Member Info for Muck165

Thought this was an interesting conversation..

https://twitter.com/BigBiteNow/status/1382960524762222596

Well, it’s clear that The ESIA was a major piece of work/milestone, but there are other requirements, notably a local content plan, which are necessary before a licence can be granted. I haven’t seen much about this on here or from the company, although I readily admit I am still learning!

Any comment from you and other posters would therefore be helpful and appreciated.

https://www.standard.co.uk/news/uk/government-denies-plan-to-halt-rapid-coronavirus-testing-b929968.html

Not everyone’s cup of tea I admit, but this helped me understand the Tanzanian legal framework governing mining in Tanzania, and I thought others might find it useful.

https://thelawreviews.co.uk/title/the-mining-law-review/tanzania

Yep, struggle to make head nor tail of the reported trading activity.

I do wish the MM’s would make the spread more attractive though...

Not sure if this has been posted, but if not this appeared in the Daily Mail on Monday.

https://www.dailymail.co.uk/sport/sportsnews/article-9454175/Dont-Premier-League-EFL-want-Covid-passport-scheme-clubs-use.html

The nice bit for us is

"A crowd of 21,000 is expected at the showpiece at Wembley on May 15, and spectators will need to show a 'covid certification' to attend.

However, football and rugby fans could watch sport at full stadiums next season using a £20 antibody test they obtain from a local pharmacy that will prove they have immunity to Covid.

A consortium of UK companies, which have developed and manufacture the test, are already in talks with football and rugby organisations about using it to help sports grounds to return to full capacity, including large stadiums with 50,000-plus seats.

The UK Rapid Testing Consortium told Sportsmail the test can be administered at a pharmacy, takes around 20 minutes, with the results being uploaded to an app on a smartphone or 'chip and pin' photocard', which can be scanned on entry to the ground, alongside a supporters' ticket or season card.

They say the advantage of a antibody test for immunity is that it can be valid for months. An antigen test has to be taken in the days before an event, to prove a person does not have coronavirus. "

I found this a useful synopsis

https://www.bbnbigbitenow.com/post/armadale-capital-where-i-am-at

Sorry if already posted.

https://www.bbc.co.uk/news/health-56750460.amp

Posted this week by Cubed..

https://jobs.cubedresourcing.co.uk/vacancies/2124/software-engineer--developer-image-processing-ipr--deep-learning-cnn.html

Note they are recruiting for several of these, which possibly suggests good things for AppDx.

https://jobs.cubedresourcing.co.uk/vacancies/2307/health-and-safety-coordinator.html.

That’s at least 11 listings for ABDX through cubed since 12 March, many of which are for multiple roles in the same position. No way this isn’t happening for a reason...

Hope this helps Fardistanthills

https://polaris.brighterir.com/public/avacta/news/rns/story/w0l7mlw

Seems that way.

I wondered if it might explain why we are having two BSI audits, when the BSI offer a single audit option albeit that would limit the accreditation to just 5 jurisdictions. Probably not, but who knows...

This is taken from https://www.bsigroup.com/en-GB/medical-devices/our-services/iso-13485/

“ The Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device manufacturer's QMS which satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations (AO), such as BSI, authorized by the participating Regulatory Authorities (RA) to audit under MDSAP requirements.

MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.”

No doubt this has been posted already and I missed it, but if not then it appears Avacta have recently updated their trademarks list.

Here is the list as at 29 September, which was appearing at least until the beginning or March, when the last google archive snapshot was taken: https://web.archive.org/web/20210125093339/https://avacta.com/wp-content/uploads/2020/10/Avacta-Ltd-Registered-Trade-Marks-summary-29.09.2020.pdf

And here is the list now (updated 29 March) : https://avacta.com/about/ip/ (you just have to dowload the trademarks summary.

Looks to me like that I have applied to Trademark AffiDx, AffiRX, and PreCision under International and Madrid Protocols, to cover Australia, Brazil, Canada, China, EU, India, Japan, NZ, Singapore, South Korea and USA.

Potentially GLR, but I'm not getting too excited....

