The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
Looking at the WHO ACT document, it says: US$1.3bn needed now for 85m tests (50% rapid, 50% molecular), and $5bn needed for 500m tests (75% rapid, 25% molecular), and WHO says rapid test ~1/5 of molecular cost by then.
Sounds like a simple equation to solve here..
ACT Diagnostic Investment Case NOW TARGET
Total cost (m) $1,300 $5,000
Total tests (m) 85 500
Rapid tests 50% $5.60 75% $5.00
Molecular tests 50% $24.99 25% $24.99
So WHO expecting molecular PCR tests to be average $25/test.. That a lot higher than we are currently seeing at NCYT.
Just want to post this question out there as Alistair has mentioned that once initial lab tests and final prototyping is complete, Avacta will be getting UK manufacturers to make the initial batches for clinical testing.
Wouldn't it make sense for Cytiva to make initial batches as they are one of the world's largest manufacturers of LFT? Is it because Avacta wants to get it third party verified? Just want to understand why Avacta chose this route that's all. I'm all for keeping it "made in UK", but Cytiva surely would be easier and quicker route to clinical validation/FDA approval.
@RingTheBell
I saved Ophidian's previous musings on the limit of detection and repaste here for you:
===== Posted by Ophidian (4 June 2020 17:14) =====
OK - I'm not going to go through all the calculations in detail but after reviewing some papers and doing a bit of maths, I think the LOD for COVID19 on a LFD is going to be 86,268 copies / ml which is way way less than they are when they first show as symptomatic. So pretty much what I guesses a couple of weeks ago when I said 1-2 days prior to showing symptoms.
Ophidian
===== Posted by Ophidian (9 May 2020 23:53) =====
The Zika Affimer test detects "early" viral loads and from various sources the peak load is an average of 9.9x 10^4 or 99,000 copies per ml this implies that the Affimer detects less than 99,000 as that is pre peak. From the Lancet article (Mar 23, 2020) on Hong Kong patients:
"The median viral load in posterior oropharyngeal saliva or other respiratory specimens at presentation was 5·2 log10 copies per mL (IQR 4·1–7·0). Salivary viral load was highest during the first week after symptom onset and subsequently declined with time (slope -0·15, 95% CI -0·19 to -0·11; R2=0·71)"
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30196-1/fulltext
5.2log10 copies per ml is 158,000 copies per ml. So I would say that at onset of symptoms and probably well before the Affimer concentration on the strip is more than enough to detect the virus based on Zika.
===== END =====
My added commentary: In addition to the above posts, Avacta mentioned 11th May they have found Affimers that also bind to the detached spike proteins, so in theory this should lower the LOD even further to below 99,000 copies per ml.
Conversely, it also makes any antibody test suspect also. If we assume a 15% prevalence of people with immunity, then even at 95% sens and 95% spec, we can only be 77% sure a positive is a positive.
@flyingmachine, Avacta's test is to help the world get back to normal. Not to identify the positive cases, but rather to be very very confident that when tested negative, you are indeed negative. This is where I think there's a lot of misunderstanding about how we can all get back to normal.
We know 80% is the minimum requirement for sensitivity, and Avacta are targeting over 90%. Even at 90% (@2% prevalence), the confidence is only 26.9% that you are really a positive so I would think if one is tested positive, then that person should be isolated and get a PCR test done to confirm 100%. This is a great safety net and will help tremendously in the current situation. Also, there will be multiple opportunities to get rapid tested so I'm pretty sure positive cases will be identified quickly in time.
From watching Alistair's video explanation today, what seems key is specificity as the point of our rapid test is to be very confident when you are negative so you can get on with your life. From the presentation, at 2% prevalence, and 90% sens & 95% spec, you can be 99.7% sure when you get a negative, it will be a negative. At 80% sens and 95% spec (the MHRA guidelines) confidence is 99.6% so still very very high. Even with a ridiculous 0% sensitivity, the Negative Predictive Value (NPV) is mathematically 97.9% - still acceptable I would say.
What is interesting now is prevalence. With total infections globally now above 9m, that equates to around 0.13% of the world population. So I've run some scenarios and it bodes very well for our test as we are targeting >90% sens, >95% spec.
@ 0.13% prevalence: 80% sensitivity, 95% specificity = NPV 99.97%
@ 0.13% prevalence: 90% sensitivity, 95% specificity = NPV 99.99% (AVACTA TARGET)
@ 1% prevalence: 80% sensitivity, 95% specificity = NPV 99.79%
@ 1% prevalence: 90% sensitivity, 95% specificity = NPV 99.89% (AVACTA TARGET)
For reference, UK total reported infections of population is 0.4%, US is 0.7%, Brazil 0.5%, Peru 0.8% and Chile is highest at 1.2%.
