Genedrive PLC NHS Ethics approval for use of AIHL test in trials
07 Outubro 2019 - 3:00AM
RNS Non-Regulatory
TIDMGDR
Genedrive PLC
07 October 2019
genedrive plc
("genedrive" or the "Company")
NHS Ethics approval for use of AIHL test in hospital trials
First ever research ethics approval for a neonatal point of care
genetic test
Opportunity for widespread NHS adoption of test for prevention
of hearing loss in newborns
genedrive plc (AIM: GDR), the near patient molecular diagnostics
company, announces that full ethics approval from the NHS Health
Research Authority and ethics committee has been received for the
use of the Company's Antibiotic Induced Hearing (AIHL) test in
hospital trials for clinical validation. The Company believes that
this represents the world's first ethical approval for a point of
care genetic test used to influence neonatal management in an acute
setting.
The novel AIHL test, which genedrive has developed for
evaluation by the Manchester Centre of Genomic Medicine, will be
used in the PALOH ("Pharmacogenetics to Avoid Loss of Hearing")
study involving approximately 1,000 patients from two large UK
intensive care units. The trial is planned to commence in November
2019 and run for circa six months.
The Genedrive(R) MT-RNR1 screening assay targets individuals
with the m.1555A>G genotype, which is estimated to occur in
1:500 people. If a baby who has the mutation is given gentamicin,
they can go profoundly deaf. In the UK alone, there are
approximately 90,000 babies treated for bacterial infections with
gentamicin each year that are candidate patients for this screening
test.
The test is performed on the Genedrive molecular platform, using
a single-use, disposable cartridge, and can deliver a rapid genetic
result in under 30 minutes, allowing the opportunity to alter
treatment as needed within the one hour treatment window stated in
the current NICE treatment guidelines.(1)
The simple test has been developed for use by the nursing staff
in a point of care setting. The primary objective of the PALOH
study will be to show how well the Genedrive(R) MT-RNR1 test
platform can be implemented into the current neonatal emergency
admissions process.
genedrive intends to demonstrate the health economic benefits of
the test to the NHS to gain adoption, in addition to European
healthcare settings. Successful implementation of the Genedrive
test would be a first in the integration into emergency care
settings of a rapid decision making, genetic-based test for safe
antibiotic use in the UK NHS.
David Budd, Chief Executive Officer of genedrive plc, said: "We
are very pleased with our involvement in the PALOH study, and the
progress we and our colleagues in Manchester and Liverpool have
made to date is truly impressive. This type of test fits very well
with our strengths - single use, low complexity, cost effectiveness
and rapid speed to result. The opportunity to bring the power of
molecular testing in a point of care acute setting will undoubtedly
significantly improve the lives of patients both in this trial and
in future adoption of MT-RNR1 testing."
Notes
1. National Institute for Health and Care Excellence, Neonatal
infection (early onset): antibiotics for prevention and treatment
(2012) NICE
For further details please contact:
genedrive plc www.genedriveplc.com
David Budd, CEO +44 (0)161 989 0245
Matthew Fowler, CFO
Walbrook PR Ltd (Media Relations & +44 (0)20 7933 8780 or genedrive@walbrookpr.com
Investor Relations)
+44 (0)7980 541 893 / +44 (0)7876
Paul McManus / Anna Dunphy 741 001
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(R) 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(R) platform in
the EMEA and SE Asia (ex-India), and with ARKRAY Healthcare pvt Ltd
for the distribution of the Genedrive(R) HCV ID Kit and
Genedrive(R) platform in India. The company also has test in
development for tuberculosis (MTB) and Antibiotic Induced Hearing
Loss (AIHL)
Further details can be found at: www.genedriveplc.com and
www.genedrive.com
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END
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