George Frangeskides, Chairman at ALBA, explains why the Pilbara Lithium option ‘was too good to miss’. Watch the video here.
Thanks PL75,
The use from professional to self I genuinely believe to be critical even more so than half a percentage point here or there in detection.
The validation studies must be incorporating this presently to demonstrate to MHRA. I'm advising corporations on COVID safety and without exception they would rather have slightly less 'performance' to ease and cost of rollout. Staffing with healthcare professionals is hugely costly and organisationally disruptive.
But as you say one never knows if Gov will white label and take over manufacturer status to allow for self test-but why take that chance?
All the best,
Chiron.
I've refrained comment for 24 hours to fully digest yesterday's RNS. Many comments have focused on scale up and market volumes however there are other significant factors to consider.
There are some critical factors that will define the success of our LFD beyond just limits of detection-
1. It must be validated as a self test for greatest capture of market share.
2. It must be nostril (anterior nare) or non-NP.
3. QR codes on each cassette to future integrate into T&T recording infrastructure being currently developed.
The professional use market is simply too limited and will not differentiate from other very good tests (Roche/SD Biosensor) already on market n.b proven to capture variants.
The importance of the above cannot be under stated in terms of its market success. Yesterday's RNS did not allude to resolving the above and thus the SP reaction (yes coupled with numerous missed timescales) being somewhat muted.
Whilst the BOD have unfairly been critiqued for progress (or lack of) by some, personally I think addressing the above, could be defining in the success.
PCR versus LFD landscape is slowly maturing to capture the sensible use of each in a defined setting. We will see wider roll out of community LFD with PCR for travel sector and where genomics needed.
If Avacta can deliver the above it will unquestionably the be the 'game-changer'. Again this doesn't reflect the other hugely exciting pipeline of offerings from Avacta but just focusing on the LFD.
As always best of luck to all,
Chiron.
Published today-
1. tinyurl.com/71biqv3p
Interestingly Wyndrum, the briefing document only specifies 'LFD' not manufacturer specific.
Agree regarding the utility of the Innova test hence I found this move surprising. The stated reason is-
"Rationale- accuracy of a positive LFD test is actually now very similar to that of a PCR test"
I hate speculating, and this is pure speculation, but, it begs the question- is there another test out there that fulfils this criteria?? I know many enjoy dot-joining, perhaps another dot!
All the best,
Chiron.
Wyndrum fair questions.
The BAMS question is difficult to answer as we have no discernable grasp on its current use. However the fact it's high throughput would still make it attractive as an offering. 1 lab-tech can run 1000 samples.
Big criticism of PCR is the widely variable use of regents and thresholds. Remember these labs need to get back to running 'normal' day-day patient samples for the NHS to resume function. Currently the COVID personnel draw is huge.
With regards to the vaccine, variable efficacy and uptake will mean the virus will become endemic and most epidemiologists share this view. Coupled with inevitable further mutations we will see wider roll out of LFDs.
Only yesterday I was in talks with a major flight operations lead about regular LFDs across their network for the foreseeable future.
Unfortunately the virus isn't going anywhere but it's impact can be mitigated to some degree by the measures we're taking.
Does that help?
All the best,
Chiron.
A contact at test and trace has informed of new policy from tomorrow. A positive LFD will NOT need a confirmatory PCR (except for certain groups). This is a big statement from Gov and big implications for the sector.
Innova on December 23rd received exceptional use authorisation for self-use, superseding the 'healthcare professional use only' status. It's likely others will follow.
UK Gov. are promoting asymptotic employer LFD testing and funding this.
Non-human primate studies and very early observational data (studies ongoing) demonstrate vaccinated persons can still be carriers. Uncertainties remain about capability to spread.
There is a clear drive away from centralised testing.
Furthermore post Brexit transition period devices will need to conform with new UKCA certification for sale in UK and CE for Europe. Not clear what impact this has on our timeline.
If one just concentrates on the Avacta LFD (which is akin to just looking at the wheels on a car to make a complete judgement on whether to buy it) there is a demonstrable medium/long term plan to move the testing sector to LFDs globally.
The market is growing rather than contracting.
The waiting is tiresome but if you're just a tyre-kicker it must be unbearable. Personally seeing the whole Avacta offering I'm steadfast in holding and looking forward to the inflection points which will be hugely rewarding.
As always, all the best,
Chiron.
https://www.gov.uk/guidance/using-the-ukca-marking
https://www.gov.uk/government/news/mhra-issues-exceptional-use-authorisation-for-nhs-test-and-trace-covid-19-self-test-device
We hear a lot about 'inflection points'. Wanted to give an opinion. Short term will be once a sizable contract is announced for the LFD/BAMS, preferably recurring.