Excellent video update by Alistair. Key point often missed is that the whole point of our test is to get the world back to normal, i.e. if you are negative, then you can go back to work, take that flight, enter that stadium, drink that pint with your mate.
At 95% specificity minimum, that means we are 99.8% confident you are indeed negative. Thats a very good %!
If you are positive, the test is only 27% confident you are indeed a true positive - you self isolate and a PCR test is needed to confirm. So keep your RT-PCR testing stocks as well - this rapid test will go hand in hand with NCYT/GDR etc.
Buys can be done bid side, and sells on the offer so I really don't understand why people here are obsessed with total 'buys' Vs 'sells' as the totals are mostly meaningless. Is it not obvious that in every single trade, there is a buyer and seller?
It's not easy to block out the market moves but I'm reminding myself why I'm invested here. Unless the LFT is a flat out impossibility, I'm sticking around. Even then, the main cancer therapeutics part of the business will be revealed 1H2021 one way or another, so that's my timeframe.
Sure you can trade around and may be able to increase your shareholding - even RichKen is doing this - but LTHs should stay firm. Nothing has changed in the last 7 days to warrant such a drop.
I see very similar price action with SONA too. Before COVID the stock languished around CAD0.15-0.2, so not too dissimilar to AVCT. They went up to CAD2, before dropping to a low of CAD1.05ish after initial test updates that the market perceived as negative. Now it's CAD3.
Called the sales team this afternoon and had a quick chat. Seems they have 500+ kits (thats >48,000 reactions) available to ship right away. List price is £842+VAT per kit, so £8.77 a test but open to bulk discounts. Not sure what to make of this but definitely not 100% sold out that's for sure. They again reiterated they are the gold standard test, fully approved, one of only two with independent 100% sens+spec testing.
"Of course the virus goes down in the summer" not sure about that statement Ivy.. Brazil weather currently 27degC, India even higher. New cases continue to rise in those countries so hot weather doesn't seem to make much difference.
Exactly. If you are developing such a test, why have a webinar to discuss the challenges unless you want to kill your own stock price? The fact that Cytiva will talk about how they overcome such challenges suggest they have figured it out.
Roll on Wednesday.
Next week at the Cytiva panel, DCN will be part of the panel with Sona and Avacta. They have a good thorough YouTube series talking through the whole POC LFT during this pandemic - filmed back in April but I think still very relevant. Interesting to hear that it typically takes a few months to develop a test, and significant manufacturing capacity already exists - Malaria for instance globally is 3-4 hundred million of tests a year. Happy weekend watching, and see you all Monday 7am.
https://www.youtube.com/playlist?list=PLLTGg5VfE-hd8ki6zmmfSj2NSoqSzA0Rw
Thanks for the research CautiousOptimist. Great work there doing the timelines. I have been following Sona too and I still think there's a chance of using their nanotubes with our antigens to provide 'another' test for Avacta as Sona's test uses a nasal swab. It is very intriguing this webinar next Wednesday by Cytiva with Sona and Avacta. Can't wait to find out more.
Another company worth keeping an eye out for is Mologic. They have already mentioned they will be developing a POC antigen test and recently announced ODX will be partnering them too. Mologic have a new manufacturing plant coming on stream later this month with max capacity for 40m tests a year, but thats likely for their antibody test.
@Weloilbeefhooked. I've tried to transcribe the relevant part from the Q&A for you:
Alistair just confirmed they are indeed the US strategic investor that runs the Sequoia Fund. They are not expected to exert any influence. They are a very sophisticated and successful fund. Alistair has been doing work in the US for the last 12 months and meeting with Ruane and many others multiple times to build the Avacta story in the US. They don't expect to exert any particular control over the company but they are a fantastic investor to have on board.
Regarding NASDAQ. AIM listed biotech has its issues but not at the stage to consider a NASDAQ listing. We have a very clear set of objectives over the next 2 years to deliver, but yes, when the opportunity and valuation is right, dual listing or a therapeutic activity in the US would give access to those scale up funds to run multiple clinical trials in parallel.
Q (Sheldon Robbins): Do you believe you COVID-19 LFT has potential to be a global best in class?
Yes I do, we simply won't be spending the time doing it if I didn't... We have a high level of confidence that we will deliver that lateral flow test strip. Clearly it is critical when we get to the point of clinical validation what the sensitivity and specificity are, but given the sorts of guidelines that we are seeing emerge, I think we are very likely to meet those performance parameters. So yes, it could be absolutely transformational for the group.