Ophidian, re: “one more puzzle piece”…
Home use authorisation?
To conclude, assuming they do want to put Affimers into some or all of the future tests, what’s to like?
- Potential for a reliable low-risk revenue stream, with a strong moat, for many years, growing over time.
- Actually helping people who’ve been neglected by the global biotech commercial model
- Lots of political goodwill, supporting commercial discussions in higher value markets
- Actually helping people
- And LOTS OF MONEY
Interesting someone mentioned Avacta’s experience with not being able to sell the Zika LFT… Perhaps they encountered the same issues as Mologic in trying to supply Zika LFTs to Low and Middle-Income Countries, namely no manufacturers wanted to be involved as the cost would have to be kept affordable and therefore margins were too low for them?
This is why this could be phenomenal commercial news and global exposure for Avacta.
Having a partner that is now most interested in the health benefit an LFT product can offer, rather than how much money can be made for it, opens up a huge market for Avacta to partner on tests for tropical diseases, which are currently completely under-addressed by existing LFTs, with a significant moat provided by:
- Lack of requirement for Mologic to turn a huge profit. Ie Cost barrier for competitors.
- Robustness of Affimers at higher temperatures than antibodies. Granted the Sars-cov-2 AffiDx IFUs say they can be stored “up to 30C”, vs 25C for Innova, and low 20s for most. But that is still quite a difference, and future products can perhaps be optimised for, or stability tested at, higher temperatures.
The return per unit sold might be less, but developing and supplying Affimers is relatively cheap compared to manufacturing the LFTs and setting up the logistical supply chain. Mologic/GAH would take on most of the risk there.
Assuming, of course, that we remain a significant part of Mologic’s plans, as they seemed to tell us back in the February RNS.
Let’s not forget:
- Millions of people in low income countries will be provided access to affordable and life changing biotech solutions. This is good.
- They are targeting completely different markets from existing LFT suppliers. I don’t think it sill materially impact LFT sellers in western markets. Unless they later expand their scope to target those markets of course, but I imagine they have bigger impact projects to go after.
Sounds plausible. Is that an educated guess or do you have a source? I didn’t see that in his Twitter thread.
Thanks Epping, as I suspected then, just the journalist googling a few Mologic facts and throwing them together in a misleadingly suggestive way. If they had found the Avacta RNS they might have been able to make some more convincing links!
Mologic basically giving away their covid antigen test design and committing to manufacture the AffiDx one absolutely makes more sense now.
Why would Deeks have had advanced notice of the Mologic deal - thoughts?
I read it as saying that tests will be sold at a reasonable and low cost in LMICs in Africa. It is still being run as a business, just not beholden to venture capitalists or shareholders whose driver is to maximise profit, and therefore price can be set to cover costs and maximise access, rather than optimised to maximise profit at the expense of reducing access. The problem is that currently, to maximise profit, the tests are being sold in higher value markets where the customers can afford to pay more, and these countries in Africa aren’t even getting a look in. Pretty sure Avacta would get paid for the Affimers and allowed to make a profit, albeit potentially modest.
Note most antigen tests suggest storing at room temperature, up to eg 22C. I’ll bet the robustness of Affimers will lend themselves much better to applications in field settings in equatorial regions with 30-40C heat.
Also there was an interesting quote from the Mologic Chief Executive in the article text Bella posted about LFTs, that the accuracy was improving and soon could rival that of molecular tests - well we know they achieved this for sars-cov-2 after incorporating Affimers, could be a reference there.
All seems to point to the potential for Avacta co-developing future tests with them. But unclear to me if the covid tests they would plan to roll out in Africa would be AffiDx, or these ones codeveloped with the Senegalese. Although if I’m not mistaken, that suggestion of the Semegalese link seemed to be the journalist’s interpretation and attempt to link facts rather than a direct quote from anyone related.
Nice one AgentB! When do you receive the tests?
The obstacle in the Uk is that with only one meaningful customer (DHSC), the assignment of LFT contracts has been “all or nothing”, and the market has gotten into the habit of thinking those are the two binary outcomes for sales of our LFT. We need to get away from this utterly myopic point of view.
Yes, the market elsewhere is saturated right now, but there’s a lot of junk out there, as well as some other tests that are pretty decent. But we’re starting to see governments assign minimum quality hurdles (eg Europe, US, UK), which in the mid to long term will play in our favour, as some of the competition either drops away in certain markets, or looks for better quality tests to manufacture under license.
With decentralised markets (Europe, much of RoW, US dependent upon FDA approval), we only need a small fraction of private companies and health institutions to decide to go for the Avacta professional-use LFT. Many of them are well informed, and care about quality. Eventually in the Uk, the gov will also move onto buying a wider variety of tests, and then looking to ultimately shift the onus for buying onto corporates and individuals.
