Of these 1699 patients, 1613 (95%) signed a HIPAA authorization permitting the ordering physician to disclose health information to Oncimmune®, and it is this group that has been followed in this audit for clinical outcomes to confirm EarlyCDT-Lung test characteristics in routine
practice. The EarlyCDT-Lung www.selleckchem.com/products/AZD8055.html panel was modified in November 2010 from a 6 autoantibody (6AAB) panel to a panel measuring 7 autoantibodies (7AAB) to improve specificity of the test, which has been previously reported [9]. This report does not focus again on this point, but the inclusion of patients tested on both the 6AAB and 7AAB panels in this dataset does allow comparison of these two sub-groups in routine practice. The patient demographics of the overall audit population (n = 1613) and the 6AAB (n = 752) and 7AAB (n = 861) panel groups are shown in Table 1 along with the 5-year lung cancer risk for each group, which was calculated using a modified version of the Spitz model that takes into account demographic risk factors such as gender, age and smoking history [10]. EarlyCDT®-Lung is a physician-ordered blood test that serves as a tool to aid in early detection of lung cancer in high-risk patients. The test is performed only in Oncimmune’s CLIA laboratory (De Soto, KS). The technology has been extensively validated and has been shown to be technically and clinically robust [9], [11], [12] and [13]. EarlyCDT-Lung
detects the presence of AABs to a panel of lung cancer-associated antigens using a semi-automated indirect ELISA-based method. A NVP-BKM120 test result was reported as positive if the antigen titration series showed a dose response
and any one or more AAB levels were elevated above the clinical cut-off. Testing of all patient specimens by EarlyCDT-Lung was performed in Oncimmune’s CLIA laboratory, including the data handling and calculation of the test result, which was performed by the Oncimmune laboratory information management system (LIMS); final test results were generated and reported to individual physicians. All EarlyCDT-Lung tests were performed prospectively upon receiving the physician’s order, and the results were reported back to the physician without knowledge of the patient’s clinical outcome, which was subsequently obtained as part of this audit. L-gulonolactone oxidase Demographic data were requested as part of the EarlyCDT-Lung test requisition form. These data were considered in the audit. Additionally, clinical follow-up data on patients who provided HIPAA authorization were collected from their treating physician. In patients with a positive EarlyCDT-Lung test, contact was made with physicians immediately following the reporting of the EarlyCDT-Lung result and maintained until the physician indicated that a diagnosis had been reached or a follow-up plan decided (i.e., anticipated timing of imaging, biopsy, surgery, etc.
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