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Yes full recommendation coming, and crucially lab testing simply isn't going to be able to handle the number of tests required. There is nowhere near enough capacity for lab testing, so that's where the Genedrive test will shine. Additionally lab testing simply isn't fast enough in many instances, so again, the Genedrive test will be the best option.
Roger, regarding "final say"...
NHS have 3 months to allocate funding...
"Funding technology appraisal guidance
The Secretary of State has directed that the NHS is required to provide funding and resources for medicines and treatments recommended by NICE through its technology appraisals work programme. It normally has three months from the date of publication of each technology appraisal guidance to provide funding and resources.
Where it is not possible to acquire the technology or where, perhaps because insufficient trained staff are available, the intervention cannot be applied within the three month period, it can be extended. Extensions are granted by the Secretary of State, on advice from NICE.
The three month funding Direction has been waived or extended for about ten percent of the technology appraisals issued to date. They include surgery to aid weight reduction for people with morbid obesity, home compared with hospital haemodialysis for patients with end-stage renal failure, patienteducation models for diabetes, continuous subcutaneous insulin infusion for diabetes (insulin pumps) and photodynamic therapy for age-related macular degeneration."
The Genedrive POC test is to be used when lab testing isn't available (currently lab testing capacity too low) and in some cases not quick enough.
The Mantara lab test uses a lab in Germany. It's highly unlikely they pose any threat to the Genedrive test for NHS use.
Roger, fear not! The Mantara test is not a POC test, it is not a direct competitor.
If there are currently talks going on around taking it private JC would not have been able to disclose anything. His reaction was more informal, at first he seemed like he wanted to explore the question but then decided he'd rather not discuss anything. This suggests there is no current plan to take it private but perhaps it's something they may consider in the future ...or the long term plan may be to sell the company off to a private buyer (when the company is worth a lot more.)
Is it possible that NICE could announce the full recommendation decision on the 26th April (or following Monday) at the end of the public consultation period, ahead of the formal guidance publication in July?
It is the recommended ‘POC’ test, only when lab testing isn’t available, lab testing is the preferred test and first choice for several reasons. It will be very interesting to hear hopefully in July how they decide to roll out testing.
Everything is in this document…
https://www.nice.org.uk/guidance/gid-dg10054/documents/consultation-comments-and-responses-2
Just to point out we don’t have £1.5m cash in the bank, it’s less than £1m now. We do though have access to the Riverfort facility from which we can draw down £1.5m in exchange for new shares. That is something management are not keen on doing though, they’d prefer a traditional placing.
I’m suggesting it’s not clear how big the market will be for the POC test, particularly so because lab testing is the preferred choice and adoption of POC tests is determined on a local authority basis rather than a single nationwide decision.
IMO it will depend on how quickly lab testing capacity is ramped up. There was a bit also in the guidance about potentially rolling out lab testing gradually as to not overload the current infrastructure. So some areas would get it before others.
What I was hoping for is mandatory national adoption of stroke marker testing from July, and a lack of infrastructure meaning our POC test would be used extensively until lab testing was able to cope. But it doesn’t sound as though that’s how it’ll be.
“ A benefit of laboratory-based testing is that in England this is commissioned nationally via the Genomic Medicine Service and delivered through the NHS Genomic Laboratory Hubs. This provides an opportunity to ensure better equity of access to testing when compared to POCT which is likely to need funding and implementation at a local level.
…
Thank you for your comments which the committee considered. Several stakeholders and experts commented that centralised testing would reduce variability in testing offered across the NHS. Experts raised concerns that if left to local centres to implement testing with point-ofcare tests, this would likely lead to considerable variation and could worsen health inequalities. Some committee members said that existing infrastructure should be preferentially used over investing in new single purpose technologies. The committee concluded that laboratorybased tested was its preferred method to implement testing. These considerations are in section 3.16 of the updated guidance. ”
He said the guidance suggests the test has to be done in 24 hours. It doesn’t explicitly state that from what I’ve read.
The modelling was based on Clopidogrel usually being given 24-48 hours after minor stroke. Lab testing has the potential to provide test results in 24 hours but currently there are delays in some labs. Basically infrastructure not there yet I think.
The Genomadix Cube has FDA clearance, European CE-IVD already and UK clearance, so it would be interesting to see how much of the market they are currently taking.
The Genedrive test is better so the hope is we will sway their customers over to us once we have CE-IVD next year and when their contracts are coming up for renewal and sign up those who aren’t using anything yet.
I would also like to know what the current lab capacity is (well from July / Aug) as the shortfall may indicate the actual POC market in the UK for stroke marker testing.
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.