NIHR and OLS Funding Package

NIHR and OLS Funding Package to address NICE Real World Evidence Generation Requirements for the Genedrive® MT-RNR1 ID Kit

Revenue of £500k over the life of the award

genedrive plc (AIM: GDR), the point of care Pharmacogenetic testing company, announces a successful funding award to its clinical partners from the National Institute for Health and Care Research ("NIHR") in collaboration with the UK Government Office for Life Sciences ("OLS") to address evidence generation requirements of the National Institute for Health and Care Excellence ("NICE") Early Value Assessment ("EVA") for the Genedrive® MT-RNR1 ID kit.

The NIHR/OLS Real World Evidence Programme is aimed specifically at technologies like the Genedrive® MT-RNR1 ID kit which have been recommended for use in the NHS via the NICE EVA, to enable the addressing of real-world evidence gaps and the potential subsequent provision of a full (non-conditional) recommendation by NICE to accelerate the widespread adoption and implementation into the NHS.

The programme is clinician consortia-based and will be led by principal investigators Professor Bill Newman and Dr. John McDermott (University of Manchester / Manchester University NHS Foundation Trust), with 14 separate hospital Neonatal Intensive Care Units across England (inclusive of some sites which have already implemented the Genedrive® MT-RNR1 ID test as part of routine clinical use), Scotland, Wales and Northern Ireland (inclusive of nine sites already utilising the Genedrive® MT-RNR1 ID test in routine clinical practice). The start date was 1 November 2024 with a maximum duration of 18 months, with sites phased into group 1 (sites already currently using the test) and group 2 (remaining sites). Group 1 site testing is funded under the programme for six months from project initiation, following which funding for continuity of routine clinical practice will be required to be sought from alternative sources by those sites.

Revenue to Genedrive for the MT-RNR1 ID kit under the programme is expected to be approximately £500,000.

Whilst scheduled for a maximum of 18 months, performance data can be submitted to the NICE EVA Evidence Generation team at an earlier point if the team believes the evidence generation requirements have been successfully fulfilled. Performance data generated during the programme is also expected to contribute towards clinical performance data requirements for FDA as part of planned De novo submission process required for commercial entry into the U.S.

Gino Miele, Chief Executive Officer of genedrive plc, said: "We are delighted with this funding package award to our clinical collaborators, representing a key step in enabling generation of real world evidence data requirements of NICE to transition from conditional to full recommendation. The programme will run in parallel with, and be complementary to, our continued sales expansion, nationally and internationally. The goal of NIHR and the Government's Office for Life Sciences via this programme is to drive adoption and implementation of innovative technologies such as ours into the UK's NHS, to drive improved patient outcomes and economic benefits."