Genedrive PLC genedrive partners with FIND to evaluate HCV test
August 08 2018 - 1:01AM
RNS Non-Regulatory
TIDMGDR
Genedrive PLC
08 August 2018
GENEDRIVE PARTNERS WITH FIND TO EVALUATE A MOLECULAR DIAGNOSTIC
KIT FOR HEPATITIS C VIRUS IN DECENTRALISED SETTINGS
-- Evaluation studies of the Genedrive(R) HCV ID Kit will take place in Cameroon and Georgia
-- Assay designed for use in low-resource settings, delivering results in 90 minutes
Manchester, U.K. and Geneva, Switzerland - 8 August 2018 -
genedrive plc, a near patient molecular diagnostics company, and
the Foundation for Innovation of New Diagnostics (FIND), announced
today a study agreement for the performance evaluation of genedrive
plc's hepatitis C virus (HCV) Genedrive(R) HCV ID Kit. The
Genedrive(R) HCV ID Kit is a qualitative HCV diagnostic assay,
performed on the company's portable molecular diagnostics platform,
Genedrive(R). The assay is designed for use in low-resource
settings, and delivers results in 90 minutes.
Under today's agreement, FIND will lead evaluation studies in
Cameroon and Georgia between September 2018 and May 2019. These
studies are designed to confirm the diagnostic accuracy of
Genedrive(R) HCV ID across diverse genotypes, as well as to assess
usability in the intended market setting. genedrive plc will
provide product in-kind to support the study.
"We are appreciative of the support of FIND in leading these
studies," said David Budd, CEO of genedrive plc. "Positive outcomes
should further facilitate our commercialisation activities in these
regions, as well as providing important clinical field data that
others look to as they decide to implement Genedrive(R) in their
own specific settings."
FIND's evaluations of Genedrive(R) HCV ID Kit will feed into the
organization's broader HCV efforts. FIND is the lead partner on a
multi-year, multi-country HCV project funded by Unitaid to support
the development of simple HCV diagnostic tools for use at the point
of care, which can be made widely available to those who need
them.
"These studies are a perfect fit with our ongoing efforts to
improve the options for affordable, easy-to-use HCV diagnostics,"
said Francesco Marinucci, Head of HCV and HIV at FIND. "We look
forward to the results and to ongoing collaboration with genedrive
plc."
The World Health Organization estimated that 71 million people
had chronic HCV infections in 2015. If left untreated, HCV can
cause serious, lifelong illness or death due to liver cirrhosis.
Levels of HCV co-infection with HIV and tuberculosis (TB) are high,
meaning failure to address HCV will affect efforts to control both
TB and HIV. The global health sector aims to eliminate viral
hepatitis as a public health threat by 2030. Given advances in HCV
drug development, treatment options have become easier and more
affordable. However, similar progress has not been made in HCV
diagnostic development. There is a critical lack of easy-to-use,
affordable tools for diagnosis at the point of care - an estimated
80% of people living with HCV are not diagnosed.([1])
FIND's contribution to this initiative is supported by
Unitaid.
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) HCV ID Kit has received CE-IVD
Certification and has been launched in Africa and Asia Pacific.
genedrive has distribution agreements with subsidiaries of Sysmex
Corporation for the distribution of the Genedrive(R) platform in
the EMEA and Asia Pacific regions, and with Arkray Pvt Ltd in
India. Genedrive(R) mTB assay is in development. Further details
can be found at: www.genedriveplc.com and www.genedrive.com
About FIND
FIND was established in 2003 as a global non-profit dedicated to
accelerating the development, evaluation and delivery of
high-quality, affordable diagnostic tests for poverty-related
diseases, now including malaria, tuberculosis, HIV/AIDS, sleeping
sickness, hepatitis C, leishmaniasis, Chagas disease, Buruli ulcer,
non-malarial fever and diseases with outbreak potential, such as
Ebola. FIND has partnered in the delivery of 20 new diagnostic
tools and created an enabling environment for numerous others
through the provision of specimen banks, reagent development and
better market visibility. FIND also supports better access to new
diagnostics through implementation, quality assurance and lab
strengthening work. FIND has nearly 200 partners globally,
including research institutes and laboratories, health ministries
and national disease control programmes, commercial partners,
bilateral and multilateral organizations, especially WHO, and
clinical trial sites. For further information, please visit
www.finddx.org
Media contacts:
genedrive plc
David Budd: CEO
Matthew Fowler: CFO
T: +44 (0)161 989 0245
Consilium Strategic Communications
Chris Gardner, Matthew Neal, Laura Thornton; Consilium Strategic
Communications
T: +44 (0)203 709 5700
genedrive@consilium-comms.com
FIND
Sarah-Jane Loveday, Head of Communications
T: +41 (0) 22 710 27 88
M: +41 (0) 79 431 62 44
media@finddx.org
# # #
[1] WHO global hepatis report 2017,
http://apps.who.int/iris/bitstream/10665/255016/1/9789241565455-eng.pdf?ua=1
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END
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