Member Info for Eureka01

CYP2C19 specialist/national commissioning has been "days/weeks away" since April when it was due. Also "soon" have been the results of the CYP2C19 pilot programme which ended last month. Other news assumed but not officially announced has been the take up by 5 new NICUs for the MT-RNR1 ID Kit and the renewal by the 9 NICUs which already have the kit. Let's hope the company does come out with some news SOON.

A reminder of the previous guidance for CYP2C19 testing from July of last year:

"Use CYP2C19 genotype testing to assess if clopidogrel is a suitable antiplatelet drug for people who have just had an ischaemic stroke or a transient ischaemic attack (TIA).

When offering CYP2C19 genotype testing:

take into account that the prevalence of different CYP2C19 genotypes may vary between ethnic groups

explain to the person having the test the possible implications of the results and give support and information.

Laboratory-based testing

Use laboratory-based testing for CYP2C19 genotype testing.

Point-of-care testing

Use the Genedrive CYP2C19 ID Kit point-of-care test for CYP2C19 genotype testing when laboratory-based testing is not available.

Use the Genomadix Cube point-of-care test when laboratory-based testing and the Genedrive CYP2C19 ID Kit point-of-care test are not available.

CYP2C19 point-of-care genotype testing is recommended only if quality-assurance processes and arrangements are in place."

The implementation guidance is indeed due any time:

"NICE is working with NHS England, who are delivering a national pilot to produce an implementation guide for providers and information to support future commissioning decisions. The pilot will run from October 2024 to May 2025. We will notify stakeholders when supporting information on implementation is available."

https://www.nice.org.uk/guidance/dg59

Todays headline: "Ministers commit to £86bn for ‘breakthrough’ UK science and tech R&D."

It would be nice if a bit of that went Genedrive's way. 🙂

Some had been wondering why we had no RNS the other day when the sp spiked up as much as 30% apparently on the back of the company's social media post: "Now available for order on NHS supply chain". I did ask the company spokesperson why we hadn't had an RNS. I was told that the Company had already disclosed in their March interim results that their products had been accepted on NHS Dynamic Procurement System permitting direct procurement by regional NHS trusts and therefore an RNS was not necessary. Clearly the market hadn't fully absorbed that and it does show what a bit of publicity can do!

The last reference to "specialist commissioning" in an RNS was in the Interims in March of last year. James Cheek wrote: "We continue to pursue all avenues to ensure we achieve specialist commissioning before the current timescale of April 2025." Gino also said, in answer to a question at the IMC in December that he was confident that we would achieve "national commissioning" by April. But here we are in June and still no word.

This is AI's take on the difference between the two sorts of commissioning:

"Specialised commissioning focuses on services for rare, complex conditions, often delivered by specialist teams in specific centres, whereas national commissioning addresses a broader range of services, including some specialised services, with a focus on national coordination and specific areas like vaccines and screening."

A little over a year ago the assumption of the board was that by the end of June 2026, just over a year from now, the company would be breaking even:

"The Board's internal assumptions of revenue growth forecast the Company transitioning to a positive EBITDA position in the second half the financial year ending 30 June 2026." (from the announcement of the fund raise 09/05/24).

However, the company does have a history of over optimistic timelines. When I spoke to James Cheek in July of last year he was sure further fund raises would not be needed and that, of course, proved wide of the mark.

So I wonder if that timeline will hold good. Hopefully so, but time will tell.

Some understandable pessimism today but AI paints a rosier picture:

"Genedrive's CYP2C19 ID Kit, CE-IVD certified under the European In Vitro Diagnostic Regulation (IVDR), is accepted in the EU and in non-European countries that recognize CE-IVD marking. While there's no definitive list of countries, it's understood that some Middle Eastern countries, including Saudi Arabia and Turkey, may accept the certification. Additionally, the UK, having achieved UKCA certification, is also actively pursuing commercialization in these regions, according to genedrive plc.

genedrive plc has also confirmed that they have initial orders from France, Austria, Greece, Saudi Arabia, Turkey, and the Netherlands, indicating acceptance of their products."

30/04/25 B_Positive:

"I said 5-7 RNS by the end of May.

I stand by that prediction.

If I'm wrong and there aren't a minimum of 5 RNS releases from GDR by the end of May then I will leave this place"

02/04/25 : Missed his target but still here. I hope we're not going to have another month of the same copy and pastes he dished out last month!🙂

Agreed Professor. I actually emailed the company spokesperson earlier this month expressing shareholder dissatisfaction with the high BoD salaries considering GDR is a loss making company. I would suggest other shareholders do the same. Maybe they will eventually get the message!

Yes National commissioning for MT-RNR1 is the next thing I'm looking out for. There have been two references to timelines. In last year's interims we were told "We continue to pursue all avenues to ensure we achieve specialist commissioning before the current timescale of April 2025". In the IMC presentation in December Gino also seemed confident that it would happen by April. So we are overdue and I believe it could happen any time.

Just a word to Guy again. You are obviously an embittered shareholder/ex shareholder who has lost a lot of money. You seem to want to take it out on the company and other posters. My fairly innocuous post on another company's success with pharmacogenetics was to emphasize the future of pharmacogenetic testing and that hopefully one day GDR will get there too. That sentiment was echoed earlier today by Gino in his post on Linkedin: "The era of trial and error medicine is ending. Pharmacogenetics is the future. We're proud to be part of it!".

"...Genedrive’s system is specifically designed for use in emergency care, where timely prescribing decisions can be critical. The platform delivers rapid, point-of-care results, helping clinicians select the most effective treatment without waiting for traditional lab testing.

The test has already earned backing from NICE, the UK’s health technology assessment body, which recommended it for use across the NHS. NICE highlighted Genedrive’s superior coverage, faster turnaround times, and stronger economic case compared to lab-based alternatives.

CEO Dr Gino Miele hailed the approval as a pivotal moment for the company."

https://www.share-talk.com/genedrive-plc-aimgdr-received-european-regulatory-approval/

Wide spread. Now 1.5p to buy, 1.4p to sell. 11 million shares traded.

6 million shares traded already. 1.45p to buy, 1.4p to sell.

Whilst I do not anticipate immediate sales from this news I hope the groundwork has been laid to have a pipeline of orders in the coming months:

" we have also focussed efforts on defining market access routes in specific European countries which CE-certification now permits, and in non-European countries in which it facilitates registrations. "

Good news. Guy will find something negative to say about it!🙂

Careful. Guy will accuse you of "fanatical ramping". 🙂

Guy, you just don't get the bigger picture do you. Haven't you got better things to do than trash the company 24/7?

Pharmacogenetics is catching on big time. This announcement yesterday:

"Helix, a leader in precision health, is announcing the release of a new suite of pharmacogenomics (PGx) tests, including a test designed to identify patients with DYPD gene variants who may be at increased risk for side effects from certain chemotherapies...Helix's PGx tests typically return results within minutes, allowing for the first time, access to genetic insights at point of care..."This is really about quality and safety, and is something we should be doing for every patient on these medications".

https://finance.yahoo.com/news/helix-expands-pharmacogenomic-test-portfolio-130000661.html

Substitute the company name and the conditions and this announcement could equally have applied to Genedrive .🙂

That would indeed be great news....in fact a game changer. What's your source Jimi?