Genedrive Regulatory News (GDR)

genedrive plc

("genedrive" or the "Company")

Antibiotic Induced Hearing Loss assay hospital trial completion

Genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces the successful completion of the Antibiotic Induced Hearing Loss ("AIHL") implementation study into the use of the genetic test in an NHS neonatal intensive care setting.

The Genedrive® MT-RNR1 ID Kit has been used over the past 11 months in a trial of what is thought to be a world first use of a genetic test in a neonatal intensive care setting. The Genedrive assay has been used at Manchester University NHS Foundation Trust and Liverpool Women's Hospital to screen babies before administering certain antibiotics that are known to cause deafness in infants.

Over the period of the study, approximately 750 babies have been tested with the Genedrive MT-RNR1 Kit, with all valid results being confirmed by DNA sequencing. Genedrive is now working with the study team to publish the data, due in early 2021, and with Inspiration Healthcare plc to plan the roll-out for commercial use. Full launch of the product is expected from June 2021, following the inclusion of feedback from the trial sites in the product configuration.

David Budd, CEO of genedrive plc, said: "The completion of the AIHL study is an important milestone in the development and commercialisation of our novel test. We have developed a unique assay with compelling health economic benefits which can provide a clinically actionable result in a relevant timeframe, and ultimately could positively alter the lives of thousands of babies every year."

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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 has tests in development for tuberculosis (mTB). The Company recently released a high throughput SARS-CoV-2 assay and has in development a Genedrive® Point of Care version of the assay, both based on Genedrive® chemistry.