Genedrive PLC Successful Clinical Results - Genedrive HCV Assay (7467Y)
March 08 2017 - 2:00AM
UK Regulatory
TIDMGDR
RNS Number : 7467Y
Genedrive PLC
08 March 2017
For release: 8(th) March 2017
genedrive plc ("genedrive" or the "Company")
Successful Clinical Results for Genedrive(R) HCV Assay
External Validation Studies Show Sensitivity of greater than 99%
and Specificity of 100% for Hepatitis C Assay Designed for
Decentralised Use in Resource Limited Settings
genedrive plc, the near patient molecular diagnostics company,
today announces that it has successfully completed clinical
validation studies to support a submission for CE regulatory
approval of its Genedrive(R) HCV ID Kit.
The studies, performed at Institut Pasteur, Paris, and Queen's
Medical Centre, Nottingham, demonstrated an overall sensitivity of
greater than 99% and specificity of 100% over a 955 sample cohort,
comparing the test to the Abbott Molecular RealTime HCV Viral Load
Assay. The Genedrive(R) HCV ID Kit sensitivity, specificity, and
limit of detection meet the Target Product Profile specifications
for decentralised use in resource limited settings, as outlined by
the Foundation for Innovation in Diagnostics (FIND). The validation
studies were supported by the European Commission FP7 PoC-HCV
programme.
The HCV test is performed on the Company's Genedrive(R) portable
molecular diagnostics platform, designed for use at the point of
need. The assay uses only a small amount of human plasma (25ul),
eliminating the need for a separate RNA viral extraction process,
and yields results within 90 minutes.
"Recently approved direct acting antiviral therapies have
revolutionised therapeutic options for treating HCV patients,
however the challenge remains to identify infected persons, many of
whom are living in geographic regions that lack access to
state-of-the-art diagnostics," said Dr Darragh Duffy of the
Institut Pasteur. "The Genedrive(R) HCV ID Kit is a rapid and
simple to use point of need test that would enable real-time
treatment and management of chronic HCV patients in decentralised
settings."
"We are very pleased with the performance of the assay's
sensitivity, specificity and speed. This presents the Genedrive(R)
HCV test with the opportunity to be the first to market as a
decentralised, qualitative, molecular HCV test," said David Budd,
Chief Executive Officer of genedrive plc. "WHO HCV testing
guidelines recommend the initiation of treatment with direct acting
antiviral agents, following a qualitative or quantitative HCV
molecular test. The Genedrive(R) HCV ID Kit is well placed to
support the goal of increasing access to HCV diagnostics in
decentralised laboratories in resource limited settings."
The Company anticipates submission for CE certification under
the EU Medical Devices Directive for Genedrive(R) HCV ID Kit by the
end of March 2017. CE certification is a key step toward product
commercialisation later this year.
- 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. The Genedrive(R) platform and MTB/RIF assay has been
launched in India.
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.
Further details on the PoC-HCV project can be found at
http://www.poc-hcv.eu/index.php
This information is provided by RNS
The company news service from the London Stock Exchange
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