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.....and NICE guidance now states that CYP2C19 testing must be done within 24 hours due to the requirement for clopidogrel to be administered within 24hrs for ischaemic stroke or transient ischaemic attack cases.

The issue with labs are:

1) only 7 in the UK

2) operating at max capacity already

3) inability to turn around tests within 24hrs, due to the first 2 points.

In addition there is arguments against the ability to scale lab tests in the short term and the ability to keep unit costs down per test given these factors and.

@Padrock - https://www.genedrive.com/assays/cyp2c19-documentation.php

Looks like another CYP2C19 ID Kit Production run was carried out on 19 June - as a COA was published.

How to interpret exactly is debatable, but good to see non the less.

Once all approved:

TOTAL SHARES of GDR = 543,141,481

MCap calcs:

@5p = £27.2M

@10p = £54.3M

@20p = £108.6M

@40p £217.3M

@bighammer, as per the last presentation, Cheek showed a slide which stated the Total Addressable Market for CYP2C19 is £220M, while further stating that this has the potential to be higher (due to more recent research and GDRs initial assumptions).

From what I was told, not all territories/countries outside the likes of UK/EU/US require individual approval to the extent of UKCA/CE/FDA status. Some countries directly accept these recognisied certifications and just have administrative paper to add.

The CYP2C19 is already UKCA marked, so yes it can be sold in the UK. However the issue here has always been, as Cheek highlighted, that the NHS do not just buy in adhoc manner - everything feeds through approved yearly budgets which feed off other 3rd party approval/ recommendation frameworks eg. NICE. So Cheek being better positioned to open comms with such budget facing individuals with the NHS has been a massive improvement for GDR

The delay to the NICE publication has absolutely nothing to do with genedrive. NICE are in full control of this unfortunetly!

Lets be honest and REAL here. One cannot start comparing Cheek with Budd and saying things like "He has made David Budd look like a productive CEO"

Has it gone to plan as laid out by Cheek - NO! as far as we can tell. But Cheek came into an operation/setup that was not positioned in any way to commercialise it's products - the commercialisation game plan was not even drawn up by the former!

Https://www.youtube.com/watch?v=a_8Hsw0LwGQ&t=815s

Hemo from 15:40

@nissangtr786, may I kindly recommend that you limit the amount of un-warranted and vague arbitrary comments. It does nothing good for your hopes nor for the general feel of the board.

@starresnstoff: the NICE review at this stag was not going to give full recommendation just yet, due to the clinical data set still being worked on which also ties into the process of attaining UKCA marking (registration required for clinical use). Once the UKCA marking is attained this data set can then be used by NICE to give a final recommendation for recommending GDRs POC CYP2C19 test kit to the NHS.

More importantly, the NICE review clearly recommended to the NHS, that CYP2C19 testing be used before any drug administration in (IS) stroke cases. Of all the tests analysed, (both lab and POCs), GDRs was the most cost-effective.

Hey @bapuk, did you get any feedback from genedrive regarding your below post??

.......

I recently came to know about this Accelerated Access Collaborative (AAC) method by which new drugs/diagnostics etc can get quicker route to NHS use/funding through this mechanism, rather than the Early Value Assessment pilot scheme which currently is how GDR have pursued this : I’m not sure if they’ve already explored this other option so I’ll email the company about it :

https://www.england.nhs.uk/aac/

@bapuk - may be worth just bringing your level of expertise and knowledge on the use of Clopidogrel outside of Stroke settings to Walbrook/Genedrive and see what they have to say about the current plans for the use/marketing of the assay outside stroke medical settings. Sounds like it can surely increase the importance on the POC assay and further increase the market for its use (win/win)!

@ldakmail
Where did you read it was FDA cleared? I've read "Disclaimer: Not available for sale outside of Europe. Contact us for more information."

https://news.sky.com/story/uk-expected-to-require-travellers-from-china-to-provide-negative-pre-departure-covid-test-12777027

Tender Noticeby SECRETARY OF STATE FOR HEALTH AND SOCIAL CARE ACTING AS PART OF THE CROWN THROUGH UK HEALTH SECURITY AGENCYTesting Solutions Dynamic Purchasing Systemhttps://bidstats.uk/tenders/2022/W24/776667357

Further to your points Cando66/Inphobe:

AIHL
This test was funded and developed in conjunction with the NHS via UK National Institute for Health Research (under the Department of Health & Social Care) and in accordance with NHS utilised NICE guidelines.
--------20 June 2018: Grant to develop and implement a point-of-care test in the NHS to avoid antibiotic-related hearing loss in newborn children (https://www.lse.co.uk/rns/GDR/grant-for-nhs-point-of-care-test-z0v7gogk4s8vxur.html)
---------07 Oct 2019: First ever research ethics approval for a neonatal point of care genetic test - Opportunity for widespread NHS adoption of test for prevention of hearing loss in newborns (https://www.lse.co.uk/rns/GDR/nhs-ethics-approval-for-use-of-aihl-test-in-trials-orc3b1no527jtcf.html)
---------03 December 2020: Antibiotic Induced Hearing Loss assay hospital trial completion (https://www.lse.co.uk/rns/GDR/aihl-hospital-study-completion-its9qqblhuu9kwt.html)
---------31 August 2021: New Genedrive® system readied for Antibiotic Induced Hearing Loss launch (https://www.lse.co.uk/rns/GDR/new-genedrive-system-readied-for-aihl-launch-r7lea91aoani1es.html)

As per Nov 2021 presentation (available via https://www.investormeetcompany.com/) David Budd confirmed:
1) EU clinical study site established and running in Greece
2) The results from the UK NHS trial conducted have been accepted by a top/influential US paediatric scientific peer review journal. This is a very important achievement for genedrive in driving direct awareness and interest from paediatric professionals in North America.
3) Once funding is avail via UK and EU sales, US approval will be assessed.

Sales Estimates
UK - 100k tests per year
EU and US - 500k tests per year, each jurisdiction (approximately GBP 25m-35m).
Which implies the tests cost about GBP50 each.

This is in reference to CDC's own developed PCR test (DC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel) ONLY.
PCR tests is still a valid Nucleic Acid Amplification Test (NAAT) for Covid19.

Ok folks, so the most pressing items on the table are: (lets get some dialogue going add any factual info please)
1) CE-mark of Genedrive® COV19-ID Kit POC
- awaiting official launch
- [RNS 10 Sep] - ".... targeting CE marking in October 2021"

2) Genedrive® MT-RNR1 assay (AIHL)
- awaiting first sales from UK after new table-top Genedrive® MT-RNR1 ID Kit CE-marked in Sep 21.
- [RNS 29 Sep] - "expecting its first sales in autumn 2021"

3)