Ryan Mee, CEO of Fulcrum Metals, reviews FY23 and progress on the Gold Tailings Hub in Canada. Watch the video here.
https://www.cambridgenetwork.co.uk/news/avacta-provides-update-affimer-therapy-covid-19-infection
This is our inhibitor therapy, recommendation made by Prof David Bhella of Glasgow university never taken up by any of the big guns.
" Given the excellent performance of these novel reagents and the other benefits of Affimer reagents there should be CONSIDERABLE interest from potential partners in developing them as a therapy for Cov19."
GSK /VIR have developed the Sotrovimab Antibody based therapy and the Yanks bought 450,000 doses for one billion$.
Several other big guns like Roche have their own Antibody therapy on the go.
Guess what they all attach themselves to the S protein preventing the virus entering the human cell. Sound familiar.
Now if we had a reagent that binds better than a big bulky mAb that would be something. It would be an investors dream !!! They say vaccines and therapies are the way ahead, big profit margins. GSK / VIR are charging 1500 -2000 $ a dose,
Excellent post, consolidated my opinion on the Affimer v Antibody comparison, blew them out the water once again.
Couple of surprises, when she informed the guests a Company called Avct had the commercial rights to Affimers. We are so far under the radar it's unbelievable.
Secondly she was using Affimers with the permission of Avct and they only had one downfall. Leeds University were not keen on using them because there was no financial gain for them. Great product no end game, maybe sour grapes after discovering Affimers only to lose out on their huge potential.
The CTDA; OVERVIEW OF THE PROCESS states;
The Desk - Top review is a systematic assessment of the evidence submitted by a supplier against minimum required data set.
"The purpose of this step is to prevent tests that are below the expected standards from progressing to a TECHNICAL VALIDATION IN A LABORATORY"
This Technical Validation is set out in following Protocol.
https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/protocol-for-evaluation-of-rapid-diagnostic-assays-for-specific-sars-cov-2-antigens-lateral-flow-devices
This to my knowledge this is the step by step process in Evaluating all LFDs.
So why do so many keep referring to the DT review as being the only step required to obtain HUA from the DHSC.
If I am missing something here please provide some evidence this is not the correct procedure being followed.
The Protocol above advances the LFD being evaluated into Phase 2 & 3 of the procedure, the DT review being Phase 1.
If the LFD progresses into Phase 3 the manufacturer has to supply a minimum of 5000 tests for review. As stated yesterday from December the UKHSA will provide pharmacies with 15 packages each containing a LFD & PCR test spread over 3000 supply outlets. Purpose to initiate a mass evaluation exercise over a 3-4 week period. In total 45,000 LFDs, imo or 8 or 9 different tests. All of which passed Phase 3 of the evaluation process and were instructed to supply 5000 tests each in order to carry out this UKHSA evaluation.
IMO the Desk Top review was passed months ago and we are waiting on the results of the UKHSA evaluation in order to confirm the DHSC / PD evaluation results carried out in Phase3 of the testing protocol
I find saying we are waiting on the DT review is mis- leading and find it hard to imagine the UKHSA would be sending out large numbers of different tests all based on a DT review. Proof of being fit for purpose can only be verified by Lab / Public testing. Anyone can produce or exaggerate their test results on paper, has it not been attempted before.
I stand to be corrected. If correct in 3 - 4 weeks Avct will be officially recognised as a top quality LFD. The DHSC / PD will also have to admit they got it wrong.
https://psnc.org.uk/our-news/evaluation-of-lfd-tests/
The UKHSA will from DEC issue pharmacies with packages containing an LFD and a PCR test. 15 packages each x 3000 outlets. Appears to be a mass evaluation exercise for LFDs, which ones who can tell.
You would imagine the tests with the highest S&S results would figure !!!
Timster, exactly what is your definition of the Desk - Top review. Mines is , it is completed when the DHSC oversight group has agreed the information supplied by the manufacturer of the LFD. In other words claimed performance and IFU to identify tests to be short listed for Phase 2&3 testing at PD.
Does that meet your understanding of the DT review or are you stating there is no testing procedure in place and the official meaning of the DT review is what we are waiting for.
Clarification would be appreciated.
MeduFlow claim the LFD is a combination of Affimers + Abs, " Unique technology using synthetic Antibodies to create more binding sites for the virus leading to industry topping S&S.
The claim industry topping S&S is the statement that bothers me, I was under the impression using only Affimers we had results beating the MeduFlow claim.
Was it not reported the LFD had 100% S&S results at < Ct 28 from a trial conducted in Spain, why would we need Abs.
Clarification required, are we using a combination of reagents or not. MeduFlow claim we are.
Dated 11th Nov 2021 ; " Rapid scale up of GADs manufacturing facilities has also been assisted with funding from the UK GOV. GAD is focusing it's initial production capabilities on tests for Covid 19 and was recently contracted by the DHSC to manufacture LFTs at large numbers as part of the UK Gov plan to encourage people without symptoms to self test."
GAD / Mologic design, assist Avct in achieving CE Mark and manufacture LFD for professional use, test is top quality.
Avct seek HUA via new Protocol of Evaluation at PD. In hand from 1st Sept. deadline, over 70 days into the process.
Logic dictates, it's only a matter of time before HUA is granted, PD cannot be that stupid. Luvvly Jubbly.
