Member Info for Lionel1

Https://assets.publishing.service.gov.uk/media/66e1b49e3b0c9e88544a0049/Lord-Darzi-Independent-Investigation-of-the-National-Health-Service-in-England.pdf

Treatments are becoming more sophisticated, but less timely. In 2024, more than

35,000 genomic tests are being completed each month. But the turnaround times are poor, with only around 60 per cent of test being performed to the agreed timeframes 161

. This can delay the start of treatment which often depends on the result.

Genedrive will feature in next video which shot other day .

@Roger , GDR will be whole new level by this time next year. If you are really invested here then Do yourself a favor, come next year .. And why on earth people here 24/7 , this is not social media .. it’s toxic , go out or spend time with your family. ..

Https://www.linkedin.com/posts/mft-research-and-innovation_working-in-partnership-to-deliver-personalised-activity-7239648195696279552-E3Wj?utm_source=share&utm_medium=member_ios

Https://www.linkedin.com/posts/emqn_emqn-pointofcare-eqa-activity-7239543270148648961-Cgwb?utm_source=share&utm_medium=member_ios

Https://my.bps.ac.uk/events/details/?id=45e71bda-3853-ef11-bfe3-7c1e522d5604

Are you insane Roger , RNR1 is under review with FDA , all this time Eureka was talking about CYP2C19 ID kit .. I think he confusing himself and everybody .

As usual you got exposed straightaway .. :-)

@Eureka , I think you are confused between RNR1 FDA and CYP2C19 FDA . 2 are different

Lol FDA not applied ? Roger where do u get this classic thoughts ? FDA breakthrough is the part of the process and it’s a big achievement for the company like GDR

@Eureka , There is a misunderstanding, speak to them again .

Go through the RNS again

“ genedrive intends to pursue the FDA De Novo regulatory pathway for entry into the U.S. market. The FDA De Novo pathway provides a vehicle for establishing new predicate devices that can reflect modern standards for performance and safety and can serve as a basis for future clearances. De Novo classification is a risk-based classification process used when there is a lack of a predicate device already cleared by the FDA.”

Mr Wan**r , nobody is ready to believe your lies anymore , Now STFU .

NHS website itself said they are looking to implement this soon .

https://www.genomicseducation.hee.nhs.uk/blog/nice-approves-genomic-test-to-prevent-secondary-strokes/

Research Project of the Year: STEM

Groundbreaking research that led to the worlds-first bedside genetic test to prevent babies going deaf has also earned a nomination.

The research, led by Saint Mary’s Hospital, part of Manchester University NHS Foundation Trust (MFT), The University of Manchester and Manchester-based firm genedrive Plc, helped to develop the pioneering, rapid bedside genetic test which was piloted at MFT in 2022.

The technology could save the hearing of 180 babies in the UK every year and bring a saving of £5m to the NHS annually. The test is now being rolled-out in all Neonatal Intensive Care Units in Greater Manchester, with a hope that this will become part of routine clinical care across the UK.

https://studentnews.manchester.ac.uk/2024/09/05/university-of-manchester-celebrates-triple-nomination-in-prestigious-times-higher-education-awards/

*Will be completed Feb 2025.

Data collection and Real world evidence pilot will be collected in Feb 2025 , I have read somewhere but don’t recollect the source , I will try to find and publish here

CYP2C19 ID Kit is game changer for Genedrive .. Give 2 years if you are not in a hurry, very good stage setup here , How many companies on AIM has 2 NICE approved products and good relationship with NHS, Precission and personalised medicine is future like AI .

https://www.ispor.org/docs/default-source/euro2023/ispor-europe-2023-dap65-cost-effectiveness-poster-ee614133405-pdf.pdf?sfvrsn=4be4b5ba_0

The Genedrive CYP2C19 ID Kit has a potential advantage over the Genomadix (Spartan) CYP2C19 tests because it does not need to be stored between -15°C and -80°C and used within 15 min of removal from the freezer. The Genedrive test also supports data being uploaded directly into patient records, which is helpful to maximise continuity of care, whereas data is only stored locally within the Genomadix test. Additionally, the Genedrive test displays diplotype plus metabolizer status, which is likely to make interpretation easier, whereas Genomadix reports diplotype only. How the GMEX System is stored, how it integrates with patient records, and what the test reports, is unclear. Questions also remain about the test failure rate and cost of these POCT, which needs to be explored in future studies.

https://www.tandfonline.com/doi/full/10.1080/14622416.2024.2392479?src=#d1e315

Lol Charts on AIM :-)

There is plenty of movement across all NHS trusts about the RNR1 and CYP2C19 ID Kit Rapid POC , we will hear a lot of news before Christmas .

@Muminr , there is no straightforward answer to the question how long does it take to get full approval . My AI tool gathered this info from all search engines with available data on the web.

The FDA's Breakthrough Devices Program is designed to expedite the development and review of medical devices that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. The process involves several stages:

1. **Breakthrough Device Designation Request**: Applicants submit a request to the FDA, demonstrating that their device meets specific criteria. The FDA aims to decide on this request within 60 days[4].

2. **Expedited Review Process**: Once designated as a breakthrough device, the device undergoes an expedited review process. For example, the average time for a 510(k) clearance under this program has been reduced from 270 days to 155 days[1]. The program also reduces the time for De Novo marketing authorization by 68 days[1].

3. **Final Approval**: Despite the expedited process, achieving full marketing authorization can still be challenging. As of recent data, out of 657 devices granted breakthrough designation, only 44 have received marketing authorization[3].

Overall, while the breakthrough designation accelerates the review process, the total time from designation to full approval can vary significantly depending on the device and the complexity of its review.

Https://healthinnovation-em.org.uk/component/rseventspro/event/110-polypharmacy-community-of-practice?Itemid=1457

@investace , They will raise a pole to shove into your a**

“ Health and Social Care Secretary Wes Streeting said: “This private investment is a significant vote of confidence in the UK and will fast-track the next generation of treatments to NHS patients. It will enhance the UK’s global competitiveness and transform the country into the epicentre of health research, supporting an NHS fit for the future. By cutting waiting lists and fixing our NHS, we can make it an engine for growth and build the healthy society needed for a healthy economy.”