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LVOne US trial results were published in an official journal of the American Stroke Association on Friday.
https://www.ahajournals.org/doi/full/10.1161/SVIN.123.001304
Upfront posted a news article about it on their site yesterday
https://upfrontdiagnostics.com/us-clinical-trial-results-published-in-american-stroke-association-journal/
“ These outstanding results confirm previous findings from a clinical study performed in the UK by Upfront diagnostics in collaboration with Newcastle University and open the door for identification of LVO patients in the pre-hospital setting. Deployment of the blood biomarkers in the field could allow fast-tracking of patients to treatment with thrombectomy, halving the risk of disability and the healthcare/societal costs of stroke. Also, with these results, Upfront positions GFAP and D-dimer as the strongest candidates for identification of LVO patients in the pre-hospital setting.
Several doctors from different American departments of neurology and neurosurgery were involved in the study: Harvard Medical School, University of Alabama at Birmingham, Duke University School of Medicine, University of Puerto Rico School of Medicine, Massachusetts General Hospital, and Brigham and Women’s, St. Michael’s University of Toronto, UCLA Stroke Center and State University of New York at Buffalo’s Jacobs School.”
Add all this in to LVOne being 1 of just 8 devices on the IDAP scheme and you have to think we have a great customer here.
Just some things to remember on this;
- Strokes will cost the NHS £43bn next year, largely through ongoing care needs. Stroke is an NHS priority.
- The whole purpose of IDAP is to fast track transformative diagnostics into widespread NHS use.
- Upfront have been developing LVOne with heavy NHS collaboration for years, to make sure the product matches the customer.
-Upfront are expecting UKCA in H2 2024, ie by the end of June.
- we are the CDMO partner, and have made all batches so far. Very reasonable to think we will carry on doing so, particularly given that we currently have a lot of currently mothballed automated manufacturing capacity in Doncaster ready to go. If I recall, capacity is “millions of tests per month”.
- in recent funding pitches, Upfront have said they could price each test at £600 and it still remain cost effective to the customer. Reality is it will likely be £200 per test.
- there is global potential for this test subject to regulatory approvals (and of course we have now significantly bolstered our regulatory resource with IVDeology.). I do wonder if that acquisition was driven by the fact that we are likely to have a lot more developers reaching the regulatory stage of the whole CDMO process now.
A great and potentially highly lucrative customer for us.
And finally, just a real world story published by the BBC last week showing the real difference early diagnosis of LVO stroke can have to people, and the NHS.
https://www.bbc.co.uk/news/articles/c0kllj7knyxo
Upfront just posted about their results
https://www.linkedin.com/posts/upfrontdiagnostics_exciting-news-alert-after-3-years-activity-7198219266465136640-hgsQ?utm_source=share&utm_medium=member_desktop
And a number of news outlets have picked it up. Here’s one example with lovely words like “groundbreaking” and “transformative”!
https://bioengineer.org/researchers-develop-game-changing-blood-test-for-stroke-detection/
Thanks for all your nuggets @muck .
They are not going unnoticed ;)
Pleasure! So many good things to keep an eye on here.
FOFH still puzzles me though. It (nor Devyn) has any web presence as far as I can see and whilst STI diagnostics is a great market to be in because rates across a variety of infections and age groups are rising globally, “investing” £500k in a new (and what appears to be) one man band venture seems bizarre unless there is an angle somewhere. Just can’t think of the angle, unless it has something to do with our rights to offer the tests as own brand perhaps with Boots in mind, or wanting a US foothold.
Our investment would value FOFH at over £2m, being about 14 of our current MCAP. On the face of it that would seem foolish at this pre reg approval/commercialisation stage unless there is a nugget somewhere.
And Yates has never struck me as foolish.
The only other reason I can think of is that FOFH couldn’t pay us, so we took equity instead. But if that were the case I would have hoped for more than 23%.
Anyway, current things on my radar are outcomes from the latest Upfront and Loop funding rounds, Upfront UKCA approval, and of course the early July trading update.
Upfront posted this video to explain their history, product, and long collaboration with North East hospitals. 20 mins and worth a watch
https://www.youtube.com/watch?v=Tv1ls6QasiY
Two little thing I did notice in the video;
- Each LVOne test actually comprises 2 LFT’s.
- They confirmed that their manufacturing partner, “based in York” has already made 20,000 “tests”, so 40,000 individual LFT’s.
So if this gets off the ground, and every indication is it will, then the manufacturing requirement will actually be double the “tests” sold.
This is why Abingdon is so confident that they will be in profit this year, becoming self sustaining as a company. Alongside Salistic in Boots and Tesco's and sales of their iron defiency tests looks like they'll be up and running in 2024. Be nice if the 5 std tests got accredited this year too. All to play for. Thx for sharing Muck165.