S&S data whilst interesting we know must be within tight parameters. We also know real-world versus bench S&S can be wildly discordant for LFD (eg Innova). There are so many factors at play beyond just the Affimer performance.
Filling for AVA6k is nothing more than a paper exercise hence no SP reaction. Yes MHRA will at some stage give approval but until phase 1 data (ie safety) not expecting huge moves in this regard. However if AVA6k phase 1 data is favourable, this will be a major inflection point. First in human positive safety data will be huge for the whole platform. Personally this is what I'll be holding to see. But first dosing will take some time in this climate.
Furthermore the diagnostics division have many more plays. As highlighted earlier in week (eg CEA). Head-head comparison of existing markers versus novel affirmer based does not require complex clinical trails but relies on much more readily available banked patient samples. I know we will hear more in this (profitable) domain.
LG are onto their third Affimer based drug target. With royalties from commercialised output the potential revenue is vast.
Not withstanding the fact that Avacta continue to seek and sign commercial opportunities that pleasantly surprise.
So in summary deramping today will be about as useful in affecting the incredible opportunity Avacta presents, as a 4 day ban will have on 'reforming' DOH. Welcome back.
We will undoubtedly see SP shenanigans till these inflection points but peeking round the corner of what is to come, makes this for me a beyond solid investment.
Happy Monday and as always,
Good luck to all.
Chiron.
Robotics,
Viral load doesn't appear to be the determinant. Essentially what it seems to boil down to is how ones own body reacts to the virus. In those that have a 'severe' reaction they tend to have a much greater immune response leading to SIRS and ARDS.
The next 'game changer' will be an immunomodulatory drug that suppresses the reaction. Many are currently researching this.
Hope that helps,
Chiron
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2769235
Mass asymptomatic testing is unlikely to happen presently. Current government focus is concentrated testing of high(er) prevalence areas reactively.
Evidence suggests using an antigen test with 70% sensitivity and 99.5% specificity, only 29% would be true positives. However with two
tests (ie repeating a positive test with another straight after, if that too is positive), this would rise to around 98%. This is very important.
Going forwards we will certainly see much wider roll out of LFDs. We're already seeing the infrastructure for this being developed. Not just in UK. Isolation periods are also being shortened for those with a negative antigen test in some countries.
Now 3 approved LFDs appear on the government website as Healgen, Innova & SD Biosensor. No new large orders for these have been placed to fulfill the above strategy. At the same time, Alistair tells us he's procured swabs due to change of sampling method.
The reality is whilst the announced timeline hasn't been met, in no way has the demand either. We will see the test come to market and holders will be rewarded for patience.
Much of the anxiety on this BB comes from baseless 'I've heard this week is going to be...' comments. The reality is no one with 'inside' knowledge would announce it in a public forum. Ignore them, green box them or let DOH & PL at them. Whatever works for you but with a wide view of the testing landscape I'm convinced this will be a very rewarding holding. This is not even taking into account the rest of the cards in Avacta's deck.
All the best,
Chiron
1. https://bit.ly/34pwqfm
2. https://www.austria.org/current-travel-information
3. https://bit.ly/3p1uYaS
Some thoughts-
-Significantly increasing numbers of private institutions are purchasing LF antigen devices to screen staff. They are here to stay.
-Vaccine news is of course welcome however bear in mind companies have signed 18-36 month supply contracts. Why? As we've seen with LFDs real world results will be divergent from 'study' environment eg inclusion/exclusion criteria, latency of immune response etc. Not quick fix.
-Undoubtedly Avacta are in Gov. tender. 'Affimer' is not a ubiquitous scientific term.
For balance-
-AVA6000 dosing in 2021 is very very optimistic. Trials will take time. A lot of time to get back on track. See CRUK link for insight.
-There are other non-listed companies/consortia who have declared sovereign antigen test development. No great info on progress.
-Finally well worth reading link below to give insight into the feelings one such consortium had dealing with Gov-
https://www.p4precisionmedicine.co.uk/p4-little-boats-consortium-for-covid-19-testing/
It's important for me to know what I'm invested in, to manage own expectations. Expecting significant value from LFD near-term with oncology much longer play.
As always, best of luck
Chiron.
1) https://tinyurl.com/y62zyhqz This is the Pfizer protocol
2) https://www.cancerresearchuk.org/funding-for-researchers/research-features/2020-04-06-covid-19-open-letter-to-cancer-researchers
Some thoughts on today's RNS-
This is the first of 3 (LFD specific) announcements we have been waiting for. We will now expect two more. Clinical validation success and then a final one for orders in place, perhaps latter two together.
Today we have learnt-
1. Technology transfer is complete. It works! And well. Analytical sensitivity is good in lab samples.
2. We will have both a saliva and nasal swab test offering.
This is the expected news flow. If the RNS has stated poor analytical sensitivity or failure of the test strips then we would be looking at a very different scenario.
