Genedrive PLC Positive final recommendation by NICE (6932U)
30 March 2023 - 5:00PM
UK Regulatory
TIDMGDR
RNS Number : 6932U
Genedrive PLC
30 March 2023
genedrive plc
("genedrive" or the "Company")
Genedrive(R) MT-RNR1 ID Test receives positive final
recommendation by NICE
NICE issues final guidance for use in the NHS through Early
Value Assessment programme
genedrive plc (AIM:GDR), the point of care molecular diagnostics
company, announces that, further to the Company's announcement on 9
February 2023, the UK's National Institute for Health and Care
Excellence (NICE) has today ratified and finalised its
recommendation following a public consultation process that the
Genedrive(R) MT-RNR1 ID Kit can be used by the NHS. The review was
conducted through NICE's Early Value Assessment (EVA) programme,
which was designed to select and recommend new technologies that
will make a real difference to patients and provide the most value
for the NHS.
The positive outcome was based on a number of key conclusions,
including that the Genedrive(R) MT-RNR1 ID Kit can quickly and
accurately identify babies with the MT-RNR1 genetic variant who may
be at risk of hearing loss if given aminoglycoside antibiotics, and
that no other test is available to provide results quickly enough
to inform decisions on antibiotic prescribing in emergency care.
These conclusions support, and are a consequence of, the Company's
strategy for the development of rapid molecular diagnostics for
emergency care.
David Budd, CEO of genedrive plc, said : "We are appreciative of
the thorough review conducted by the NICE team. The final report
issued today entirely reflects the preliminary conclusion published
in February. As we continue with commercial roll out and product
adoption, the NICE EVA framework will give us the opportunity to
support specific performance and impact data that NHS users and
commissioners may look for in future guidance. NICE, whose guidance
is formally applicable to the NHS in England and Wales, is an
internationally respected health authority and the tools and data
supplied in its review will be relevant to the rest of the United
Kingdom and to the other international markets which we are now
accessing."
NICE's recommendation on using the Genedrive(R) MT-RNR1 test in
NHS England and Wales through its EVA program will support
additional data generation requirements whilst the test is being
used routinely within NHS sites. It is anticipated that this data
collection process will be several years in duration. Further
guidance on data collection from NICE is expected in the coming
months.
NICE's final EVA report can be accessed here:
https://www.nice.org.uk/guidance/indevelopment/gid-hte10009/documents
For further details please contact:
genedrive plc +44 (0)161 989 0245
David Budd: CEO / Russ Shaw: CFO
Peel Hunt LLP (Nominated Adviser
and Joint Broker) +44 (0)20 7418 8900
James Steel / Oliver Duckworth
finnCap (Joint Broker) +44 (0)20 7220 0500
Geoff Nash / 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 are currently developing a genetic test
for CYP2C19 metaboliser status.
The Genedrive(R) MT-RNR1 ID Kit, selected as 1 of the 10 EVA
pilot projects, is the world's first commercial point-of-care
genetic test for emergency care. It helps to avoid irreversible
lifelong hearing loss in specific infants exposed to
aminoglycosides by rapidly detecting the m.1555A>G gene variant
that can cause lifelong deafness, allowing for alternative
antibiotics to be prescribed. Product information can be found at
https://www.genedrive.com/assays/rnr1-product.php
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