MANCHESTER, England,
March 8, 2017 /PRNewswire/ --
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® 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® 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®
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® 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®
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® 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® HCV ID Kit by the
end of March 2017. CE certification
is a key step toward product commercialisation later this year.
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® 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
For further details please contact:
genedrive plc
David Budd: CEO
Matthew Fowler: CFO
+44-(0)-161-989-0245
Peel Hunt LLP
James Steel
Oliver Jackson
+44-(0)-207-418-8900
Consilium Strategic Communications
Chris Gardner
Matthew Neal
Laura Thornton
genedrive@consilium-comms.com
+44-(0)-203-709-5700