Member Info for Eureka01

With respect, Espen35, the email Joey received is no different from what the company posted on June 27: "genedrive plc (AIM: GDR), the point-of-care pharmacogenetic testing company, acknowledges, as announced on 3 April 2024, that the UK's National Institute for Health and Care Excellence ("NICE") has recommended in draft guidance that CYP2C19 genotyping should be used to guide clopidogrel use after Ischaemic Stroke ("IS") or Transient Ischaemic Attack ("TIA"), and that the Genedrive® CYP2C19-ID test should be used as the test of choice for point-of-care strategies.

The final publication was expected by NICE on 10 July 2024, but the Company notes from the NICE website that this has recently been extended to 31 July 2024"

Whatever the arguments about how long it would take to scale up the POC tests or lab testing, POC testing has some clear advantages over lab testing. There is an excellent article on POC v lab testing by Truvian, a specialist provider of POC blood tests. The salient points:

"Altogether, it can take up to a week from when the patient provides the sample until the results are delivered due to shipping, lab capacity, test processing, and data sharing."

"Patient test results from point-of-care diagnostics are usually delivered quickly, and they require only a minor amount of training"

" Rapid test results empower providers to integrate data into their treatment plan, with clear benefits across different care settings"

" POC testing achieves significant cost-efficiencies for patients and providers"

https://truvianhealth.com/blog/point-of-care-testing-vs-laboratory-testing/

Stocksaint, as has been pointed out multiple times, labs are too overstretched and time consuming so the POC test would still be in great demand.

No problem Roger65, we won't argue over semantics :-) . For the avoidance of doubt this was how the announcement in April was worded: "genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, announces that the UK's National Institute for Health and Care Excellence ("NICE") has recommended in draft guidance that the Genedrive® CYP2C19-ID test should be used as the point-of-care ("POC") test of choice before clopidogrel administration in the management of Ischemic Stroke ("IS") and Transient Ischaemic Attack ("TIA") patients"

Honest_money, At the moment the stroke test has provisional recommendation. A full recommendation is expected both by the market and by the company themselves who regard it as in the bag. Full recommendation would allow the test to be used and funded by the NHS throughout the UK. It is believed that Genedrive has been ramping up production of the test in anticipation of this. I myself have had confirmation from the company that they expect sales to kick in from September.

"The trusts have to follow NICE guidance."

The response I had from NICE when I enquired about the delay to the final publication (previously scheduled for July 10) sounded to me like a positive outcome as to what that guidance will be:

""RE CYP2C19 genotype testing to guide clopidogrel use after ischaemic stroke or transient ischaemic attack

Resolution has now concluded, so we plan to publish as soon as we can. NICE is working in partnership with colleagues at NHS England and NHS Improvement, to develop a resource to support the implementation which will publish alongside the final guidance. To allow time for the implementation resource to be finalised, the earliest anticipated publication date for the final guidance will be 31 July 2024."

Yes,rbr08, there's a lot of news we can look forward to re the AIHL test in the next 8 or 9 months:

Additional sites in the UK for AIHL....any time

Commercial progress for AIHL in Europe and the Middle East....any time

FDA, start of submission process for AIHL....late 2024, subject to funding

Specialist commissioning for AIHL....by April 2025

Most people who trade, at least with CFDs, lose money. The European Securities Markets Authority (ESMA) reported that between 74% and 89% of all new CFD traders lose money.

All the focus is on the stroke test at the moment with NICE publication due next Wednesday but let's not forget AIHL. This latest post from the company on linkedin:

NICE guidelines state sepsis in newborns should be treated within the golden hour. The first line treatment is gentamicin, an aminoglycoside antibiotic which can cause permanent hearing loss in patients with a variant in the MT-RNR1 gene.

In under 30 minutes healthcare professionals can perform a rapid genetic test to identify patients who are susceptible to aminoglycoside induced hearing loss, before prescribing antibiotics.

•The Genedrive® System includes connectivity to various middleware platforms to automatically record results, which are displayed in an easy to interpret format on the touch screen.

•Evidence shows that implementing the test does not significantly change the time to antibiotic prescription.

