https://avacta.com/update-on-affimer-therapy-for-covid-19-infection/
Did nobody at AZN think this was worth a try, two years down the line and they are giving mAbs a go.
The days of the Affimer playing second fiddle are numbered imo.
Vaccines have arrived however they have many unknowns especially how long immunity would last. A neutralising therapy would be a better method of containing the virus. No more needles or organising mass vaccination centres, maybe a glass of water and a tablet is the way forward ?
Put a valuation on that.
wyndrum you constantly post the LFD failed which to my knowledge is not true. Failed, I assume you mean " to judge or be judged as being below the officially accepted standard required".
https://www.lse.co.uk/rns/AVCT/update-on-affidx-and-detection-of-omicron-variant-x2zwsj4vf49p42n.html
According to my interpretation of the above statement the LFD did not fail it worked effectively. Its standard did fall however if you are well above the official standard in the first place dropping back into the mediocre pack does not constitute a fail as you put it.
Avct can improve the standard of their test, the rest can only dream of doing so. When the dominant reagent in the Diagnostic market fails to produce the top product you have to wonder how long it will remain in top spot.
Failed, far from it imo.
The UK approved tests are poor quality and the majority were flung into the market without large scale studies of their performance being evaluated. Innova appear to be the only exception where large scale testing was carried out in Liverpool and the results were not convincing.
All UK approved tests detect the virus pre -Omicron at what is rated a high viral load. Much higher than the AffiDX LFD and therefore inferior in quality.
Omicron reduced sensitivity in the LFD at lower viral loads however sensitivity was retained at higher viral loads as stated in the RNS. Logic dictates presently the LFD is still superior in quality in detecting all known variants even with a flawed mAb present.
Not one approved test officially detects Omicron with no loss in sensitivity against Omicron, nobody knows. UKHSA /PD dilly dally around for 14 weeks evaluating the favoured tests and we still have no data proving these tests retain their original sensitivity figures.
AffiDX is the best test because we know sensitivity is reduced by Omicron and we are doing something about it. The remaining poor quality tests remain poor with the chance of becoming an embarrassment to PD.
At present the chances of carrying out an approved test and it detecting Omicron with no loss in sensitivity is 50 /50.
https://inews.co.uk/news/new-covid-variant-worse-than-omicron-likely-seasonal-peaks-1534740
The need for a top quality LFD still exists. Inferior tests based on flawed mAbs reagent cannot produce a quality test, a proven fact.
Affimers can and will imo. Millions required World wide for years to come.
https://www.bmj.com/content/376/bmj-2021-066871
Basically hammers Innova however all five Uk approved tests are validated to the same High Viral Load. Expose one and the rest all fall into the same category, crap.
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1042688/RA_Technical_Briefing_32_DRAFT_17_December_2021_2021_12_17.pdf
Real World Performance Monitoring Data from LFDs in Deployment gone missing after 3 months evaluation.
What if the UK approved LFDs do show a loss in sensitivity against the Omicron variant, what then.
Would the UKHSA / PD have the balls to release the data, what an embarrassment.
SILENCE !!!!!!.
Posted by trillsg in January ; https://vimeo.com/666444931
" thought it might be of interest to some on here due to their partnership with Avct".
A kind gesture by a very knowledgeable Dvrg poster.
An early warning system in detecting whatever pathogen you wish to target about to go World wide.
Affimers are involved and the market is huge, little golden nuggets detecting covid, E coli, etc, etc, etc.
Covid has blinkered the fact Affimers are a direct replacement for Antibody reagents ordinary used in POC Diagnostics.
The Affimer v Antibody contest was a knockout for Affimer, however the judges voted Antibodies the winner in a rigged contest.
This is a nice little side line earner for Avct, one of many about to explode on the market. Now for that second Affimer to replace the flawed Antibody in the AffiDX LFD.
Who was it said ; We know a lot more about the virus and the antigens we are interested in, which epitope, which part of the antigen is least vulnerable to mutation.
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1042688/RA_Technical_Briefing_32_DRAFT_17_December_2021_2021_12_17.pdfhttps://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1042688/RA_Technical_Briefing_32_DRAFT_17_December_2021_2021_12_17.pdf
Para ; 2.1 - A 10 week wait and not a peep from UKHSA / PD
Five poor quality LFD evaluation into detecting the Omicron variant gone missing .
Validated by PD to detect high viral loads pre - Omicron and PD imo now withholding results on their crap tests.
It took Avct 25 days to change the AffiDX LFD detected the Omicron variant / had reduced sensitivity at Lower viral loads.
Fact ; none of the 5 approved tests sensitivity to Lower viral loads ( Ct 28 -31 ) were above 70% pre - Omicron.
All five not fit for purpose detecting Lower viral loads. Criminal.
