Member Info for JimiHendrix

The PALOH UK purpose is real-world validation, not classical clinical testing of the device’s safety or efficacy — those were already demonstrated in the original PALOH trial and in routine use at the early adopter sites.

The RNR1 test will almost certainly be commissioned nationally as soon as enough real world data has been captured in routine care. Scotland is already commissioning it to begin national rollout in October.

From the info I've managed to dig out the guide is just waiting for signoff which can take a couple of weeks apparently.

National commissioning will be effective from the date of the publication of the implementation guide & toolkit.

Lol, both tests are developed with the NHS for the NHS... there is pretty much no chance NICE will decide against it.

It's as good as guaranteed imo.

All key hurdles – clinical utility, cost-effectiveness, feasibility – look favourable. Only needs validation in routine practice which is well underway.

Once NICE converts MT-RNR1 from conditional to full recommendation, national commissioning is then highly likely, given the strong health-economic case and political backing for genomic “test-before-treat” antimicrobial stewardship.

By "fully paying" I mean GDR are receiving payment for the RNR1 tests and instrument used at the Cardiff site rather than it being a free trial (it is commercial), the purchase orders are grant-funded. Once enough evidence has been generated (by end of H1 26) NICE will update their recommendation guidance and it'll be commissioned nationally (£8.5m per year).

In the meantime we should hear very soon that CYP2C19 testing is being nationally commissioned (40-70% of £18m per year).

Roger, no this is group 2 of the PALOH-UK evidence generation. It's a fully paying live site :)

Four more to be listed / announced shortly.

Cardiff & Vale UHB (University Hospital of Wales NICU) is now live from what I can see on the NIHR Be Part of Research (PALOH-UK) page.

Cardiff’s NICU has finished its R&D governance and is now enrolling babies into PALOH-UK; it’s popped onto the public list even before a trust press release has been issue.

Cardiff is the first genuinely new unit outside England to join PALOH-UK; its NIHR listing confirms it is essentially live (or hours away).

Might get an announcement shortly.

https://bepartofresearch.nihr.ac.uk/trial-details/trial-detail?trialId=56066

June 20th - UMC Utrecht begins a cardiology feasibility study using the Genedrive POC platform to guide dual-antiplatelet therapy in primary PCI.

First continental-EU deployment; Utrecht’s cardiology group publishes widely—positive data here accelerates mainland uptake.

June 24th - King Faisal Specialist Hospital & Research Centre lists the Genedrive analyser on its new “Rapid Pharmacogenomic Panel” tender (MOH/23/2025/1159).

Gulf Cooperation Council states often adopt UK NICE diagnostics once CE-IVDR cleared; inclusion in a tender is an early commercial signal.

Stephen, that’s just based on the stroke portion.

Because the cardiology decision window is shorter than stroke, and a high proportion of PCI patients go home the same day, POC testing is an even tighter operational fit in cath-labs than in HASUs.

That means Genedrive’s POC share in cardiology is likely to be higher than the 40–50 % we model for stroke/TIA once the market matures, with an approx ceiling as high as 70% of the market.

I honestly think we could see a share price as high as 15-30p next year.

NHS England’s Genomic Testing Pathway guide affirms that CYP2C19 testing will be taken forward for national commissioning once the toolkit is published.

The HASUs will need to use the GDR POC in order to meet the less than 24 hrs turnaround time KPI once national funding is made available (tariff etc). I understand that the guide and toolkit are now just waiting for sign off.

We should see something like this in the guide and toolkit…

* One-page commissioning annex with the Directory code, funding route, service start-date.

* KPI table (“≤ 24 h TAT”) and “use POC where lab cannot meet this”.

That equates to at least 40-50% of the market, which is why the company expects to breakeven between Jan - June 26.

Sorry after delving deeper, this isn’t actually in the minutes. So it may or may not be happening, I don’t know for sure. ChatGPT has inferred it from some remarks it came across.

NHS Scotland Medicines Consortium (SMC) minutes note that CYP2C19 testing “will follow MT-RNR1” and that a business case for a national POC service will be presented in September.

Over 50% of the Scottish market will go to GDRs CYP2C19 POC. Revenue estimated at approximately £1m per year. So to clarify it appears there is going to be a parallel national rollout for both tests in Scotland Q4 :)

Yes! Thank you :)

Just to clarify that H2 26 refers to 1 January 2025 - 30th June 2026.

Genedrive’s published reports use the UK convention that a fiscal year is named for the calendar year in which it ends. So FY26 begins 1st July 2025.

So break even expected at some point between January and end of June 2026.

The annual UK market for CYP2C19 seems to have increased significantly according to the presentation, previously it was £8.5m but now £18m.

That pretty much doubles the revenue figures I’ve been estimating. I’ve been estimating 40-50% of £8.5m p/a for CYP2C19 but seems twice that now.

Looking at their total global figures they’re anticipating about 55% of the market going to POC.

Breakeven by mid 26 will be achieved largely from national commissioning of CYP2C19, due “any day now” quoting myself :)

Roger, genedrive will be paid from the £800k

Roger are you suggesting the company won’t receive income from the Scottish rollout? If so you’re mistaken.

The implementation guide isn’t delayed, if you research into the process it takes a couple of months after an NHS pilot before it arrives – so literally any day now.

Around October not including income from the 5 new NICUs, the initial phase of Scottish national rollout, recurring income from the existing 9 NICUs. And initial orders for the stroke test once the guide is published.

Income from those could push the cash runway to December or further.