TIDMGDR
Genedrive PLC
10 April 2018
For release: 10 April 2018
genedrive plc ("genedrive" or the "Company")
Publication of Genedrive(R) Hepatitis C Test Performance Data in
BMJ Gut
Studies in UK, France and South Africa showed >98%
sensitivity and 100% specificity across all major HCV genotypes
genedrive plc (AIM: GDR), the near patient molecular diagnostics
company, today announces the publication of analytical performance
and field evaluation studies of its Genedrive(R) HCV ID Kit in
Europe and Africa in the prestigious BMJ Gut, a leading
international journal in gastroenterology and hepatology[1].
The paper is available to view online at:
http://gut.bmj.com/content/gutjnl/early/2018/04/03/gutjnl-2017-315783.full.pdf
The publication reports on assay performance data generated and
used for Genedrive(R)'s CE-IVD certification, including analytical
performance data as well as field performance evaluation. Field
performance evaluation studies were performed in Europe by the
Institut Pasteur, Paris and Queen's Medical Centre, Nottingham, and
in Johannesburg, South Africa by Lancet Laboratories, a commercial
clinical facility providing testing services for patients from
South Saharan countries.
Pan-genotype performance, with excellent exclusivity for non-HCV
pathogens and sensitivity of greater than 98% and speci city of
100% in samples of European and African origin (including South
Africa, Kenya, Ghana, Nigeria, Uganda is reported), was observed.
The test was validated in a real clinical setting in a
resource-limited country.
The paper concluded that Genedrive(R) HCV ID Kit was a rapid,
simple, portable and accurate near patient molecular test for HCV,
with sensitivity and specificity that fulfils the recent FIND/WHO
target Product Profile for HCV decentralised testing in low income
and middle-income countries.
David Budd, Chief Executive Officer of genedrive plc.,
commented: "This high impact peer reviewed publication provides
further validation of the performance of our Genedrive(R) HCV ID
assay. We are first to market with a decentralised qualitative
molecular HCV test for use at point of need and believe we have the
potential to positively impact the continuum of care from screening
to cure by supporting real-time treatment decisions."
Dr Darragh Du y of the Institut Pasteur, said: "Whilst direct
acting antiviral therapies have revolutionised therapeutic options
for treating HCV patients, the challenge remains to identify people
infected with the virus, many of whom are living in geographic
regions that lack access to state-of-the-art diagnostics. We are
proud to have partnered with genedrive through our EU Framework 7
funded POC-HCV consortium to aid realisation of this rapid point of
need test that enables real-time treatment and management of
chronic HCV patients in decentralised settings, and to have seen
our work published in this prestigious journal following extensive
peer review."
genedrive has distribution agreements with subsidiaries of
Sysmex Corporation for the distribution of the Genedrive(R)
platform in the EMEA and SE Asia (ex India), and with ARKRAY
Healthcare pvt Ltd for the distribution of the Genedrive(R) HCV ID
Kit and Genedrive(R) platform in India. genedrive recently
announced first commercial sales of instruments and assays in
Africa and Asia Pacific, excluding India.
- 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
Stanford Capital Partners Limited +44 (0)203 815 8880
Patrick Claridge
Institut Pasteur Press office
MYRIAM REBEYROTTE +33 (0)1 45 68 81 01
AURELIE PERTHUISON +33 (0)1 45 68 89 28
presse@pasteur.fr
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) HCV-ID test 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 SE Asia (ex India), and with ARKRAY Healthcare pvt Ltd
for the distribution of the Genedrive(R) HCV ID Kit and
Genedrive(R) platform 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.
[1] Llibre A, Shimakawa Y, Mottez E, et al. Gut Epub ahead of
print: doi:10.1136/gutjnl-2017-315783
This information is provided by RNS
The company news service from the London Stock Exchange
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