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"Footballers given green light to tackle"
'Team sports have been granted permission to resume full contact training, even if they do not have a coronavirus testing process in place. While Premier League footballers have already begun twice-weekly tests for their players and staff, at a cost of £4million, a similar programme is not a requirement in the new government guidance for elite sports. Step two of the guidance is published today and will allow tackling and one-on-one sparring in combat sports'.
Source -Telegraph front page 25/5/20.
Agree- a nice commentary.
ACE2 receptors are widely distributed in the body. Angiotensin-Converting Enzyme receptors. As the article says they are the means via which covid-19 virus enters a cell.
They are present in small blood vessel lining cells, and via the enzyme above they are an important part of control of your blood pressure.
ACE inhibitor drugs (their various names end in "-pril" generally) are a commonly used medication for BP control - I take one of them. Angiotensin-receptor blockers are also often used (ARB's).
There has been some debate whether these drugs could have an effect on covid-19 infections or not.
The Covid-19 Symptom Study (I think about 3 million take part in this in the UK via an app) suggests, reassuringly, that they have little/no effect. If there is a small change, it is that they might even lessen the severity of infection.
Having read the template,, and re-read it again, I am mightily reassured that for an EUA it is not necessary to recruit hordes of positive patients to donate samples. Very few in fact.
I'm quite surprised, & I must say, relieved!
I've spent some time wading around the FDA website looking at guidance for antigen test submission.
Eventually found this-!
"Antigen Template for Manufacturers"
If you're interested access this via this link :
https://tinyurl.com/wu8anl2
... and see under 'Antigen Template for Manufacturers (May 11,2020)'
Happy reading! May look for an equivalent guidance document for CE submission tomorrow unless someone else beats me to it!
I have wondered about that for a few days now. It is good news of course that the numbers getting covid-19 are declining quite quickly now it seems, but it does make the conduct of trials (such as Avacta will need to do) an issue potentially.
I referred to this in a way in my last post when I said I hoped Avacta/Cytiva had lined up trial centres already to utilise next month.
Would we if necessary be able to organise the first patient studies in more distant "hot-spots" like S America for example?
Abraham21 - 20:28 : "The fact it takes several weeks to even produce a prototype device (that then after that still needs to be tested and validated at scale) suggest it’s not as cut as dry as people on here are implying."
I agree that it still needs to be 'tested and validated at scale'.
We do need to remember that it is Joe Public who will be a one of the main user groups of the LFT. So not trained professionals in a professional environment. Approval by the regulators will therefore be appropriately demanding in terms of test robustness. Rest assured however simple the test seems, if there is something that can wrong with its use then Joe Public will unearth it! The authorities will be well aware of that and their procedures and requirements will reflect that.
Also, I hope that in anticipation of a positive outcome technically of the current development work being done by Cytiva/Avacta that arrangements are well in hand for recruitment of trial centres with a flow of patients ready to be tested.
I imagine they are.
These centres may well have to get approval from their Ethics Committees, despite the fact that sample acquisition is pretty non-invasive. Such are the regulations these days.
Having said that, we are all quite confident that all will be well in the end. I do think Myles's estimate that Avacta could be "commencing commercial production in July" is feasible, but optimistic.
Here's hoping!!
Probability rapid covid-19 test is successfully released to mass demand: 50%
- Average price per test sold (bearing in mind bulk orders may be heavily discounted): £15
- Cost of manufacturing per test: £6
- Other costs per test e.g. distribution, admin: £2
- Avacta % of profit share with Medusa19: 35%
- Number of months of mass demand: 9
- Average # sold per month of mass demand: 150m
Interested to see the final summary, CautiousOptimitist - thx for doing this.
The biggest hurdle is no 1 in your list - probability of a successful release. Life is full of surprises - good and bad. It was Macmillan who was once asked by a reporter "What, Prime Minister, do you fear most in the future?" (or similar words) - to which he replied "Events dear boy, events".
