The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
It is my understanding all LFDs need to go through this process in order to be listed as an acceptable LFD and placed on a register of tests. Non compliance negates the right to be sold legally in the UK.
The validation process is to be conducted at PD in three separate Phases, any test already validated at PD is exempt from this protocol.
In phase 2 saliva samples spiked with the virus and diluted to give solutions of 1 million down to 100 pfu/ ml are to be used. Negative samples from 71 different individuals are also used.
Avacta initially reported in the early stages of developing the LFD they had excellent results at a reading of 390 pfu / ml equivalent to around Ct < 25. This was then reduced to 50 pfu / ml at a later stage producing a Sensitivity of 100% at Ct < 27.
These results indicate a progress into phase 3 testing should be a formality.
Phase 3 requires 4000 kits to be supplied testing 1000 true negatives and 200 true positives. The negatives will be fresh samples, the positives frozen samples. A declaration stating following recent work at PD to support this Protocol which found there to be no discernible difference in performance when using frozen samples.
Are Avacta in agreement with this Protocol procedure for phase 3.
In there declaration PD has claimed using frozen positive samples achieves a fair result to both types of tests ( N&S )
Does using frozen positive samples discriminate against our type of test?
From past experience the Government record in complying with legal procedures is abysmal. Do we fly through with flying colours or sue the clowns for discrimination.
Blinkers are applied too increase the focus on a single objective. Remove the blinkers and behold all is revealed. Avacta's third party licensing / research agreements with multiple companies will provide royalty revenues and become a major income stream for the company on its own.
No justification imo for the SP too fall any further, except too satisfy the greed culture of the parasites in the City. Multiple deals in the pipeline with a product that works.
I updated him recently about the scandalous treatment British companies have received in getting their LFDs to market. HE has been highly critical of the Innova test and the procurement procedure adopted by the Government.
His response was ; " I have reflected on your e-mail and will look to put down some Parliamentary written questions to highlight the points you made. I hope to sponsor an event which will take place in Westminster in the coming month in order to raise the profile and visibility of these issues."
Having named Avacta as one of the companies involved in this fiasco there is a fair chance we will get a mention when he forwards his questions. A bit of name dropping too enhance the Avacta profile.
Googled it , read it and came to a simple conclusion. The American plan on the Therapeutic / Diagnostic side can be improved. Reason; The binder used too develop the inhibitor / rapid test is a Monoclonal Antibody. The Affimer has without doubt proved it has several advantages over Antibodies making it a very competitive alternative.
So when will the penny drop, Avacta can produce high quality, high volume cheap Affimers within weeks of sighting the target. It can be modified quickly to combat mutation changes and has excellent batch to batch consistency. Vast sums of money will now be be invested in similar projects around the World.
America will spend 65 billion $ on this plan and considering covid has cost them 16 trillion $ so far this has to be a very wise investment. Exciting times ahead for AVACTA.
A total investment of 65 billion $ set against a cost of 16 Trillion $ too fight the covid virus. A very small investment for a very large potential return.
Orient Gene do not have to apply on the grounds it passed the PD validation process and it would be a waste of time repeating the procedure. Their LFD uses antibodies as the reagent and it is well documented they have batch to batch variation issues. This being the case is it a good idea to exclude their test from the DHSC Test Approval process.
We tend too forget Avacta are in line for massive payment milestone and royalty revenue from the likes of Daewoong, LG Chem and ADC Therapeutics. All three companies endorsing the performance of the Affimer technology by expanding their multi target collaboration agreements.
These companies are also targeting multiple cancer and stem cell treatments.
Googled the above on how too carry out the ACON Flowflex LFD packaged in a blue / white box or you could use a Orient Gene test in a green / white box. Appears Innova has been dumped and these two tests are the new Government choice.
ACON is an American company with manufacturing sites in China, Orient Gene also Chinese and at a guess both using the same Antibody reagent. As always the Yanks manage too sniff out a profit and lap dogs in the UK tag along at the heel.
China will be chipping in as usual too keep the cost down making it an unfair market place, from steel too LFDs. We legislate against forming an unfair market place and proceed too shoot ourselves once more in the foot.
