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"MB, I really hope you are right in your theory. I think the government has been slow to react to the importance of what diagnostic companies can offer.
I think there should be something set up to help and bridge the gap between the diagnostics firms and the health authorities, enabling a clearer route to market and allowing for a better engagement with the relevant body.
There just seems to be too much bureaucracy going on within the health authorities of the U.K., it appears to hinder things when instead the best cause of action Would be to act.
My biggest issue is with the MHRA and their perceived lack of urgency. Maybe something needs to be done to change things there to make decisions speedier, someone on this board might be able to shed some light there..?"
This *is not* a health authority issue.
This *is not* an MHRA issue.
This *is* a Westminster government issue.
The MHRA have prioritised the approval of experimental products I’ve been involved in. “Next day” for some.
The antibody test isn’t the same as a potential life saving new therapy but it has massive implications when we get approval politically.
MB, I really hope you are right in your theory. I think the government has been slow to react to the importance of what diagnostic companies can offer.
I think there should be something set up to help and bridge the gap between the diagnostics firms and the health authorities, enabling a clearer route to market and allowing for a better engagement with the relevant body.
There just seems to be too much bureaucracy going on within the health authorities of the U.K., it appears to hinder things when instead the best cause of action Would be to act.
My biggest issue is with the MHRA and their perceived lack of urgency. Maybe something needs to be done to change things there to make decisions speedier, someone on this board might be able to shed some light there..?
"Aside from the immediate covid testing opportunity, this pandemic will transform the UK diagnostics industry from a handful of small niche businesses into a large nationwide powerhouse. These covid test will pay for the next generation of tests and fuel m&a to strengthen the industry."
I sincerely hope that this is the case...
...but i fear other issues may scupper the transformation over the next few years.
Aside from the immediate covid testing opportunity, this pandemic will transform the UK diagnostics industry from a handful of small niche businesses into a large nationwide powerhouse. These covid test will pay for the next generation of tests and fuel m&a to strengthen the industry.
Thanks for that knowledge Regulator.
It is, it just needs the MHRA approval and then we are away.
It is for professional use/settings.
Just waiting for home use approval.
Sorry if this is common knowledge - I'm still catching up. This CIGA page says the UK-RTC AbC-19 is now available for commercial distribution.
https://www.suresignprofessional.com/
Thanks chaps I’m getting a bit punch drunk with it all I need a holiday gla
beat me to it Regulator! :)
"I wonder what sort of reply would be received if a similar email was sent to the Odx marketing department"
ODX won't be marketing the the UK-RTC test in the UK. CIGA are the official distributor on behalf of the consortium.
I wonder what sort of reply would be received if a similar email was sent to the Odx marketing department
"Thanks Maylands. More great info. Thought occurs to me on the antibody/antigen debate. At the minute people are waiting 5-7 days for lab results. Antigen home test looks as if will be delayed for some time if ever it reaches required sensitivity. Meantime, if the antibodies appear at 4/5 days, why bother with an antigen test.....just wait the 4/5 days for a negative/positive antibody test. Saves huge amount of lab expense."
Because it not that straightforward.
There are different antibodies that start to appear at different times. The first to appear are IgM. These can begin to appear from Day 1 of an infection. However, they may not be measurable until much later, depending on the individual.
IgG don't appear until about Day 10 - Day 14.
So if you have any antibody test that includes IgM it might give you an early indication of an active infection - but the most reliable way, at the moment. remains molecular testing. The next best would be antigen testing, as as when that can be reliably scaled up.
Crikey, that's a bit steep, MOQ of 200.
Avizandum1, correct. Adding IgM makes it into a hybrid test. If lab capacity is going to get stretched even more, the solution will be to self isolate & take this test on day 5-7 from symptom onset. It's the only reason to add IgM surely? Am i right in also thinking samples that are currently sent to labs are perishable?
I'm sure Han**** on TV this morning . Wonder if he going to say anything about testing .The government needs to do something as they are at a low point at moment
Avizandum1 I must admit I have been thinking this too
If you need to isolate for whatever reason - return from holiday, symptoms showing etc - then on day 4 you can take a test and potentially be released.
I think Maryland’s info and thank him/her for it is priceless and as informative as the deleted bbi tweet
@Maylands - awesome info.
Thanks Maylands. More great info. Thought occurs to me on the antibody/antigen debate. At the minute people are waiting 5-7 days for lab results. Antigen home test looks as if will be delayed for some time if ever it reaches required sensitivity. Meantime, if the antibodies appear at 4/5 days, why bother with an antigen test.....just wait the 4/5 days for a negative/positive antibody test. Saves huge amount of lab expense.
Maylands - thank you
Cheers
My company sells bits and pieces to dentists. I contacted CIGA healthcare (official reseller for the product)
I'll copy parts of the response to my enquiry to buy below:
"The tests we have available are professional use only antibody tests, does this meet your requirements? How many tests do you require?
In October we will have a new product available, the ABC Covid-19 IgG/IgM antibody test, initially this will be for Professional use only but is due to be CE marked for patient self test by the end of 2020.
This test is the development of a UK based consortium which was set up by the UK government in order to produce a very sensitive antibody test, this has been achieved with a sensitivity of 98.6% and the UK government will be taking the first manufacture this month. I will get back to you as soon as possible with stocks of our current product and prices."
Next message:
"That will be available for general sale in October, price should be in the region of £13.00 per test but yet to be finalised. MOQ will be 200 tests. I will put you on my list of accounts wanting the test and I will get back to you as soon as it becomes available."
Obviously these are reseller prices with their margin added.
Share price will fluctuate between 84-90 until substantive news drops. My advice would be to look at the 5 day graph and don't obsess with the daily peaks and troughs.
Hope this helps. Maylands
Colin definitely said they could only sell privately once the UKGOV order was in so I think we will have an exciting 4 weeks now!
Fabulous stuff we are in production and on sale all be it within the confines of the consortium via abc19.com we really need to know how this works I feel it kind of may point to the govt not being our no1 customer but that doesn’t phase me at all think we need info from Odx on how the consortium is set up regarding proportions etc