15th Jul 2016 07:55
LONDON (Alliance News) - Oncimmune Holdings PLC said Friday it has received a European CE mark for the compounds used in its product EarlyCDT-Lung.
EarlyCDT-Lung is a blood test designed for the early detection of lung cancer. The CE mark certifies the compounds in the blood test meet the European Union standards of manufacturing and quality control, to enable the product to be legally placed on the market.
EarlyCDT-Lung was launched in 2012 in the US and was the cancer detection company's first product. It is currently being used in a study of 12,000 high-risk non-smokers, the "largest ever" randomised trial for the early detection of lung cancer.
The company said the "internationally recognised" CE mark should support certification in other territories, such as Asia.
"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. We now satisfy regulatory requirements in both Europe and the US, where we already have the CLIA certification," said Oncimmune Chief Executive Geoffrey Hamilton-Fairley.
The stock was untraded Friday at 122.00 pence.
By Lucy Heming; [email protected]
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