Geoffrey Hamilton-Fairley, CEO of Oncimmune LON:ONC, 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.”
Oncimmune Holdings plc (AIM: ONC.L), a leading early cancer detection company developing and commercialising its proprietary EarlyCDT(R) platform technology, has told DirectorsTalk 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.
