :)

However most people are confident we will have material sales with the EUA, and imo there's a high chance we'll see material sales in Europe soon too. Let's see how things pan out over the next couple of weeks!

Ah regulatory approval for the RT-PCR Covid test is also needed. Coming soon I'm sure, new cases in India are at all time highs and DIVOC are one of the few laboratories in India that has been able to secure NABL accreditation.

I got the impression they were doing everything they can but because the Indian regulatory people kept coming back and asking for more information, and then the delays between communication, that they were simply frustrated with the process and unable to see if this was ever going to happen. But looking at Divoc's site it certainly looks as though regulatory approval has been granted at last. It's unclear whether it's needs to be granted for the test kit also however they're clearly marketing the Genedrive kit all over their site as the PCR test they're using.

Interesting... it sounds as though it's just the lab that they were waiting for... this is the first time I've seen that they have obtained regulatory clearance.

Previously just this... "DIVOC has applied for regulatory clearance in India. The Indian regulatory process has recently been amended and now requires successful performance evaluation by the Indian Council of Medical Research, which DIVOC is pursuing. The Company is optimistic that India registration could be obtained. DIVOC is also working on healthcare delivery models that will enable quality healthcare to be delivered through technology."

Now... "We have received NABL certification to run molecular biology testing in our lab and have ICMR permission for running RT PCR COVID 19 testing." ...I think some other parts of the site are new too, I don't remember seeing the test kit page all about Genedrive last time I looked.

Nice to see Maestro's thread has been removed lol :)

Well Beckman Coulter are now distributors and have started marketing towards Western European countries. It's reasonable to assume a company of their status, scale, reputation and experience will probably have some success selling the test kit! :)

They won't be popping out of nowhere either, a lot of work will have gone on and will continue to go on behind the scenes :)

With the Southern hemisphere coming towards winter now, I can imagine the COVID situation getting even more dificult in the cooler regions of South America, Australasia...SA etc.

Well spotted Rambo. Hopefully Genedrive’s will be imminent, something is definitely happening in the background having just seen and read the email from Beckman Coulter promoting the Genedrive kit.

There is also the fact that global new cases are still rising, most countries have an upward trend in new cases over the recent days and weeks. With the South African variant and issues with vacines on top, I defintely don't think Genedrive are too late. EUA approvals are coming through daily, so evidently they are needed.

Remove the #umbrella-molecular sorry... https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2

Yes, the rarely updated list still shows Beckman Coulter Access SARS-CoV-2 Antigen as not having EUA approval.

This is the best... https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2#umbrella-molecular

PerkinElmer latest PCR with EUA approval showing 12th April, though we know there was another yesterday. Seems like daily approvals now ...GDR should be soon (if not already, BC still show the EUA filter).

Preefty, this one shows approvals and updates going through with usually a 1 day delay. The dates in the left column are updates but the 3rd column shows the date of approval. Seems to be one approved every 1 or 2 days now.
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2#individual-molecular

In the real world this home PCR test still relies on the average Joe who is medically unskilled and inexperienced not to contaminate the liquid or swab, accuracy will turn out lower than Genedrive's PCR test.

https://seekingalpha.com/news/3681027-fda-issues-eua-for-luciras-at-home-covid-19-test

It's a good product but it isn't going to replace labs that's for sure.

How do you know there is a massive backlog? Do you have a link with a list that is kept up to date that shows all the applications waiting?

I'd expect Genedrive to be pretty close to the top considering they applied about 11 months ago, that is if one of their tests hasn't already been reviewed :)

PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit

There is no doubt the frequency of approvals has increased over the past few weeks.

Also rollover trades are usually arranged to go through exactly the same time, though there are 10 seconds between these 2.

It looks like 2 separate buys to me, as if it was some kind of transfer from one account to another the first trade would have been at the sell price. Both trades were at the buy price, second higher because it pushed the price up IMO. Would surely be too much to be a bed and ISA, as would only get the tax free benefits on a tiny amount of it... can't see much advantage in doing that. We'll see... maybe there will be a TR1.

30 people confirmed with South African variant in South London.....surge testing to be carried out with pcr tests.

It's also interesting that the Genedrive kit that has the EUA tag on BC's website (Fast Plate format) is the one that was verified for use on the Applied Biosystems 7500 Real-time PCR series (the same as the Thermo Fisher kit that's received EUA today).