genedrive plc

("genedrive" or the "Company")

Consultation to inform NHS England commercial strategy for rapid MT-RNR1 testing

genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, welcomes publication from NHS England of a Preliminary market engagement notice under the Procurement Act 2023, to inform the NHS commercial strategy for rapid genetic MT-RNR1 testing in neonates to prevent antibiotic induced hearing loss. 

Dr Gino Miele, CEO of genedrive plc, said: "We welcome the communication of this premarket engagement by NHS England and the clarity it provides with respect to intended future commitment at a national level. To date, since introduction, our rapid MT-RNR1 test has been used as part of routine clinical practice by approximately 900 neonatal nurses for over 10,000 babies admitted to NICUs, enabling more than 30 to avoid lifelong hearing loss as a result of aminoglycoside antibiotic exposure.  

"As a UK-based diagnostics vendor, that has worked in close proximity with various NHS partners, we are proud to have developed and brought this product to a previously unaddressed clinical market of global significance, and look forward to all babies admitted to NICUs throughout the UK being able to benefit regardless of geographical residence. We believe we are uniquely positioned to address this anticipated tender and look forward to communicating progress in due course."

In the UK, Genedrive® MT-RNR1 ID kit is being implemented and used in the Neonatal Intensive Care Units ("NICU") of 14 hospitals across the four UK nations as part of a real world evidence generation programme (PALOH-UK) funded by the National Institute for Health and Care Research (NIHR) and the UK Government Office for Life Sciences (OLS). The test also has conditional recommendation for use in the NHS by the National Institute for Health and Care Excellence ("NICE") whilst further real world evidence is generated. genedrive estimates that annual NICU admissions in these NICUs represent approximately 10% of admissions in the UK. 

Additionally, since October 2025, implementation of the Genedrive® MT-RNR1 ID kit into all NHS Scotland Health boards has been actively progressing under a phased implantation programme with the Accelerated National Innovation Adoption (ANIA) pathway led by the Scottish Centre for Sustainable Delivery.

The PALOH-UK programme is scheduled to complete by July 2026, with subsequent NICE review and issuance of final guidance communicated to be approximately July 2027. Post PALOH-UK and ahead of final guidance, business case progression will continue as planned to enable PALOH-UK sites to rapidly transition to Business as Usual use.

In addition to anticipated timelines, the premarket engagement notes anticipate a publication date of tender notice of 1 January 2027 and go-live target date of 1 July 2027, subject to NICE guidance outcome. 

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About genedrive plc (http://www.genedrive.com).

genedrive plc is a UK-based, commercial-stage pharmacogenetic testing company focused on rapid, point-of-care diagnostic tests to guide safe and effective drug prescription in emergency and acute care settings.

genedrive's proprietary technology platform enables clinicians to prescribe safer and more effective therapies based on a patient's genetic profile, supporting improved outcomes while reducing pressure on healthcare systems, lowering downstream healthcare costs through the prevention of avoidable complications and earlier, more effective intervention

The Company has two CE-IVD approved and NICE-recommended tests in NHS clinical use. The Genedrive® CYP2C19 ID Kit identifies stroke patients who will not respond to the current standard of care, Clopidogrel, used to reduce risk of secondary stroke. The Genedrive® MT-RNR1 ID Kit helps prevent antibiotic-induced hearing loss (AIHL) in newborns, enabling treatment decisions within actionable timeframes at the point of care.

Headquartered in Manchester, genedrive is focused on scaling UK-developed precision diagnostics within routine care and leveraging real-world evidence to support broader international adoption and commercial growth.