Genedrive Regulatory News (GDR)

genedrive plc

("genedrive" or the "Company")

First NHS Deployments of the Genedrive® System for Antibiotic Induced Hearing Loss

genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that the first six installations of the Genedrive® MT-RNR1 Antibiotic Induced Hearing Loss ("AIHL") system have now been deployed to Manchester University NHS Foundation Trust ("MFT"), with four installations for Saint Mary's Hospital and two at Wythenshawe Hospital (both part of MFT).

The Genedrive® MT-RNR1 System screens infants in an urgent care setting for a genetic mutation that will cause lifelong hearing loss ("Ototoxicity"), when carriers of the mutation are given certain antibiotics. Those that carry the mutation can be given alternative treatments. MFT will become the first NHS trust to implement the technology into routine clinical care. The test will deliver a genetic determination of MT-RNR1 status in 30 minutes, from a simple cheek swab.

The Genedrive MT-RNR1 System is available in the UK and Ireland in cooperation with Inspiration Healthcare (AIM: IHC). Hospitals interested in discovering more about how to manage ototoxicity can visit

 https://www.genedrive.com/assays/rnr1-product.php.

Clinicians at MFT, supported through the National Institute for Health Research, Manchester Biomedical Research Centre (Hearing Health, Developing Genetic and Genomic Solutions) partnered with the Company in the development and validation of the innovative MT-RNR1 genetic test.

David Budd, CEO of genedrive plc, said: "Final completion and commissioning of these installations is important for the health and safety of infants being admitted into newborn intensive care units ("NICU"). They are also important as their routine use will serve as a model for other Trust and NICU's looking for innovative ways to improve patient safety and overall outcomes. This is a cornerstone installation for us as we commercialise our unique AIHL assay."

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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 a point of care test for Covid-19.

About Manchester University NHS Foundation Trust

Manchester University NHS Foundation Trust (MFT) is one of the largest NHS trusts in the country and a leading provider of specialist healthcare services. Its 10 hospitals are home to hundreds of world class clinicians and academic staff, committed to finding patients the best care and treatments. Its hospitals are Manchester Royal Infirmary, Saint Mary's Hospital, Royal Manchester Children's Hospital, Manchester Royal Eye Hospital, North Manchester General Hospital, University Dental Hospital of Manchester, Trafford General, Altrincham Hospital, Wythenshawe Hospital and Withington Hospital. More information is available at: www.mft.nhs.uk.

About the NIHR Manchester Biomedical Research Centre

The NIHR Manchester Biomedical Research Centre (BRC) is hosted by Manchester University NHS Foundation Trust and The University of Manchester, in partnership with Salford Royal NHS Foundation Trust and The Christie Hospital NHS Foundation Trust. The BRC's vision is to drive health improvements and lasting change for all through creative, inclusive and proactive research that identifies and bridges gaps between new discoveries and individualised care.

Funded by the NIHR from 2017-2022, Manchester BRC provides world-leading research into:

• Biomarker Platforms

• Cancer

• Dermatology

• Informatics and Data Sciences

• Hearing Health

• Musculoskeletal Disease

• Respiratory Disease

About the National Institute for Health Research (NIHR)

The mission of the National Institute for Health Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:

• funding high quality, timely research that benefits the NHS, public health and social care

• investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services

• partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research

• attracting, training and supporting the best researchers to tackle complex health and social care challenges

• collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system

• funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.

NIHR is funded by the Department of Health and Social Care.