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1042688/RA_Technical_Briefing_32_DRAFT_17_December_2021_2021_12_17.pdfhttps://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1042688/RA_Technical_Briefing_32_DRAFT_17_December_2021_2021_12_17.pdf
Para ; 2.1 - A 10 week wait and not a peep from UKHSA / PD
Five poor quality LFDs evaluation into detecting the
https://ukhsa.blog.gov.uk/2021/12/08/investigating-omicron-what-ukhsa-is-doing-now/
Purpose ; to make sure that we are using the best possible LFD tests in our testing programme in the UK.
Action ; to confirm they detect the Omicron variant and establish the sensitivity of each test by measuring the amount of virus it can detect to generate a positive response.
REALITY ; Now in its third month establishing the above. In the mean time the UK has a testing programme in place where nobody knows how these tests ( Innova, Orient Gene, Acon Flowflex and two Surescreen LFDs) perform against the Omicron variant.
FACT ; AffiDX LFD results pre -Omicron ( Ct < 28 ) 100% sensitivity. ( Ct 28 - 31 ) 98% sensitivity. Considered a Low Viral Load in comparison with the established UK LFDs with a sensitivity of > 90% (Ct < 25 ).
All the five tests sensitivity is reduced when tested against a Lower Viral Load pre -Omicron. This fact is being ignored and replaced by a twisted interpretation of the RNS. Will PD play it safe or for once provide a true evaluation of their crap tests.
CONCLUSION ; The test I completed today is inconclusive, nobody has provided proof the test detects Omicron without a reduction in sensitivity. What a shambles.
The disaster as you call it is the result of a flawed validation process / Market greed / Antibody limitations and a get rich quick agenda. The SP is a joke when the best LFD is in the process of improving its quality. Where is the flaw in the Affimer Technology, nobody has come up with one yet. Antibodies are not doing so well and I understand all the LFDs using them as their regent employ several versions. Could it be they are related to the dud Avct were provided with and are ditching.
The UKHSA /PD are at present carrying out Real World Performance Monitoring Data from LFDs on the market. Innova, Flowflex, Orient Gene and two tests from Surescreen. These five tests are are being evaluated against the Omicron variant checking for any loss in Sensitivity. The Manufacturers claim they perform as well as previous results on other variants.
Avct on the 10th Jan said the LFD was found to bee less Sensitive to omicron at Lower viral loads versus other variants. A mere 25 working days through the festive period to reverse their original findings. The UKHSA / PD are now approaching 50 days and still no data proving these tests retain their Sensitivity levels . At this rate Omicron will have been and gone before any results appear. There is no shortage of live virus so what is holding up the Performance Monitoring Data?
Curiously Performance Data for the famous five pre - Omicron :
All five tests perform in the > 90% Sensitivity range at viral load level of Ct < 25. This level of viral load no longer represents
the suggested infectious range. When the viral load is reduced in these tests their performance is reduced to the realms of not fit for purpose. Results for viral load Ct 28 - 31 :
Innova 65%, Orient Gene 50%, as for the remaining three tests Flowflex and the two Surescreen tests their Sensitivity is measured at Ct <25 and and falls into the low 90% bracket.
Avct statement ; Tests carried out found the LFD is less Sensitive to Omicron at Lower viral loads versus other variants. Our determination only to provide High Performance Diagnostic tests has led to the decision to pause marketing. It is clear imo the AffiDX LFD performs to a very high Sensitivity at higher viral loads with the Omicron variant well within the range of the tests on the market. The statement said at lower viral loads Ct 28 -31, not Ct < 25.
Fact, the only way these five approved tests can repeat their Sensitivity levels in this performance evaluation is to retain the poor quality standard that got them there originally. Increase the quality level and these tests will fail the performance evaluation as their Sensitivity results reveal. Two months down the line and not a peep from PD, the purpose of the evaluation is to provide the best test for the consumer preferably before the new variant fades away.
Conclusion ; PD are struggling, what will they eventually report!!!!!
The blinkers are off only to be replaced by a bag over the head outlook. Inside this bag all vision of what is ahead has been removed. I believe the Affimer Technology is second to none, a fact proven in the Diagnostic side of the business. A Diagnostic market worth billions and dominated by an inferior reagent.
The Therapeutic side of the business speaks for itself, an absolute no brainer for me, never had blinkers or a bag fitted. Happier days ahead imo.
https://twitter.com/woland01
Anybody got any constructive comments ref Woland01 post on Feb 6th. Personally thought he came up with a few very interesting points on the Doxorubicin dose escalation.
https://www.youtube.com/watch?v=NZHIxNQT4Tg
Listen from 36min 45sec in and digest what the CEO is stating, customers are showing interest in the new technology. They are more interested in the new Tech below the bonnet , he thought the test results would be the main point of interest. A focus on the new Tech would be introduced into the business development side going forward.
The Affimer technology is way under the radar, in fact it is trundling down the runway. This imo is about to change very soon, Investors will be presented with the facts. Affimers perform better than Antibodies in the Diagnostic side of the business and the potential in the Therapeutic side is enormous. Boom!!
