Member Info for JimiHendrix

Are they referring to the same pilot study that NICE said they were working with the NHS on in the guidance?

If so the pilot is clearly the Genedrive POC rather than lab testing…

“… Previously, genetic testing for CYP2C19 could only be carried out using specialist laboratories, a process which can take several days. The innovative test was used at Manchester Royal Infirmary and the Manchester Centre for Genomic Medicine, Saint Mary’s Hospital, both part of MFT, over six months, to evaluate performance in the clinical setting.”

“Greater Manchester’s Hyper Acute Stroke Unit (HASU) at Salford Royal Hospital, part of Northern Care Alliance NHS Foundation Trust, to establish the benefit for patients across Greater Manchester. HASU is the largest dedicated unit in the region and provides care for people across Greater Manchester.”

“This pilot is an important step in understanding the set-up costs, workforce and other requirements to roll out this innovation wider.”

....And 5 new hospitals expected to be routinely using it by this September, that will be a decent bit of extra cash.

Correct to expect a sales update fairly imminently on MT-RNR1 ID.... 5 further UK hospitals are expected to be using it for routine use by September (four months from the May update).

"genedrive expects a further five UK hospitals progressing to routine clinical use within four months and a further five in 12 months taking the total to 14. The Company has been selling direct in the UK since February 2024 and sales ramp up in the UK is expected to be greatly accelerated by either of two routes: i) NHS specialist commissioning which is expected in April 2025 and / or (ii) change in NICE guidance from conditional to full. Through the rest of 2024 genedrive expects commercial progress in nine other countries across Europe and the Middle East where contracted distributors are in place and are currently in the in-county pilot phase."

Sales news can be expected this month and September for the stroke marker test imo going by their comments regarding having manufactured a certain number of tests recently to meet the anticipated demand from NHS. We also know from the website documents they ramped up production. I think it’s a matter being patient over the coming days and weeks as it seems highly probably an NHS sales announcement will be made.

1p easily reachable in the near term here.

The tests should sell themselves with NICE recommendation. AIHL is obviously still waiting for the full recommendation and specialist commissioning in April but the stroke marker test is ready to go. Very interesting article yesterday about pharmacies potentially taking up the test.

I’m now thinking perhaps lab testing will be used for the 36000 non-minor strokes (who usually begin clopidogrel within 2 weeks) and Genedrive POC for the 64000 minor strokes (patients who usually start the drug within 24 hours). It seems to make sense from time perspective. Plus NICE made it clear that testing is more cost effective than not testing.

My thoughts after mulling it over today are…

1. Although you could sense his frustration, if he left by his own accord he would have surely given notice and remained onboard to support a smooth transition / handover to a new CEO.

2. His LinkedIn comment - perhaps this upset somebody he was asked to leave with immediate effect? Surely though he would have been asked to restrain from making such tongue in cheek (no pun intended) comments rather than being sacked!

3. The comment may have been the catalyst to a major falling out or disagreement within the company and as a result he had to leave with immediate effect.

4. Company being bought out / taken over - seems there’s something in this going by Eureka’s post however a new owner would more likely sack the CEO and any other key management they no longer needed after taking the company over not before. I’m going by accounts from friends who’ve experienced that exact thing after selling their own companies.

5. JC was brought in for his marketing and NHS sales experience. Seems highly unlikely Gino becoming CEO was planned however there was no mention of him being interim ceo whilst they seek a replacement for James.

The only thing I’m fairly sure about is that it wasn’t a planned change. Hypothetically if a big Pharma bought out Genedrive they would use their own marketing team so maybe James wouldn’t be needed but I think a takeover would happen before anyone was sacked and we’ve not heard anything.

Gloria, no just lots of things adding up.

I had a feeling recently he may leave, seemed frustrated. It doesn’t look so good for NHS rollouts and specialist commissioning now imo.

Anthony, the 24 hours is regarding minor strokes. With non-minor (major) strokes the clopidogrel was typically started within 2 weeks.

The committee acknowledged that implementing laboratory-based testing for everyone who has a stroke or TIA could be done in a stepwise process. This would involve a gradual increase in numbers tested while capacity is established. Testing could be initially started in groups of people who could benefit most from it, because of higher risk of stroke recurrence, such as people with non‑minor stroke. Alternatively, point-of-care testing should be considered as an alternative if laboratory-based testing is not feasible at this scale, or while capacity for laboratory-based testing is increased. See section 3.21 for further discussion of these issues.

But first there will be a pilot study.

Maybe the pilot study will be smaller, like the lung cancer national pilot study for 10000 patients I mentioned before. The tricky bit will be identifying a subgroup I imagine.

Yes I think likely a pilot for the 36k non-minor strokes providing NHS thinks labs can handle the capacity. They will consider using POCs whilst capacity is increased but personally I think they’ll manage to get labs handling them.

Also worth noting from the guidance documents is that clopidogrel is usually started on non-minor stroke patients within 2 weeks, so that’s plenty of time to get the results back.

Only technology appraisals have to be implemented within 3 months. I think diagnostic tests fall under another category unfortunately, diagnostic assessment programme? Correct me if I’m wrong.

“NICE Technology Appraisals are statutory guidance for which NHS healthcare services must make funding available and implement within three months of their date of issue. All other guidance, guidelines and quality standards are non-binding advice intended to assist the NHS in exercising its statutory duties.”

“NICE is working with NHS England, who will initially deliver a national pilot to inform future implementation of the guidance”

I was reading about national pilots briefly yesterday and found an article from March 24 about the NHS planning a new national pilot to test for cancer on 10,000 individuals beginning next March 25. These tests will be carried out in the genome labs.

This makes me think a few things. Firstly it could take a while yet before the clopidogrel pilot study begins. Secondly it seems the decisions are being made by the NHS centrally and there clearly must be wriggle room regarding lab capacity.

Previously I was thinking each trust will need to buy the POC kit as a backup, however that’s not going to be cost effect at all if lab testing is the number one choice (it’ll potentially double the costs). So how is the NHS going to decide which trusts will use the POC and which use labs? The idea of a trust ordering a POC adhoc when there’s no lab availability doesn’t make sense as they’ll need to wait for it to be delivered and be trained already.

So I’m thinking the pilot study might be a population size lab testing can handle. If the cancer pilot is 10000 maybe they can cope with the non-minor 36000.

I’m keen to know more about the pilot study NICE mentioned, it’s not clear at all how big this will be and for how long. I’m also not sure now if individual trusts can purchase / take up the test or if we have to wait for central NHS decisions.

Looks like the gap will be filled at 2.9, PEEL were dropping the ASK even after buys, at one point lower than the sell price so obviously trying to drive the price down.

In other words if Genedrive say we're currently out of stock and waiting for the next batch to arrive, I would expect a trust to have to get the Genomadix to use temporarily until Genedrive is available again.

Gloria, I considered that but don't think it's the case... the trusts need to have a POC option and Genedrive is recommended and cheaper than Genomadix so they'll buy Genedrive unless for example Genedrive say they've ran out of tests. They won't need to buy both POC tests.

No the shareprice naturally falls back after a large rise, whilst the market awaits further news.