RE: £50m - £100m Market Cap this year10 Apr 2024 11:35
Dr John McDermott posted below on Linkedin on the day NiCE published guidance .I believe the next set of news is CE IVD certification which is few any min.
The headline recommendation is that CYP2C19 genotype testing should be used to assess if clopidogrel is a suitable antiplatelet for people who have just had an ischaemic stroke or TIA.
If adopted into routine practice, this represents a major transformation in the way we manage stroke in this country.
Some key points 👇
- There are an estimated 110,000 strokes and TIAs in the UK each year and the first line treatment for a majority of these is clopidogrel.
- Clopidogrel needs to be activated by the CYP2C19 enzyme - but a significant proportion of the population carry loss of function (LoF) variants in the CYP2C19 gene which reduce the activity of this enzyme.
- These individuals are at increased risk of secondary vascular events, which is why NICE has made this recommendation, suggesting alternative antiplatelets could be used.
❓ But how do we actually deliver CYP2C19 genotype testing for all the patients who are eligible?
- CYP2C19 genotype testing (and pharmacogenetics more broadly) is fundamentally different from most of the genetic testing we currently
deliver.
- Unlike with most rare disease and cancer tests, CYP2C19 results are required rapidly and used by professionals who may not have experience of handling genetic data.
- Lab testing will form a part of any strategy, but pathways must be established to 1) transport samples to specialist labs, 2) deliver testing at speed and scale, and 3) return results in a clinically relevant format to clinicians who can action these.
- This last point is critical. Many stroke centres operate a "hub and spoke" model, where patients are admitted to a hyperacute specialist centre (the hub), before being repatriated to their local centre (the spoke) for ongoing care.
- If the lab CYP2C19 test has been requested in the "hub" and the patient is repatriated, how do we ensure these results are returned to clinicians caring for the patients in the local centres. This is logistically and administratively challenging, to say the least.
- One alternative would be to adopt a mixed model of genotyping, with rapid point of care testing strategies sitting alongside lab testing.
- With that in mind, NICE has recommended the genedrive CYP2C19 ID kit as the first line point of care test. This can identify CYP2C19 genotype in ~1 hour from a cheek swab.
- We're currently undertaking a verification of the system here at MFT Research and Innovation for CE-IVD certification as part of the Innovate UK funded DEVOTE programme.