Member Info for JimiHendrix

Implementation guide & national commissioning decision due any day now. Most likely scenario imo will result in 40-50% of the market coming GDRs way (£3-4m p/yr).

On top of that news there should be sales income from…

1. Existing 9 MT-RNR1 NICUs – recurring cartridges. 9 NICUs × 600 babies/yr × £110 per test = £594 k/yr

2. Group-2 PALOH NICUs (x5) (from May)

3. Scotland MT-RNR1 rollout – national programme (expecting income details any time over the summer).

4. Initial CYP2C19 orders from the EU (sounds like they have some orders lined up that were waiting for CE-IVD).

Stocksaint, yes I do realise that and also special commissioning is different to national commissioning. It's still possible that RNR1 will get special commissioning before the NICE full thumbs up like Cheek was trying to achieve but for now I'm expecting the evidence study to complete first as haven't heard anything recently about special commissioning. The company said it will take max 18 months and that they can submit the evidence earlier if appropriate (so around Q1 2026 or sooner).

CYP2C19 though is by the looks of it on the cusp of receiving national commissioning, which will include funding mandates for both lab and POC testing.

RNR1 does not yet have full NICE recommendation, it'll get national commissioning next year I think after the evidence generation period has completed and NICE update their guidance.

CYP2C19 is a different kettle of fish, the NHS pilot’s specified goal (based on stroke-service audits) was “result back within 24 hours so it can influence the first definitive antiplatelet prescription.”

Commissioning is test-based rather than platform-specific. Trusts can adopt whatever method meets the standards (e.g. rapid PCR in a lab or a POC cartridge at the bedside). If a hospital cannot hit the required TAT with its regional lab, it can justify a bedside Genedrive analyser and still reclaim costs under the same tariff.

Regional Genomic Medicine Service Alliances are planning for dual reimbursement pathways. Which indicates NHSE and ICB finance teams are already preparing to honour costs for cartridge-based POC use.

I was replying to Slacker's post there Re. his falsehoods.

Lol but most of those are not facts, they're falsehoods 😂

Guy, not if they start receiving CYP2C19 orders late summer. There’s company referred to the second half of the year ending June 26 for breaking even so anytime between January and June.

I believe the implementation guide & commissioning sign-off will likely be announced within days of each other (or same day) which will include the “how-to” toolkit and decision on who pays (e.g. Genomic Medicine Service tariff or MedTech Funding Mandate).

After this the trusts won’t need to fund it themselves. The CYP2C19-ID Kit will be added to NHS Supply Chain / DPS with national price and trusts will receive a funding code.

Commissioning decisions in genomics focus on delivering the right result inside a specified TAT; NHSE has repeatedly funded more than one technical route to achieve that.

• Stroke HASUs that need a ≤ 1-hour genotype will be able to procure and reclaim cartridges for the Genedrive POC test, while lower-acuity sites can stay with the 24-h regional lab and bill the same tariff.

• This dual-route funding approach keeps the service equitable (no post-code lottery) and cost-effective (POC used only where it adds real clinical value).

Stocksaint, I think that’s all about to change.

Currently, the NHS Genomic Medicine Service does not commission point-of-care tests, and the CYP2C19 test for clopidogrel in stroke is not yet approved for routine commissioning. This means that, at present, the costs for such tests fall to individual trusts. 

However, the NHS England and NICE genomic testing pathway sets out a joint approach to identify, prioritize, and assess new genomic technologies before they are considered for commissioning by the NHS in England. Once a decision has been made to commission testing nationally, it will be added to the National Genomic Test Directory and delivered by the NHS Genomic Medicine Service, which is commissioned nationally by NHS England.

By end of June 2026 sounds about right, I think 40-50% of the UK CYP2C19 market will be going GDR’s way beginning fairly soon. Bringing in £3.4 - £4.2m, this is base case reflecting current reality: labs averaging 24–48 h, POC needed for same-day decisions in hyper-acute settings.

We should have full guidance for RNR1 too by then, nationwide roll out for that is £8.5m a year on top.

A mcap of £50-100m by then is quite plausible.

I think they will manage to stretch their cash (including already announced sales income for Scotland and the 5 new NICUs) until the first-wave roll-out of the CYP2C19 test in the UK is completed (by Q1 2026). IMO based on thorough research this will include all HASUs and some district stroke units accounting for 40-50% of the market (£3.4 – £4.2 m per year). I believe orders for these will begin late this summer.

I expect a decision on who pays (e.g. Genomic Medicine Service tariff or MedTech Funding Mandate) any day now with the implementation guide, then once trusts know the test is paid for, purchasing can be signed off within weeks.

No the actual bid is much higher than 1.4 EC, it’s just MM games. It’s actually 1.5 to sell and 1.53 to buy at the moment.

I think it’s likely we will and possibly an EU sales order or two, that has been in the works waiting for CEIVD to be received.

Also in the latest NHS Pilot webinar from March, I believe the Dr said the implementation guide would be published in April or May so I’m expecting this any day now too.

Everything I’ve heard about CYP2C19 NHS adoption suggests they won’t need a placing. Momentum should start to build with the share price over the coming days and weeks as the market comes to realise just how undervalued we are imo. I’ve topped up this morning with this news, I think EU orders will follow.

Expecting Scottish contract terms soonish too as well as what sounds like a possible ME order in the near term.

And this regarding NHS adoption…

“Commissioners are watching the final pilot read-out (due this summer). If the cost-saving and outcome data match early signals (20 % of stroke/TIA patients need an immediate drug change), NHS England is expected to move the test onto a nationally funded pathway—either via the Genomic Medicine Service Directory or a MedTech Funding Mandate. That would remove the last local-budget hurdle.”

Fantastic news! Strongly suggests imminent commercial activity both within and beyond European borders.

Combined with NHS national adoption and a likely 40% of the UK market, and then considering the EU market is £93.5m, well… this is looking very good indeed.

Approx timelines for CYP2C19 orders…

1. Implementation guide & commissioning sign-off (Due any day)

NHSE/NICE publish the “how-to” toolkit and Decision on who pays (e.g. Genomic Medicine Service tariff or MedTech Funding Mandate).

2. Framework procurement & pricing (Approx 4-8 weeks after sign-off)

Genedrive CYP2C19-ID Kit added to NHS Supply Chain / DPS with national price; trusts receive funding code.

3. Trust business case & purchase order (Approx 4-6 weeks after tariff is in place)

Stroke lead submits one-page case; capital ≈ £5 k analyser + starter cartridges; approval by Medical Devices or TIF panel.

No they should receive the orders from those HASUs this year around Q3. This will likely be significant sales income that should negate the need for a fundraise.

Yes, the pilot study has also said lab results are on average taking 24-48 hours.

• Every HASU – still needs POC unless its regional lab can guarantee < 24 h 24/7.

• District stroke units – choice will hinge on local length-of-stay and whether out-of-hours cover is required.

• TIA clinics/out-patients – lab testing already fits their timelines; POC adds little.

The realistic share of testing that goes POC could settle anywhere from about 40 % (if only HASUs buy analysers) up to ~50 % (if many district units also want weekend/on-call cover). The labs’ inability to hit the ≤ 24 h mark consistently is precisely why those high-acuity centres will keep ordering Genedrive devices.

So, while the headline UK market is ~£8.5 million annually if every stroke/TIA patient is genotyped, the portion flowing specifically to Genedrive’s point-of-care cartridges is most plausibly £3–4 million per year in the initial national roll-out, with upside or downside depending on how fast labs can consistently deliver ≤ 24 h results.