Genedrive Shares Gain 9 Percent Following UK Guideline Support for Hearing Loss Test

Shares in genedrive PLC rose 9% to 1.09p on Monday following the publication of a UK clinical guideline that recommended the genetic testing technology which forms the basis of the company’s primary product. The guideline specifically names the firm’s testing kit.

Published in the British Journal of Clinical Pharmacology, the guidance addresses MT-RNR1 genotype testing as a preventive measure against antibiotic-induced hearing loss. Such damage may occur after a single dose of an aminoglycoside antibiotic, a class of drug routinely deployed in emergency and neonatal care settings, when administered to patients carrying a specific genetic variant.

The guideline advocates testing across all age groups and genetic ancestries prior to administration of the antibiotic, provided results can be obtained with sufficient speed to inform clinical decisions. Regarding point-of-care testing, which involves analysing samples at the bedside rather than in a centralised laboratory, the guidance states that this approach should be considered wherever available in acute care environments.

The document identifies the Genedrive MT-RNR1 ID Kit by name. The device detects the relevant genetic variant from a cheek swab sample and delivers results in approximately 26 minutes.

The guidance was developed by the UK Centre of Excellence in Regulatory Science and Innovation in Pharmacogenomics. Gino Miele, chief executive of the AIM-listed company, stated that the kit represents the only point-of-care test of its type currently in routine clinical use within UK neonatal intensive care units. He indicated that the recommendations provide additional support for broader adoption throughout the National Health Service, particularly across acute care settings.

The guideline also references an Early Value Assessment from the National Institute for Health and Care Excellence, which supports deployment of the kit in newborn populations whilst additional evidence is compiled. Early economic modelling conducted by the health technology assessor suggested the test could deliver both cost savings and improved clinical outcomes compared with standard care protocols.

The Institute has confirmed that evidence emerging from the PALOH-UK programme, which is intended to address the identified evidence gaps, will inform a planned review of the existing guidance.