Oncimmune Regulatory News (ONC)

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Oncimmune Holdings plc

("Oncimmune" or the "Company")

Oncimmune Launches EarlyCDT®-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® liquid biopsy platform technology, today announces that it has completed development of its EarlyCDT®-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®-Liver is the second test, after EarlyCDT®-Lung developed by Oncimmune based on its proprietary EarlyCDT® platform technology which has been shown to detect cancer up to four years earlier than other methods. The EarlyCDT®-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®-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®-Liver test, the second product from our EarlyCDT® 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®-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®-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® 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® 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®-Lung, was launched in 2012, as a CLIA test in the USA and since then over 155,000 commercial tests have been sold. EarlyCDT®-Lung is available through physicians in the US and also privately in the UK and other regions. EarlyCDT®-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