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1042688/RA_Technical_Briefing_32_DRAFT_17_December_2021_2021_12_17.pdf
Part 2 Para 2.1 :
PD has carried out a small sample Laboratory evaluation of their 5 favoured tests against the Omicron variant.
Acon Flowflex, Innova Biotime, Orient Gene and two Surescreen tests.
Result all 5 show no reduced Sensitivity to the Omicron variant, however Real World Performance Monitoring is on going.
All 5 tests displayed mediocre Sensitivity results in comparison to the AffiDX LFD pre- Omicron.
PD testing procedure, Wet Lab testing with contrived samples from sequence confirmed cultures of the Omicron variant.
Viral load ; > 1,000,000, >100,000 & > 10,000 viral copies / ml. The lowest viral load has a < Ct 20 rating.
Taking no chances there, why not reduce the viral load to the levels these tests were evaluated at < Ct 25 .
The Real World Performance Monitoring results will be an interesting read. All 5 will soon be registered in the CTDA evaluation programme imo.
FDA / National Institute of Health ( RADx Programme ) to study the performance of Antigen tests with live patient samples that have the Omicron variant. " the best way to evaluate a true test".
Their goal, to manufacture millions of tests per week for Americans.
PD goal, to prove they were correct in their evaluation programme, gave up on this lot a long time ago.
America here we come.
.
Submission date 1st Sept 2021, Phase 1 Desk Top Review will undertake evaluation of manufacturers claimed performance.
VOC at this date Delta therefore test performance based on this variant
Three months down the line VOC changes to Omicron, Delta data out of date.
New Omicron performance data required from December a time consuming task.
The FDA declare omicron may reduce the Sensitivity of the LFDs on the market and will carry out tests
Germany who use Flowflex as their choice of Chinese tests carrying out the same check.
Results from these investigations pending, PD imo has to go down the same path, hence the delay in CTDA evaluations.
My opinion on the delay others have their own theories.
Drvg use the two reagents in Microtox PD & BT, yet another example of 2+2 = 5
https://www.londonstockexchange.com/news-article/DVRG/microtox-bt-eval-n-of-sars-cov-2-from-breath-test/14902642
We know Affimers detect the Omicron variant, Aptamer group reported a couple of days ago Optimers did as well.
Dvrg RNS merely confirms a third party agrees with the Aptamer Group findings.
Affimers v Optimers who has the proven record in S&S results, show me where Optimers perform better than Affimers.
Both work so good luck to the Apt Group.
Water pollution is a World wide problem, to dismiss this technology as trivial imo is a mistake . This is not a one trick pony detection system, hundreds, thousands of different reagents required.
China and America involved, massive market potential. DYOR.
Courtesy of : Init2winit Twitter ;https://mobile.twitter.com/heliumfly1.
The Shadow Sec. for Health asks Sajid Javid why the British Government are not supporting LFTs made in Britain. He is told the Government only buy tests approved by our Independent Regulator. No plug given to PD, the swine - fever experts.
The RH Andrew Gwynne is Labours Under Sec for Health who has no knowledge of the PD fiasco and needs to do his homework before wasting everyone's time. Absolutely pathetic, PD were incompetent in their handling of the testing procedure and stubborn in their refusal to openly admit their failings. This issue needs to be addressed imo.
https://www.londonstockexchange.com/news-article/APTA/optimer-binder-shown-to-detect-omicron-variant/15289220
Interesting read, their Optimer reagent develops a high affinity for the Spike protein of the Omicron variant.
The reagent also demonstrates the binder can function within an Antibody - Optimer pair. Sounds familiar!!!
Both Avct / Aptamer Group provide reagents to DeepVerge for Wastewater Covid detection. Potential covid clusters can now be detected 10 - 14 days prior to an outbreak. Game changing in the way we tackle the virus and Affimers play their part.
AS states in the RNS all Covid tests should be subjected to similar Omicron studies to ensure the public have confidence in the results these tests generate. A view now being taken by America and the EU.
Should I be confident in my Flowflex test carried out this morning, the manufacturers say Omicron does not reduce the tests Sensitivity.
The German Health Minister says we do not know exactly how well these tests work on Omicron. Germany has been using Flowflex from March last year and the test was officially given HUA in May last year. Conflicting statements, not exactly a confidence booster.
The FDA has indicated that Antigen tests will detect the Omicron variant but may have reduced Sensitivity.
If by some chance the Sensitivity of the Flowflex test was reduced what would be the likely result.
Flowflex Sensitivity 94% at Ct < 25 independently validated by the Paul Ehrlich Institute. Not Exactly what you would call a confidence boosting result. At lower levels of viral loads it would safe to say this test would not be fit for purpose.
Verdict ; I am confident the confidence level in this test has been shattered.
Even at its reduced level of Sensitivity for the Omicron variant the AffiDX imo was a better quality test compared to Flowflex.
Out of all the LFDs on the market only one can improve their sensitivity to the Omicron variant, the rest tread water or sink. The crap test making millions the quality test being slaughtered. Criminal.