Avoiding antibiotic induced hearing loss in babies

One in 500 people carry a genetic variant which causes profound irreversible hearing loss when given gentamicin, a common antibiotic used to treat infection. Previously, testing for this genetic variant would take several days.

Working with a small Manchester biotech company, genedrive plc, researchers within the Diagnostics and Technology Accelerator (DiTA) at Manchester University NHS Foundation Trust (MFT) designed and developed the world’s first rapid bedside genetic test, which could deliver a result in 26 minutes.

DiTA worked with genedrive plc to identify and prioritise use. We focused on testing babies in the neonatal intensive care unit (NICU) because gentamicin is the recommended antibiotic for neonatal sepsis and newborn babies with the genetic variant are particularly susceptible to its toxicity.

Babies admitted urgently to NICU need antibiotics within an hour of admission. In the context of sepsis, testing is not possible with the standard laboratory test but is feasible with genedrive’s rapid bedside test.

Research funded by the NIHR Invention for Innovation (i4i) programme allowed MFT, supported by DiTA, to conduct a trial at Saint Mary’s Hospital, part of MFT and Liverpool Women’s Hospital. A cheek swab was used to predict whether newborn babies who need antibiotics should be given an alternative treatment. We tested 751 babies before antibiotic prescription and three babies were identified with the genetic variant. These babies were then prescribed an effective alternative antibiotic. Every month researchers met with parents to advise on the study and support the ethical approval process.

This is the first time that a point of care test has been used in an acute clinical setting. We demonstrated that this is possible and can make a practice changing, cost effective impact, with integration into standard clinical pathways.

Our work has led to the publication of international guidelines for the use of genetic testing to prevent hearing loss due to gentamicin use. The test has been improved, CE marked and given NICE Early Value Assessment approval (HTE, March 2023).

Through Health Innovation Manchester, the test has been introduced across neonatal units across the North West, including MFT, before national adoption. The test could prevent ~14,000 cases of hearing loss each year worldwide. In the UK, this test could prevent 200 cases of profound hearing loss in neonates, saving the NHS £7m per year.

The work was awarded the New Statesman Positive Impact in Healthcare Award 2022. The work underpinned a successful Innovate UK Award for time sensitive genomic test development with a number of biotech companies in Manchester (£4.2m 2023-2025).

The HealthTech Research Centre in Emergency and Acute Care will build on the success of MFT’s DiTA to ensure that state-of-the-art technologies and innovations are assisting our clinicians to diagnose diseases earlier and ensure appropriate treatments are provided sooner to our patients from Greater Manchester and beyond.