•The test can be performed by nurses with no laboratory experience required following training sessions with our dedicated team

One nurse, who has been using the test, said, “at first I was a bit wary of it, because you don't know what it's going to involve but I thought it was going to delay giving all the antibiotics… but when you see how quick it is and the benefits of actually doing it, it makes sense to do it.”

https://www.linkedin.com/company/genedrive-plc/posts/?feedView=all

I posted this on the 19th June when the sp was 1.925p: "No idea what the price will actually be if good news, as expected, arrives on the 10th but I'm pretty sure 1.5p will be a distant memory." Then we had a slight delay but that 1.5p will IMO still be a very distant memory.🙂

The big boys are moving in.🙂

Some recent headlines:

FDA Grants Emergency Use Authorization for Nano-Ditech's Flu/COVID Point-of-Care Test

Published on Jul 24, 2024

Genalyte Receives FDA 510(k) Clearance for TSH Assay on Point-of-Care Maverick Device

Published on Jul 23, 2024

Nuclein Submits Combo COVID, Flu Point-of-Care RT-qPCR Test for FDA 510(k) Clearance, CLIA Waiver

Published on Jul 22, 2024

Hopefully Genedrive's name will be up there one day as well. 🙂

Slacker246: "Can any Ramper answer me a question

What do you expect from a NICE recommendation for the stroke marker test??"

I'm not a ramper but I'll answer the question. As I posted previously, I had this from the company: "Commercialisation of the stroke test in the UK has already started. The company is in discussions with trusts, stroke centres and health Innovation groups. Most will wait until the recommendation is published at the end of July but the company is looking at first sales coming in from September onwards."

Whilst we are all focused on the impending stroke test news due exactly a week from now let's not forget that big news from last week concerning the MT-RNR1 kit. This from the CSO on Linkedin:

"FDA "Breakthrough Device Designation" awarded for our MT-RNR1 kit!

- recognising that it "provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions", in addition to "there being No Approved or Cleared Alternatives" and "Device Availability being in the Best Interest of Patients".

The Genedrive® MT-RNR1 kit is the world's first rapid point-of-care test to screen infants in an urgent care setting for a genetic variant that can cause life-long hearing loss when carriers of the variant are given certain antibiotics. Those infants identified as carrying the variant can then be given alternative antibiotics. It has the potential to save thousands of children from lifelong hearing loss, whilst providing a net positive financial outcome case to healthcare systems.

The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorisation. Breakthrough Devices must meet the FDA's standards for device safety and effectiveness in order to be authorised for marketing.

In 2021, 3.7 million babies were born in the USA, with 10.5% born prematurely. It was estimated that malpractice litigation settlements in cases related to deafness caused by the use of aminoglycosides average over US$1.1 million per case, further adding to the positive health economic case of providing accurate and timely testing to reduce unwanted side effects of gentamicin usage. Extrapolating from UK figures, it's estimated that approximately 1,000 babies per annum in U.S. Neonatal Intensive Care Units ("NICU") are at risk of aminoglycoside induced hearing loss."

Genedrive is not a one trick pony!

My apologies for yet another exposé but I feel it's important for people to know where these bashers are coming from.

Stocksaint didn't always post under that moniker. Previously he posted under the moniker of a notorious deramper, starresnstoff. The evidence? My thanks to GloriaMarket for this shrewd detective work last year:

"Stocksaint = Starresnsnstoff evidence

1. both initials SS

2. same writing style

3. same lack of grammar

4. same deramping posts (or realistic posts - depending on how you interpret them)

5. starres also mentioned 12p as support

6. stocksaint was created last weekend - the weekend Starres was banned, presumably

7. stocksaint hasn't posted anywhere else."

Starresnoff aka starres became so irksome that he was eliciting this sort of comment:

"Starres.. have you ever considered that.. for all you know.. you might be a lunatic?"

Finally one poster had enough:

"I have never posted on a BB I am not invested in, ever before - and I humbly apologise for doing so now - However, I felt the need to do so in the case of the Now, Your Poster - 'starres'.

Starres sold up his holding in Our GDR back in April, and bought into your LON: Bur - However, he continues to post masses of Derogatory posts on our GDR BB - even though he is No-Longer Invested in GDR.

"If you can please stop 'starres' from posting on our GDR BB, I will not post another post about 'starres' on your BB. I am asking for Your help here !!"

It seems to have had the desired effect. Starresnoff was banned as he never posted under that moniker again and all his posts disappeared. But who suddenly appears...stocksaint!

