EarlyCDT Lung for assessing risk of lung cancer in solid lung nodules

EarlyCDT Lung (Oncimmune) is a blood test to assess the malignancy risk of solid lung nodules found by chest CT or X-ray. It is an enzyme-linked immunosorbent assay and is available as a CE-IVD kit. EarlyCDT Lung measures the presence of autoantibodies to a panel of 7 lung cancer associated antigens (p53, NY-ESO-1, CAGE, GBU4-5, HuD, MAGE A4 and SOX2). After blood collection, the test is carried out in a laboratory in a secondary healthcare setting. Positive results are reported as 'positive-moderate' if at least 1 of the 7 autoantibodies is elevated above a predetermined 'low' threshold, but all are below the 'high' threshold. If at least 1 of the 7 autoantibodies is elevated above the 'high' predetermined threshold, the test is reported as 'positive-high'.

EarlyCDT Lung is proposed as a 'rule-in' test to be used in addition to standard care for the detection of lung cancer. A positive EarlyCDT Lung result would be used to update a pre-test malignancy risk from either the Brock or Herder risk models. The pre-test risk would be unchanged if the EarlyCDT Lung result is negative. The estimated post-test risk is intended to help clinicians make decisions about further testing or intervention.