Genedrive Share Discussion Threads

[z1co] 26/7/2024 09:44

Can't buy a bean @ 4.15p!!!

[countbasie1] 26/7/2024 09:42

BatiatusHave you found Spartacus?

[bones698] 26/7/2024 09:41

People buying in before the news only today and Monday before it might arrive. Could see 5-6p by end of play Monday if people pile in the rush

[diggit180] 26/7/2024 09:39

She's turning

[z1co] 26/7/2024 09:29

Has gone NT to 50,000 @ 4.05p

[countbasie1] 26/7/2024 09:27

Happy days

[z1co] 26/7/2024 09:25

Off topic

Is Beeksy still in the bathroom ???

[z1co] 26/7/2024 09:23

hazl

This Batti is also one of the worse having sold her small trade last week she's been causing havoc with her LIES and i'm actually very surprised that BROWNSTONE did not ban her for posting LIES.

She has also cost the small traders by scaring them to sell with her LIES.

And even created 2 fake id's over the weekend.

[z1co] 26/7/2024 09:17

After all nasty and deramping posts the price is close to 4.0p than 2.5p.With only 2 trading days left the MM's are about to share price back towards the 5p region before the expected APPROVAL news.

[z1co] 26/7/2024 09:13

Absolutely hazl

Some nasty peeps who have scared the small traders on to selling their shares ahead of what will be a transformational week for this company when it gets approval for this WORLD CLASS PRODUCT

[hazl] 26/7/2024 09:10

So they are getting back in again Z1CO.
Nasty bunch....cheating the little guys out of their shares with fear mongering.

IMO

[bones698] 26/7/2024 09:09

Batiatus filtered another deramp ing mong with no cats or figures to back up his one liners. So many trolls these days who can't put together a decent reason and debate but just come out with stupid one liners.

Unfortunately a reflection of the state of this country, but that's another topic.

Meanwhile sce heading north as buyers will want in got the NICE news and rollout plan.

[z1co] 26/7/2024 09:08

Batti

Are you watching the price , keep watching it all the way to 5p before it explodes upon approval confirmation.

You're just a 2 bit clueless trader

Ho hum

[z1co] 26/7/2024 08:59

Edit

Price now 3.85p V 3.90p

[z1co] 26/7/2024 08:58

MM's have been getting a lot of cheap shares from traders like Beeksy and others ahead of the anticipated surge in volume and share price next week.

Currently i can SELL 500,000 at above the mid price and yet can't buy even 50,000 @ 3.85

[z1co] 26/7/2024 08:53

LOLOL

This batti is a BLATANT LIAR having already lied that GDR has got no products approved , he's posted another above.

Idiot there are a lot of people that wants this test to get approved.It's likly to save 1000's of lives every year.

It will be significantly important for the NHS hospitals to have such a test.As well as saving lives it will save the NHS £ millions.

STOP POSTING LIES

[batiatus] 26/7/2024 08:43

Or the share price will fall sharply.

Buy on rumour selling on news.

No one actually believes in GDR.

They are only here for the spike in share price

[bones698] 26/7/2024 08:00

2 days trading left before the 31st so watch as people buy in before it arrives. Mkt cap 20m and we know Nice will give it full recommendation and plan to roll it out ASAP.. 7000 tests plus machines is a nice revenue stream to begin with. All imo I expect this to rise sharply very soon

[z1co] 26/7/2024 07:49

3 April 2024

NICE recommends the Genedrive® CYP2C19-ID Kit

Genedrive® CYP2C19-ID test for genotype-guided clopidogrel treatment in the NHS

chosen as the preferred platform for UK point-of-care genotype testing

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.

Clopidogrel is an antiplatelet drug used after IS or TIA to reduce the risk of blood clots that can cause further strokes. Clopidogrel is metabolised into its active form by an enzyme encoded by the CYP2C19 gene which in some people has variations that reduce the enzyme's function which means that clopidogrel does not work as well in these people.

The Genedrive® CYP2C19-ID point of care genetic test uses a single, non-invasive cheek swab sample, and rapidly identifies six important genetic variants of the CYP2C19 gene, which are instrumental in the loss of metabolism function. The Genedrive® System automatically interprets the information for the clinician, allowing prompt administration of an optimised treatment plan.

According to the World Stroke Organization, there are over 77 million people globally who currently have experienced ischaemic stroke and it is estimated by the Stroke Association that there are 100,000 strokes in the UK each year. Suboptimal response to antiplatelet treatment following stroke is common, affecting about 20%-30% of patients in the general UK population, which increases to about 50%-60% in certain ethnic groups.