When home-use authorisation lands, which may be soon or some months away - let’s not be too impatient on this - the even bigger market of self-testing will open up. Again, only a small fraction of the market need to opt for AffiDx for Avacta to achieve transformational sales volumes. Many people, especially those visiting vulnerable relatives for example, will care about quality.
Sales through Bioserv are already happening. Do you think PIs are the only ones making orders? I somewhat doubt it. The rest is still in play, in a game with sadly no end in sight, on a playing field where quality will win out in the long run.
Mikey, confidentials…
Any update on current estimated delivery date?
Nice.
Anyone with a business tried ordering from them lately?
Not sure about Europe, but the only UK-made LFT I’m aware that the DHSC is buying is SureScreen. It’s sensitivity is actually worse than Innova, failing the sensitivity criteria in this comparative LFT study:
https://www.medrxiv.org/content/10.1101/2021.05.11.21257016v1.full.pdf
Would it be shocking to find that Porton Down’s quality bar is a MAXIMUM sensitivity, and they don’t want to pass good tests?
Where did I see earlier today, some mention from Parliament of a requirement for 97m tests per week in the UK if we are to step up surveillance? I think the government has realised that if “freedom day” is going to be at all workable, they need every tool in the box, not just vaccines. So LFTs en masse, and talk of adding suppliers “including” Orient Gene, ie the door to others remains open.
I doubt we end up using anything near 97mln/week, but there’s no way Avacta can supply anything near that many (for now). So others are needed, and established channels prevail, despite inferior quality. Avacta still need to pass PD and home use authorisation. Fwiw I think we probably will eventually pass these, and be mixed into the rotation here and at that point take over most/all of the government-funded capacity, which may be making Chinese tests in the meantime. But I’m beyond hoping for any sort of leg up from this government - nice to have, if it comes. We’ll sell loads to private industry, Europe and RoW while they dither.
It’s worth a more complete read of the paper and annexes. Very interesting indeed, and nice to learn more about binding reagents and the associated commercial space from a perspective external to Avacta.
The main take-home I get is that “animal-derived antibodies” means those that are extracted from sera after immunising animals. “Non-animal-derived antibodies” includes recombinant monoclonal antibodies that are generated via phage display. As a technique that is now post-patent and open to all to apply, the focus of the paper is largely about comparing this method of generating antibodies with those using animals’ immune systems.
There is a strong mention for alternative scaffold-based binding reagents, and some of the advantages they can offer over antibody scaffolds, such as robustness, and ease and cheapness of production in E. coli. But I think the report’s authors see protection of these platforms by patents as more of an obstacle to widespread uptake than an economic benefit for those discovering them. However, it’s written by scientists, not investors! There is a mention of Avacta in the last 3 pages among companies currently offering catalogues of alternatives.
The good news is there is no suggestion to open up access to the IP associated with antibody alternatives. And also it sounds like the widespread expertise in the phage display method, required to switch all antibodies across to this, isn’t there yet and will take time to develop. The number of companies offering related services and non-animal binders are relatively few. And the vast majority of antibodies currently in use are “animal-derived” and would need to be switched out for an alternative in the long run.
Great stuff EGTP.
You could suggest that a highly sensitive test, that takes the infectious out of circulation, will ultimately save us a lot money by driving down case rates, driving down hospitalisations, reducing the burden of long covid, and protecting our over-stretched NHS more effectively.
Please don’t tell him it’s “100% accurate”, as I see a lot of people stating. With current 99% specificity, it’s about 99% accurate given low viral prevalence. Better to say “almost 100% sensitive for infectious cases” or “100% sensitive up to Ct27”.
Difficult to say what you’ll need in the toolbox though! You could ask him what his biggest challenges are, ask him questions to steer him towards more sensitive tests as a solution, and ask if we have any such developed in the UK, as per noise from fog late last year, which has gone quiet of late. As soon as he gets a whiff that you’re an interested shareholder, I could imagine him shutting down. You sound well connected though, so I’m sure you’re more aware than me of how these things work!
AVA6k is based on the PreCision platform, not Affimers.
I think good candidates for the first Affimer trials in humans are:
- LG Chem using the PD-L1 inhibiting Affimer (aka AVA004) with Affimer XT serum
- AffyXL with stem cells that produce Affimers, possibly the sars-cov-2 neutralising ones
Wow. Great find. Some big players in the antibody space are going to be looking for an alternative pretty soon if this passes.
Thanks TheAlchemyst. Clear.
Wonder if the “delay” in announcing the ISO accreditation was while they haggled over the scope?