Genedrive PLC Genedrive HCV Kit received CE Marking (2849Q)
September 11 2017 - 1:00AM
UK Regulatory
TIDMGDR
RNS Number : 2849Q
Genedrive PLC
11 September 2017
11 September 2017
genedrive plc ("genedrive" or the "Company")
Genedrive(R) HCV ID Kit received CE-IVD Certification
Hepatitis C assay provides decentralised molecular testing to
support the identification of patients that could benefit from
direct acting antiviral therapy
genedrive plc (LSE:GDR), the molecular diagnostics company,
today announces that the Company has achieved CE certification
under the EU Medical Devices Directive for its Genedrive(R) HCV ID
Kit, a qualitative molecular assay for Hepatitis C (HCV). CE
marking allows for introduction of the assay into Europe as well as
low and middle income countries that accept CE certification under
their national regulations. In other countries, CE marking can be a
necessary prerequisite to begin local registration processes and is
an important endorsement for potential distribution partners.
David Budd, CEO of genedrive plc, said: "It is an exciting
achievement to be the first company to launch a molecular HCV test
designed to be used in smaller hospital laboratories and clinics.
CE Marking will allow us to engage with many of the countries where
HCV is an endemic healthcare issue. The combination of national
screening programs, the availability of cost effective treatment,
and consequently a growing demand for molecular diagnostics is an
area we can contribute to in a meaningful way. Treatment with
pan-genotypic direct acting antivirals can be initiated immediately
following a positive HCV result using the Genedrive HCV assay
allowing for effective linkage to care, and reducing patient loss
during the follow up."
The Genedrive(R) HCV assay is performed on the Genedrive(R)
instrument, an innovative and affordable system providing molecular
diagnostics at the point of need. The proprietary assay is
performed directly from a small, 25ul plasma sample and does not
require a separate viral nucleic acid extraction process. The assay
provides results within 90 minutes from lyophilised PCR reagents
packaged into a single-use, disposable cartridge. Performance
evaluation studies to support CE marking of the assay (Institut
Pasteur, Paris & Queens Medical Centre, Nottingham)
demonstrated sensitivity and specificity fulfilling the
requirements published by FIND, the Foundation for Innovation in
New Diagnostics.
- Ends -
For further details please contact:
genedrive plc
David Budd: CEO +44 (0)161 989 0245
Matthew Fowler: CFO
Peel Hunt LLP
James Steel
+44 (0)207 418 8900
Oliver Jackson
Consilium Strategic Communications
Chris Gardner +44 (0)203 709 5700
Matthew Neal
Laura Thornton
genedrive@consilium-comms.com
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.
Further details can be found at: www.genedriveplc.com and
www.genedrive.com
About Hepatitis C
Hepatitis C is an international public health challenge,
comparable to other major communicable diseases, including HIV,
tuberculosis and malaria. It is estimated that 150-200 million
people, or approximately 3% of the world's population, are living
with chronic hepatitis C, and more than 350,000 people die yearly
from hepatitis C related diseases. In 2016, WHO published the first
global health sector strategy on Hepatitis with a goal of
eliminating viral hepatitis as a major public health threat by
2030. New oral, well-tolerated treatment regimens can achieve cure
rates of over 90% however access to rapid, inexpensive and accurate
diagnostics are a critical bottleneck that must be addressed to
eradicate Hepatitis C.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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