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NICE recommends BIVDA member Genedrive’s test

By April 6, 2023No Comments

BIVDA is delighted that Genedrive’s genetic test has been officially recommended for use in NICE’s final guidance. The assessment of the test was carried out carried out through NICE’s Early Value Assessment pilot project, which aims to enable earlier access to digital products, medical devices and diagnostics that address national unmet needs in health and social care.

We hope to see many more tests from BIVDA member companies assessed and authorised in this way in future to ensure patients across the country can access the most innovative, impactful tests on the market.

Genedrive’s genetic test prevents deafness in babies by ascertaining whether they are allergic to commonly used post-birth antibiotics, allowing doctors to act accordingly. In normal circumstances, doctors would use the antibiotic gentamicin to treat a neonatal bacterial infection, however, some babies possess the m.1555A>G genetic variant which means the antibiotic would inflict serious hearing problems.

Through a simple cheek swab, doctors can rapidly detect whether the baby has the genetic variant. This process takes less than an hour compared to laboratory testing which would take much longer. If the variant is detected, doctors can then use alternative but equally effective antibiotics.

Around 1,249 babies are born in England and Wales with the variant each year – meaning thousands of children each year are prevented from suffering life changing hearing loss. Moreover, the test saves valuable NHS funds. In just the first year, the estimated cost of treating hearing loss with a bilateral cochlear implant is around £65,000 – a cost that the test prevents.

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

“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.”

David Budd, CEO of genedrive plc, said: “We are appreciative of the thorough review conducted by the NICE team. The final report issued today entirely reflects the preliminary conclusion published in February. As we continue with commercial roll out and product adoption, the NICE EVA framework will give us the opportunity to support specific performance and impact data that NHS users and commissioners may look for in future guidance.”


Natalie Creaney