New UK clinical guideline for MT-RNR1 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.

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