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Studies were completed with 573 patients known to have lung cancer who were matched against normal patients (no lung cancer) for the same age, sex and smoking history. The test, which is regulated under CLIA, has 40% sensitivity and 90% specificity. This means that the test detects 40% of lung cancers, including early stage disease (Stages I and II), and the overall accuracy of the test is greater than 88%. This performance compares favorably with other well known tests such as mammography in younger women or in the case of lung cancer, where EarlyCDT-Lung performance is at least twice as good as CT. Study findings suggest that the autoantibody test is not influenced by sex, ethnicity, geographic location of patients or the presence of benign autoimmune diseases. Previous studies have shown that autoantibodies can be detected up to five years before tumors can be seen in routine diagnostic imaging procedures such as CT.
Oncimmune researchers also set forth the modeled cost-effectiveness of EarlyCDT-Lung as an aid to lung cancer diagnosis, with an estimated $6,000 potential cost savings for every QALY (quality-adjusted life year) saved. Study results are being introduced in multiple poster presentations June 6, 2010, at the annual meeting of the American Society of Clinical Oncology... [PDF] Oncimmune's Press Release -