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The UK's National Institute for Health and Care Excellence ("NICE") has recommended in draft guidance, that the Genedrive® CYP2C19-ID test should be used as the point-of-care test of choice in the NHS before clopidogrel administration in the management of IS and TIA patients
That reads decent tbf
Where’s the money coming from to keep going ?
Massive achievement after a long wait and way overdone stock.
Ey CYP2C19-ID test performance milestone achieved
genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, is pleased to announce that a key milestone has been met in The Development and Validation of Technology for Time Critical Genomic Testing ("DEVOTE") programme for its CYP2C19-ID kit. The programme has now passed the patient numbers required for a subsequent submission for an in vitro diagnostics CE certification ("CE-IVD"), which is still anticipated in early 2025.
The Genedrive® CYP2C19-ID point of care genetic test is UK Conformity Assessed ("UKCA") certified, uses a single, non-invasive cheek swab sample, and rapidly identifies several important genetic variants of the CYP2C19 gene (Loss Of Function ("LoF")), which are instrumental in an individual's response to the drug clopidogrel which can be prescribed in Ischemic Stroke ("IS") and Transient Ischaemic Attack ("TIA"). The test automatically interprets the CYP2C19 DNA variant information for the clinician and allows for prompt administration of an alternative treatment plan for the circa 30% of individuals that are less likely to respond favourably to clopidogrel.
DEVOTE is an all-comer study in which CYP2C19 DNA variants in patients presenting in the acute emergency care setting are tested with the Genedrive® CYP2C19-ID test and results compared with those obtained by reference laboratory platform testing, with testing on a third laboratory platform in instances where there is disagreement in test results. In the tests run to date the Genedrive® CYP2C19-ID test has out-performed the reference laboratory-based test with respect to coverage of LoF variants and accuracy (correct identification of variant).
The DEVOTE programme, through its lead partner the University of Manchester ("UoM"), has supported the Company's requirement for assessing performance in acute care patients and provided valuable supporting infrastructure to assess the real-world clinical performance of time-critical clinical tests in NHS settings. The study addresses clinical requirements of the In Vitro Diagnostic Medical Devices Regulation ("IVDR") for CE-IVD submission and subsequent commercialisation in those countries recognising CE-IVD, in addition to current UKCA certification allowing UK commercialisation.
Approximately 30% of patients in the cohort harboured CYP2C19 LoF variants as expected. The Genedrive® CYP2C19 test outperformed the laboratory test with respect to accuracy of identification of LoF alleles, and broader inclusion of LoF alleles. Genedrive® CYP2C19-ID test results are available in ~70 minutes.
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 test of choice in the NHS before clopidogrel administration in the management of IS and TIA patients (https://www.nice.org.uk/guidance/indevelopment/gid-d
Nothing stopping this quickly of returning to 10p
Key CYP2C19-ID test performance milestone achieved
genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, is pleased to announce that a key milestone has been met in The Development and Validation of Technology for Time Critical Genomic Testing ("DEVOTE") programme for its CYP2C19-ID kit. The programme has now passed the patient numbers required for a subsequent submission for an in vitro diagnostics CE certification ("CE-IVD"), which is still anticipated in early 2025.
GLA.
Stephen11.
Speaking if hitting a milestone, milestone rns
Positive RNS
Should see a little pump to .20
They definitely stand a chance of doing it if they can raise the £6m. On the other hand, will always be significant chance of another raise, especially is £6m isn't really a lot of money, so little margin for error in the forecast. At the same time, if they hit some milestones, they might not so much difficulty raising more money from IIs anyway.
It’s stated in the 9 May RNS the forecast is positive EBITDA in first half 2026, it also details how they’ll get there in respect of sales and revenue from each product, subject to the expected caveats.
True Slacker, but why bother repeating the same tiresome post over and over again. There's lots of basket case companies on AIM anyway. To me the very fact that the REX platform exists is further proof that AIM is in trouble. It obviously difficult for firms like these to raise all the capital they need from IIs in the traditional way as before, through underwritten placings.
Stand back everyone.. what's left of Spackers brain is about to explode...
This investment has only ever a been a complete and utter bag of sh ite.
GENEDRIVE moves at a painful absolute snails pace and we are rinsed dry of £400.000 every single month WTF!!!!!!!!!!!!
The reason the company discounted by such a large percentage is because they feared they would not get the up take they need. And by their own admission they would find it difficult to get funding by other means.
From a shareholder perspective they have destroyed the share value and have diluted massively so have been hit twice . Whilst the executives have not sacrificed any salary in the pursuit of financial security.
On the up side the business will be e funded for at least 12 months.
But there’s a huge question mark as to when they will reach breakeven point with sales income let alone make a profit.
They have made predictions of potential sales in both the Uk and Europe but haven’t put timescales .
So anyone buying in will be blind to the likelihood of true success . Cheek has already shown he can’t be trusted just as Budd couldn’t be either ….time will tell…. I guess….. IMHO
No need to take up the placing offer as this is now going to be cheaper than 1.5p you just couldn’t make it up.
I don’t see it dropping below 1.5 before the Placing, but I see it dropping below that leading up to the stroke news.
Yes a kick in the teeth to shareholders if it drops below placing price
I would say to turn the other Cheek but that would be just wrong
Genedrive have no income but they continue to spend £400,000.00 every month !!
What do they spend this money on??
Cheeky takes 6.25% every month !!
If its definitely going below 1.5p and probley closer to 1p than 1.5p !!!!
If this drops below 1.5p before the 31st will the £6m target fundraise not be met? Then what? Conditional placing doesn’t go through and shareholders get left holding a steaming bag?
Of course it's going down to the placing price seen it too many times. If they had done the placing at 3p the SP would have reacted a lot more positively. we might even have climbed to 4 or 5. Lost all confidence in the BOD.
Gloria.. you appear to have been drinking.. I approve.. sometimes it's necessary in order to say what needs to be said.
Meanwhile.. Joey.. you make me LMAO.. once a cretin always a cretin LMAO
Under 1.5p unfortunately.
Has everyone sold their holdings to buy back cheaper later ? 🤔
"Bigliar67- you said we where funded until 2025 without the need for a raise, you clearly lied again!"
No mr Carlos, mr bigal didnt lie, hes simply not very good at simple maths nor reading RNSes and then calls his opinions " the Truth" with a capital T.