Genedrive (AIM:GDR) said Betsi Cadwaladr University Health Board and Cardiff and Vale University Health Board will extend routine clinical use of its Genedrive MT-RNR1 ID kit, funded from 1 May until the National Institute for Clinical Care and Excellence (NICE) delivers its final assessment in July 2027.
The point-of-care pharmacogenetic testing company's test screens neonates for a genetic variant linked to antibiotic-induced hearing loss, allowing clinicians to switch newborns to an alternative antibiotic when the variant is detected.
The two Welsh trusts cover roughly 750 neonatal intensive care admissions a year and are among 14 sites in the PALOH-UK programme, set up to generate real-world evidence for NICE.
Seven of those 14 sites have now moved the test into routine clinical service, following earlier adoption at Manchester University NHS Foundation Trust and University Hospitals Sussex NHS Foundation Trust.
More than 40 critically ill babies have been identified with the MT-RNR1 variant since the test's UK introduction.
"We are in active discussions with the remaining hospitals, helping to ensure that newborn babies across the UK continue to have access to this preventive test," said Dr Gino Miele, chief executive of Genedrive.
Patient recruitment across PALOH-UK has now finished, with nearly 6,000 babies tested, and clinical cohort analysis is due for publication in scientific literature roughly October.
The test has exited NICE's Early Value Assessment pathway and moved to technology appraisal following ministerial referral from the Department of Health and Social Care.
NHS England has flagged an anticipated tender notice for 1 January 2027, with a go-live target of July 2027 subject to NICE's final guidance.
News Intelligence what this means for the company
Two major Welsh health boards have committed to fund Genedrive's MT-RNR1 hearing loss test through July 2027, when NICE will issue final guidance. This extends routine clinical use at sites covering ~750 neonatal admissions annually and follows adoption at five other NHS trusts; seven of 14 PALOH-UK programme sites now run the test as standard practice. The pathway has shifted from Early Value Assessment to full technology appraisal, with NHS England signalling a tender notice for January 2027 and go-live aligned to NICE's decision—a concrete timeline for potential national rollout.
The extension locks in revenue visibility through mid-2027 and signals momentum toward NHS-wide adoption, but the investment case remains contingent on NICE's July 2027 appraisal. Positive real-world evidence (nearly 6,000 babies tested, >40 variants identified, clinical cohort analysis due October) supports the case, yet NICE rejection or restrictive guidance would halt expansion; the tender notice and go-live target are conditional on that outcome.
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