The EU over ruled a law prohibiting subsidised products entering their market place. The pandemic being the over riding factor they allowed Chinese LFDs to flood the market. In the UK it was business as usual and fair play was out the window, just keep on shooting ourselves in the foot. Result we become dependant on cheap poor quality products from abroad and British industry melts like the Artic glaziers.
The UK jump first and Innova LFDs are snapped up so much so nobody else gets a sniff. The EU go for Flowflex their choice of Chinese tests in the interest of Public Health. The super efficient Germans obtain HUA for the Flowflex test in a matter of months. We give EUA to which ever test is the flavour of the month, or whoever decides not to cheat the system. In the interest of Public Health.
Where is the interest in the Public Health when a LFD is classed not fit for purpose when in fact it is one of the best fit for purpose.
In the interest of Public Health Innova's 60% Sensitivity at < Ct 28 allows 40 people in every 100 to walk around spreading the virus. We have known for months Avacta's LFD eliminates such a pathetic performance.
In the interest of Public Health we need PD to get their finger out, say they were wrong and validate our test.
One point interest imo, Avacta has created the foundation on which to build the next generation of Diagnostic products all in the interest of Public Health.
For those all Aquiver
Icecool, BIVDA the National Industry Association for Manufacture & Distribution of IVD Products also criticised the new Protocol of Evaluation. The Government basically asked for feedback on this new validation and it looks like they ignored the concerns raised by both Organisations.
A point of note was the delay this would inflict on Companies, which is proving to be spot on. The Protocol states a 20 day response time for results, it's now over 70 days and counting since Avct submitted their application.
The only good point we can take out of this shambles is, sample type was discussed and it would appear clinical samples will replace the artificial ones. Explains why we entered the validation process, Affimers love clinical samples so when PD eventually get round to pulling their finger out they can officially report they were wrong.
Read this the other day, so much for the 20 day turn around forecast. Did however say the DHSC will keep you updated on your applications progress.
Interestingly in the RNS it states LFD suspended until the ongoing Desk Top evaluation of the test has been successfully completed by the agency and the test is put on the CTDA register. A very confident statement from Avacta implying imo PD will not make the same mistake second time around.
The excellent clinical performance should be demonstrated this time around. No more artificial samples only clinical samples to be used. Unfortunately 9 months down the line PD will almost certainly have to register the LFD and display its excellent performance levels. What if.
It appears PD has change tact in their LFD "Protocol For Evaluation of Rapid Diagnostic Assays For Specific Sars-Cov-2 Antigens."
Original Phase 3 validation samples were ARTIFICIAL, a point raised by Avacta way back in February.
New Phase 3 validation samples to be sourced by Oxford University Hospitals.
1000 true Negative, 200 true positive.
Negative will be fresh, Positive frozen. The following statement is then made.
" This following recent work at PD to support the development of this Protocol which found there to be no discernible difference in performance when using frozen samples."
Will / have Avacta applied, I hope they have to stop all this, they failed PD validation We would be the best British LFD on their list.
Luvvly Jubbly.
LumiraDX Ltd receive Nasdaq listing and opened up at $10 a share, fell back slightly now around $8.
Small POC Diagnostic Company based in Stirling seeking EUA from the FDA for their Covid test.
Not a LFD, needs a machine to deliver very accurate tests.
Relevance; Demonstrates the need to be listed on Nasdaq and leave this cesspit.
Lets be clear the PD assessment of the LFD was a farce, do you honestly think the Government would contest any legislation brought against them in this matter. They have been proved wrong, mistakes were made however in the middle of a pandemic Avacta got on with it.
The aim of this list is too inform the public which LFDs work and to what degree. The cost imo will play a small part in peoples decision as the differential in many cases will be small. Quality always sells and if the Government were stupid enough to exclude the Avacta LFD any legislation would be settled out of court. The lawyers are not that stupid.
In the end the CEO has said we have one chance at this and the result is outstanding. The reputation of producing a top quality product using a new technology paves the way for riches far in excess of any LFD delay to the market imo.
Interesting statement, he said in relation to producing a reliable Diagnostic Assay for future pandemics, Monoclonal Antibodies are NOT good enough. He must be very confident Affimers outperform Antibodies and will dominate the Diagnostic market in the future.
The reference to how virus samples provided by suppliers displayed significant variation explains why delays were inevitable in the early stage of developing the LFD.
In future standardised samples need to be provided to Company Assay developers was what the man said. Avacta from the start produced an Affimer with excellent binding properties to the spike protein however PD did not provide virus samples fit for purpose. More delays.
Why produce a Rolls Royce car and test it in a loch only to report it is not fit for purpose , it sank. RR respond, send it to a top EU test track, result it didn't sink and drove like a dream.
Very informative gadgie, cheers.
Their annual manufacturing capacity for LFDs in 2021 was reported to be in the region of 150 million. Vatic Know How claim they have signed an agreement with ABDX to produce 70 - 100 million tests per annum. This leaves 50 - 80 million spare capacity.
Avacta has a superior test in terms of S&S results, Vatic claiming a Sensitivity of 95.6 % and a Specificity of 100% with a LoD in the range of 500pfu/ml or Ct < 25.
If all goes well with TT AVCT appear to have around a 50/50 manufacturing capacity with Vatic approx 6 .5 million tests per month.
Vatic has already started their advertising campaign claiming their test is more Sensitive than OTHER Rapid Antigen tests available.
The need for clarity on LFD performance is now a priority, with TT so close why would ABDX pledge around 50% of their LFD capacity on an inferior test, or will orders drive who gets the lions share.