10 September 2026

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genedrive plc

("genedrive" or the "Company")

Welsh hospitals extend routine clinical service of genedrive's MT-RNR1 test

-       Seven of the 14 UK sites participating in the PALOH-UK Programme now in routine clinical service demonstrating growing adoption of Genedrive® MT-RNR1 in NHS neonatal care

-       PALOH-UK patient recruitment has now completed with nearly 6,000 babies tested

genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, is pleased to announce that Betsi Cadwaladr University Health Board and Cardiff and Vale University Health Board, will extend routine clinical service of the Genedrive® MT-RNR1 ID kit for the prevention of Antibiotic Induced Hearing Loss ("AIHL") in neonates admitted to Neonatal Intensive Care Units ("NICU"). Continuation is funded, effective from 1 May 2026, until the outcome of the final NICE assessment expected in July 2027. 

These hospitals together represent approximately 750 NICU admissions annually and are two of the 14 sites participating in the PALOH-UK programme, which was established to address National Institute for Clinical Care and Excellence ("NICE") Real World Evidence generation requirements. Since the introduction of the test in the UK, more than 40 critically ill babies have been identified with the MT-RNR1 variant, allowing clinicians to prescribe an alternative antibiotic and helping to prevent AIHL.

The extension of routine clinical service in Wales follows recent business-as-usual adoption at Manchester University NHS Foundation Trust and University Hospitals Sussex NHS Foundation Trust, demonstrating continued progress in genedrive's ambition to transition the MT-RNR1 test from evidence generation into routine NHS clinical practice.

Dr Gino Miele, CEO of genedrive plc, said: "We are delighted that these hospitals in Wales have extended the routine clinical use of our rapid MT-RNR1 genetic test through to the expected issuance of final guidance by NICE. This commitment ensures babies and families in Wales will continue to benefit from timely access to this preventive genetic test and demonstrates the important role NHS Wales is playing in integrating rapid pharmacogenetic testing into routine neonatal care.

"Seven of the 14 sites participating in the PALOH-UK programme have now transitioned to routine clinical use of our MT-RNR1 test. We are in active discussions with the remaining hospitals, helping to ensure that newborn babies across the UK continue to have access to this preventive test."

Patient recruitment in the PALOH-UK programme has been completed, with nearly 6,000 babies in neonatal care receiving the Genedrive® MT-RNR1 ID test. Clinical cohort analysis is underway with publication expected in scientific literature around October 2026. Funding for PALOH-UK sites is provided by the Office for Life Sciences ("OLS") and National Institute for Health and Care Research ("NIHR").

Following completion of patient recruitment, the Genedrive® MT-RNR1 ID Kit has exited NICE's Early Value Assessment pathway and has been selected for technology appraisal following ministerial referral from the Department of Health and Social Care. The test currently has a conditional NICE recommendation. NHS England has communicated an anticipated tender notice publication date of 1 January 2027 and a go-live target of July 2027, subject to the outcome of NICE guidance.

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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.