To get anywhere near the market this has to complete the trial, get good results, and then get authorisation - that is likely to take some time yet. And remember there are already companies out there with a saliva test - Vatic, Surescreen to name two, and by the time Sona have finished its likely I think that AVCT (and others) will have one as well.

Also I note this trial is a comparison against PCR on symptomatic people. Surely the best, and most commercial use for an LFT, particularly saliva based given the ease of sampling, is for use on the asymptomatic masses as a screening tool.

Currently the only test Sona can sell, for professional use only, is their NP swab test. That's not something the UK govt is interested in at all, the FDA de-prioritised Sona's EUA application, and even Health Canada don't seem interested.

It would be great if we could know for sure who ABDX has contracted to manufacture for (accepting we do know about AVCT).

Benharper - I’ve always wondered if 19 April is a key date given section 3.1 of https://docs.google.com/viewer?url=https://www.contractsfinder.service.gov.uk/Notice/Attachment/0e2237f3-e917-4957-9711-6de1c33be75d

I’d assumed this “start of significant manufacturing”, related only to sample collection consumables, but maybe not....

I’ve always liked BBN, and he’s just prepared this blog on ABDX

https://www.bbnbigbitenow.com/post/abingdon-health-some-key-thinking

Is it possible that we might use a dedicated web page to mkt the LFT? The affidx.com domain was sold a while ago if I recall..

My view...

- Govt funds initial testing stock and sets quality standards, all to get Covid under control pending vaccine completion.

Govt doesn’t want to keep funding long term, so wants an effective mkt that maintains quality at reasonable cost.

Govt expects business to buy from the mkt in future

Pt 3
“For example, only 25 per cent passed through all stages of DHSC lateral flow validation to be considered of sufficient quality for procurement.”

It warned that currently “tests are permitted to enter the market without going through the process of an independent validation of their performance and not all tests are performing to a sufficiently high standard.

“This is despite nine in 10 suppliers having the CE mark, with three-quarters meeting the ISO 13485 standard in relation to post market surveillance.

“Though we would expect the market to drive up quality in time, this is insufficient to meet our goals around managing Covid-19 and we need to rapidly increase quality in the private market to at least the same baseline as those procured for the NHS.”

The Department for Health and Social Care has been approached for comment.

Pt 2
Any changes could be introduced under the Medicines and Medical Devices Act 2021 before the end of this year, officials said.

A consultation document titled “Private Covid-19 testing validation” recommended tough action on inadequate kits saying: “Tests that fail this process would be barred from sale.

“Retailers, distributors and manufacturers of tests that attempt to sell unvalidated tests would face sanction.

“This will apply equally to those companies based in the UK and overseas who are importing into the UK.”

The consultation warned that “there is currently no legal requirement available for independent validation of Covid-19 tests performance.

“Entry to the market is controlled by CE marking which is currently a self-declaration process for the performance of this type of test kit or equipment.

“This means performance is not independently verified ahead of sale.”

It said: “Currently the data used by each manufacturer to achieve its CE marking is unique and designed by each manufacturer.

“This allows manufacturers to tailor their use cases to ensure the most optimal performance of their tests.

“This prevents consumers comparing the data and acts as a barrier to effective competition."

Officials had found “evidence that some Covid-19 tests do not perform as expected and as disclosed in their instructions for use (IFU)", the document said.

Pt 1

All private coronavirus tests will be subject to UK quality assurance checks, it has emerged as the Government admits too many are hitting the market that do not work properly.

Ministers have set out plans to ensure that all new tests meet “minimum performance standards” because as few as 25 per cent of privately-made lateral flow devices are "of sufficient quality for procurement".

The news comes after Number 10 announced that everyone in England will be offered twice-weekly Covid-19 tests as part of the push to “reclaim a more normal way of life”.

Lateral flow test kits, which can provide results in just three minutes, are available for free through workplaces, at testing sites and via the post from last Friday.

Under the plans, the Government will establish “a requirement that all Covid-19 tests placed on the UK market undergo a mandatory validation process”.