Member Info for Eureka01

" There is increasing evidence for the utility of pharmacogenomics in clinical practice to reduce adverse drug reactions and/or improve drug efficacy. This is evidenced by the introduction of DPYD (dihydropyrimidine dehydrogenase) genetic testing before the use of fluoropyrimidines and the recent approval by NICE of CYP2C19 genetic testing prior to the use of clopidogrel in patients who have suffered a stroke or TIA. "

https://my.bps.ac.uk/events/details/?id=45e71bda-3853-ef11-bfe3-7c1e522d5604

"Currently, there is no NHS laboratory-based genotype testing for CYP2C19 in England. NICE is therefore working with NHS England to deliver a national pilot to inform future implementation of CYP2C19 testing in stroke. The NHS England pilot is at an early stage and we will keep you updated as information becomes available."

https://ney-genomics.org.uk/pharmacogenomics-in-focus-aug-sept-2024/

Allguessing January 2023: "I know I am the most miserable poster on here". You've got some competitors but it's a close run thing.

I'm with the company on this one. We have the Final Results probably next month when all will be revealed and it's an expensive thing to put out RNS's all the time. What company does announce every sale?

A little patience needed.

A while ago someone posted the link for the batch numbers: https://www.genedrive.com/assays/cyp2c19-documentation.php

19-Jun-24 CoA Genedrive® CYP2C19 ID Kit Lot Number 241701

18-Sep-24 CoA Genedrive® CYP2C19 ID Kit Lot Number 243601

So, assuming the numbers go up sequentially, 1900 kits have been produced in 3 months. Hopefully those are on the back of sales, not to put in cold storage!

I have , like many here, been concerned by the lack of news on sales of the stroke test from the company since NICE's final published guidance. So I contacted the company on this issue. The response I received from a company spokesperson offers some reassurance and at least an explanation. "We can’t update with every sale, but Salford is the largest Hyperacute Stroke units (HASU) in England and the significance of it being the first to implement the test warranted release."

So hopefully sales are going on in the background but the company just aren't telling us!

John Henry, "At least companies like POLX in a very similar position to GDR but with a vastly bigger market are upfront with targets and have said they will be profitable by the end of 2027..."

Well, from their internal forecasts GDR has said it expects to reach break even by June 2026. so a year and a half before POLX!. Moreover, James, when I spoke to him, seemed confident that another fund raise would not be needed.

Hmmm, I see there are some who are determined to trash the company at all costs. Question is...if they have no faith in the company and the future of its products why are they here in the first place??

JohnHenry, You're forgetting that GDR raised £6 million in the placing. So probably around £4.5 million cash remaining which hopefully will see them to break even.

The pessimists are forgetting the potential good news to come.

!)AIHL test additional go live sites in the UK. Any time.

2)Stroke test additional go live sites in the UK. Any time.

3(AIHL test sales in Europe. Any time.

4)Commencement of FDA registration for AIHL test. By the end of the year.

5)CE-IVD for stroke test. Early 2025.

6)Specialist Commissioning for AIHL test. By April 2025.

7)Eventual FDA approval for AIHL test to permit sales in the US.

Hi Gloria, What I was told: " "We are looking to get further sales in Europe and the Middle East from September onwards, a lot of the pilots are due to finish at the end of July but with most of Europe shutting down during August we are looking at further progress coming in September onwards."

Not yet the end of September but if it doesn't happen please don't shoot the messenger!🙂

Hi Roger, The route for MT -RNR1 is the De Novo one. From the wording of the announcement "genedrive intends to pursue the FDA De Novo regulatory pathway for entry into the U.S. market" I would understand that it has not yet started, assuming that the company will put out an RNS when it does start.

Systemzero, filtered. I can put up with your countless daily predictions which rarely turn out right (even the broken clock is right twice a day) but not your insults.

Gloria, I posted the company explanation earlier: "We are currently in discussion with a number of CYP2C19 testing centres in the USA and Key Opinion Leaders". The FDA was not mentioned as being part of those discussions. Make of that what you will.

To clarify the earlier debate, I have had further confirmation from the company spokesperson that the uncertainty on the route to take concerns the stroke test (CYP2C19-ID Kit) as was made clear in the response I quoted previously but the RNS of the 15th July referred to the AIHL test (MT-RNR1 ID Kit). So there has been no change of mind as they are two different tests!

The route for one test ((MT-RNR1 ID Kit)) has been decided, the other (CYP2C19-ID Kit) has not. My apologies for my part in the confusion.

Ok, I'll shut up. I really don't care if I am believed or not, but, as I said, don't shoot the messenger!

Lionel, the response clearly refers to CYP2C19 FDA!!

Ok so now it's turned. Maybe there is something there or just rumours?

"SCGL About to moon . Just heard huge news on route" Hmm. I see Jimbob is spamming that on multiple sites. Result? Sp down 2%.

For the timeline I would refer you back to the answer I had from the company:

"We are currently in discussion with a number of CYP2C19 testing centres in the USA and Key Opinion Leaders to consider if we go with a reduced solution via a 510k submission using Genomadix as a comparator or if we go via the Denovo route with all of our testing capability.

The 510k route could be quick and give us access to the USA market with 6 to 9 months but we would only be able to operate in the same way as Genomadix or the Denovo route takes 18 months to 2 years but would allow us to compete with the full range of the CYP2c19 test. Once we have gathered all of the information from the references in the USA we will make a decision."

Hi BigAl, I have already posted the relevant snippets from the 2 emails I received on the subject. All my communication is through Walbrook. I just happened to have been lucky enough to have had one to ones arranged with both David Budd and James Cheek.

Roger65, they're not having second thoughts on whether to go into the American market but just which route to take!