Member Info for JimiHendrix

Slacker, it has to be available which means it needs to be bought. Then it's up to the clinician to use the most appropriate test, if they want a result quickly and lab testing isn't available they'll use the Genedrive test.

There's no way Genedrive will give them the machines for free. The difference between this and AIHL currently is it has full recommendation without any caveats or further evidence generation needed. The Genedrive test has to be available at every location where testing is offered, so if anything we have them over a barrel.

Roger, not knowing about the NICE extension (if true) simply means just that. They will have known that NHS were figuring out a plan regardless of whether NICE extended publication date or not.

They’ve ramped up production for anticipated demand so they must have a very clear idea what’s happening.

Does anybody know if the tests have an expiry date by the way? And if so what it is.

Wow! ...that was this...

"the Company will now actively pursue commercialisation" lol

I'm quite sure they'll use them if purchased.

POC tests have to be made available in the hospitals otherwise CYP2C19 genotype testing is not recommended.

Well that's what I understand from this part right at the top of the recommendation....

"Use CYP2C19 genotype testing to assess if clopidogrel is a suitable antiplatelet drug for people who have just had an ischaemic stroke or a transient ischaemic attack (TIA). CYP2C19 genotype testing is only recommended if: quality-assurance processes and arrangements are in place for point-of-care tests"

It's also very clear that wherever testing for clopidogrel is offered, they must be able to offer a point of care test. This surely means full UK rollout of the Genedrive test...

"Recommendations:

Use CYP2C19 genotype testing to assess if clopidogrel is a suitable antiplatelet drug for people who have just had an ischaemic stroke or a transient ischaemic attack (TIA). CYP2C19 genotype testing is only recommended if:

quality-assurance processes and arrangements are in place for point-of-care tests"

Great news today, waiting for rollout update now.

🐌 For CYP2C19 guided antiplatelet therapy to work in practice, we recognised that current laboratory based testing paradigms were too slow for many clinical situations - a point of care approach was needed.

🤝 Through the Innovate UK funded DEVOTE programme, we've been able to support the validation of the genedrive CYP2C19 assay at MFT Research and Innovation.

🏆 The performance of the platform in clinical practice has been outstanding, exceeding all of our expectations. These data will be published over the next few months once analysis has taken place with our partners at The University of Manchester.

💡 Following release of the NICE - National Institute for Health and Care Excellence guidance this morning, our team at the NHS North West Genomic Medicine Service Alliance are already working with colleagues around the country to support implementation efforts, exploring optimal models of service delivery.

The NICE publication deadline was extended until today to allow NHS to work out a plan to roll out testing (presumably the pilot?).

We havent had any news on that so I’m thinking there must surely be another update coming. Otherwise why did they extend the deadline, there isn’t much in today’s final recommendation that wasn’t in the draft. There must be something from NHS coming.

This is the bit I like in the recommendation…

“ Use CYP2C19 genotype testing to assess if clopidogrel is a suitable antiplatelet drug for people who have just had an ischaemic stroke or a transient ischaemic attack (TIA). CYP2C19 genotype testing is only recommended if:

quality-assurance processes and arrangements are in place for point-of-care tests”

So regardless of which kind of test is used, if testing is offered then they must have the POC (genedrive) test available too. Thus surely means the test will eventually be rolled out nationwide (after the pilot).

A mixture of strong buying in the last 40 mins or so …but then lots of people derisking imo around 4p.

IMO

Comments about current lab capacity are in the consultation documents. They’re already at max capacity (over in fact). POC will be used during the considerable amount of time needed to expand lab infrastructure.

Good consolidation forming just above the 100 EMA, I’m expecting a push up from here this afternoon into close.

It’ll be the part describing how the NHS are going to rollout the test that’ll give this a huge boost imo, we know that the delay in releasing the publication was allow NHS to form a plan. Fingers crossed for 36,000 genedrive tests needed imminently as lab capacity already at max :)

On Wednesday we should get a clear picture of how many tests the NHS are going to buy. That’s definitely not priced in as we can only speculate until Wednesday. Fingers crossed for 36,000 units per year, I’d expect 9p could be reached on that considering we have AIHL further rollout too, plus FDA and specialist commissioning not far away.

Data has already been provided to satisfy NICE.

Great insights Roger, I’m of similar thinking.

Also the apparent ramp up in production suggests they’re anticipating NHS orders.

It’s worth baring in mind the comments made regarding lab testing infrastructure … “considerable amount of time and resource required in order to upscale capacity to meet this demand.” …and the comments from NICE regarding testing being more cost effective than not testing at all.

It starts to look quite likely that the Genedrive test will play a large roll in providing CYP2C19 testing in the NHS for a considerable amount of time.

At current £20m mcap and £5m+ cash that’s definitely not priced in. Plus there’s AIHL FDA being fast tracked and further UK rollout coming soon and specialist commissioning in the Spring. It’s looking very exciting!

Meant to post here sorry for the double pist…

I believe the Genedrive POC test will be used to test the 35,900 non-minor strokes per year, as currently there there isn’t the infrastructure for labs to handle anything extra, they’re already over capacity.

“The committee noted that compared to no testing, CYP2C19 testing after a nonminor stroke generated more net monetary benefit than testing after a minor stroke or TIA”

“The committee also agreed that point-of-care testing should be considered as an alternative if laboratory based testing is not feasible at this scale, or for use while capacity for laboratory-based testing is increased.”