Member Info for JimiHendrix

If they get as much of the UK market for the stroke test as I’m hoping then I don’t believe they will need to raise again. It will depend how quickly NHS push through funding to the regions, which will be a new frontier in terms of how POC tests have been funded up until now. The implementation guide should be published soon.

The chap in the latest webinar said April/May, with a bit more emphasis on May from the way he said it. So I’m thinking there’s a good chance in it being published by the end of next week or the following week.

We should hear about the 5 new NICUs too and revenue received from the 9 existing NICUs. Potentially a very lucrative month ahead for the company.

We’re promised news on Scotland’s MTRNR1 rollout too at some point, which should include the plan for phased rollout and how much revenue will be received for each phase. I’m anticipating at least £300k for the initial phase but it could be more (£800k in total I recall).

There’s a very reasonable chance recurring revenue will get a huge boost over the coming months from the CYP2C19 test…

based on pilot progress and stakeholder positions, the prospects are strong that Genedrive’s CYP2C19 point-of-care test will see a broad NHS rollout in the wake of the pilot. The pilot’s influence has been to validate feasibility and gather buy-in, which it has achieved. Barring unforeseen negatives, one can expect NHSE to endorse routine CYP2C19 testing for stroke patients across England, with Genedrive’s rapid test playing a key role in delivering this service where speed is critical. In practical terms, this could mean that later in 2025 and into 2026, many NHS stroke units will start implementing genotype testing protocols, combining central lab testing and on-site Genedrive testing as appropriate. The net outcome will be more personalized stroke care – patients getting the antiplatelet therapy that matches their genetics – and Genedrive is well-positioned to be an integral part of that new standard of care.

Gloria, I believe the market is partly waiting to see the news. I expect the share price to move up in anticipation next week.

The big news due any day is the NHS Pilot implementation guide. From my research, this could result in several million per year in extra from the UK :)

Plenty of cash…

So about £2.5m cash in the bank as of today (2/5/25), and at 500k per month this takes them forward 6 months to beginning of October

Other cash expected…

- [ ] £250k for the 5 new NICUs going live from May as part of PALOH-UK group 2 (Group 2, the remaining five sites, with phased go-live from May 25.)

- [ ] £450k for restocking the 9 existing NICUs should in theory be restocking 12 months supplies in April as their 6 months funding runs out May

- [ ] £300k for initial Scotland orders by October

If this additional £1m is received then they should have cash until beginning of December 2025.

Pretty sure it’s not self certified…

Self-certification: In some cases, manufacturers can self-declare that their products meet the requirements of the relevant directives or regulations and affix the CE marking themselves.

Notified Body involvement: For most IVDs, especially those with higher risk classes, a Notified Body (an organization designated by a member state to perform conformity assessments) is required to review the product and issue a CE certificate.

Class A IVDs: Class A IVDs (low-risk IVDs) that are not sterile can be self-certified.

Sterile Class A IVDs: Even Class A IVDs, if sold sterile, may require Notified Body involvement.

EU IVDR (In Vitro Diagnostic Regulation): The new EU IVDR has introduced changes, and many IVDs that were previously self-certified under the IVDD (In Vitro Diagnostic Directive) now require Notified Body involvement.

The national pilot is April/May according to the recent webinar. But we’re also expecting…

• CE-IVD

• 5 new NICUs from May

• 9 restocking for May

• European/ME distribution or new sites

• Perhaps something unexpected around FDA / NICE related

Anybody spotted any changes yet? Looks the same to me as of now.

RNS Monday morning is my guess and website updating tonight / over the weekend perhaps.

NICE/NHS will push the GDR test in my opinion, hence why the competitor has resulted to giving away free trials now... and reassuringly even then the hospital are waiting for the implementation guide to come out from the pilot (in the next few weeks I think) before making a decision.

I've done some deep research and get the impression funding is probably going to be made available for POC testing in this instance, specifically for CYP2C19 testing for strokes. Which will be a change in how POC testing has been funding up until now.

I said Bristol and Oxford are using the competitor's test.

If you watch it all you'll see that they wanted to take part in the UK pilot and use teh GDR test but were not selected and GDR were not giving out free trials. They were going to wait for the trial to complete but were approached by the competitor and offered a completely free trial so had nothing to lose but try it. They're now waiting for the UK pilot to finish before making any financial commitments.

The Oxford guys are using it because GDRs wasn't available at the time. They are also not using it for strokes, it's for something else that requires much less frequent testing.

Hi Gloria, actually I found that information online very recently, I have been meaning to dig it out again and post it. Watch the March 2025 webinar just over mid way down the page...

https://www.nw-gmsa.nhs.uk/about-us/our-projects/genomic-networks-excellence/pharmacogenomics-and-medicines-optimisation-genomic-network-excellence/clopidogrel-pilot-project-cyp2c19-genetic-testing-stroke-and-tia-patients

The mentions of the competitor startled me at first, but it became apparent why.

I know Bristol and Oxford are using it, Bristol is a free trial though. Oxford is using it a couple of times per week for another condition that I can’t remember off the top of my head (not strokes). They received the device and fridge free of charge I believe but pay for the tests.

Bristol wanted Genedrive but wasn’t able to take part in the pilot and Genedrive offered no free trials. They were going to wait until the pilot finishes but in the meantime were offered a free trial by the other guys, they had nothing to lose so are trialling it.

“The Chinese Stroke Association guideline also recommends rapid CYP2C19 testing for patients with non-cardioembolic minor ischemic stroke or TIA who present within 24 h of symptoms onset.”

Seems to me that rapid testing (POC) testing is going to be the way forward for TIA.

They’ve been giving away free trials in the UK, to hospitals waiting for the pilot study conclusions. There’s no doubt POC will be used imo from what I’ve heard, it’s just how it will be implemented.

In person training is provided. From what I have heard recently, once training has been given, the testing process becomes very straightforward. The only question as I understand it currently is how POC testing can be implemented nationally, whether it will be in the actual hospital or in the community. If it's in the community it would add a few hours to the testing time frame which is not ideal for many patients who need a result faster.

How it will be funded is the other question. I think we'll have these answers end of April / early May within the implementation guide from the national pilot.

The competitor's test needs 3 swabs and a fridge so is less practical that the Genedrive test which only requires 1 swab and doesn't need a fridge at all. The Genedrive test is also superior in performance, even compared to a lab.

I understand the lab results are taking around 7 days in the national pilot, which is far too long. Surely funding is going to need to be made available for trusts or local communities to adopt POC testing.

Yes, rapid/point of care testing for CYP2C19 is getting picked up, not only for clopidogrel.

Theirs is an inferior product so I’m not sure about strong opposition, Slacker.