Genedrive (AIM:GDR) has completed patient recruitment for its PALOH-UK programme, testing nearly 6,000 babies across 14 neonatal intensive care units in the UK.
The AIM-listed point-of-care pharmacogenetic testing company's Genedrive MT-RNR1 ID Kit screens newborns for a genetic variant that raises the risk of permanent deafness from a common antibiotic used in neonatal care.
The programme, funded by the National Institute for Health and Care Research alongside the UK Government Office for Life Sciences, was designed to generate real-world evidence for the National Institute for Health and Care Excellence (NICE), which had granted the test conditional recommendation under its Early Value Assessment pathway.
The test has now exited that pathway and moved into NICE technology appraisal following ministerial referral, with NHS England targeting a tender notice by 1 January 2027 and a go-live date of July 2027.
Clinical cohort analysis is underway, with publication expected in scientific literature around October.
"To date, more than 13,000 babies have been tested using the Genedrive MT-RNR1 ID Kit in the UK and internationally, with over 40 babies avoiding aminoglycoside exposure and the risk of lifelong deafness," said Dr Gino Miele, chief executive of Genedrive.
Two NHS trusts, Manchester University NHS Foundation Trust and University Hospitals Sussex NHS Foundation Trust, have already transitioned to routine use of the test.
News Intelligence what this means for the company
Genedrive has completed recruitment of nearly 6,000 babies for its PALOH-UK hearing-loss screening trial, moving the MT-RNR1 ID Kit from NICE's conditional Early Value Assessment into full technology appraisal with a target NHS go-live date of July 2027. This clears a critical evidence hurdle: the trial was designed to generate real-world data for NICE's formal appraisal, and clinical results are due for publication around October, positioning the company for potential NHS procurement within 18 months.
Completion of a 6,000-patient trial funded by NIHR and the UK Government removes execution risk on the evidence generation phase and validates the test's clinical utility in a real-world NHS setting. The pathway to NHS tender and deployment is now concrete, though reimbursement and adoption rates remain contingent on October's clinical publication and NICE's formal appraisal outcome.
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