Oncimmune secures CE mark for EarlyCDT-Lung
Early cancer detection technology company Oncimmune Holdings announced on Friday that it has obtained the CE mark for the reagents used in its EarlyCDT-Lung product - an autoantibody blood test that can detect cancer up to four years earlier than other methods.
Oncimmune Holdings
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16:35 08/11/24
The AIM-traded firm said the CE mark certified that the reagents used in EarlyCDT-Lung meet the EU standards of manufacturing and quality control dictated by the In Vitro Diagnostics Medical Devices Directive.
Its board said the product was the company’s first, and was launched in 2012 as a CLIA laboratory test in the US, with more than 145,000 commercial tests being sold since.
EarlyCDT-Lung is available through physicians in the US, the board stated, as well as privately in the UK and other regions.
It is also being used in the largest-ever randomised trial for the early detection of lung cancer using biomarkers - the NHS Scotland ECLS study of 12,000 high-risk smokers - for which further results are expected to be reported in December.
“Securing CE marking for EarlyCDT-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,” said Oncimmune CEO Geoffrey Hamilton-Fairley.
“We now satisfy regulatory requirements in both Europe and the US, where we already have the CLIA certification.”
Hamilton-Fairley said achieving the significant milestone of CEO marking is also an important precursor to the development and subsequent CE marking of the kit form of the 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.”