Genedrive Regulatory News (GDR)

genedrive plc

("genedrive" or the "Company")

Antibiotic Induced Hearing Loss assay kit demonstrates high clinical accuracy

First neonatal point of care genetic test, showing sensitivity and specificity of 100%

genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that in its case-control clinical validation, the Antibiotic Induced Hearing Loss assay (the Genedrive® MT-RNR1 ID kit) acheived a diagnostic sensivitiy of 100% and specificity of 100% on a cohort of 303 samples. The assay was found to be unaffected by common bacteria and interfering substances that may be expected to be encountered in patients. Genedrive assays are unique in that they are performed from relatively crude patient samples, so robust design has been key in ensuring these excellent results.

The Genedrive RNR1 kit targets the m.1555A>G mutation genotype. If a baby carrying the mutation is given gentamicin, a common treatment for bacterial infections, it can cuase lifelong deafness. In the UK, there are approximately 90,000 babies treated with gentamicin each year who could benefit from this screening test. The m.1555A>G mutation can occur in cells at levels less than 100% and the Genedrive RNR1 kit can detect the m.1555A>G mutation down to at levels of 10%.

This CE marked test is performed on the Genedrive molecular platform, using a single-use disposable cartridge, and can deliver a rapid genetic result in approximately 30 minutes, allowing the opportunity to alter treatment as needed within the one hour treatment window stated in the current NICE treatment guidelines.

To place an order for tests or for further details visit: https://www.genedrive.com/assays/rnr1-assay.php

David Budd, Chief Executive Officer of genedrive plc, said: "We are extremely pleased with the performance of the test and very excited about the impact the test could have in emergency settings. The next step will be to undertake our implementation study in Manchester and Liverpool hospitals, where the goal is not only to replicate the analytical performance outcomes, but also to ensure the test can be implemented in an NHS environment. By doing so we aim to maximise uptake at admission and ensure test results can be obtained quickly and acted upon in the relevant clinical time window. At the same time, we are looking to establish commercial opportunities across targeted areas of the EU under our CE marking."

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Notes to Editors

About genedrive plc

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 Genedrive® HCV-ID test has received CE-IVD Certification and has been launched in Africa and Asia Pacific. genedrive has distribution agreements with subsidiaries of Sysmex Corporation for the distribution of the Genedrive® platform in the EMEA and SE Asia (ex-India), and with ARKRAY Healthcare pvt Ltd for the distribution of the Genedrive® HCV ID Kit and Genedrive® platform in India. The company also has test in development for tuberculosis (MTB).

Further details can be found at: www.genedriveplc.com and www.genedrive.com