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At present, CYP2C19 genotyping is not widely available from the genetic laboratories that serve the UK National Health Service (NHS) and, as existing infrastructure has been developed to mainly deliver rare disease and cancer testing in the outpatient context, results may take many weeks. Given the potential scale of CYP2C19 testing recommended by NICE and considering the acute nature of most stroke admissions, with a clear time pressure to commence definitive antiplatelet therapy, this represents a major unmet need.

A POCT approach could address this challenge, with the capability to generate results in a clinically relevant time frame without the need to send samples to centralized laboratories. This article reports on the development and analytical validation of the Genedrive CYP2C19 ID Kit, a technology designed to address this significant unmet need by generating results in a clinically relevant format and time frame at the point of need.

This looks new, dated March 2025…

Development and Validation of a Rapid Point-of-Care CYP2C19 Genotyping Platform

https://www.jmdjournal.org/article/S1525-1578(24)00312-X/fulltext

https://www.linkedin.com/posts/the-journal-of-molecular-diagnostics_openaccess-activity-7302787212859887618-SJmP?utm_source=share&utm_medium=member_ios&rcm=ACoAAAFKxQYBHUxpBg36FYArMiSKxNehxDvVWWo

The UK market alone for the CYP2c19 test is £8.5m per year, considering that the 60p prediction is not as far fetched is it sounds.

Total annual addressable Market estimate = £220M p.a

• Middle East & US are key international markets

• Stroke incidence in Middle East is high and age of onset is in younger age group (50% under 45yrs in UAE).

In Scotland the NHS health boards have proposed to replace CYP2c19 lab testing with POC testing as the lab turnaround time is 7 days (far too slow). In England I think it'll be a mixture of both but lets see, considering the superiority and speed of the Genedrive POC it's quite plausible that it eventually ends up being entirely POC (unless labs are somehow able to significantly increase speed consistently and capacity across the UK).

Great post DaffyPicker. Popeye, what you've said there is deramping nonsense.

I think come end of March it may change, as a result of the pilot study the POC test may get commissioned nationally along with lab testing to deliver this service consistently across the country. Currently labs vary across the country, there needs to be consistency in turnaround time and gene variation coverage.

Well of course Stocksaint, The East Genomic Laboratory Hub is a lab lol.

Some interesting information in the PDF on this page indexed a few days ago "CYP2C19 genotype testing - Implementation Guidance Jan 2025 v1"

https://www.eastgenomics.nhs.uk/for-healthcare-professionals/genomic-tests/pharmacogenomics/cyp2c19-implementation-support/

It's pretty obvious from the amount of focus on point of care testing in this PDF, that both point-of-care and lab testing will be used.

This bit below should be updated with the validation study results that showed the Genedrive POC actually beat the lab test in all areas including the coverage of genetic variations of the gene...

"Point of care testing (e.g. using Genomadix or Genedrive testing kits) generally have faster turnaround times, but limited coverage of the CYP2C19 gene, only identifying key genetic variations, and potentially omitting rarer ones." ...that applies to Genomadix but not Genedrive which is superior to the best of my knowledge.

But tkevin there are multiple commercially focused updates expected in the next few weeks. If only a few of these come through the market cap will be radically higher than it is currently as the share price reacts to increased revenue and further potential.

The research and expected news flow has been shared by many here. Well worth watching the presentation again and looking through the Q and A for a refresher.

A few years ago there was a fundraise at a higher price than the previous. But as many have said, there is no reason to expect a fundraise at all until the end of the summer.

2p has proved to be very strong support for months so it's hardly a falling knife! :) ...it's getting ready for another big move up imo as we approach April, nobody will want to miss out.

Well said John ...as usual these derampers are hoping they can top up at a little bit cheaper than the already rock bottom current price, but I think they're going to get caught out. It'll be back to 2.5+ in minutes on any positive news or increased buying. Simply not worth being out at the moment imo as we draw closer to the end of Q1 with so much due.

The share price will imo hit at least 4-5p before any potentially needed fundraise is announced at the end of the summer. Just look at the expected news. Foolish to sell at this point in my view, but good luck trying to buy in on the day of announcements – the price will be marked up considerably.

Thanks Eureka! Last year we received an RNS on the 15th March 2024 specifically to confirm they have received the tax credit, so I would expect a similar update in the next couple of weeks for the £700k, before the results are announced.

"genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, today confirms it has received an R&D tax credit of c£0.8m"

Tkevin no the £3m they had at the end of November runs out 6 months later, so end of May. However they've also confirmed £500k for PALOH-UK and they have a tax rebate (expected this month) of £800 (I need to check whether it's 800 or 700 as per Eureka's post).

So that takes them to early August.

On top of that we can be fairly confident on the sales we've already mentioned coming in before then, so the cash runway could be extended well beyond the end of the summer.

My view is if there is one it’ll be at the end of the summer at the earliest.

The sales I think we can confidently add in the near term are approx 750 for Scottish rollout, approx 450 for renewing supplies at the existing 9 hospitals using RNR1, I’ve included the 500 for PALOHUK.

There’s also this statement and the outcome of the stroke pilot that could potentially extend the runway much further still…

“pipeline of opportunities that, if converted, would see a significant step up in revenues during calendar year 2025 and a reduction in the level of cash burn”

Tkevin, they have enough cash to see them through to mid August including the tax credit. They are in a better cash position now than the same time last year, plus there is additional income expected from rollout of both tests to various hospitals.

They usually only raise when they absolutely need to at the last minute. Almost no chance of a fundraise until the end of the summer imo and that’s if there are no sales. With sales it could push the runway beyond the summer.

Please do share which bits are factually incorrect or exaggerated, thanks. It’s all correct to the best of my knowledge and research.

Quite likely with so much positive news expected in the next few weeks! Incredible opportunity here at the moment…

1. First sales to largest Hyper Acute Stroke Centre in NHSE & several other stroke centres expected to implement in advance of NHSE pilot concluding (before April)

2. National Commissioning of our products brings significant upside to the sales forecasts (on track for April)

3. Five new NICUs adopting the AIHL test (any day now)

4. Full Scottish rollout for RNR1 is coming (any day now) bringing revenue of approx £750 imo based on 15 neonatal units.

5. Scottish plans or rollout for CYP2c19 (any day now)

6. CE-IVD for commercial sales within Europe (by April)

7. Tax credit £800k (this month)

8. Stroke pilot study concluding end of this month

There are 15 neonatal hospitals in Scotland and 3 NICUs. I’m thinking 500k revenue sounds realistic if it’s initially only the NICUs who are adopting, however the plan I think eventually is for all neonatal units across the UK to have the test, so there is a good chance imo that the Scottish rollout maybe for all 15 neonatal hospitals… in which case the revenue will be higher than 500k for sure.

Sounds like things must be progressing very well…

“pipeline of opportunities that, if converted, would see a significant step up in revenues during calendar year 2025 and a reduction in the level of cash burn.”