Genetic test quickly identifies babies at risk for antibiotic-induced hearing loss


A world’s first genetic test, partly developed by scientists at the University of Manchester that could save the hearing of hundreds of babies each year, has been successfully developed and piloted in the NHS.

In just 25 minutes, the bedside machine identifies whether a critically ill baby admitted to intensive care has a gene that could lead to permanent hearing loss if treated with a common emergency antibiotic.

The new swab test technique would replace a test that traditionally took days and could save the hearing of 180 babies in England alone each year.

People admitted to intensive care are usually given an antibiotic called gentamicin within 60 minutes. While gentamicin is used to safely treat around 100,000 babies a year, one in 500 babies carry the gene that can lead to permanent hearing loss.

Developed in Manchester, the new test means babies with the genetic variant can be given another antibiotic during ‘golden hour’.

The test is expected to save the NHS £5million each year by reducing the need for other interventions, such as cochlear implants.

First-year nursing student Mary, from Preston, is the mother of 18-month-old Khobi, who was born and cared for at Saint Mary’s Hospital, part of Manchester University NHS Foundation Trust.

Mary said: ‘Khobi was born with her intestines outside her womb which put her at risk of infection – she needed antibiotics quickly but she received this new genetic test which showed that she was likely to lose her hearing due to gentamicin.

“He was given another antibiotic which did not affect his hearing, and it worked well. She is doing well and is such a happy and sociable baby.

“This test is awesome, and I think every baby should have it.”

“I am absolutely delighted with the success of the study and the fact that this test will now be used in three of our Trust’s neonatal intensive care units – it will actually make a real difference to babies not losing their hearing. for a preventable reason. The trial demonstrated that it is possible to deploy rapid genetic testing in a clinical setting and that testing can be done during the “golden hour” when critically ill babies need to be treated with antibiotics” -Professor Bill Newman

NHS National Medical Director Stephen Powis said: “The successful trial of this bedside test is fantastic news for the hundreds of babies – and their parents – who would otherwise lose their hearing if they received this common antibiotic in critical care situations.

“Through world-class innovation, the NHS is delivering cutting-edge treatments to save and improve the lives of patients, while delivering on the commitments of the NHS long-term plan.”

Professor Bill Newman, Consultant in Genomic Medicine at the University of Manchester’s NHS Foundation Trust and Professor of Translational Genomic Medicine at the University of Manchester, led the Pharmacogenetics to Prevent Hearing Loss (PALoH) study. He said: ‘I am absolutely delighted with the success of the study and the fact that this test will now be used in three of our Trust’s neonatal intensive care units – it will actually make a real difference to babies not not lose their audience for an avoidable reason.

“The trial demonstrated that it is possible to deploy rapid genetic testing in a clinical setting and that testing can be done during the ‘golden hour’ when critically ill babies need to be treated with antibiotics.”

Following the completion of the breakthrough study, the NHS Genomic Medicine Service Alliance and the NHS will explore how this technology can be launched as part of a clinical service through the NHS Genomic Medicine Service.

About 300 nurses are being trained to use the machine through MFT at Saint Mary’s Hospital, Wythenshawe Hospital and North Manchester General Hospital, and the test is expected to be used routinely in all neonatal units at hospitals in Manchester. a few weeks ago, which are part of Saint Mary’s Managed Clinical Service within the trust.

Professor Dame Sue Hill, Scientific Director for England and Senior Genomics Officer at the NHS, said: “Genomic medicine is transforming healthcare, and it is a powerful example of how genetic testing can now be done extremely quickly and become a lifeblood. triage – not only in intensive care but in all of our services.

“It also shows the importance of thinking about how advances in technology can rapidly transform the way we use genomics closer to care for our patients.”

Professor Newman, associate head of genomics solutions for hearing health at the NIHR Manchester Biomedical Research Center (BRC), said the team had managed to transfer the precision of the machine in the laboratory to work efficiently on a ward. At the same time, clinicians quickly adapted to incorporate the test into their routine care of very sick children in the neonatology ward.

The idea for the test came five years ago, and trials began in 2020 with further adaptations and adjustments so that the current machine, which is called the Genedrive system, is now fully CE certified for use in a clinical setting.

The study results were published in JAMA Pediatrics – the world’s top-ranked pediatric journal – last week.

Backed by £900,000 in funding from the National Institute for Health Research (NIHR) and support from the charity Royal National Institute for Deaf People, the Genedrive system, which costs £80 per baby, was developed by Genedrive, a start-up based at the University of Manchester. It was developed in close collaboration with Professor Newman’s team at the Manchester Biomedical Research Centre.

Mike Hobday, Director of Policy and Campaigns at the National Deaf Children’s Society, said: “The National Deaf Children’s Society welcomes the release of this important study. The introduction of a rapid test to identify susceptibility to deafness caused by the antibiotic gentamicin will be greatly appreciated by many newborn families.

“Until now, genetic testing has taken too long to come back from the lab to be useful for babies in need of urgent treatment, but a rapid test will be a game-changer.”

David Budd, CEO of Genedrive, said: “There is a strong drive within the NHS to alert healthcare professionals to the impact of antibiotic-induced hearing loss and encourage them to consider genetic testing. before the start of treatment.

“This is an excellent example of using human genetics to guide specific therapy, which has now taken center stage in clinical management globally. The application of Genedrive’s technology shows how a rapid and affordable point-of-care test could impact patient treatment and quality of life in this area as well as in a wide range of fields.

Reference: McDermott JH, Mahaveer A, James RA, et al. Rapid point-of-care genotyping to avoid aminoglycoside-induced ototoxicity in neonatal intensive care. pediatrician. 2022. do: 10.1001/jamapediatrics.2022.0187

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