Genedrive PLC Antibiotic Induced Hearing Loss Assay CE marking (6579T)
November 18 2019 - 1:00AM
UK Regulatory
TIDMGDR
RNS Number : 6579T
Genedrive PLC
18 November 2019
genedrive plc
("genedrive" or the "Company")
Antibiotic Induced Hearing Loss Assay receives CE marking
genedrive's genetic screening test could prevent thousands of
infants from needlessly going deaf
genedrive plc (LSE: GDR), the near patient molecular diagnostics
company, announces that its Antibiotic Induced Hearing Loss test,
the Genedrive(R) MT-RNR1 ID kit, has obtained CE marking. The
Genedrive(R) MT-RNR1 ID kit will be used in critical care settings
to screen babies for a genetic mutation, which if present, can
cause lifelong deafness when they are given certain
antibiotics.
genedrive's RNR1 test is believed to be the first example of a
commercial genetic screening test designed for use in an infant
emergency care environment. Some infants are born with a mutation
in their MT-RNR1 gene, making them susceptible to lifelong,
profound hearing loss if given the frontline antibiotic gentamicin.
Infants with suspected infection need to be treated with
antibiotics within one hour (National Institute for Health and Care
Excellence) of arriving in a neonatal intensive care unit. The
current genetic tests that check the risk of hearing loss
associated with gentamicin treatment are done from a hospital's
centralised Genetics Department, and typically take 3-5 days to
return results. This does not meet the one hour requirement of an
urgent care setting. The Genedrive test allows patients to be
screened for the mutation upon admission in less than 30 minutes,
and those that are found to have the gene mutation can be
prescribed an alternative, safer treatment.
David Budd, Chief Executive Officer of genedrive plc, said: "We
are very pleased to have achieved this important milestone,
pioneering the availability of the first genetic acute care test
for infants. CE marking of our RNR1 test allows for the next phase,
with implementation evaluation by our NHS partners in Manchester
and Liverpool. At the same time, we will look to the opportunities
outside of the UK where CE marking gives us market entry."
Professor William Newman, Clinical Head of Division in Genomic
Medicine Manchester University NHS Foundation Trust, commented: "We
have been very pleased to partner with genedrive in the development
and availability on the antibiotic induced hearing loss test. We
are planning to deploy use of the test across Manchester and
Liverpool for the next 6-8 months, to show how it can be
successfully implemented in an NHS environment. There is a huge
level of enthusiasm on the sites amongst our neonatal consultants,
nursing staff, and patient groups as we launch a truly novel
genetic test that offers the possibility of improving the lives of
thousands of babies and their families."
For further details please contact:
genedrive plc www.genedriveplc.com
David Budd: CEO / Matthew Fowler: CFO +44 (0)161 989 0245
Peel Hunt LLP +44 (0)20 7418 8900
James Steel / Oliver Jackson
Stanford Capital Partners Limited +44 (0)20 3815 8880
Patrick Claridge / John Howes
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) mt-RNR1-ID kit has received CE-IVD
Certification and will be launched into Europe and other markets
following full evaluation by the UK National Health Service. The
Company has assays on market for the detection of HCV, certain
military biological targets, and has tests in development for
tuberculosis (mTB).
About Antibiotic Induced Hearing Loss
Aminoglycosides are broad-spectrum antibiotics, and are one of
the most frequently prescribed medicines globally, used in cases of
gram-negative sepsis, pseudomonas colonisation and treatment of
multi-drug resistant tuberculosis.
The National Institute for Health and Care Excellence (NICE)
advises the use intravenous benzylpenicillin with gentamicin as the
first-choice antibiotic regimen for empirical treatment of
suspected infection in the neonatal period (NICE CG149). This
combination has the major advantage of having a narrow spectrum of
activity and lower risk of antibiotic resistance compared to
alternative antibiotic regimens.
The side effect profile from protracted courses of
aminoglycosides is well known, with ototoxicity commonly recognised
in some patients. Antibiotic Induced Hearing Loss clusters within
families, and is caused by a mutation in the 12S rRNA (RNR1)
m.1555A>G. The incidence is estimated at about 1 in 500. In the
UK, 90000 babies are admitted to NICU units each year, and 80-85%
of them receive gentamycin.
It has previously been observed that genetic testing should be
used in children requiring aminoglycosides to prevent hearing loss
and that this approach would be cost-effective when balanced
against the costs of lifelong deafness and the cost of bilateral
Cochlear implants. However, prior to the Genedrive test, no system
has existed that could meet this need in a critical care
environment.
Further details can be found at: www.genedriveplc.com and
www.genedrive.com.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
MSCUBSARKWAAAAA
(END) Dow Jones Newswires
November 18, 2019 02:00 ET (07:00 GMT)
Genedrive (LSE:GDR)
Historical Stock Chart
From Apr 2024 to May 2024
Genedrive (LSE:GDR)
Historical Stock Chart
From May 2023 to May 2024