Oncimmune Holdings PLC Oncimmune Launches EarlyCDT®-Liver Test in the US (8918N)
May 14 2018 - 1:00AM
UK Regulatory
TIDMONC
RNS Number : 8918N
Oncimmune Holdings PLC
14 May 2018
The information contained within this announcement is deemed by
the Company to constitute inside information stipulated under the
Market Abuse Regulation (EU) No. 596/2014. Upon the publication of
this announcement via the Regulatory Information Service, this
inside information is now considered to be in the public
domain.
Oncimmune Holdings plc
("Oncimmune" or the "Company")
Oncimmune Launches EarlyCDT(R)-Liver Test in the US
Nottingham, UK - 14 May 2018: Oncimmune Holdings plc (AIM:
ONC.L), a leading early cancer detection company developing and
commercialising its proprietary EarlyCDT(R) liquid biopsy platform
technology, today announces that it has completed development of
its EarlyCDT(R)-Liver test for hepatocellular carcinoma (HCC), and
that it will be commercially available from today in the US. The
test has high specificity at 97% and means that positive test
results can be followed up with a high degree of certainty. This
high specificity complements current imaging detection methods as
well as the diagnostic test alpha fetoprotein (AFP) used in
Asia.
EarlyCDT(R)-Liver is the second test, after EarlyCDT(R)-Lung
developed by Oncimmune based on its proprietary EarlyCDT(R)
platform technology which has been shown to detect cancer up to
four years earlier than other methods. The EarlyCDT(R)-Liver test
is a simple blood test which is complementary to diagnosis via
imaging and can aid in stratification of high risk patients whose
diagnosis is indeterminate following ultrasound and CT or MRI. The
test can also aid in the risk assessment and early detection of HCC
in high-risk patients with hepatic lesions less than 1cm.
EarlyCDT(R)-Liver will initially be available through
Oncimmune's existing distribution network in the US and the Company
intends to seek further specialist distribution partners in the US
and other global markets who target hepatologists with a view to a
full national launch during H2 2018.
Geoffrey Hamilton-Fairley, CEO of Oncimmune, commented: "We are
very pleased to announce the commercial availability of our
EarlyCDT(R)-Liver test, the second product from our EarlyCDT(R)
platform technology, on schedule. Currently most HCC cases are only
detected once symptoms appear and usually in later stages of the
disease. Our test, which measures autoantibodies, with exceptional
specificity, can detect liver cancer in its early stages of
development, giving the patient the chance of more treatment
options and better prognosis. The validated test performance on
early stage cancers means it should add significantly to current
imaging."
Oncimmune has also started the CE marking process of a "kit"
version for distribution in the rest of the world which is expected
to be complete by the end of Q1 2019.
Liver cancer is the second most common cause of death from
cancer worldwide and is particularly prevalent in Eastern and
South-Eastern Asia with China accounting for approximately 50% of
cases globally. It is associated with hepatitis B and C infections,
consumption of alcohol, smoking, and, in the West, with fatty liver
disease related to poor diet. The prognosis for liver cancer is
very poor and there is a clear clinical need for improved
diagnostic testing. Globally 700,000 new cases are diagnosed each
year and the annual death rate is in excess of 600,000. The
EarlyCDT(R)-Liver test has the potential to offer a highly
cost-effective screening tool to complement the performance of the
current existing diagnostic test alpha fetoprotein (AFP), which has
come under scrutiny as the levels can be raised in many patients
who have liver disease but not HCC.
Data relating to the EarlyCDT(R)-Liver panel was published at
the International Liver Cancer Association showing that a panel of
10 autoantibodies could detect HCC with high sensitivity and
specificity.[i]
Oncimmune has a framework agreement with Genostics Company
Limited ("Genostics") for China signed as part of a license,
distribution, manufacturing and future development agreement for
all products related to Oncimmune's EarlyCDT(R) platform for the
People's Republic of China.
For further information:
Oncimmune Holdings plc
Geoffrey Hamilton-Fairley, Chief Executive Officer
contact@oncimmune.co.uk
Zeus Capital Limited (Nominated Adviser and Joint Broker)
Giles Balleny, Hugh Kingsmill Moore
+44 (0)20 3829 5000
Bryan, Garnier & Co Limited (Joint Broker)
Phil Walker, Dominic Wilson
+44 (0)20 7332 2500
Berenberg (Joint Broker)
Toby Flaux, Charlotte Sutcliffe
+44 (0)20 3207 7800
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 155,000
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 National Health Service (NHS) Scotland ECLS study
of 12,210 high-risk smokers.
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
[i] Welberry C, Irving W, Murray A, Chapman C, Autoantibodies as
additive biomarkers to AFP for the detection of HCC, 11(th) Annual
International Liver Cancer Association (ILCA) 2017; Seoul,
P-083.
This information is provided by RNS
The company news service from the London Stock Exchange
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