Subsequent follow-up on patients with a positive EarlyCDT-Lung test was then structured around the physician-described follow-up plan. Information concerning whether a patient was diagnosed with cancer was requested from physicians for all individuals regardless of test result at 6 months after the test. This timeframe

was chosen (i) because it was felt to represent a timeframe within which the immediate value of a positive test result could be assessed, (ii) it allowed time for all patients with a negative EarlyCDT-Lung test to present with lung Rigosertib cancer in order to reduce the chance of observer bias in preferentially following up individuals with a positive EarlyCDT-Lung test result. One patient with a positive test was diagnosed just outside the

6 month period: this patient has been included since they were being actively investigated during the six month period for a lesion identified on imaging as being suspicious of lung cancer. The overall percentage of individuals followed-up at six months in the positive and negative EarlyCDT-Lung groups was 99% and 93%, respectively (Table 2); these data are also further broken down by the 6AAB and 7AAB groups (Table 2). This report, therefore, focuses on the initial presentation and outcomes of all patients within 6 months following testing by EarlyCDT-Lung. Wherever possible, histology/cytology reports were reviewed and considered for diagnostic classification; some patients did not have a Olaparib cell line tissue diagnosis but were diagnosed, for example, based on imaging reports. It was decided from the start of the audit that if a physician diagnosed a lung cancer, then only in circumstances where there was specific proof to the contrary, and this

was confirmed by an external expert, would the diagnosis by the treating physician not be Megestrol Acetate accepted; this rule was applied for all patients regardless of EarlyCDT-Lung result. The EarlyCDT-Lung test performance is presented in terms of standard test characteristics, such as sensitivity (the percentage of true positives) and specificity (the percentage of true negatives). Positive predictive value (PPV; the probability of cancer given a positive test result) was also calculated. These analyses were performed using Microsoft Excel. Comparison of sensitivity and specificity of EarlyCDT-Lung for the 6AAB and 7AAB groups is also presented; these comparisons were made using chi-squared tests. Of the 1613 test results, there were 14 patients where the test result was declared ‘Invalid’ (by pre-determined criteria, as outlined in the laboratory’s standard operating procedures) on the report sent to the treating physician. There were 222 patients who tested positive (14%) and 1377 tested negative (86%) (Fig. 1). The percent positive for the 6AAB and 7AAB panels was 18% (n = 139) and 10% (n = 83), respectively.