Nowadays he is very tight lipped when questioned but he did drop one or two clues initially as to where he was coming from and to his trading style:

"And another thing, I've worked with the pharma industry for nearly 30 years" 13/08/23

"I put 5k in yesterday as thought it might bounce off 12p. If it falls below 11p, I'll probably sell" 15/08/23

Over the last year he has posted 574 times almost entirely on the GDR board. So the possibilities:

He is a short term trader.

He is a shorter.

He is a disgruntled ex share holder who lost money on his trades.

An intriguing possibility mentioned by one poster, he own a testing laboratory or at least works in one.

Whatever the truth, it seems incredible that someone presumably no longer invested in view of his negative comments continues to post day after day on this board.

" they really going all out on lab testing " Ok stocksaint so please tell us:

1)Why the company is not concerned about competition from lab tests because of the speed of the POC tests compared to lab testing?

2)Why the response I received from NICE seems to indicate that they are taking GDR's test very seriously:

"RE CYP2C19 genotype testing to guide clopidogrel use after ischaemic stroke or transient ischaemic attack

NICE is working in partnership with colleagues at NHS England and NHS Improvement, to develop a resource to support the implementation which will publish alongside the final guidance. To allow time for the implementation resource to be finalised, the earliest anticipated publication date for the final guidance will be 31 July 2024."

Would they really be going to all that trouble if the test was going to be side lined??

"They say GDR's point of care is best alternative." So, stocksaint, according to the article I just posted, GDR's test could be cost saving and could reduce the rate of secondary strokes all backed up by a recent real-world study of 1,530 patients comparing central lab testing to point-of-care genotyping where the POC group received much faster actionable results with significant savings on medication costs​. Which would you choose??

Genetic testing can identify those at risk of suboptimal response to Clopidogrel and alternative treatments can be selected. However, testing in a central lab facility delays the result and the correct treatment cannot be started immediately.....

Point-of-care pharmacogenetic testing is advantageous in selecting the right treatment for the patient’s genetic make-up and starting that treatment straight away. A recent modelling study of UK stroke management pathways concluded that use of the Genedrive® CYP2C19 ID Kit in stroke units could lower the rate of secondary stokes. The data also suggested the POC strategy could be cost saving​ ....

A recent real-world study of 1,530 patients compared central lab testing to point-of-care genotyping. The POC group received much faster actionable results with significant savings on medication costs​ ....

"Our vision is to enable these paradigms, and our product solutions for point of care MTRNR1 and CYP219 variants unlock emergency care pharmacogenetic testing in these indications. Approaches such as these are the future of pharmacogenomics in emergency care and will ultimately significantly improve patient outcomes as well as being cost-effective for healthcare systems."

https://www.ttp.com/insights/distributing-diagnostics-locations-motivations-metrics-part-3/

A concerted attack by the shorters and the short, by the disgruntled and the undisclosed in the days leading up to the NICE final decision. I would remind that small but persistent band of dissenters that the company themselves are not concerned about competition from laboratories. It's like comparing horse drawn carriages and Ferraris when it comes to speed of results.. And from what I've seen from NICE and company sources, full recommendation is already in the bag.

"Such a simple question to the naysayers" The question was put to Shivest and he didn't answer it but he has previously disclosed his position:

"Sold on the bell at 3.66, had a quote to buy back in at 3.52, but refreshed it too many times hoping for it to dip below 3.50."

Note the difference of tone before and after the sale.

Before

"I've bought back in now, hoping this is bottom of the tree shake. If not, still got NICE to look forward to" 15/07/24

"I have more shares now than I ever have after a top up last week. I don't want in cheap. I want out expensive" 15/07/24

"Could see a significant move after 2:30" 12/07/24

"There's big upside potential here but I sure won't wait around long to take profit" 12/07/24

"I'd make an exception for GDR as things are looking very bullish over the next few weeks" 11/-7/24

After

"I'm surprised people are buying in when an RNS could drop any second when the technical issues get fixed" 19/07/24

"You still holding onto the 5p dream?" 19/07/24

"I never claimed to know what was going to happen. That's why I de-risked at 3.66" 18/07/24

"Got my money elsewhere now. I'm not looking to re enter" 18/07/24

Conclusion.

Shivest is very active on this board and not posting elsewhere. For someone who sold out and claims to no longer have any interest, there certainly does seem to be a preoccupation with the share.

Still hoping to see the share price lower and get back in??