The Delta outbreak in 14 Provinces in China was started in Nanjing, the virus spread among airport staff working on International and domestic flights. A Russian aircraft was the source and the incident went undetected for 10 days. China roll out mass testing of millions.
One incident undetected for 10 days and talk of lockdowns to prevent the spread. A grim reminder covid is here for the long term and testing is in its infancy. Good quality tests will be in demand for a very long time.
Tangential issues as you put it ND71 in this case is the way out of any future pandemic, much more important than a LFD. Testing is carried out when the virus prevalence is high. The technology capable of identifying hot spots prior to the infection rate taking hold has now been proven using Affimers.
Microtox PD installed into wastewater can monitor various pathogens using a single chip, readings taken every 15 mins rapidly detects potential hot spots days before the infection takes hold. Identify / Test / Isolate / result no need for lockdowns. Not wait for areas of concern too develop before testing is carried out.
Microtox PD can detect the virus down to PCR levels and below using Affimers and AI incorporated into the monitoring unit. LFDs test time 20 minutes, wastewater monitoring 4 seconds x 672 tests per week.
Superior not tangential and yet another money earner for Avacta, chips required to be changed every 4 weeks. Covid 19 , E.Coli , flu, and may more on one chip. Massive.
Avacta = Affimers = the best reagent in detecting the virus, a fact proven by all the validated tests out there. Roche the largest pharmaceutical in the World with billions to spend on R&D produce a LFD for covid and don't even get a mention. Lets put that right, their test is inferior to ours, why because they can't use our golden nuggets.
If Roche cannot compete who can, we are sitting on a gold mine, remove the blinkers and improve your vision of a Company with a great future. How do remain top dog, use the best, what did AS say about being the next Roche.
Missed what boat, we are building a bigger one.
Mologic used Aptamer group too supply their reagent in the LFD , they know by the LFD test results Aptamers are second best. Why would they want to use second best. Mologic will make a profit from the rich Countries supplying Diagnostic products, in turn this will subsidise their non profit making venture. Logically Avacta will provide Affimers to both sides of the Company.
Big numbers here Neutronic, early pandemic PCR testing was 300,000 a day, Deeks predicts 660,000 a day will be required if the infection rate reaches 100,000 a day. We could possibly reach this number of infections over the coming months. Less Lab capacity than before, could be an extra 400,000 a day tests required.
Bams 1000 x no of machines installed in hospitals, a quicker, cheaper test carried out by a technician . Can Adeptrix supply the number of tests required that is the question. Millions a month required.
FACT: Avacta now has the most potent reagent in the multi billion pound Diagnostic market. Antibodies and Aptamers are second and third best, what an endorsement for the products they are used in. All the big hitters will be using inferior binding agents a fact not factored into the SP imo.
In short the Affimer will dominate the Diagnostic market, nobody wants silver or bronze when gold is available. So why all the negativity, we are sitting on a gold mine, keep digging.
Along with Innova passed Phase 3a trials at PD using spiked samples. Innova Sensitivity for Ct 28-31 was 76% and Orient Gene 78%. If they are advertising a Sensitivity greater than these figures it has to be Ct < 25. If not they produced a cracking batch of reagent for their validation. I assume their CV was carried out in China, say no more.
Getting better and better up to Ct < 29 now, I wonder if Deeks will comment. A great tactic, keep raising the bar and blowing the opposition out the water. We don't have too mention any names, it's the inferior ones.
That 60% was a guess, not everybody returned a PCR test and someone asked a good question. How many of the other four found to be positive by PCR were infectious. For a man driven by numbers a guess and failing to identify the infectious does him no favours.
He did produce one genuine fact, if a better test had been used the infectious in the four identified would have been found. Pity he didn't mention the best test that would have doubled his factual statements.
He won't mention Avacta by name because of the number of people tested in the CV trial. Stickler for those numbers once again.
Spain are desperate to reignite tourism, they validated our test and know how good it is, unlike many. Applying for Special Approval for self testing is imo a no brainer for them. Individual EU countries can apply through their respective medical authorities. In our case the MHRA, in Germany TUV SUD, why would Spain sit on a test when they have the opportunity too open their tourist trade.