Early value assessment (EVA) guidance on the Genedrive MT-RNR1 ID Kit for detecting a genetic variant to guide antibiotic use and prevent hearing loss in babies.
August 2023: NICE has developed tools and resources, in association with relevant stakeholders, to help organisations put this guidance into practice, including an evidence-generation plan. The evidence-generation plan discusses the prioritised evidence gaps and outcomes, ongoing studies, potential real-world data sources, and how remaining evidence gaps can be resolved through the design of real-world evidence studies.
Guidance development process
EVA guidance rapidly provides recommendations on promising health technologies that have the potential to address national unmet need. NICE has assessed early evidence on these technologies to determine if earlier patient and system access in the NHS is appropriate while further evidence is generated.
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 EVA approach.
This guidance updates and replaces NICE's medtech innovation briefing on the Genedrive MT-RNR1 ID system for detecting single nucleotide polymorphism m.1555A>G in newborn babies (MIB290).
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.