A genetic test that establishes vulnerability to hearing loss in babies has been recommended by the National Institute of Health and Care Excellence (NICE).
When babies develop a neonatal bacterial infection, doctors and midwives would usually give the antibiotic gentamicin. However, the use of this antibiotic can increase the risk of hearing loss in babies if they have the m.1555A>G genetic variant. Other antibiotics are available, but they cannot be widely used because they are linked to a higher risk of antimicrobial resistance.
Hearing loss affects around one to two babies in every 1,000 born. This increases to about one in every 100 babies who have spent more than 48 hours in intensive care.
Widening tests to detect hearing loss in babies
Current laboratory testing would not produce results quickly enough to administer treatment within one hour – in line with guideline recommendations.
Now, an independent NICE committee has conditionally recommended the use of a genedrive kit, a diagnostic test for detecting the m.1555A>G variant in newborn babies being cared for in a hospital.
The test works with a swab of DNA from inside the newborn’s cheek and runs it through the genedrive device to discover if the baby has the genetic variant. The results are displayed on the screen in under an hour.
If the m.1555A>G variant is found, the baby can be treated with alternative, equally effective antibiotics.
Figures show that around 1,249 babies are born in England and Wales with the m.1555A>G variant each year. Presently, babies treated with gentamicin who go deaf are only discovered to have the genetic variant after DNA testing afterwards.
The estimated cost of treating hearing loss in babies 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.”
Genedrive kit could transform neonatal care
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 administer antibiotic treatment between standard care and when using the genedrive device. This means the test will not delay the time it takes to administer antibiotics.
The assessment of genedrive was carried out through NICE’s Early Value Assessment (EVA) pilot project, which is designed to accelerate access to digital products, medical devices and diagnostics.
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 rollout of technology, which could play a pivotal role in preventing deafness in a small number of babies in the future.”
