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Oncimmune Gets CE Mark for Early Lung Cancer Kit

NEW YORK (360Dx) – Oncimmune Holdings said today that it has obtained the CE mark for its autoantibody, blood-based EarlyCDT-Lung test in an ELISA kit format.

The test can detect lung cancer up to four years earlier than other methods, the firm said, adding that it will now be made available "to hospitals around the world for running in their own laboratories."

The first batch of commercial kits will be available within four months when it launches the kit, Oncimmune said. It runs on ELISA-96 well-microplate instruments that hospitals worldwide have adopted as standard equipment in their laboratories, the firm said.

In 2012, Oncimmune launched EarlyCDT-Lung as a test conducted in its CLIA-certified laboratory in the US. The firm said that it has already sold more than 150,000 commercial tests in the US, the UK, and other regions.

The firm noted that it is developing EarlyCDT tests for liver and ovarian cancer.