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

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

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

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

Developed in 91直播, the new test means that babies found to have the genetic variant can be given an alternative antibiotic within the 鈥榞olden hour.鈥�

It is expected the test could save the NHS 拢5 million every year by reducing the need for other interventions, such as cochlear implants.

First-year nursing student Mary, from Preston, is mother to 18-month-old Khobi, who was born and treated at Saint Mary鈥檚 Hospital, part of Manchester University NHS Foundation Trust.

Mary said: 鈥淜hobi was born with her bowel outside her tummy, which put her at risk of infection - she needed antibiotics quickly but was given this new genetic test which showed she was susceptible to hearing loss from gentamicin.

鈥淪he was given an alternative antibiotic which didn鈥檛 affect her hearing, and it worked well. She鈥檚 doing fine and is such a happy, sociable baby.

鈥淭his test is great, and I think all babies should have it.鈥�

NHS national medical director Stephen Powis said: 鈥淭he successful trial of this bedside test is fantastic news for the hundreds of babies - and their parents - who would otherwise lose their hearing when given this common antibiotic in intensive care situations.

鈥淭hrough world-class innovation, the NHS is delivering cutting edge treatments to save and improve patients鈥� lives as well as delivering on the commitments of the NHS Long Term Plan.鈥�

Professor Bill Newman, a consultant in genomic medicine at 91直播 University NHS Foundation Trust and Professor of Translational Genomic Medicine at the University of Manchester, led the Pharmacogenetics to Avoid Loss of Hearing (PALoH) study. He said: 鈥淚 am absolutely thrilled with the success of the study, and that this testing is now going to be used in three of our Trust鈥檚 Neonatal Intensive Care Units -  it鈥檚 actually going to make a real difference so babies are not going to lose their hearing for a preventable reason.

鈥淭he trial demonstrated that you can deploy rapid genetic testing in a clinical setting, and that the tests can be carried out within the 鈥榞olden hour鈥� when severely unwell babies should be treated with antibiotics.鈥�

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

Around 300 nurses are being trained to use the machine across MFT at Saint Mary鈥檚 Hospital, Wythenshawe Hospital, and North 91直播 General Hospital, and the test is expected to be routinely used in all the hospitals鈥� neonatal units within weeks, which are part of Saint Mary鈥檚 Managed Clinical Service within the Trust.

Professor Dame Sue Hill, Chief Scientific Officer for England and Senior Responsible Officer for Genomics in the NHS, said: 鈥淕enomic medicine is transforming healthcare, and this is a powerful example of how genetic testing can now be done extremely quickly and become a vital part of triage - not only in intensive care but across our services.

鈥淚t also shows the importance of thinking about how advances in technology can rapidly transform how we use genomics closer to care for our patients.鈥�

Professor Newman, who is Associate Lead, Hearing Health Genomic Solutions at NIHR 91直播 Biomedical Research Centre (BRC), said the team had successfully transferred the accuracy of the machine in the lab to working effectively in a ward. At the same time, clinicians adapted quickly to incorporate the test into their routine care for very sick children in the neonatal ward.

The idea for the test came five years ago, and trials started in 2020 with further adaptations and fine-tuning so that the current machine, which is called the Genedrive System, is now fully CE certified to be used in a clinical setting.

91直播 鈥� the top-ranked paediatrics journal in the world 鈥� last week.

Backed by 拢900,000 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 拢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鈥檚 team at 91直播 Biomedical Research Centre.

Mike Hobday, Director of Policy and Campaigns at the National Deaf Children鈥檚 Society, said: 鈥淭he National Deaf Children鈥檚 Society welcomes the publication of this important study. The introduction of a rapid test to identify susceptibility to deafness caused by the antibiotic gentamicin will be greatly valued by many families of newborn babies.

鈥淯p to now the genetic test has taken too long to return from the lab to be useful for babies requiring urgent treatment but a rapid test will be a game-changer.鈥�

David Budd, CEO of Genedrive, said: 鈥淭here is a significant drive within the NHS to alert healthcare professionals to the impact of antibiotic-induced hearing loss and encourage them to consider genetic testing prior to initiation of treatment. 

鈥淚t鈥檚 a great example of using human genetics to guide specific therapy, which is now taking front and centre in clinical management globally. The application of Genedrive鈥檚 technology shows how a rapid, affordable, point-of-care test could impact patients鈥� treatment and quality of life across this as well as a wide range of fields.鈥