Genedrive PLC NICE to accelerate evaluation of Genedrive test (5094A)
September 26 2022 - 01:00AM
UK Regulatory
TIDMGDR
RNS Number : 5094A
Genedrive PLC
26 September 2022
genedrive plc
("genedrive" or the "Company")
NICE to accelerate evaluation of the Genedrive (R) MT-RNR1
Test
New Early Value Assessment Programme identifies technologies
more rapidly
genedrive plc (AIM: GDR), the near patient molecular diagnostics
company, announces that the UK's National Institute for Health and
Clinical Excellence ("NICE") has transferred the evaluation of the
Genedrive(R) MT-RNR1 test to a new Early Value Assessment Programme
("EVA"). EVA is a new review process, created to drive innovation
into the hands of healthcare professionals by actively drawing in
digital products, medical devices and diagnostics that address
national unmet needs.
The EVA allows the NICE diagnostics advisory committee to
consider the technology much faster, which will result in a
published report in a six month timeframe instead of the initial 63
weeks (approximately 14 months) via the Diagnostics Assessment
Programme. A provisional schedule has been published by NICE which
indicates the consultation process will occur in February 2023.
The Genedrive(R) MT-RNR1 assay is the world's first rapid
point-of-care test to screen infants in an urgent care setting for
a genetic variant that will cause life-long hearing loss when
carriers of the variant are given certain antibiotics. Those that
carry the variant can then be given alternative treatments
following detection of the variant by the Genedrive(R) test.
David Budd, CEO of genedrive plc, said: "We are grateful to NICE
for their engagement and interest in our innovative technology and
pleased that the Genedrive(R) MT-RNR1 test has been fast tracked
via their new EVA programme, which may allow clinicians and
patients to benefit from the test sooner. This is a testament to
our technology and our ability to address this unmet need."
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
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 has assays on the market for the detection
of MT-RNR1, HCV, certain military biological targets, a high
throughput SARS-CoV-2 assay and a point of care test for
Covid-19.
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