Genedrive Completes PALOH-UK Recruitment: Nearly 6,000 Babies Tested for Antibiotic-Induced Hearing Loss Risk
核心洞察
Genedrive has completed patient recruitment in the PALOH-UK programme, with nearly 6,000 newborns tested across 14 UK neonatal intensive care units using the Genedrive® MT-RNR1 ID Kit (搜索).
Clinical cohort analysis is underway with publication expected around October 2026, as the test exits the NICE EVA pathway and enters formal technology appraisal.
Over 13,000 babies have been tested to date in the UK and internationally, with more than 40 cases of irreversible aminoglycoside-induced hearing loss (搜索) prevented.
Genedrive plc (搜索) has completed patient recruitment in the landmark PALOH-UK programme, with nearly 6,000 babies across 14 neonatal intensive care units (NICUs) in all four UK nations receiving the Genedrive® MT-RNR1 (搜索) ID test. The point-of-care pharmacogenetic test identifies newborns at risk of irreversible aminoglycoside-induced hearing loss (搜索) (AIHL), enabling clinicians to avoid administering these antibiotics to genetically susceptible infants. Clinical cohort analysis is now underway, with publication in the scientific literature expected around October 2026.
The PALOH-UK programme, funded by the National Institute for Health and Care Research (NIHR) in collaboration with the UK Government Office for Life Sciences (OLS), was designed to address evidence generation requirements set by the National Institute for Health and Care Excellence (NICE) under its Early Value Assessment (EVA) pathway. The programme is led by Professor Bill Newman and Dr John McDermott, clinical geneticists at Manchester University NHS Foundation Trust (MFT) St. Mary's Hospital.
"We are delighted to have recruited nearly 6,000 babies to PALOH-UK across 14 neonatal units throughout the UK," said Dr John McDermott, NIHR Academic Clinical Lecturer at the University of Manchester and Co-Chief Investigator of the PALOH-UK programme. "This successful recruitment is a real testament to the commitment of the neonatal teams at each participating site, who have integrated the genedrive technology into their routine clinical practice."
Regulatory Pathway Advancement
The Genedrive® MT-RNR1 ID Kit (搜索) has now exited the NICE EVA pathway and has been selected for technology appraisal under NICE following a ministerial referral from the Department of Health and Social Care (DHSC). The company is believed to be the first in the UK to make this transition. NHS England has communicated an anticipated tender notice publication date of 1 January 2027 and a go-live target date of July 2027, subject to NICE guidance outcome.
The test currently holds a conditional recommendation for use in the NHS by NICE. Manchester University NHS Foundation Trust and University Hospitals Sussex NHS Foundation Trust have already successfully transitioned to business-as-usual (BAU) use, and genedrive will continue business case progression to enable all PALOH-UK sites to rapidly follow suit.
Clinical and Economic Impact
To date, more than 13,000 babies have been tested using the Genedrive® MT-RNR1 ID Kit (搜索) across the UK and internationally, with over 40 babies having avoided aminoglycoside (搜索) exposure and the associated risk of lifelong deafness.
If the prevalence observed to date continues across the wider NHS population, the number of babies identified each year as being at risk of AIHL could increase from approximately 200 per year—as assumed in the original NICE economic model—to approximately 300 per year. On the same basis, associated annual NHS cost savings from avoided cochlear implant procedures alone could rise from approximately £13 million to £20 million.
Beyond direct healthcare savings, NHS Scotland has estimated that broader social care savings associated with avoiding profound aminoglycoside-induced hearing loss (搜索) could amount to approximately £14.5 million, comprising reductions in the need for additional educational support and lifetime disability-related payments.
Commercial Momentum
Genedrive also reported unaudited income of approximately £1.4 million for the 2026 financial year, up from approximately £1.0 million a year earlier. Growth was supported by wider adoption of both the MT-RNR1 (搜索) and CYP2C19 (搜索) pharmacogenetic tests, with international markets now accounting for around one-quarter of total revenue. A fundraising completed in March 2026 generated net proceeds of approximately £4.9 million, leaving the company with cash of around £3.0 million at the financial year-end.
The MT-RNR1 (搜索) test is now moving towards routine clinical use in more than 20 NICUs, with around 25 NHS business cases currently progressing. Internationally, the company is advancing pilot programmes in Spain, has secured a three-year commercial agreement in the United Arab Emirates, and is working with health authorities in Saudi Arabia on implementation and procurement plans.
Dr Gino Miele, CEO of genedrive plc (搜索), commented: "The PALOH-UK programme is an exemplar of how NHS, academia and industry collaboration, when supported by government, can successfully translate scientific innovation into measurable patient benefit and deliver life changing patient solutions whilst offering substantial financial and productivity gains to pressured healthcare systems. It also demonstrates in practice the shift from treatment to prevention at the heart of the NHS 10 Year Plan in action."
The Genedrive® MT-RNR1 ID Kit (搜索) was developed through collaboration involving national funding and policy partners, including the Royal National Institute for Deaf People, NIHR, the Office for Life Sciences, Innovate UK, and the Greater Manchester innovation ecosystem, providing a model for delivering future healthcare innovation across England.