A genetic test to establish whether a newborn baby is vulnerable to deafness if treated with gentamicin has been recommended in draft guidance by the National Institute for Health and Care Excellence (NICE).1

The Genedrive kit works by detecting the m.1555A>G variant from a swab of DNA from inside a newborn’s cheek, with results available in under an hour. If the m.1555A>G variant is found the baby can be treated with alternative antibiotics, which cannot be more widely used because of antibiotic resistance.

At present laboratory testing would not produce results within an hour in line with guideline recommendations, and babies who go deaf after being given gentamicin are discovered to have the variant only afterwards, with DNA testing. The estimated cost of treating hearing loss with a bilateral cochlear implant is around £65 000 (€73 200; $78 500) in the first year.

Evidence presented to the NICE committee from the Paloh study2 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, suggesting that the test would not delay the time taken to administer antibiotics.

Gathering evidence

The Genedrive kit has been assessed through NICE’s Early Value Assessment pilot project, which has been created to enable earlier access to digital products, medical devices, and diagnostics to tackle national unmet needs in health and social care.

Once the kit is in use the NHS will collect real world evidence to ensure that the test can be applied in a variety of maternity settings and that it does not lead to increased use of antibiotics associated with higher risk of antimicrobial resistance or a longer time to antibiotic treatment. The results will then be scrutinised by the independent NICE committee as part of the kit’s full assessment.

Mark Chapman, interim director of medical technology at NICE, said, “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, 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.”