A revolutionary genetic test that prevents hearing loss in critically ill newborns has been successfully implemented across all eight neonatal sites in Greater Manchester and will now be extended as part of a two-year study to 14 neonatal units across England, Scotland, Wales and Northern Ireland.

The Genedrive MT-RNR1 test, which identifies babies at risk of hearing loss after treatment with the antibiotic gentamicin, has already safeguarded the hearing of 11 newborns and tested over 4,000 babies as of October 2024.

Developed by researchers at Saint Mary’s Hospital, part of Manchester University NHS Foundation Trust (MFT), and The University of Manchester, in collaboration with genedrive plc, as part of the Pharmacogenetics to Avoid Loss of Hearing (PALOH) programme, the test provides results in just 26 minutes using a simple cheek swab. This rapid turnaround allows clinicians to identify newborns carrying a genetic variant that makes them susceptible to gentamicin-induced hearing loss and prescribe alternative antibiotics within the critical ‘golden hour’ of care.

Every year, around 90,000 newborns in intensive care receive gentamicin to treat life-threatening infections. While effective, the antibiotic poses a risk of irreversible hearing loss for babies with a specific genetic predisposition. Until the PALOH study to develop the test, there were no rapid screening tools available to detect at-risk infants, leading to unnecessary cases of permanent hearing impairment.

HInM played a crucial role in integrating this innovative test into neonatal care, providing funding to ensure its implementation across Greater Manchester. The success of this rollout has paved the way for a national expansion. Following a successful £1.5 million bid to the National Institute for Health and Care Research (NIHR) and the Office for Life Sciences, the ‘PALOH-UK’ study commenced in November 2024.

The PALOH project aligns with the UK government’s broader commitment to advancing genomic medicine. Insights gained from this initiative have also informed the Development and Validation of Technology for Time Critical Genomic Testing (DEVOTE) programme. Supported by The University of Manchester, MFT,  HInM and industry partners, DEVOTE aims to develop and implement rapid genetic testing solutions in other critical healthcare settings. The increasing integration of genomics and informatics has also attracted leading biotech firms, such as Qiagen (APIS Assay Technologies), to establish research hubs in Manchester, reinforcing the city’s position as a global leader in genomics .

Health Innovation Manchester is proud to support this transformative work, which not only protects newborns from preventable hearing loss but also demonstrates the power of genomic medicine in delivering rapid, life-saving interventions. As the PALOH-UK study progresses, this pioneering approach has the potential to reshape neonatal care across the NHS, improving outcomes for thousands of families nationwide.

Jonathan Massey, Programme Director for Academia at HInM spoke of the success:  “The implementation of this technology has prevented antibiotic–induced hearing in several vulnerable babies – the impact is profound in terms of avoided surgery, follow-up appointments, and a life of living with potential disability. I feel this is the start of a revolution in pharmacogenetic testing in the NHS. Health Innovation Manchester has supported the wider adoption of the technology across the city-region, ensuring that the work translates to better and equitable patient outcomes, wherever a child is treated in Greater Manchester”

Dr John McDermott, Clinical Geneticist at MFT and joint lead for the PALOH-UK study said: “We are incredibly proud to be leading this research at MFT, having already seen the difference this new genetic test has made across Greater Manchester. We are excited to explore how it can be used effectively at other neonatal units across the UK.

“The PALOH-UK study will demonstrate how the test can be used in a timely way to ensure babies get a safe, effective antibiotic without affecting normal clinical practice, on a much larger scale.”