Genedrive Regulatory News (GDR)

genedrive plc

("genedrive" or the "Company")

NICE to accelerate evaluation of the Genedrive® MT-RNR1 Test

New Early Value Assessment Programme identifies technologies more rapidly

genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that the UK's National Institute for Health and Clinical Excellence ("NICE") has transferred the evaluation of the Genedrive® MT-RNR1 test to a new Early Value Assessment Programme ("EVA"). EVA is a new review process, created to drive innovation into the hands of healthcare professionals by actively drawing in digital products, medical devices and diagnostics that address national unmet needs.

The EVA allows the NICE diagnostics advisory committee to consider the technology much faster, which will result in a published report in a six month timeframe instead of the initial 63 weeks (approximately 14 months) via the Diagnostics Assessment Programme. A provisional schedule has been published by NICE which indicates the consultation process will occur in February 2023.

The Genedrive® MT-RNR1 assay is the world's first rapid point-of-care test to screen infants in an urgent care setting for a genetic variant that will cause life-long hearing loss when carriers of the variant are given certain antibiotics. Those that carry the variant can then be given alternative treatments following detection of the variant by the Genedrive® test.

David Budd, CEO of genedrive plc, said: "We are grateful to NICE for their engagement and interest in our innovative technology and pleased that the Genedrive® MT-RNR1 test has been fast tracked via their new EVA programme, which may allow clinicians and patients to benefit from the test sooner. This is a testament to our technology and our ability to address this unmet need."

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About genedrive plc (http://www.genedriveplc.com) genedrive plc is a molecular diagnostics company developing and commercialising a low cost, rapid, versatile, simple to use and robust point of need molecular diagnostics platform for the diagnosis of infectious diseases and for use in patient stratification (genotyping), pathogen detection and other indications. The Company has assays on the market for the detection of MT-RNR1, HCV, certain military biological targets, a high throughput SARS-CoV-2 assay and a point of care test for Covid-19.