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NICE Recommends Genedrive Test in Draft Guidance to Prevent Hearing Loss in Newborns

NEW YORK – The UK's Institute for National Health and Care Excellence (NICE) on Thursday in a draft guidance recommended that Genedrive's MT-RNR1 ID Kit for the prevention of antibiotic-induced hearing loss in newborn babies should be adopted by the country's National Health Service.

NICE is a part of the UK Department of Health and Social Care and publishes guidance for healthcare professionals. The institute has been assessing Genedrive's test since last year, and in September accelerated its evaluation via its new early value assessment program.

Genedrive's assay relies on a reverse-transcription loop mediated isothermal amplification approach to test newborns for the m.1555A>G variant in MT-RNR1 that predisposes carriers to hearing loss when they are prescribed the broad spectrum antibiotic gentamicin. The test is intended for screening babies admitted to intensive care units. Genedrive's test can be run using a cheek swab and has a turnaround time of about an hour. The Manchester, UK-based company obtained a CE-IVD mark for the test, which runs on its portable Genedrive System, in 2019.

Following the publication of its draft guidance, NICE has opened a public consultation that will end later this month, and a final guidance is expected in March.

Genedrive CEO David Budd said in a statement that his firm was "encouraged" by the draft stage recommendation and urged stakeholders to take part in the consultation. The firm now awaits the final NICE report.

According to NICE, about 1,250 babies are born in England and Wales with the m.1555A>G variant annually. The cost of treating antibiotics-induced hearing loss with a bilateral cochlear implant is around £65,000 ($79,000) in the first year.

In a statement, Mark Chapman, interim director of medical technology at NICE, said that NHS staff to date have not been able to quickly test newborns for the variant in question. The availability of Genedrive's test, he said, will allow the NHS to 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," commented Chapman.

NICE's recommendation only applies to NHS England and NHS Wales, the institute noted.