Oncimmune Holdings PLC CE Mark for EarlyCDT®-Lung (2652E)
July 15 2016 - 2:00AM
UK Regulatory
TIDMONC
RNS Number : 2652E
Oncimmune Holdings PLC
15 July 2016
PRESS RELEASE 15 July 2016
Oncimmune Holdings plc
("Oncimmune" or the "Company")
CE Mark for EarlyCDT(R)-Lung
CE Mark Paves Way for Further Commercialisation
Nottingham, UK - 15 July 2016: 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 the reagents used in
EarlyCDT(R)-Lung, an autoantibody blood test that can detect cancer
up to four years earlier than other methods.
The CE mark certifies that the reagents used in EarlyCDT(R)-Lung
meet the strict EU standards of manufacturing and quality control
dictated by the In Vitro Diagnostics Medical Devices Directive
98/79/EC (IVD Directive).
EarlyCDT(R)-Lung, the Company's first product, was launched in
2012 as a CLIA laboratory test in the USA, and since then over
145,000 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 also being used in the
largest ever randomised trial for the early detection of lung
cancer using biomarkers, the National Health Service (NHS) Scotland
ECLS study of 12,000 high-risk smokers, for which further results
are expected to be reported in December 2016.
Geoffrey Hamilton-Fairley, CEO of Oncimmune, commented:
"Securing CE marking for EarlyCDT(R)-Lung is a testament to the
quality of our test and processes and was one of the key objectives
laid out for the Company at its recent IPO. We now satisfy
regulatory requirements in both Europe and the US, where we already
have the CLIA certification.
"Achieving this significant milestone of CE marking is also an
important precursor to the development and CE marking of the kit
form of our test, which will more easily enable widespread
international adoption. Demonstrating conformity to the exacting
standards required to achieve the internationally recognised CE
mark will also support certification in other territories,
including Asia."
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, Andrew Jones, Dominic Wilson
+44 (0) 203 829 5000
Media enquiries:
Consilium Strategic Communications
Chris Gardner, Mary-Jane Elliott, 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 145,000
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 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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