New UK clinical guideline for MT-RNR1 testing

Genedrive PLC

03 August 2026

 

3 August 2026

genedrive plc

("genedrive" or the "Company")

New UK clinical guideline published for MT-RNR1 genotype testing

-     Guideline recommends MT-RNR1 testing before aminoglycoside treatment and supports point-of-care testing in acute care settings

genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company, notes the publication of the UK clinical guideline "MT-RNR1 genotype testing for preventing aminoglycoside-mediated ototoxicity" in the British Journal of Clinical Pharmacology. The recommendations are intended to help prevent antibiotic-induced hearing loss ("AIHL"), which can occur following a single dose of an aminoglycoside antibiotic.

Developed by the UK Centre of Excellence in Regulatory Science and Innovation in Pharmacogenomics ("CERSI-PGx"), the guideline recommends MT-RNR1 genotype testing for people of all ages and genetic ancestries before aminoglycoside administration where results can be obtained within a clinically achievable timeframe, supporting broader clinical implementation of MT-RNR1 testing in acute care.

Specifically in relation to point-of-care testing, the guidelines state that it should be considered where available in all acute clinical settings, naming the Genedrive® MT-RNR1 ID Kit, which detects the m.1555A>G variant from a buccal swab and provides a result in approximately 26 minutes.

Dr Gino Miele, CEO of genedrive plc, said: "The publication of this new UK clinical guideline is an important step in the adoption of MT-RNR1 testing in acute care. The Genedrive® MT-RNR1 ID Kit is the only point-of-care MT-RNR1 test currently in routine clinical use in UK Neonatal Intensive Care Units, and these recommendations provide further support for wider NHS implementation of our test into routine acute care settings."

The guidance references the National Institute for Health and Care Excellence ("NICE") Early Value Assessment, which recommends the Genedrive® MT-RNR1 ID Kit for use in newborn babies while further evidence is generated. NICE's early economic modelling suggested that point-of-care testing with the Genedrive® MT-RNR1 ID Kit could be cost-saving and more effective than standard care. NICE has indicated that evidence from the PALOH-UK programme, which is addressing evidence gaps identified through the Early Value Assessment, will be considered as part of its planned review of the guidance.

genedrive plc	[phone]
Gino Miele: CEO / Russ Shaw: CFO	https://investors.genedrive.com/s/e0025c
Peel Hunt LLP (Nominated Adviser and Broker)	[phone]
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5654 & Company (Media & Investor Relations)	[e-mail]
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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.

 

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