Member Info for JimiHendrix

As of now, UK community pharmacies are more likely to offer point-of-care (POC) testing for something like CYP2C19, if it's rolled out in that setting...

Here's a breakdown of how this might play out:

Point-of-Care Testing in Community Pharmacies — Likely Scenario

Trend toward decentralization: There's growing NHS interest in using community pharmacies as frontline health hubs (e.g., Pharmacy First scheme). Offering pharmacogenomic tests like CYP2C19 at the point of care aligns with that vision.

Practical advantages:

Faster results for time-critical decisions (like stroke/TIA antiplatelet choice).

No need for cold chain logistics or central lab coordination.

Patient convenience: walk-in access and rapid turnaround.

Genedrive's tech is built for POC:

It uses buccal swabs.

It doesn’t need a full lab.

Designed for rapid, near-patient use (results in

It is POC tests for the community pharmacies, from what I have read previously.

I think they're built in the UK but could be mistaken.

Can you send links? I can’t find any mention on socials about this.

Many smaller EU countries don’t have their own regulatory body and will in fact look directly at NICE’s recommendation, so we could see some adoption very quickly. Particularly considering the sales team have already been doing the ground work.

Also NICE guidance is quite influential in EU countries, it will give the CYP2C19 test credibility and help support adoption.

Looks like there’s a 24 hour delay in showing trades.

Management should publish a QA, good idea John. Thus would be most useful after the NHS Pilot implementation guide has been released and CEIVD marking received imo.

Nice one Eureka! It was odd that they only received £500k, glad to hear that they are chasing it.

Glad to hear they are busy commercialising. I think the NHS/NICE pilot study outcomes will be something they would want to have before any kind of presentation, there wasn't much about it at all in the interims and all I"ve found online is about Doncaster who are using the labs...

https://www.dbth.nhs.uk/news/130-patients-tested-in-groundbreaking-stroke-pilot-at-dbth-with-20-identified-for-life-changing-treatment/

But with a focus on time critical mini/minor strokes the POC test should be the prefered option... "Running from December 2024 to April 2025, the pilot is focused on high-risk patients, such as those who have had a mini-stroke or minor stroke."

Tally seems to be gaining quite a lot of interest from the public, perhaps insiders buying the shares up too. I've decided to hold mine, I also think the price will go up once people who are desperate to sell have sold.

This might be new, a Barcelona based distributor (B Value Group) has recently been reposting a lot of Genedrive’s CYP2C19 posts on LinkedIn.

“Welcome to b-value where innovation meets healthcare excellence. We are a pioneering medical devices company that has redefined the commercialization chain by embracing a holistic approach rooted in the principles of value-based healthcare. At the heart of our mission is a commitment to revolutionizing the way medical devices are produced, marketed, distributed, and utilized, all with a singular focus on improving patient outcomes.”

All I know is one of the new 5 NICUs going live on 1st May must be in Wales.

"The PALOH-UK study, which began in November 2024, will involve 14 NHS neonatal units across England, Scotland, Wales, and Northern Ireland."

"In Wales, the University Hospital of Wales (UHW) in Cardiff houses a large Neonatal Intensive Care Unit (NICU), and a regional unit, while Singleton Hospital in Swansea also has a significant NICU, and pharmacogenomics is being increasingly integrated into healthcare delivery, with a focus on tailoring drug therapies."

I think it'll probably start moving up after the equity fundraise has successfully completed tomorrow. Once that is confirmed the company should have cash until early October. Not including the approx £1m expected for minimum sales during that period...

- Estimating £250k for the 5 new NICUs going live in May as part of PALOH-UK group 2

- Estimating £450k for restocking the 9 existing NICUs by May

- Estimating at least £300k for initial Scotland orders by October (could be more but I'm conservatively expecting 6 initial units as part of the phased rollout).

I'm flattered, thank you Gloria lol. No I have just accumulated a lot of research and am attempting to piece everything together to figure out what is likely to happen. I do think we'll see FDA progress soon after receipt of CE-IVD certification.

I have a few friends in the medical profession which helps put things in to perspective and context, most of whom hold shares.

I also think it's reasonable to think that receipt of the CE-IVD marking for CYP2C-19 may trigger an update on the FDA submission or indeed the actual submission.

Genedrive is systematically advancing its CYP2C19 ID Kit through UK and European regulatory pathways and clinical validations. These efforts are designed to build a solid foundation for a future FDA submission, ensuring comprehensive data supports the application.

We should receive an RNS for the 9 existing NICUs restocking for the next 12 months this month, which must be around £450,000. Plus 5 new NICUs adopting from 1st May, bringing in the remainder from PALOH UK which will be around £250k.

Additionally the CYP2C19 testing implementation guide and toolkit from the NHS pilot is expected anytime now, and positive mention of adopting the point of care test could sky rocket the share price here, with an £8.5m annual UK market.NHS England will be looking to rollout before Scotland imo, or at least at the same time (October 1st).

Amers, I only know what the company has said that it will be up to 18 months man’s from November 2024 and that they can submit the evidence before then if they are satisfied. I’m half anticipating that there could be an early submission after the group 2 NICUs have been taking part for 6 months, so a total of 12 months evidence generation (Group 1 - 1st Nov 2024 to end of April 2025 and Group 2 - 1st May 2025 to 1st November 2025) …but if it’s the full 18 months that Genedrive have said then we can expect it around Spring/Summer 2026.

Ah clearly RNR1… well my thinking is they are waiting for the PALOH UK evidence generation which I imagine will be used in the submission a to reduce the need for or amount of US studies.

Are you referring to the CYP2C19 kit or RNR1 kit?

Great find John! That might be the grant funding opportunity mentioned in the interims RNS.