Genedrive Regulatory News (GDR)

genedrive plc

("genedrive" or the "Company")

Genedrive® MT-RNR1 to commence roll out in Greater Manchester

Project to follow NICE final recomendations scheduled for end of this month

genedrive plc (AIM:GDR), the point of care molecular diagnostics company, announces that the Genedrive® MT-RNR1 ID Kit is in process for roll out at two further hospital sites in the North West NHS. The implementation project, scheduled to commence from April, will follow the NICE final recommendation for the use of the Genedrive MT-RNR1 ID test in the NHS (England and Wales) which is due towards the end of this month.

The Manchester Academic Health Science Centre (MAHSC) Women and Children Domain, part of Health Innovation Manchester (HInM) are supporting and project managing the further roll out across Manchester University NHS Foundation Trust. The Company continues to work alongside HInM on specific plans for the roll out across an additional five neonatal sites in Greater Manchester. Once fully subscribed at this regional level, the test would be available when needed to circa 30000 newborns over the next NHS fiscal year, of which 10-12% are modelled to be admitted to a regional neonatal unit.

MAHSC is one of eight national centres designated by NHS England and the National Institute for Health and Care Research for demonstrating excellence in patient care and driving innovation into the health service.

Dr. Ajit Mahaveer, Clinical Head of Division - Newborn Services, Manchester University NHS Foundation Trust (MFT) said: "The Genedrive MT-RNR1 test was piloted here at MFT. This initiative will allow us to expand testing to the neonatal units at North Manchester General Hospital and Wythenshawe Hospital. We are also intending to work with NICE on ongoing data collection to support the long term recommendations for the product."

Jonathan Massey, Programme Director for Academia at Health Innovation Manchester said: "The Genedrive MT-RNR1 test was developed alongside our NHS partners and supported by the National Institute for Health and Care Research. This programme will support its wider adoption across the city-region, ensuring that the work done to date will translate to better and equitable patient outcomes, wherever a child is treated in Greater Manchester."

David Budd, CEO of genedrive plc, said: "While we work with clinicians and implementers nationally on a Trust by Trust basis, near-term roll outs such as this one in Greater Manchester will benefit from additional coordination and support. We are grateful for the engagement from HInM and MFT, which will be an example for future regional roll outs elsewhere in the country. It's an important milestone for the Company as we work to ensuring every newborn has access to the Genedrive MT-RNR1 ID test when needed."

The Genedrive® MT-RNR1 ID Kit is the world's first commercial point-of-care genetic test for emergency care. It helps to avoid irreversible lifelong hearing loss in specific infants exposed to aminoglycosides by rapidly detecting the m.1555A>G gene variant that can cause deafness, allowing for alternative antibiotics to be prescribed. Product information can be found at https://www.genedrive.com/assays/rnr1-product.php

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About genedrive plc (http://www.genedriveplc.com) genedrive plc is a molecular diagnostics company developing and commercialising a low cost, rapid, versatile, simple to use and robust point of need molecular diagnostics platform for the diagnosis of infectious diseases and for use in patient stratification (genotyping), pathogen detection and other indications. The Company has assays on the market for the detection of MT-RNR1, HCV, certain military biological targets, a high throughput SARS-CoV-2 assay and a point of care test for Covid-19. The company are currently developing a genetic test for CYP2C19 metaboliser status.