National Institute for Health and Clinical Excellence (NICE)
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NICE recommends genetic test to prevent newborn babies going deaf

A genetic test to establish if a newborn baby is vulnerable to deafness if treated with a commonly used antibiotic has been recommended by NICE in final guidance.

If babies develop a neonatal bacterial infection doctors and midwives would usually give the antibiotic gentamicin.

However, the use of gentamicin carries the risk of hearing loss if the baby has the m.1555A>G genetic variant. Other alternative antibiotics are available but cannot be more widely used because they are associated with an increased risk of antimicrobial resistance.

At present laboratory testing would not produce results quickly enough to give treatment within an hour – in line with guideline recommendations.

An independent NICE committee has conditionally recommended the use of the genedrive kit, a diagnostic test for detecting the m.1555A>G variant in newborn babies being cared for in hospital.

The test works with a swab of DNA from inside the newborn’s cheek and run it through the genedrive device to discover 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.

Around 1,249 babies are born in England and Wales with the m.1555A>G variant each year. At the moment babies treated with gentamicin who go deaf are only discovered to have the genetic variant with DNA testing afterwards.

The estimated cost of treating hearing loss with a bilateral cochlear implant is around £65,000 in the first year.

Mark Chapman, interim director of Medical Technology at NICE, said: “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.

“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.”

Susan Daniels OBE, chief executive of the National Deaf Children’s Society and lay specialist committee member, said: “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. 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."

Ralph Holme, Director of Research and Insight at Royal National Institute for Deaf People, said: “RNID is thrilled that this new rapid test, which we helped to kickstart, has been approved by NICE and can now be used to save the hearing of hundreds of babies a year across the UK.

“This research will make a life changing difference to hundreds of families, protecting the hearing of their new born children in intensive care and preventing them from developing lifelong hearing loss caused by commonly used antibiotics.

“At RNID, we want a future where the 1 in 6 people in the UK with hearing loss can access treatments and cures, and research is vital to make this happen. This new test is an exciting step forward in the field of hearing research, which wouldn’t have been possible without our supporters.”

Evidence presented to the independent NICE committee from the PALOH study carried out in Manchester and Liverpool showed no statistically significant difference between the time to antibiotic treatment between standard care and when using the genedrive device. This suggests that introducing the test will not delay the time it takes to administer antibiotics.

The assessment of the genedrive kit has been carried out through NICE’s Early Value Assessment pilot project which has been created to enable earlier access to digital products, medical devices and diagnostics that address national unmet needs in health and social care.

It will provide quicker assessments of early value to identify the most promising technologies that can be safely used in the NHS. It means clinicians and patients can benefit from medical technologies while further data is collected to inform a full NICE assessment of the device’s cost and clinical effectiveness.

Once in use, 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. This additional real world evidence will also be scrutinised by the independent NICE committee as part of the kit’s full assessment.

You can read the full guidance on Genedrive MT-RNR1 ID Kit for detecting a genetic variant to guide antibiotic use and prevent hearing loss in babies on the NICE website.

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