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Oncimmune receives certification for early stage lung cancer test

The early stage cancer testing group has obtained the CE mark for the reagents used in its EarlyCDT-Lung test.

Cancer cells
The CE mark certifies that substances used in the test meet strict EU standards.

Oncimmune Holdings PLC (LON:ONC) announced that it had obtained the CE (Conformité Européene) mark for the reagents used in its lung cancer detection test.

The meditech group’s EarlyCDT-Lung is an autoantibody blood test that can detect cancer up to four years earlier than other methods.

The CE mark certifies that the reactive substances used in the test meet EU standards dictated by the In Vitro Diagnostics Medical Devices.

"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 chief executive Geoffrey Hamilton-Fairley.

He said the CE mark will also support further certification in other territories including Asia.

Since the launch of EarlyCDT-Lung in 2012, over 145,000 commercial tests have been sold in the US.

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AIM:ONC
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