Incorporating a nasal swab is shrewd. This will be clinically validated rapidly and be readily marketable. Given simplicity of use this may even receive home use swiftly hence why I believe AS has chosen this path.
Saliva detection works, however clinical validation will take longer given numerous variables involved. Suspect this will come online after. Note- it is only the sample type (swab/saliva) that is different not the test, hence why I believe the above to be the case.
Market reaction is nonsensical given above but we've seen this before. We are demonstrably closer to a final saleable product. One final point-had the SP risen 10% this morning the reaction on this board would have been considerably different. The fundamentals haven't changed, just people opinions as influenced by short term MM plays.
As always, best of luck
Chiron
For those interested in how the LFTs are being rolled out-This short video from a care home today in Hammersmith & Fulham presents it well. It's the Innova test as mentioned in my last post. But gives a vision of how things are headed.
This will be expanded. Several large private companies/organisations are already regularly testing staff going into offices, using private nurses administering rapid tests.
Note the QR code on each cassette for those wondering how can these be recorded.
The algorithm is very simple. Regularly test staff. If rapid test positive they go home and request NHS confirmatory PCR test. If that's positive, isolate. If negative back to work.
Rapid testing is here to stay for at least the next 12-18 months. A rapid saliva test will be market capturing. There was chatter about no one being able to 'get saliva to work' earlier in the week. Odd comment considering the CE marked product Medusa19 (love them or hate them) are currently selling is a saliva antibody test!
When Avacta deliver this will have a huge positive impact on getting some normality back to our everyday.
As always good luck all,
Chiron
https://youtu.be/NNhjBodX1zM
Superb find Milcait, thought I'd share this as seeing the lack of Innova on that list strengthens what I have been thinking following some updates from DHSC this week-
Very interesting about turn this week. Last week CMO wrote to Jeremy Hunt (yes not MH) assuring all patient facing NHS staff would be tested with LAMP technology. Specifically LAMP.
*This week Prof Stephen Powis (national medical director) wrote to NHS staff specifically stating they will be using Innova lateral flow tests to twice weekly test asymptomatic patient facing staff. Staff will test themselves at home before coming to work.*
One can only presume due to the reports of poor real world Innova tests used on the public that they are now looking for alternative avenues to use up these tests. They are also sprinkling a few to local authorities but in no meaningful numbers.
Where does that leave us? Well clearly with a boat load of Innova tests now looking like being used up on NHS staff and STILL no credible solution to mass population testing with a rapid test.
With the logistical reality of rolling out vaccines slowly sinking in (not to mention other serious concerns-but that's for another day) and still no viable LFT for mass testing a huge opportunity still remains.
We will hear from 2 more vaccine developers within the next 4-6 weeks. What will happen to our SP? Who knows. But the list of credible LFT options is narrowing by the week. If Alistair delivers, and from all the collateral evidence it seems he will, we will be in for a very profitable few months.
As always, best of luck
Chiron
The LFT in Liverpool is the Innova test.
At 1.04 (one minute four seconds) you can clearly see boxes marked as such under the table where the LFTs are.
Hope that helps!
Chiron
https://news.sky.com/video/share-12125603
To change tack-
LAMP testing technology is being rolled out for mass testing of patient facing NHS staff only. They undertook a pilot study on 1200 NHS staff using saliva according to DHSC correspondences I've seen.
Whilst the NHS employs c.1.2m people 90% of these are in non-clinical roles. A good proportion of these non-clinical roles are working from home presently and would not need to be regularly screened. Thus this 'opportunity' does not represent a vast number of tests.
There continues to be an appetite to mass screen the population and the only credible option is a rapid home test.
Like many I would love to have heard positive news already. It's not helped by some posters claiming 'big news next week' etc. The fact is when tech transfer is complete we will hear.
After which validation will be very rapid. Optigene and Nanopore took 21 days for clinical validation (using 3 NHS sites and one university) and now in use in Liverpool. Analysis of results took additional time.
We know the test strips worked and thus a BAMS and tech transfer RNS announcement are expected. Managing expectations and green boxes will be key in the weeks ahead!
