Genetic test recommended to prevent new born babies going deaf

The NHS could adopt a genetic test for new-borns who develop neonatal bacterial infection to reduce the risk of loss of hearing, it has been announced.

The usual treatment for these bacterial infections is the antibiotic gentamicin, however, this carries the risk of hearing loss if the baby has the m.1555A>G genetic variant.

While alternative antibiotics are available, they cannot be more widely used because they are associated with an increased risk of antimicrobial resistance, according to the National Institute for Health and Care Excellence.

Laboratory testing would not produce results quickly enough to give treatment within an hour – in line with guideline recommendations – so an independent NICE committee has conditionally recommended the use of the genedrive kit, a diagnostic test for detecting the m.1555A>G variant in new born babies being cared for in hospital.

The test takes a DNA swab from inside the newborn’s cheek and runs it through the genedrive device to establish if the baby has the genetic variant. The results are displayed on screen in under an hour.

If the m.1555A>G variant is found, the baby can be treated with alternative, equally effective, antibiotics, NICE says.

Mark Chapman, interim director of medical technology at NICE, said: “Until now there has not been a test quick enough to ensure that new born 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.

“Our independent committee has rapidly assessed the evidence for this simple swab test and NICE is conditionally recommending it be used within the NHS while further evidence is generated.

“The costs associated with hearing loss to the NHS are high, so driving an innovation like genedrive into the hands of health and care professionals to enable best practice can also ensure that we balance the best care with value for money, delivering both for individuals and society as a whole.”

The recommendation was welcomed by Susan Daniels, chief executive of the National Deaf Children’s Society.

“Speaking both as a deaf person and as chief executive of the National Deaf Children’s Society, it’s very encouraging that more evidence will be gathered on this important development,” she said.

“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."

Evidence from the PALOH study, which was carried out in Manchester and Liverpool, found no statistically significant difference between the time to antibiotic treatment between standard care and when using the genedrive device.

The assessment of the genedrive kit was carried out through NICE’s Early Value Assessment pilot project.

The NHS will collect further evidence to ensure the test can be put in place in a variety of different maternity settings and it does not lead to an increased use of antibiotics associated with an increased risk of antimicrobial resistance or an increased time to antibiotic treatment.

Comments on the recommendations can be made via until Tuesday, 21 February 2023.

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