Genedrive Regulatory News (GDR)

genedrive plc

("genedrive" or the "Company")

NICE to evaluate the Genedrive® MT-RNR1 Test under their Diagnostics Assessment Programme

genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that the UK's National Institute for Health and Clinical Excellence ('NICE') has started an evaluation of the Genedrive® MT-RNR1 test via their Diagnostics Assessment Programme ('DAP'). DAP evaluations are designed to provide robust recommendations on the use of new products, which is presented in the form of NICE guidance, and to promote rapid and consistent adoption of clinically innovative and cost-effective diagnostic technologies in the NHS.

An independent advisory committee considers the evidence provided, makes draft recommendations for public consultation and ultimately makes final recommendations for publication in NICE guidance. The guidance produced is used by NHS commissioners, practitioners, healthcare operational managers and purchasing and procurement organisations.

genedrive's 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® MT-RNR1 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 was selected for this programme following successful publication of the NICE Medtech innovation briefing ("MIB290") in March. The NICE guidance is an important element required to drive uptake and adoption of the test in the NHS by demonstrating the cost-saving efficiencies. The application of Genedrive's technology shows how a rapid, affordable, point-of-care test could impact patients' treatment and quality of life."

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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 market for the detection of MT-RNR1, HCV, certain military biological targets, and a high throughput SARS-CoV-2 assay. The Company recently released a point of care test for Covid-19.