A test which detects if a newborn baby has a genetic variant that could make them susceptible to hearing loss if given the antibiotic gentamicin, has been given conditional approval by NICE.
Last year, researchers from two NHS hospitals in Manchester published data showing the Genedrive test, could identify babies with the MT-RNR1 genetic variant (m.1555A>G variant) within 26 minutes of a swab being taken from the inside of their cheek (see BioNews 1140). This meant that newborn babies who presented in hospital with a bacterial infection could be given the correct antibiotic without delay to treatment, which guidelines dictate should be given within one hour. Available to staff at two NHS neonatal intensive care units in Manchester and Liverpool since the end of the trial in April 2022, the test is set to be rolled out to more hospitals following conditional NICE approval.
Mark Chapman, interim director of medical technology at NICE told the BBC: 'Until now, there has not been a test quick enough to ensure that newborn babies with a bacterial infection and the m.1555A>G variant gene are treated with an appropriate antibiotic. Having this test available to NHS staff can avoid the risk of hearing loss in babies with the variant who need treatment with antibiotics. Hearing loss has a substantial impact on the quality of life of the baby and their family.'
Gentamicin is used routinely in newborn babies as there are concerns about the risk of side effects and antimicrobial resistance when other antibiotics are used. However, by avoiding use of gentamicin in newborns with the variant, it is hoped that money will be saved on the cost of treating hearing loss. Currently children with hearing loss as a result of antibiotic use only find out they have the variant due to later genetic testing.
Data on the impact of the test in different types of hospitals and on antibiotic use will be gathered and assessed by NICE before final approval is granted.
'I hope this additional evidence will support the argument for the roll out of technology, which could play a pivotal role in preventing deafness in a small number of babies in the future,' said Susan Daniels, chief executive of the National Deaf Children's Society.
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