Member Info for JimiHendrix

The NHS need to make the test available to everyone equally across the UK, which isn’t feasible with lab testing capacity and variations between labs. So I believe trusts won’t have a choice but to fund the Genedrive POC test. The pilot finishes in 4 weeks and findings published in April, though I’d imagine the company will have a pretty good idea what’s happening before then.

Genedrive MT-RNR1 ID kit will be fully adopted across Scotland very soon, there are 15 neonatal units in Scotland. They are just waiting for the funds to be signed off.

CYP2C19 testing is also going to be rolled out in Scotland, at the same time I believe but initially this will be using labs. However POC testing has been proposed by NHS to improve turnaround times which are currently 7 days !! ...Genedrive is the recommended POC test. Sounds very promising to me that Genedrive will be used throughout Scotland as 7 days turnaround time is obviously not ideal.

Yes a lot of significant news items expected in the next 4 weeks! I’d be very surprised if the share price isn’t over 3p by the end of March.

It is likely just impatient people selling whilst we wait for news. It has dropped back 5-10% to the support level so nothing to worry about. I expect early to mid-March ahead of news there will be a significant increase in buying, with so much positive news expected.

Currently they have cash until mid August including the tax rebate and funds from PALOH UK.

Additionally we should get some decent sales news before then…

“pipeline of opportunities that, if converted, would see a significant step up in revenues during calendar year 2025 and a reduction in the level of cash burn.”

They might be waiting until the NUCE evidence generation is complete before FDA submission, as they plan to use it.

I don't think this has been posted before... Press release from November 2024...

https://www.genedriveplc.com/press-releases/dbt_uk_genomics_spotlight.pdf

"Whilst scheduled for a maximum of 18 months, performance data can be submitted to the NICE EVA Evidence Generation team at an earlier point if the team believes the evidence generation requirements have been successfully fulfilled. Performance data generated during the programme is also expected to contribute towards clinical performance data requirements for FDA as part of planned De novo submission process required for commercial entry into the U.S."

It started 1st November, Group 1 (the existing 9 NICUs) completes after 6 months (end April) – My hope is that the team has enough data by that point to submit to NICE Evidence Generation.

The evidence generation is "up to a maximum of 18 month" but the team can basically conclude it earlier if they feel enough evidence has been generated. Could be 6 months! :)

Great find Lionel, thanks.

“Innovate UK is pleased to announce these seven new CERSIs, which represent a landmark in healthcare innovation regulation. Backed by up to £1 million each, they will drive safer pathways for groundbreaking medicines and devices, ensuring the UK remains at the forefront of global medical advancements. By fostering collaboration between academia, business and regulators, these centres will pave the way for life-changing innovations to reach patients more swiftly and safely”.

The Liverpool-led project will also involve collaborators from The University of Manchester, Queen Mary University of London, Bangor University, The Office of Health Economics, The British Pharmacological Society, JS O’Brien Business Solution and Alderley Lighthouse Labs.

Enhertu is different as it was developed by a drugs company and wasn’t recommended by NICE. Genedrive’s AIHL test was co-developed by the NHS and has already received recommendation from NICE (with the caveat that further evidence is generated whilst being used routinely in 15 NHS NICUs).

Expected news items in the near term…

1. First sales to largest Hyper Acute Stroke Centre in NHSE & several other stroke centres expected to implement in advance of NHSE pilot concluding (before April)

2. National Commissioning of our products brings significant upside to the sales forecasts (on track for April)

3. Five new NICUs adopting the AIHL test

4. Scottish rollout for both tests

5. Another £500k or so from the existing 9 NICUs who will need to fund the tests themselves again after April.

6. CE-IVD for commercial sales within Europe (by April)

7. Tax credit £800k (March)

I’m quite sure it will be full rollout. What I’m unclear about though is whether it will be all neonatal units or just the NICUs. From previous correspondence I’ve had with an English distributor I understood that initially the test will be available in the NICUs and then later in all neonatal hospitals… so perhaps that will be the same for Scotland where there are 3 main NICUs.

“Proposed PGx testing also includes point of care (POC) testing in NHS Scotland hospital wards (e.g. a neonatal POC test to identify and remove the risk of permanent hearing loss for babies from gentamicin (antibiotic) induced ototoxicity.“

We know there are 5 new NICUs to be announced soon and that all areas of the UK will be taking part in evidence generation so it’s quite possible 3 of those will be in Scotland (the other two Wales and NI).

Could be any day now.

They are market leaders with their POC tests. To get to this point though they’ve needed to raise funds through dilutive fundraising, which is what every company on the AIM market does in order to grow hence why share prices tend to go down over time. Huge upside from here though :)

Newbieinvest, there is tons of news expected by April. I expect 5-8p will be reached in the next couple of months. I'll post a list of nearterm news items this evening unless somebody beats me to it.

We only heard about the Scottish rollout about 3 months ago via the Scottish positive appraisal. The thing I posted below came out a few days ago.

The NHS Tayside P4Me – CYP2C19/ clopidogrel innovation is undergoing approval for rollout to other Scottish healthboards through the ANIA programme. This testing is seen as a pathfinder to broader PGx testing in NHS Scotland. Proposed PGx testing also includes point of care (POC) testing in NHS Scotland hospital wards (e.g. a neonatal POC test to identify and remove the risk of permanent hearing loss for babies from gentamicin (antibiotic) induced ototoxicity.)

Scottish rollout is coming...

The company is heading in the right direction for sure with 2 ground breaking tests and backing from NICE on the cusp of major commercialisation.

Should see several significant rises in the share price before they *may* need to fundraise late summer. Hopefully sells / commissioning for both tests will remove the need though.

Fundamentally we’re in a far better position. In terms of share price for newcomers or those averaging down the company has never looked stronger.