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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Genedrive MT‑RNR1 ID Kit for detecting a genetic variant to guide antibiotic use and prevent hearing loss in babies

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    DAP66 Gentamicin Early Value Draft Guidance to stakeholders .docx

    The National Institute for Health and Care Excellence (NICE) is producing early value guidance on using Genedrive MT‑RNR1 ID Kit in the NHS in England. The diagnostics advisory committee has considered the evidence and the views of clinical and patient experts. This topic is part of the pilot using the new early value assessment approach. Early value assessment guidance recommendations are conditional while more evidence is collected on the technology to address uncertainty in the evidence base. Once further evidence is collected, this guidance will be reviewed to make a decision on the routine adoption of the technology.

    This document has been prepared for public consultation. It summarises the evidence and views that have been considered, and sets out the recommendations made by the committee. NICE invites comments from registered stakeholders, healthcare professionals and the public. This document should be read along with the evidence (an early value assessment report and the early value assessment report erratum).

    The advisory committee is interested in receiving comments on the following:

    • Has all of the relevant evidence been taken into account?

    • Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

    • Are the recommendations sound, and a suitable basis for early value guidance to the NHS?

    Equality issues

    NICE is committed to promoting equality of opportunity, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and others. Please let us know if you think that the recommendations may need changing to meet these aims. In particular, please tell us if the recommendations:

    • could have a different effect on people protected by the equality legislation than on the wider population, for example by making it more difficult in practice for a specific group to access the technology

    • could have any adverse effect on people with a particular disability or disabilities.

    Please provide any relevant information or data you have about such effects and how they could be avoided or reduced.

    Note that this document is not NICE's final guidance on Genedrive MT‑RNR1 ID Kit. The recommendations in section 1 may change after consultation.

    After consultation, NICE will consider the comments received. The final recommendations will be the basis for NICE's early value guidance on using the technology with evidence generation.

    For further details, see NICE health technology evaluations: the manual.

    Key dates:

    Closing date for comments: 21 February 2023