21 December 2017
Oncimmune Holdings plc - Validation of EarlyCDT®-Liver test
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.
Commercial sales expected to begin in the first half of 2018
Nottingham, UK – 21 December 2017: Oncimmune Holdings plc (AIM: ONC.L), a leading early cancer detection company developing and commercialising its proprietary EarlyCDT® platform technology, today announces that the Company has validated its EarlyCDT®-Liver test on schedule and a commercial test will be available on time from the first half of 2018.
The EarlyCDT®-Liver test is the second Oncimmune has developed based on its proprietary EarlyCDT® platform technology which has been shown to detect cancer up to four years earlier than other methods. Oncimmune is beginning commercial implementation of the EarlyCDT®-Liver test in the US and full launch is expected to take up to six months. The Company is also immediately starting the CE marking process of a “kit” version for distribution in the rest of the world. This is expected to be complete by the second half of 2018.
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. 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 hepatocellular carcinoma (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.
 Welberry C, Irving W, Murray A, Chapman C, Autoantibodies as additive biomarkers to AFP for the detection of HCC, 11th Annual International Liver Cancer Association (ILCA) 2017; Seoul, P-083.
"The validation of the EarlyCDT®-Liver test is one more deliverable in our path to commercialisation as was laid out at the IPO. It demonstrates the wider potential of Oncimmune’s proprietary EarlyCDT® platform technology and is a further step in successfully progressing our strategy to generate multiple revenue streams from multiple products in multiple territories. Earlier this year we announced that EarlyCDT®-Liver test would be validated by the end of the year and we have achieved this important milestone on schedule.”
Geoffrey Hamilton-FairleyCEO, of Oncimmune
For further information:
Oncimmune Holdings plc
Geoffrey Hamilton-Fairley, Chief Executive Officer
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
Consilium Strategic Communications
Chris Gardner, Matthew Neal, Lindsey Neville
+44 (0)20 3709 5708
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 150,000 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. EarlyCDT® 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