Member Info for JimiHendrix

Mid-Summer / July is the earliest realistic window for National Commissioning I believe (based on typical NHS timelines) and NHSE often drops a tariff update in the last week of July.

We've been told the implementation guide is going to be published "soon" ...personally I think it could be published any day now but July looks like a good bet.

Hi Eureka,

This explains the differences much better than I can...

CYP2C19 Genotyping – Expected National Commissioning

NHS England is expected to commission CYP2C19 genotype testing nationally for stroke/TIA patients via the National Genomic Test Directory this Summer, which will likely set a uniform turnaround-time target (≤ 24 hours). Hospitals unable to meet this through central labs will adopt Genedrive’s rapid point-of-care (POC) test. The market value for CYP2C19 testing across the UK is around £8.5m per year. Genedrive’s share—primarily driven by hyper-acute stroke units requiring same-day results—is realistically estimated at about 40–50% of this total (£3–4 million annually). Implementation will be phased but likely rapid, with most units adopting by mid-2026.

MT-RNR1 (AIHL) Genotyping – Specialised Commissioning Effort

For the MT-RNR1 neonatal hearing-loss test, Genedrive’s CEO, James Cheek, was advocating for "specialised commissioning." This route differs from standard national commissioning; it’s specifically for rare or specialist conditions managed centrally by NHS England’s Specialised Commissioning group. The MT-RNR1 test addresses aminoglycoside-induced hearing loss, a niche but clinically critical area, making it suitable for such specialised commissioning. Securing this status would guarantee dedicated funding and faster, coordinated national rollout. Without specialised commissioning, the uptake is slower, regionally varied, and funded through local budgets or innovation grants rather than centralised NHS budgets.

...

Funding route

CYP2C19: Routine Genomic Medicine Service tariff (per test).

MT-RNR1: Central specialised-service block budget (per unit).

Decision stage

CYP2C19:In final clearance; toolkit expected late-summer 2025.

MT-RNR1: Still in evidence-generation; business case being drafted.

Commercial certainty

CYP2C19: High — tariff guarantees payment; hospitals adopt as soon as KPI threatened.

MT-RNR1: Medium/low — depends on NHSE agreeing a new specialised service and earmarking funds.

Addressable revenue by 2026

CYP2C19: £3–4 m p.a. cartridges (40–50 % share) + £0.3 m analysers.

MT-RNR1: £6–8 m p.a. cartridges if fully adopted, but earliest widespread income 2027+

Eureka, that was special commissioning that Cheek was trying to get for MT-RNR1 by April. National Commissioning for CYP2C19, as John mentioned is any day now.

We are proud to have genedrive as a sponsor for UKPGxx2025.

Genedrive Diagnostics Ltd is a pharmacogenetic testing company developing and commercialising a rapid and simple to use point of need pharmacogenetic platform for the diagnosis of genetic variants. Based in the UK, the Company is at the forefront of Point of Care pharmacogenetic testing in emergency healthcare.

Pharmacogenetics informs on how your individual genetics impact a medicines ability to work for you. Therefore, by using pharmacogenetics, medicine choices can be personalised, made safer and more effective. The Company has launched its two flagship products, the Genedrive® MT-RNR1 ID Kit and the Genedrive® CYP2C19 ID Kit, both developed and validated in collaboration with NHS partners.

CYP2C19 national commissioning is just days/weeks away!

Why are you expecting that next week System?

Clearly a buyer who understands what is happening. National commissioning is imminent and GDR will receive a huge share of the £8.5m UK market.

*once not was

We received loads of news around April.

The CEIVD was delayed a month and has now been received. The 5 new NICUs have a phased rollout beginning May, the names of these will appear on the NIHR study page was internal approvals sorted.

The NHS pilot website had initially said the implementation guide was expected to be released in April. But later the webinar estimated May, and we’ve been told it’ll be soon. My expectation is we’ll have it by the end of this month, this should be the big one!

The UK markets weren’t very good today across the board. Volume will perk up as news draws closer, in particular the implementation guide and toolkit (which will contain national commissioning) could arrive any day now.

Keeping an eye out for group 2 NICU live sites to be listed publicly. I understanding they’re waiting for sign offs.

Much more likely to be announcement of the Group 2 NICUs taking up MT-RNR1 and then CYP2C19 National Commissioning within the Implementation Guide & Toolkit before any new funding. Sales revenue from these (and Scotland) should push cash runway to the end of the year.

Going by previous NHS implementation guides & toolkits, and rollouts, the service goes live very shortly after publishing. The wait is almost over it seems :)

Winni, so do you not believe the CYP2C19 test is imminently about to be nationally commissioned?

It’s not just law suits, there are major consequences for trusts that fail to reach testing turnaround targets…

SSNAP audit – every hospital submits data on every stroke case. Hospitals falling short show red in public league tables.

ICB/Commissioner performance framework - Persistent breach is logged in NHSE’s Recovery Support Programme escalation ladder. Trust placed on a formal Support/Improvement notice.and risks losing CQUIN/quality-premium income until the turnaround time is met.

Care Quality Commission (CQC) can cite the failure in public reports, damaging reputation and risking enforcement.

Actually it’ll likely be that all hospitals/stroke centres that can’t consistently reach less than or equal to 24 hrs with their regional lab will need to use POC.

HASU’s will likely have a 1 hour or less target, so will order POC.

EC because CYP2C19 testing will become the standard, hospitals will be expected to provide the service and whether they use a lab or POC will depend on target turnaround times (TAT). Hospitals that provide hyper-acute stroke care need to meet a ≤ 24 h turnaround so will need to order POC.

There won’t be slow uptake after the implementation guide is published.

The cost of GDR’s machines is negligible compared to the NHS budget. The tests will be funded regardless of this boost.

The implementation guide should contain a National Genomic Test Directory code (e.g. “Rxxx”) and description.

• Tariff reference (the £-per-test price that GLHs and trusts can reclaim).

• Who invoices whom (GLH vs trust pharmacy if POC).

The service will then be live for reimbursement shortly after.

Essentially, it’ll show which trusts will need to use the POC test and which can use labs, based on who needs results within 24 hours. All HASU’s in other words will need POC.

This will be funded nationally and rollout will follow.

The Dr in the webinar said April/May for the implementation guide and toolkit, so it’s possible it’s just getting signed off or prepared to be published.

It could have a massive impact on the share price.