Genedrive Regulatory News (GDR)

genedrive plc

("genedrive" or the "Company")

NICE issues Medtech Innovation Briefing on Genedrive ® MT-RNR1 Test

genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that the UK's National Institute of Clinical Excellence (NICE) has today issued a new Medtech Innovation Briefing (MIB) on the Genedrive® MT-RNR1 test. genedrive's assay is the world's first 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. The Medtech Innovation Briefing is an important step to increase awareness in the NHS of new innovation and ultimately support adoption in the UK.  

The MIB, titled "Genedrive ® MT-RNR1 ID System for detecting single nucleotide polymorphism m.1555A>G in newborns" is now available here:

Overview | Genedrive MT-RNR1 ID System for detecting single nucleotide polymorphism m.1555A>G in newborn babies | Advice | NICE.

The MIB was initiated in October 2021, prior the announcement of the pivotal Manchester clinical publication (PALOH), published 21 March 2022. The PALOH publication addresses several observations in the MIB including the evolution of the design of the Genedrive® MT-RNR1 test, the excellent adoption levels of the device with in a NICU setting, and the ability to perform the test within the 1-hour admission window required. There is no other test currently available that fulfils the requirements of MT-RNR1 testing in an acute setting. Details of the test can be found on the Company's website at https://www.genedrive.com/assays/rnr1-product.php

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 tests was selected for a MIB review. This NICE MIB documentation, our cooperation with Inspiration Healthcare plc and the publication of the PALOH study results are all important components needed to successfully promote our innovative test for antibiotic induced hearing loss screening."

MIBs are designed to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. MIBs are commissioned by NHS England and published by NICE to inform NHS clinicians and managers about new technologies for their decision-making, commissioning and/or policy development. MIBs do not make recommendations but contain a summary the technology, published evidence, health economic overview and expert options on the advantages and disadvantages.

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