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Lung Cancer Autoantibody

EarlyCDT-LungTM, a test offered by Oncimmune (USA) LLC, detects autoantibodies against six cancer associated antigens found in different types of lung cancer. An indirect enzyme-linked immuno-sorbant assay is utilized to detect antibodies to a panel of antigens that includes p53, NY-ESO-1, CAGE, GBU4-5, Annexin1, and SOX2. A positive result is reported if antibodies to any one of the six antigens are detected at a concentration above a defined cut-off (Ann Oncol 2010 Feb 2 [Epub ahead of print]).

In a study presented at the 2010 annual meeting of the American Society of Clinical Oncology (J Clin Oncol 2010;28(15_suppl):7032), this test was performed on 453 patients with newly diagnosed lung cancer and matched high-risk controls (samples collected from multiple sites in the USA, Canada, and Europe) and a second set of 211 small cell lung cancer patients and matched high-risk controls. The overall sensitivity of the test was 40%. Sensitivity for early stage non-small cell lung cancer was 35% (89/258) and for early stage small cell lung cancer was 46% (45/97). Overall specificity for all high-risk individuals was 88%.

This test is being marketed as an aid to risk assessment and early detection of lung cancer in high-risk, asymptomatic patients and for use in conjunction with imaging studies. It should be noted, however, that with 40% sensitivity and 88% specificity, the positive predictive value is only 10% even in the recommended high-risk patient population ( Therefore, most patients that test positive will not have cancer, although they may have to undergo additional testing, and high-risk patients with a negative test will still need to be followed regularly. Likewise, although a positive result in a patient with a lung nodule increases the likelihood that it is malignant; a negative test result does not exclude the possibility of malignancy. A biopsy is required for definitive diagnosis in either case.

This test is currently not approved by the FDA. Patient must first obtain a collection kit from Oncoimmune. Oncimmune will bill the patient’s insurance provider if they have Medicare Part B as their primary insurance or if they have private health insurance coverage. If the patient does not have insurance coverage, they must include payment with the collection kit. List price for the test is $475.

July 21, 2010

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