Genedrive PLC Antibiotic Induced Hearing Loss update
March 03 2021 - 2:00AM
RNS Non-Regulatory
TIDMGDR
Genedrive PLC
03 March 2021
genedrive plc
("genedrive" or the "Company")
Antibiotic Induced Hearing Loss update
New clinical guidance in the UK supports assay
genedrive plc (AIM: GDR), the near patient molecular diagnostics
company, provides an update on its Antibiotic Induced Hearing Loss
("AIHL") assay.
As announced on the 3 December 2020, an 11 month implementation
trial at Manchester University NHS Foundation Trust and and
Liverpool Women's Hospital successfully concluded in November 2020.
The results of the study will be published in a peer reviewed
journal. The study's primary outcomes were very positive, showing
genedrive's utility as the world's first rapid genetic test in an
emergency care neonatal setting. In excess of 750 babies were
tested and 160 hospital staff were trained to provide rapid testing
in this critical care setting.
Since completion of the trial, there has been new clinical
guidance in the UK(1) on the importance of the management of
specific genetic mutations and their role in hearing loss as a
result of antibiotics ("ototoxicity"). Government and Society
guidance are considered a key factor influencing the speed and
extent of future adoption. The Company and Inspiration Healthcare
Group plc (AIM: IHC), the distribution partner for the AIHL assay,
believe this will lead to increased demand for the genedrive AIHL
test in the UK. This new government guidance reminds healthcare
professionals about the impact of antibiotic related ototoxicity
and to consider the need for genetic testing prior to initiation of
treatment. genedrive's assay is the only commercial point of care
test available for the testing of MT-RNR1, the most important
mutation contributing to AIHL in infants.
The launch of the genedrive AIHL assay remains on track for
summer 2021 and the Company is enthusiastic about both the
commercial prospects and the clinical benefits of this novel test
to prevent potential irreversible hearing loss and this test
becoming a standard of care. The Company is executing initial stage
key opinion leader engagement in the UK alongside Inspriration
Healthcare in preparation for commercial launch.
David Budd, CEO of genedrive plc, said: "We had the privilege of
working with Manchester University NHS Foundation Trust and
Liverpool Women's Hospital throughout 2020 on the first deployment
globally of a point of care test system to screen for MT-RNR1 - a
mitochondrial mutation closely associated with ototoxicity in
infants. Despite the emergence of COVID-19, our clinical partners
showed huge dedication in keeping this important project on-track,
becoming the first in the world to generate valuable information on
the utility of this approach in an emergency care setting. As we
see updated guidance and greater awareness to the requirement for
genetic testing, we only expect increased interest in our novel
assay."
(1)
https://www.gov.uk/drug-safety-update/aminoglycosides-gentamicin-amikacin-tobramycin-and-neomycin-increased-risk-of-deafness-in-patients-with-mitochondrial-mutations
For further details please contact:
genedrive plc +44 (0)161 989 0245
David Budd: CEO / Matthew Fowler:
CFO
Peel Hunt LLP (Nominated Adviser
and Joint Broker) +44 (0)20 7418 8900
James Steel / Oliver Jackson
finnCap (Joint Broker) +44 (0)20 7220 0500
Geoff Nash / Kate Bannatyne / Alice
Lane
Walbrook PR Ltd (Media & Investor +44 (0)20 7933 8780 or genedrive@walbrookpr.com
Relations)
+44 (0)7980 541 893 / +44 (0)7876
Paul McManus / Anna Dunphy 741 001
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(R) Point of Care version of the assay, both based on
Genedrive(R) chemistry.
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