NICE recommended in the May 2023 draft guidance that people who have just had an IS or TIA should have a CYP2C19 genetic test prior to antiplatelet treatment. Following a public consultation of this draft guidance, which ends on 26 April 2024, final recommendations are expected to be published by NICE on 10 July 2024. The public consultation documents and summary review of NICE's information can be found at:



The specialist NICE diagnostics assessment committee systematically reviewed the clinical and economic impact of genetic testing, including both laboratory-based and POC tests, concluding that it would be beneficial for people with loss-of-function CYP2C19 alleles to receive alternative antiplatelet treatment to clopidogrel and CYP2C19 genotype testing is also cost effective compared with not testing regardless of which alternative antiplatelet therapy people have.

In addition to being dominant in cost effectiveness models, NICE recommends the Genedrive® as the point-of-care platform of choice for CYP2C19 genotyping strategies in the NHS. The decision was based on several differentiating features of the Genedrive® technology; (1) its greater coverage of genetic variants compared to the other point-of-care system assessed, permitting increased equitable access to healthcare across ethnic populations, (2) no requirement for cold-chain storage logistics, (3) its ability to integrate with patient electronic healthcare systems.

As previously communicated, the Company's ongoing valued long-standing partnership with clinical genetics collaborators in Manchester under the DEVOTE programme will supplement our existing clinical performance data used for UKCA certification and lead to anticipated CE-IVD certification and commercialisation within the European Union, and those additional countries that recognise CE-IVD, in early 2025. Following the completion of the DEVOTE clinical performance, together with final NICE recommendation due on 10 July 2024, the Company would intend to actively pursue commercialisation in the UK.

James Cheek, CEO of genedrive plc, said: "We are delighted to receive this recommendation from NICE for our CYP2C19 point of care pharmacogenetic test. The NHS has done significant work on both strokes and mini strokes, with campaigns for FAST (Face, Arms, Speech, Time) and promoting changing lifestyles to prevent a stroke. This guidance is just the next step in stroke management, ensuring that if you have a stroke, specifically related to a disruption of the blood flow, that the medicine given has a positive effect. Clopidogrel is the NICE recommended front line treatment for these types of strokes. However, if you are one of the estimated 20%-30% who are unable to metabolise Clopidogrel effectively you have the opportunity to be identified quickly and given an alternative medication. We are delighted to be part of this change which is in line with our strategy to deliver point-of-care pharmacogenetic testing to positively impact patient outcomes. With MT-RNR1 getting a NICE EVA conditional recommendation last year, further funding applied for to achieve a full recommendation this year, a strategy in place to achieve Food and Drug Administration ("FDA") approval and sales being realised from new customers in 2024 we feel there is growing momentum within the Group's POC pharmacogenetic testing strategy."

[z1co] 26/7/2024 07:46

Contrary to what all the drerampers are commenting , they will be gone once we get the confirmation that NICE has approved CYP2C19 Test next week.

21 May 2024

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.

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 ( The draft guidance is expected to be finalised on 10 July 2024.

James Cheek, CEO of genedrive plc, said: "This study has been invaluable in progressing our requirements for CE-IVD certification to complement our existing UKCA certification. Our CYP2C19 test is the only one we are aware of that can deliver clinically actionable results for these DNA variants in the CYP2C19 gene in a rapid timeframe in emergency care settings at the point of care. We are excited that the availability of this intervention has the potential to make a difference to patients' lives and we look forward to working with UK stroke networks in the NHS to bring this vital test into day-to-day use."

Professor Bill Newman, Professor of Translational Genomic Medicine at the University of Manchester and Lead of the NHSE Network of Excellence in Pharmacogenetics and Medicines Optimisation at Manchester University NHS Foundation Trust, said: "It has been very positive working with genedrive as part of the Innovate UK funded DEVOTE project to test clinical samples and determine how well the assay performs in this setting. It is clear that the test will offer an effective rapid solution to doctors and pharmacists to guide effective prescribing for patients with stroke."

Professor Ben Bridgewater, Chief Executive at Health Innovation Manchester, said: "This is a great example of how the GM Health Innovation Accelerator programme is supporting development of our innovation ecosystem specifically in this case through validation of a novel and valuable rapid diagnostics test. Congratulations to genedrive for this achievement as they continue to collaborate with academic strengths in the city region to develop products to improve the health of our local population and address inequalities in care."

[hazl] 26/7/2024 07:33

And a reason I have only started a handful of threads.
They are too much hard work.

Unbelievable to think that these people must be adults.

[hazl] 26/7/2024 07:31

Two good posts.

[brownstone22] 26/7/2024 00:14

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[z1co] 25/7/2024 23:41

WOW

Beeksy has NOT posted for over 6 hours, at his age he probably needed a proper clean up