Following user feedback from the successful PALOH* study, various product improvements and refinements have been incorporated into this next generation platform. These include informatic and ergonomic improvements. The new system has been validated by external users as part of the CE-IVD marking process and is ready to be deployed initially at key sites in the UK, followed by the EU. A system overview is available at www.genedrive.com/genedrive-system/genedrive-system.php
genedrive is now commencing its roll out of the Genedrive MT-RNR1 IC Kit in partnership with Inspiration Healthcare plc as its distributor in the UK and Ireland, and is expecting its first sales in autumn 2021. The Company estimates the total addressable market in the UK and EU at around £35m and has recently raised funds to support its commercial activities to drive sales and exploit thus attractive market.
Professor Bill Newman**, said: “The use of the Genedrive® MT-RNR1 system in our neonatal intensive care units represented the first time point of care molecular diagnostics has been ever used in this urgent care situation. Antibiotics should be delivered within an hour of any decision to treat, and current lab-based genetic technologies are not sufficiently rapid to detect the MT-RNR1 mutation within a clinically relevant timeframe. Our engagement with genedrive in the PALOH study has been very positive as well and rewarding for our teams. It’s very encouraging to see the Company quickly incorporate the study findings and our teams’ suggestions into this next generation platform, which we think will support the urgent need of ensuring antibiotic induced hearing loss can be significantly reduced.”
David Budd, CEO of genedrive plc, said: “Developed in partnership with NHS collaborators, the Genedrive® MT-RNR1 Kit and Genedrive® System represent several world firsts – the first commercial availability of an MT-RNR1 test, the first use of our new Genedrive® platform, and the first use of point of care molecular diagnostics in a neonatal urgent care setting. The excellent clinical and performance data that supports these new innovations puts us in a strong position for commercial roll out in the UK alongside Inspiration Healthcare, our commercial distributors in the UK and Ireland.
“With the EU scheduled to follow early next year, our first EU pilot site is already established, and will serve as a reference site as we target selected EU countries. The creation, development, and evaluation of the AIHL test and the new Genedrive® System to support the kit has been very considered, and we are pleased to be at the forefront of this innovation in patient care.”
*The prospective Pharmacogenetics to Avoid Loss of Hearing (PALOH) Trial was a prospective performance trial led by Manchester University NHS Foundation Trust and NIHR Manchester Biomedical Research Centre. It was designed assessed the proportion of neonates that could successfully tested for the mt-RNR1 variant on admission vs the number of neonates prescribed antibiotics. Secondary outcomes measured whether implementation maintained existing routine clinical admission practices. The study authors have submitted the results for publication, a summary of which was recently been presented at the European Society for Human Genetics.
** Dr Newman is Professor of Translational Genomic Medicine at the University of Manchester, Consultant at Saint Mary’s Hospital, part of Manchester University NHS Foundation Trust and National Institute for Health Research (NIHR) Manchester Biomedical Research Centre, Developing Genetic and Genomic Solutions, Associate Lead.
