REG - Genedrive PLC - NHS England commercial strategy for MT-RNR1

GenedriveAnnouncement

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RNS Number : 1979B  Genedrive PLC  21 April 2026

21 April 2026

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.

 

 

 

 genedrive plc
                                                        +44 (0)161 989 0245
 Gino Miele: CEO / Russ Shaw: CFO
                                                        https://investors.genedrive.com/s/e0025c
                                                        (https://investors.genedrive.com/s/e0025c)

 Peel Hunt LLP (Nominated Adviser and Broker)
                                                        +44 (0)20 7418 8900
 James Steel

 5654 & Company  (Media & Investor Relations)           genedrive@5654.co.uk
 Matthew Neal                                           +44 (0)7917 800 011
 Melissa Gardiner                                       +44 (0)7757 697357

 

Subscribe to our news alert service: https://investors.genedrive.com/s/efea03
(https://investors.genedrive.com/s/efea03)

 

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

 

 

 

 

 

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