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Surplus tests to sovereign use I understood will be available for us to brand label using the capacity not required which leads me to think AffiDX was picked by HMG. Without the early results from Wetherby last year and the desire to beat covid being an imperative the government push to build a consortium of manufacturers would never have happened. AVCT has had to become a test proprietor to fulfil a consortium produced sovereign test so the government can produce the correct documents if you like. This is what the achievement has been; becoming a test developer and outsourcing manufacturer from a position of just being an affimer reagent/affimer licencing company in just over a year. It has been a tough year for AS and the Government but I think it won't be long now.

Basically the LFT is almost done/as good as done/on the final run in with no more hurdles. Just need McNulty and Hill to boost the SP.

The CE mark will then be transferred to Avacta when it achieves ISO13485 accreditation, which is expected early in May 2021.

From today's prelims

ISO is required first for the sovereign test to be supplied by us- a legal requirement.

AffiDX® SARS-CoV-2 Lateral Flow Rapid Antigen Test for potential mass deployment
This section of the Preliminary Results stresses the ISO and hold up due to a covid case at Wetherby. I think the significance of ISO was initially underestimated by AS for the sovereign test to be called 'ours' and for the manufacturing partners to be be required to call the test AffiDX without AVCT actually having their own ISO accreditation for TT- tech transfer purposes. This makes a big difference to the commercial value to AVCT but I did not fully appreciate the importance of my comment in my 12/4 19.28 post.

That is a page out of my book Fardistanthills. Glad AS tested against Innova? and one other too as I suggested. Deeks's data defeated I would say on thse two points.

Excellent point Muller. I can understand kicking the covid while it is down and unlikely to have an unacceptable number of isolations.

manana but positioned for tomorrow.

https://mark-mabon.medium.com/well-enough-alone-the-case-for-natural-immunity-70c83a0de79d

I don't advocate delay I am pro any affimer test asap to feed data into the experiment. The risk element was in my calculations a long time ago as in fomo. The government has both helped and hindered. It has standardized a test and put us in the frame but both them and AS are chasing the impossible dream instead of allowing affimers to be openly validated in use.

It's all experimental and we are all participants hence why the gov is so keen on retrieving test results but let them at least be some of ours.

It has always had to be like brushing your teeth. A simple message for Whitty to understand but have I ever heard him say it?

no need to ringfence

The Government is playing it badly too as sidelining the market in favour of validating or not all tests put forward- they are giving themselves unecessary work.. Will all tests remain effective and they have sort of valdated Innova so the bar can't be too high. I remember a poster saying a major pharma got it's start from an innefective drug that regulators passed. I trust AVCT to alter their test as required as this is the sales pitch that affimers have so need to ring fence one particular LFT. The S&S one day may not be the same a month later.
I don't think there will be many tests to challenge ours but there is actually no need for prescribing test parameters as they will buy the best and the public can't, I imagine, passport with all tests, they will be approved ones. The Government is part of the market and will not buy tests to provide free eg for the NHS if they do not like the product.
When we get ISO we will be truly able to go it alone for ours and others tests and is potentially a very good move.
Good thing beheadings are no longer around as a show I can therefore avoid starring in.

jdt; the improvements to the test would be in response to the mutating virus. A narrow remit with covid can only be applied for the pandemic on a particular day and even that will be late. Affimers appear to be the quickest way to respond to mutations. A test can only be measured in use and the government thinks Innova is pretty good as does Mina but I think ours would be better for curbing spread in a test for back to normality in society (plus regular test) scenario.
Lockdowns are not an option and a whole year of affimer tests has been wasted imo.

jdt; that unfortunately is a failed procedure. It is precisely because I want to see affimers applied in myriad directions that the most simple of measures has to prove how good they are so get a test out there.

wherever AS

Affimers are specific and early to detect so a test out there will prove that point. Preferably saliva, wherever As can get it on the market. Speed is of the essence with this virus so address the imperative not the regulators narrow remit and then in the market you have a test you keep tweeking to improve it. The government have been bending the rules for CE marked tests so trained staff can oversee.

The right strategy would have been to get an antigen spike test on the market and selling with the data collected as per innova for a straight head to head. The proof is in the pudding not the regulators lab. Apparently it is the easiest thing to do unless you are AS. It does not matter about the S and S just what the test does in use. I believe in the affimer if it ever sees the light of day.

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