Member Info for JimiHendrix

Genedrive’s stroke marker test came second. It was the best POC test but not the best test overall which is lab testing. Read the NICE documentation.

Lab testing is NICE’s preferred testing method. Genedrive’s POC test (point of care) is recommended where lab testing is not available. And the Geomadix one can be used as third choice if the other 2 are not available.

The market of £8.5m for stroke marker testing doesn’t take into consideration that the preferred test is the laboratory test. The genedrive test as far as I understand will be used when/if lab testing isn’t available. It’s really unclear how big the market actually is.

They also say if the Genedrive test isn’t available then the Canadian one can be used (as third choice), which I believe is already available.

My impression was that they probably have discussed taking it private but have no plans to do so in the near term. Sounded like the FDA strategic partner wants them to sort out funding before contracts are finalised, so I'm expecting funding announcement before details of the partner deal are released.

I would have liked more details on what happens when/if they get full recommendation in July for the stroke test... they said they can then begin sales, however I thought full NICE recommendation means the NHS have to take up the test, so I'm unclear how that works exactly.

JC definitely didn't sound so optimistic that specialist commissioning will happen soon. I was hoping he'd mention something about their discussions regarding getting it for Manchester hospitals this month. There wasn't a hint of that though, he seemed quite frustrated that he hasn't been able to influence the timescales as much as he hoped.

I picked up a real desire to get some long term funding sorted, it was mentioned so many times made me wonder at one point whether it has been partly sorted already and that they had to keep it under wraps... ie forward selling going on and price yet to be determined.

I think the 2 new sites he mentioned must be sites that they're working with on business cases, rather than new go-live sites - otherwise they would have had to announce them properly in RNS's and would have been more excited about them.

Stocksaint, also mentioned in the presentation that was very interesting is that clopidogrel is a drug that is used for many other things, not just strokes and is the 36th most used drug in the USA. They basically said that their test could be used outside the realms of strokes, for anybody being given clopidogrel, to test whether the patient will have problems metabolising it or not. So potential market for the test could be much higher than currently forecasted.

Lab testing infrastructure simply isn't in place for the amount of testing needed, so Genedrive's test will be used. There are a lot of comments discussing this in the consultation docs.

Slacker, we're talking about the stroke marker test... the one the company sound most excited about currently.

Stocksaint, I had a read through the NICE documentation and particularly the consultation comments and the picture becomes clear that there isn't enough capacity or infrastructure for their prefered method of testing via labs, and so they recommend Genedrive's Point of Care test to be used as well. This could as far as I see mean vast numbers being sold to the NHS.

There simply isn't any way that the labs will be able to cope with what NICE are recommending, hence including Genedrive's test not only for situations that require speedy results but also to make up the shortfall in lab capacity.

They're considering using the remaining £1.5m in the Riverfort facility though they'd prefer a funding deal that benefits shareholders. My impression is a placing won't be for a few weeks yet.

Interesting it was mentioned that there are 2 new sites coming on board this week, hopefully this will be RNS'd next week.

Also great to hear Gino confirm that in his opinion the stroke marker test will get full recommendation in July without any conditions. I understand this would mean the NHS have to take up the test from that point?

He just said...

£1.2m cash in the bank (more like £1m now) and an additional £1.5m available in the facility to drawdown.

That’ll be the last of RF asking for new shares then, unless we make a further drawdown from the £1.5m remaining available in the facility.

“This application for listing is to satisfy all amounts currently outstanding under the Equity Prepayment facility.”

Worth reading through the comments in the NICE documents.

The prefered testing method is likely to be lab testing with Genedrive's POC test filling in gaps. Interestingly regarding lab testing there are lots of concerns over capacity and infrastructure. NICE acknowledge this and recommend Genedrive's POC test to be used where lab testing will be too slow or when there isn't enough capacity for lab testing. It will take a long time before there is enough capacity for lab testing to be used for everyone and even when there is, in many cases it will be too slow anyway.

I get the impression further validation and data gathering won't be required. One comment mentions an existing POC test that isn't very good because it only works well on white-europeans, Genedrive's is much better.

All makes me think orders will come quickly from the NHS once recommendation is published in July.

Worth reading through the comments in the NICE documents.

The prefered testing method is likely to be lab testing with Genedrive's POC test filling in gaps. Interestingly regarding lab testing there are lots of concerns over capacity and infrastructure. NICE acknowledge this and recommend Genedrive's POC test to be used where lab testing will be too slow or when there isn't enough capacity for lab testing. It will take a long time before there is enough capacity for lab testing to be used for everyone and even when there is, in many cases it will be too slow anyway.

I get the impression further validation and data gathering won't be required. One comment mentions an existing POC test that isn't very good because it only works well on white-europeans, Genedrive's is much better.

All makes me think orders will come quickly from the NHS once recommendation is published in July.

It won't be years, the DEVOTE programme is set to finish at the end of March and then NICE publish the recommendation July. Genedrive has said sales in the UK will then begin.

I'm under the impression from today's RNS that the stroke marker test won't need any further data gathering which would have meant only a conditional recommendation being given.

Remember though that they have the RF facility with £1.5m left to drawdown, which would increase cash runway until August.

I'm sure they will do a fundraise but I'm not sure when it'll be. There's a strong chance further positive news around FDA, specialist commissioning (April was mentioned for Manchester) and simply the build up to UK sales starting in July could mean that the shareprice is much higher by the time funding is agreed.

Fantastic news!

The DEVOTE study ends at the end of May and then sales to the UK begin as soon as the NICE guidance is published in July.

Guy, yes but they actually stated in the RNS that they've been trying to obtain SC funding to begin this April (for Manchester hospitals) ...hence I said possibly this month.

The latest RNS...

"We continue to pursue all avenues to ensure we achieve specialist commissioning before the current timescale of April 2025. In line with specialist commissioning being devolved to the Integrated Care Boards ("ICBs"), our initial discussions have been with the Manchester ICB to obtain funding from April 2024 for the live sites across the Greater Manchester region."

Specialist commissioning for Manchester hospitals possibly coming this month.