TIDMGDR
Genedrive PLC
16 January 2018
For release: 16 January 2018
genedrive plc ("genedrive" or the "Company")
First Successful Field Evaluation of Genedrive(R) HCV Assay in
Africa
Performance Study in Johannesburg Demonstrated 100% Sensitivity
and Specificity
genedrive plc, (AIM: GDR), the near patient molecular
diagnostics company, today announces successful results of the
first field study of its Genedrive(R) Hetaptitis C (HCV) ID Kit in
Africa.
The study, performed in Johannesburg at Lancet Laboratories, one
of the leading private pathology testing laboratories operating
throughout Africa, was designed to verify genedrive HCV's assay
performace across the diverse genotypes which are prevalent in
Africa compared to Europe.
In a cohort of 130 clinical samples from South Africa, Kenya,
Ghana, Nigeria, Uganda, and other Sub-Saharan countries, the
Genedrive(R) HCV ID Kit demonstrated sensitivity and specificity of
100% compared to the Abbott M2000 HCV Real time assay as a
reference. The cohort was composed mostly of HCV genotypes 1a, 4,
and 1b, with the remaining 16% samples from genotypes 2, 3, and 5.
The test also demonstrated efficiency of 95.4% (result achieved
first attempt).
"These positive results with the genedrive HCV assay in customer
hands on local samples confirms that our good clinical validation
performance can be translated into real-world settings where the
test will be used, " said David Budd, Chief Executive Officer of
genedrive plc. "Our test is the rst to market as a decentralised
qualitative molecular HCV test for use at the point of need. We
remain confident it can play an important role in the diagnosis and
management of the disease in Africa and in other territories where
access to centralized laboratories is limited."
Dr Allison Glass, Pathologist-in-Charge at Lancet Laboratories
Johannesburg, commented, "Our trained laboratory staff found the
Genedrive(R) HCV system and kit easy to operate, and, compared to
the Abbott M2000 platform, required no maintenance, had a small
laboratory foot print and faster processing time. Many of the
original samples were haemolysed but produced valid results first
time, demonstrating the robustness of using PCR direct from plasma.
The genedrive HCV kit has the potential to decentralise clinical
management of chronic HCV, which may result in the expansion of
treatment programmes to rural areas of resource-limited
countries."
The study follows the recent announcement that genedrive plc has
signed a distribution agreement with Sysmex Europe GmbH, a
subsidiary of Sysmex Corporation, a world leader in clinical
laboratory systemization and solutions, for the Genedrive(R) HCV ID
Kit and Genedrive(R) platform in the EMEA region with an initial
focus on Africa. genedrive plc also entered into a distribution
agreement with Sysmex Asia Pacific Pte Ltd, a subsidiary of Sysmex
Corporation, for its CE-marked Genedrive(R) HCV ID Kit and
Genedrive(R) platform in the Asia Pacific region.
- Ends -
For further details please contact:
genedrive plc
David Budd: CEO +44 (0)161 989 0245
Matthew Fowler: CFO
Sysmex Europe GmbH
Fernando Andreu: Senior Executive Officer +49 40 527 260
Jens Behrens: Director, Marketing Communications
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) HCV ID Kit has recived CE marking.
Further details can be found at: www.genedriveplc.com and
www.genedrive.com
About Sysmex Europe
Sysmex Europe GmbH (SEG), located near Hamburg, Germany, is a
subsidiary of the Sysmex Corporation from Kobe, Japan. From our
Hamburg offices - designated a Great Place to Work(R) in 2014 and
2016 - we serve our affiliates, distributors and customers
throughout EMEA - Europe, the Middle East and Africa. Globally we
employ around 8000 staff, of whom 1300 work in the EMEA region.
Sysmex is the global leader in haematology and a renowned
specialist in haemostasis, urinalysis, and laboratory automation.
As our expertise in the interdependency of disease and medical
disciplines grows, we are growing to cover other pressing areas
such as oncology, flow cytometry, liquid biopsy and essential
healthcare in resource-poor regions. This is allowing us to deliver
clinical value that primary healthcare workers such as physicians,
surgeons and other specialists can use directly to deliver better
diagnostics, treatment and monitoring, and so improve the quality
of life of their patients. Everything we do is driven by a single
mission: Shaping the advancement of healthcare. For more
information about Sysmex Europe, please visit
www.sysmex-europe.com, and for details on Sysmex Africa
www.sysmex.co.za
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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