Member Info for Eureka01

Popeye:14/11/23 "I've started to build a sizeable position"

Sp was then around 8p. So I suspect he was forced to sell at a loss as he then spent several months trashing the company as the sp went down. It looks like the same has happened again and we will be getting more of the same from him.

An unbalanced post from Balanced66. The covid situation was very different. Now GDR has products which are selling and which have a bright future IMO.

A step in the right direction:

"MT-RNR1 is now in routine use in the NHS at 9 hospitals and the NICE EVA programme via NIHR will see this increase to 14, throughout the UK nations."

You seem very sure of another fund raise being needed. Yet the company is not so sure. I spoke to James Cheek earlier in the year and he was certainly confident that another fund raise would NOT be needed.

But let's look at the figures. There is the £500, 000 grant going directly to the company which in itself is part of a £1.45 million grant going towards the hearing loss project. Then there is the tax rebate due in March which this year was £800,000. Then there are the sales. We now know that nine sites are already utilising the MT-RNR1 ID test in routine clinical practice. Specialist Commissioning for the hearing loss test, which would open up the doors for a national rollout, is scheduled for April 2025. If the hearing loss test, nominated for STEM Research Project of the Year, wins that award that would be a huge bonus for the test. We will know the results in a few days time.

Then we have the stroke test. We know of one centre, Greater Manchester’s Comprehensive Stroke Centre, the largest in the country, that has already adopted the test. We may find about others in the final results. CE IVD certification for the stroke test which would allow for sales in the EU and certain other countries is scheduled for early 2025. The Pilot scheme for the stroke test in England is due to complete by April 2025.

The main drain on cash would be the FDA submission for the hearing loss test The FDA submission for the test is due to start early 2025. Yet here we have a US partner who would bear some, if not all, of the cost. The announcement in April 2024 stated "The partnership will support clinical studies required for engagement with the US Food & Drug Administration."

So I remain unconvinced that we will need another fund raise. Time will tell.

Thank you Lionel. Yes £500k goes directly to GDR but nevertheless the fact that £1.4 million is being granted to this project as a whole must surely help the company as it contributes towards some of the expenses that they would otherwise have to shoulder in developing the study. Manchester University NHS Foundation Trust (MFT) in particular now has the funding to shoulder more of the burden.

Sorry, I see already posted!

Seems to be confirmed in this article:

"Now, having successfully received £1.4m funding from the National Institute for Health and Care Research (NIHR) and the Office for Life Sciences, researchers at MFT will lead PALOH-UK, a new two-year study across 14 neonatal units, from large intensive care units to small special care baby units."

https://www.manchester.ac.uk/about/news/genetic-test-for-deafness-in-newborns-to-be-trialled-across-the-uk/

Whilst on a stopover in the Middle East (Dubai) on my way to the Far East, I have seen the encouraging news of the £500k grant and that 9 sites have adopted the MT-RNR1 Kit. Before flying out I had prepared a list of 10 areas where I hoped to see positive news. Events have overtaken me and 2 of these have now come about, the meaningful sales for the hearing loss test and the grant. Let's hope for more to come! Here is what I had prepared:

This is the latest the announcement of the Final Report has ever been. I suspect to allow more time for positive news to flow in. There are 10 areas where I am hoping we shall be getting updates, hopefully positive, on what has already transpired as well as what should transpire in the next 6 months. We won't necessarily get all the boxes ticked but if we do get positive news on at least a majority of these issues I shall consider that progress.

1) Meaningful sales of the MT-RNR1 ID Kit (hearing loss test) in the UK, the EU and the Middle East.

2) Meaningful sales of CYP2C ID 19 Kit (stroke test) in the UK.

3) Pilot scheme progress for stroke test in England. Due to complete by April 2025.

4) Accelerated National Innovation Adoption for the stroke test resulting in national rollout for the pilot test in Scotland?

5) CE IVD certification for the stroke test which would allow for sales in the EU and certain other countries. Scheduled for early 2025.

6) Progress on the FDA submission for the hearing loss test. Originally due to start late 2024 but now, it seems, early 2025.

7) Specialist Commissioning for the hearing loss test which would open up the doors for a national rollout. Scheduled for April 2025.

8) Hearing loss test, nominated for STEM Research Project of the Year. Winner to be announced on the 28th November.

9) Grant for hearing loss test to allow for genetic testing in centres around the country. News now overdue.

10) Tax refund. Due March 2025. This year it was £800k.

