Genedrive PLC New Genedrive system readied for AIHL launch
August 31 2021 - 1:00AM
RNS Non-Regulatory
TIDMGDR
Genedrive PLC
31 August 2021
genedrive plc
("genedrive" or the "Company")
New Genedrive(R) system readied for Antibiotic Induced Hearing
Loss launch
genedrive plc (AIM: GDR), the near patient molecular diagnostics
company, provides an update on a new Genedrive(R) system platform
which has been designed for the upcoming launch of the Genedrive(R)
MT-RNR1 assay, used for the detection of Antibiotic Induced Hearing
Loss ("AIHL") in newborns.
The Genedrive(R) MT-RNR1 assay targets the m.1555A>G mutation
genotype. If a baby carrying the mutation is given the antibiotic
gentamicin, a common treatment for bacterial infections, it can
cause lifelong deafness. In the UK, there are approximately 90,000
babies admitted to NICUs each year who could benefit from this
screening test.
A large-scale implementation trial of the Genedrive(R) MT-RNR1
assay was performed on 750 newborns by Manchester and Liverpool
Hospitals and concluded in November 2020. The trial represented the
world's first use of a genetic point of care test in a Neonatal
Intensive Care (NICU) setting. The results of this innovative trial
have now been submitted by the study team for publication.
Extensive feedback was taken from over 150 nurses who performed
AIHL testing over the trial period and this has resulted in a
number of refinements being made to the Genedrive(R) unit design
principally to further enhance usability in a NICU setting.
Improvements have been made to the cartridge and instrument
interface and data management options, as well as onward results
transmission capability. The new Genedrive(R) system has a 7-inch
integrated touch screen, replacing the separate smartphone
configuration that was used in the trial. This avoids the issue of
a misplaced phone or the complication of users trying to run
multiple Genedrive(R) units from a single smartphone. The Graphical
User Interface ("GUI") menus have been streamlined and larger data
fields capture NICU specific clinical and patient parameters. This
reduces interaction time and decreases any chances for delays due
to missing field information. The size of the Genedrive(R) system
has been increased to support the new GUI screen. The patented
Genedrive(R) assay cartridge has also been modified with a clip
mechanism to ensure an auditory 'click' when the cartridge is fully
inserted and engaged in the instrument. The cartridge is also now
enabled with an RFID(1) electronic lock to prevent the use of
expired reagents.
The Company will be seeking CE mark clearance for the new
Genedrive(R) system in the coming weeks prior to commercial
launch:
https://www.genedrive.com/genedrive-system/genedrive-system.php
David Budd, CEO of genedrive plc, said: "It has been very
rewarding to see the positive effect of point of care AIHL testing,
and the feedback and engagement of the NHS teams has been a
tangible benefit to the Company and will ultimately be a key driver
of adoption in the market place. Following this refinement of the
overall AIHL system, we are looking forward to the impending
commercial launch and the improved healthcare outcomes it will
offer as an innovative point of care test in a NICU care setting.
Many children every year will be able to live profoundly different
lives as a result of this successful development
collaboration."
1. Radio Frequency Identification
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 / Victoria Erskine
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 and certain military biological targets. The Company recently
released a high throughput SARS-CoV-2 assay and has a point of care
version of the SARS-Cov-2 test due on market during 2021.
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