Oncimmune Holdings PLC CE Mark for EarlyCDT-Lung Kit (6166G)
May 31 2017 - 2:00AM
UK Regulatory
TIDMONC
RNS Number : 6166G
Oncimmune Holdings PLC
31 May 2017
31 May 2017
This announcement contains inside information
Oncimmune Holdings plc
("Oncimmune" or the "Company")
CE Mark for EarlyCDT(R)-Lung Kit
EarlyCDT-Lung Kit Paves Way for Further Expansion into World
Markets
Nottingham, UK - 31 May 2017: Oncimmune Holdings plc (AIM:
ONC.L), a leading early cancer detection company developing and
commercialising its proprietary EarlyCDT(R) platform technology,
announces it has obtained the CE mark for EarlyCDT(R)-Lung test in
an ELISA kit format. EarlyCDT(R)-Lung is a simple autoantibody
blood test that can detect lung cancer up to four years earlier
than other methods.
The CE mark certifies that the kit meets the strict EU standards
of manufacturing and quality control dictated by the In Vitro
Diagnostics Medical Devices Directive 98/79/EC (IVD Directive). The
Company is now ordering its first batch of commercial kits which
will be available within four months in time for launch.
The kit has the advantage of running on already well established
ELISA-96 well-Microplate-Instruments that hospitals worldwide have
as standard equipment in their laboratories.
Geoffrey Hamilton-Fairley, CEO of Oncimmune, commented: "The
development and completion of a kit version of the EarlyCDT(R)-Lung
test was a key part of the commercial growth strategy laid out at
the time of our IPO. This success positions us to make the test
available to hospitals around the world for running in their own
laboratories.
"Until it was certain that the EarlyCDT(R)-Lung(R) test would
successfully transfer to a kit, Oncimmune's commercialisation plans
for territories outside of the US were conservative as adoption of
the test was likely to be slower if we could only offer a central
laboratory test. The CE marked kit now allows us to address these
markets and support our distributors with a simple test in a
well-known, easy to use format. We believe this development will
greatly help us in accelerating our appointment of global
distributors and support their ongoing performance."
For further information:
Oncimmune Holdings plc
Geoffrey Hamilton-Fairley, Chief Executive Officer
contact@oncimmune.co.uk
Zeus Capital Limited (Nominated Adviser and Broker)
Phil Walker, Giles Balleny, Dominic Wilson
+44 (0) 203 829 5000
Media enquiries:
Consilium Strategic Communications
Chris Gardner, Matthew Neal, Lindsey Neville
oncimmune@consilium-comms.com
+44 (0) 20 3709 5708
About Oncimmune
Oncimmune is a leading early cancer detection company developing
and commercialising its proprietary EarlyCDT(R) platform
technology. Oncimmune has pioneered the development of autoantibody
tests that can detect cancer up to four years earlier than other
methods and can be applied to a very wide range of solid tumour
types. The Company's first product, EarlyCDT(R)-Lung, was launched
in 2012, as a CLIA test in the USA and since then over 150,000
commercial tests have been sold. EarlyCDT(R)-Lung is available
through physicians in the US and also privately in the UK and other
regions. EarlyCDT(R)-Lung is being used in the largest ever
randomised trial for the early detection of lung cancer using
biomarkers. The NHS Scotland ECLS study of over 12,000 high-risk
smokers is now fully recruited and in the final follow up stage.
EarlyCDT(R) tests for liver and ovarian cancer are in
development.
Oncimmune, headquartered in Nottingham, United Kingdom with
testing facilities in the US, joined AIM in May 2016 under the
ticker ONC.L. For more information visit www.oncimmune.com
This information is provided by RNS
The company news service from the London Stock Exchange
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