As always wish all well,
Chiron
https://www.ethnicity-facts-figures.service.gov.uk/workforce-and-business/workforce-diversity/nhs-workforce/latest
Today the President of European Council Charles Michel has outlined desire for a unified European testing strategy-
"While the PCR tests that have been favoured so far – the much talked-about ‘nasal swabs’ – are reliable, they are cumbersome to administer and to process in a laboratory, and getting the results back to the patients is also no easy matter.... That is why this technique needs to be supplemented through the implementation of antigen tests, which – although currently regarded as less reliable – are more efficient, yielding results within 15 minutes, and therefore make it faster and easier to identify, on a large scale, individuals who are carriers of the virus and contagious, in particular when they are asymptomatic"
"We must not make the same mistakes as before: we must coordinate the approval of those tests in order to ensure that they are recognised Europe-wide. Furthermore, production capacity needs to be strategically assured at European level so that such tests can be available and accessible everywhere at the same time. We cannot see a repeat of a situation along the lines of last spring’s "race" for masks"
I cannot think of a better placed company to deliver the above. As always, all the best,
Chiron
https://www.consilium.europa.eu/pl/european-council/president/news/2020/10/27/20201018-pec-newsletter-3/
-Prevalence is rising despite non-pharmacological interventions in place (physical distancing/hand washing etc).
-We are seeing confirmed re-infections which is likely a function of the point above and concerns about lasting immunity being realised.
-Well documented latent effects of 'mild' infections causing significant morbidity long-term.
-Pharmacological interventions only authorised for severe infections at present.
-In England impact on health services is regionally very disparate presently.
-Clear concerns with testing accuracy versus analytical test accuracy. In other words cannot just look at how accurate a test is in a lab but need to consider whole process to calculate true accuracy.
-WHO have reversed stance on 'rapid' tests in-line with current evidence.
-Generalised post-code lockdown extremely blunt instrument.
On the upside, clinical validation will be rapid given above, once pilot batch available.
We're in a considerably different position globally than we were even 4 weeks ago. These scenarios make an accurate rapid saliva based antigen test more needed then ever. There is no single immediate intervention that will positively impact tragectory of pandemic than such a test. I look forward to upgrading my M&S suits when Avacta deliver.
All the best as always,
Chiron
Today in HoC-
https://twitter.com/Jeremy_Hunt/status/1316703804453203968?s=20
Evening all , Just a random total side note on a grey Saturday. Just read this article of a crazy swab related complication. Of course it's super rare but nonetheless it happened!
Puncture of brain layers and leak of cerebrospinal fluid after COVID swab!
All the best
Chiron
https://jamanetwork.com/journals/jamaotolaryngology/fullarticle/2771362?utm_source=silverchair&utm_medium=email&utm_campaign=article_alert-jamaotolaryngology&utm_term=mostread&utm_content=olf-widget_10082020
Muck165- it's a good question because the wording implies some sort of machine hence 'devices'. Primerdesign do supply the Genesig q32 Real-Time PCR devices which run 32 samples in around an hour. I must be honest I'm not overly familiar with them.
The Genesig assays have been PHE signed off-look 10 tests down on the link below-
https://www.gov.uk/government/publications/covid-19-phe-laboratory-assessments-of-molecular-tests
So I suspect this is the case. I think Ophidian is best placed to confirm if he's about.
All the best
Chiron
Seadogsteve- the point of highlighting is DH are not interested in purchasing the Abbott offering. Potentially a competitive product. It is a rapid antigen test on the market, albeit using a nasopharyngeal swab.
Combined with Prof Deeks statement in my previous post of-"The UK seems a bit transfixed by getting a point-of-care antigen saliva test" I think this is positive news for Avacta. The government aren't interested in another product on the market.
If we were to hear they (UK GOV) had placed a huge order of the Abbott test I think may have implications here.
The fact the article says-"government is continuing with other plans, which include a pilot scheme for a fast..." I'm not sure would be what I focus on.
But everyone reads into things differently.
All the best
Chiron
Quite a cathartic day on the BB. Interesting email communication reported from DH by pharmaphorum:-
"Despite the UK’s well-documented issues with delays to tests, the government said it is pushing ahead with its own pilot schemes.
But it said it had no immediate plans to buy the Abbott test that is being purchased by the US government and the World Health Organization.
The test in question developed by Abbott and SD Biosensor costs around $5, and the WHO has already bought around 120 million tests over six months to distribute in countries badly affected by the coronavirus.
In an email conversation with pharmaphorum a spokesperson for the UK’s Department of Health and Social Services said there were no immediate plans to order the test.
When asked if the UK had plans to order the Abbott test, seen by some as a game changer allowing lockdown measures to be relaxed, the spokesperson said “not at the moment”.
Instead the government is continuing with other plans, which include a pilot scheme for a fast test that can return results in 20 minutes."
Despite 'fear of missing out' or FOMO as the kids say no evidence to support such fear. Whilst we all wait for 'that RNS' the BB will undoubtedly get a little fruity. Personally, I just ignore the noise. I'll happily continue to share any finds as not doing so ultimately rewards the hecklers.
Happy Friday all,
Chiron
https://pharmaphorum.com/news/uk-has-no-plans-to-buy-rapid-covid-19-test-favoured-by-us-and-who/