I have borne in mind that there is always the possibility of delays and the chance of disappointing sales but with so much potentially positive news to come.... I'm IN!🙂

Announced back in May but worth reminding. EMQN (The European Molecular Genetics Quality Network) is a company which offers external quality assessment to help molecular diagnostic providers give the optimal service to patients. It announced that it was set to launch an EQA scheme tailored specifically for the Genedrive MT-RNR1 ID Kit in the autumn of 2024, followed by a pilot for CYP2C19.

Some of the highlights in its announcement:

"Notable examples of genomic POCT are: The NICE approved Genedrive® MT-RNR1 ID Kit... CYP2C19 testing."

"EMQN CIC is set to launch an EQA scheme tailored specifically for the Genedrive® MT-RNR1 ID Kit in the autumn of 2024, followed by a pilot for CYP2C19. This groundbreaking initiative is poised to elevate the standards of genomic POCT by providing rigorous quality assessment and fostering continuous improvement. In addition, EMQN CIC will also provide a package of materials to support the validation of POCT machines in situ, currently performed with clinical patient samples."

"...the Point-of-Care devices offer unparalleled convenience and speed,..."

"We work with >2500 laboratories in 89 different countries."

..."the healthcare landscape has begun to rely increasingly on the use of point-of-care testing at, or close to, the patient’s bedside..."

https://poctinnovators.com/enhancing-point-of-care-testing-poct-emqn-cic-to-introduce-innovative-eqa-schemes-for-genomic-poct/

https://www.emqn.org/enhancing-point-of-care-testing-poct-emqn-cic-to-introduce-innovative-eqa-scheme-for-mt-rnr1-m-1555ag-poct/

Last year we had the full year results on the 30th November. For the last 4 years the results have been in November and prior to that in October. So it is likely that the results will be by Friday 29th November though it is always possible the company might wish to extend to give an opportunity to bring out more news. In 2023 the notice of results was on the 16th. So on that basis we should be seeing an announcement tomorrow or Monday.

I'm hopeful that when we get the results we shall, amongst other things, be seeing news of meaningful sales and of FDA progress.

I suspect the rise today had nothing to do with the short positions going down a fraction but rather the "great first day" at the Medical Expo with the CEO, the Chief Commercial Officer and the Marketing Manager all in attendance. As the GDR tweet says "Bring on Day 2!"

....if we had a fraction of the funding another POC test has got. The Cytovale IntelliSep test point-of-care diagnostic tool that helps clinicians identify the risk of sepsis in adult patients presenting to the emergency department has recently been cleared by the FDA to help improve the early detection of sepsis. A large-scale study found that the test accurately predicts sepsis risk and severity.

The company has been backed by $184 million in recent funding.

A reminder that the Dusseldorf Medical Trade Fair starts in 4 days time. Genedrive will be exhibiting the MT-RNRI Kit. Their brochure highlights the advantages of using the kit including:

Results in just 26 minutes

Easy to operate touch screen

Wireless connectivity

Test history tracking

Minimal training needed

Non invasive buccal swabs

https://pdf.medicalexpo.com/pdf/genedrive/genedrive-mt-rnr1-product-range/128410-252128.html

That's 1900 kits in 3 months and I don't think they'd be gathering dust on shelves!

Is this what you are referring to Stephen?

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

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

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

Lots of discussion here about sales news (or lack thereof). As I posted a month ago, the company has told me that they can't update with every sale, but as Salford was the largest hyperacute stroke unit in England and was the first to implement the test, it warranted release.

I'm confident that other sales both for the CYP2C19 ID Kit (stroke test) and the MT-RNR1 ID Kit (hearing loss) are going on in the background and that we shall hear about them in the forthcoming final results. AIMHO

The market is waking up to the news. Up 5%🙂

Most recurrent strokes prevented by GDr's POC test:

"The cumulative number of recurrent strokes prevented

over 5-years was 943, 961 and 958 for the laboratory-based, Genedrive and Genomadix tests,

respectively.

Low failure rate:

"CYP2C19 genotype test failure rates are low: 0.6% for the Genedrive system (one study,

n=250), 0.4% to 19% for the Genomadix test (10 studies, n=5,000), and

"The Genedrive point of care test is cost incurring in year 1 compared with no testing, with an

additional net cost of £415,985 in year 1. From year 2 onwards, point of care testing with the

Genedrive device is resource saving compared with current practice, with resource savings of £9

million in year 5."