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A. Murray

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    P1.03 - Poster Session with Presenters Present (ID 455)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Radiology/Staging/Screening
    • Presentations: 1
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      P1.03-007 - Improvement in Performance of an Autoantibody Panel Test for Detection of Lung Cancer by Addition of a Single Novel Biomarker (EDB1) (ID 5039)

      14:30 - 15:45  |  Author(s): A. Murray

      • Abstract
      • Slides

      In order to provide optimal cost-benefit, the US national lung cancer screening program is restricted to a relatively narrow group of high risk individuals, with 70% of patients with lung cancer falling outside the CT screening inclusion criteria. Additional tests that can identify those at increased risk who do not qualify for CT screening may be useful. A biomarker assay that measures a panel of autoantibodies and is intended to be used as an aid to early detection of lung cancer is commercially available. It has high specificity but moderate sensitivity. The aim of this study was to investigate the performance of an additional biomarker that may increase the sensitivity of the autoantibody test in order to improve its clinical utility.

      All lung cancer cases were individually matched to controls by age, gender and smoking history. Discovery screening of a panel of 39 potential protein biomarkers was performed on a multiplex Luminex system using a cohort of 44 lung cancers and 44 controls. Validation studies were performed on 334 lung cancers and 326 controls plus 140 samples from patients with autoimmune disease obtained from Oncimmune biobanks as well as 197 cases and 301 controls obtained from the Cleveland Clinic using a singleplex microtiter plate ELISA (Biotechne). The autoantibody test was performed by Oncimmune Ltd.

      The discovery screen identified one protein biomarker (EDB1) that demonstrated clear cancer/normal differentiation and high specificity in both control groups (risk matched and inflammatory/autoimmune disease). The validation studies provided the performance data in the table. The specificity of EDB1 in patients with benign autoimmune disease was 97.8%.

      Cohort Biomarker Test Sesitivity Specificity PPV
      Oncimmune biobank Autoantibody test 31.0% 86.2% 7.3%
      EDB1 35.0% 92.6% 14.3%
      Autoantibody test + EDB1 56.4% 79.8% 8.9%
      Cleveland clinic Autoantibody test 37.1% 87.4% 9.4%
      EDB1 19.3% 83.7% 12.0%
      Autoantibody test + EDB1 46.7% 83.7% 9.2%

      Running a single biomarker (EDB1) in combination with the autoantibody test improves the sensitivity for detection of lung cancer by between 10 and 25% with minimal adverse effect on specificity so maintaining the PPV of the test.

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