31 May 2017
CE Mark for EarlyCDT®-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® platform technology, announces it has obtained the CE mark for EarlyCDT®-Lung test in an ELISA kit format. EarlyCDT®-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.
“The development and completion of a kit version of the EarlyCDT®-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®-Lung® 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.”
Geoffrey Hamilton-FairleyCEO of Oncimmune
For further information:
Oncimmune Holdings plc
Geoffrey Hamilton-Fairley, Chief Executive Officer
Zeus Capital Limited (Nominated Adviser and Broker)
Phil Walker, Giles Balleny, Dominic Wilson
+44 (0) 203 829 5000
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 NHS Scotland ECLS study of over 12,000 high-risk smokers is now fully recruited and in the final follow up stage. 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