First IVD topic enters England’s National HealthTech Access Programme

The National HealthTech Access Programme (NHAP), launched in February 2026, extends NICE’s Technology Appraisal approach beyond medicines to selected medical devices, diagnostics, and digital health technologies. The programme is intended to support more consistent NHS adoption by linking positive recommendations to a national funding requirement.

Rapid MT-RNR1 testing is the first IVD topic selected for assessment through NHAP. The technology is used to identify a genetic variant in newborns before treatment with aminoglycoside antibiotics, helping reduce the risk of antibiotic-induced hearing loss.

One product, the Genedrive MT-RNR1 ID Kit, had previously been assessed through NICE’s early-use HealthTech Guidance in 2023. The topic was subsequently selected for reassessment in February 2026.

In September 2026, NICE published the final scope confirming that the topic would proceed through NHAP. Two technologies are included in the appraisal:

• Genedrive MT-RNR1 ID Kit;
• VitaSIRO solo MT-RNR1 SNP assay.

Publication of the final NHAP guidance is scheduled for August 25, 2027. If NICE issues a positive recommendation, the technology would be subject to the NHS mandatory funding requirement, normally within three months.

What does it mean?

The inclusion of rapid MT-RNR1 testing is significant because it shows that IVDs can now be selected for assessment through a pathway that is more closely linked to national funding and implementation than traditional diagnostic guidance routes.

For IVD manufacturers, this may create a more direct route from NICE assessment to NHS adoption for selected technologies. At the same time, NHAP is not a general pathway for all diagnostics: topics are selected, and companies will still need to demonstrate sufficient clinical and economic value under a Technology Appraisal-style assessment.

The first IVD topic will therefore be important to follow, as it should provide an early indication of how NICE will apply NHAP to diagnostics in practice, what evidence expectations will look like, and how effectively positive recommendations translate into adoption across the NHS.

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