I have every hope and expectation for my Avacta investment of course, and every confidence, and I speak as a ex-scientist & medic. But there are persisting doubts of course until we arrive! I worry for folk who talk about early retirement, paying off mortgages, Ferraris and lambo's etc, perhaps not so much for them as many speak in just I think, but for others they may well influence.
Roll on Tuesday, but meantime enjoy a relaxing w/e peeps!
I guess others here like me are reporting daily for this study using the 'Zoe' COVID Symptom Study app. It is being conducted at Kings College Hosp. London by Prof Tim Spector. They produce a regular webinar and this is the latest one:
https://www.youtube.com/watch?v=rEnwcU8beew&feature=youtu.be
It concentrates this time on risk factors for covid-19. About 55 mins duration. I put it up here as you might find time during this quieter long weekend to watch this interesting presentation.
I think it's 2 to 3 million who contribute daily to the app at the moment, in England. It is now also being used in Sweden.
The discussion on "risk factors" in this webinar is perhaps not immediately relevant to Avacta, but one interesting fact is that their very recent data suggest that in England just now there are about 10,000 new cases of covid-19 every day.
I am not aware of what field studies Avacta/Cytiva are, or will be, carrying out for submission to the regulatory authorities to get the Lateral Flow ST approved, or where these are to be done. But that's how many cases per day there are here in England to go at the moment.
They still want more volunteers to register (free) and contribute to the app. So do it if you're interested!
I think he was talking about antigen tests. How soon after you have acquired the virus an antigen test will pick it up depends on the sensitivity of the antigen test used, and the adequacy of the sample used of course.
Sorry "to butt in" rh619, but I think there is no doubt that specificity is over 99%, and is very likely 100%.
Sensitivity needs to be over 98%, ideally over 99%.
Personally, I have little doubt that our affimer(s) will meet these criteria. Which is why I am fully invested here.
Perhaps it will be that the formal start of TTT occurs before the availability of our antigen test, but hopefully not long before.
It would be great for AVCT commercially if the testing aspect was possible with our POC test though, would it not?
Launch both simultaneously?
"Boohoo founders swap the catwalk for antibody [sic] tests".
A company set up by the founders of online fashion firm Boohoo has secured a deal to sell coronavirus tests to the public.
Medusa19 will hand out saliva testing kits aimed at telling buyers within minutes if they already had covid-19 and are therefore likely to be immune [sicc!!].
The firm – set up by Boohoo co-founders Mahmud Kamani and Richard Hughes – has exclusive rights to distribute kits made by the AIM-listed biotechnology business Avacta Group.
Mr Kamani. whose son Umar is a shareholder in Avacta, stepped down as chief executive of Boohoo last year to become executive chairman of the company he founded with Mr Hughes and daughter Carol Kane in 2006, according to the Sunday Times Rich List.
Medusa19 will initially offer home testing to consumers, but also hopes to sell kits to businesses so they can test their workforce.
Mr Kamani and Mr Hughes said the test was potentially groundbreaking, adding that it could be used in airports, offices, factories and at home with no need for medical supervision.
The pair will receive a share of the profits generated from sales of the tests as part of the deal. Mr Kamani and Mr Hughes said: “We immediately recognise the global opportunity to distribute the simple and unique saliva-based Covid-19 rapid test being developed by Avacta.
“The enormous worldwide demand for these tests requires a robust and scalable platform which we are in the process of creating. Hundreds of millions of tests are required and this demand will continue”.
Alastair Smith, the chief executive of Avacta, said: :”The potential size of this market and the expected demand from businesses for workforce screening is substantial.
“I expect the commercial impact of this partnership to be very significant to Avacta”.
Mr Hughes, whose wife is also a shareholder in Avacta, is the founder of investment bank Zeus Capital, which recently coordinated a share placing with investors to raise £200m for Boohoo.
The fashion company is planning to spend the funds raised on a buying spree of rival retailers.
PL75
I subscribe to the Telegraph so I'll see if I can get the text. But I agree sloppy title by the author of the piece - I have emailed her about that. We might get a correction later, or in tomorrow's paper ideally!