Association of clinical characteristics with the use of proteomic testing for lung nodule malignancy risk stratification at a safety-net hospital.

Abstract

e20036 Background: The NodifyLung CDT and XL2 tests use proteomics to risk stratify lung nodules. This test has emerged as a valuable tool in facilitating clinical decision making in low to moderate risk lung nodules. Nodify CDT testing classifies lung nodules in three risk groups (High, moderate and No Significant Level of Autoantibodies Detected (NSLAD)) to help further guide diagnostic testing. Nodify XL2, used as a “rule out” test categorizes patients into three groups: Indeterminate, Reduced risk, and Likely benign. We sought to identify clinical and demographic variables and their significance with utilization of the NodifyXL2 test. Methods: A retrospective chart analysis was conducted on all patients who underwent Nodify XL2 testing at the Lung Cancer Screening Clinic at Wyckoff Heights Medical Center, a New York City Safety Net Hospital, from 8/2023 through 9/2024. All patients were found to have NSLAD on the Nodify CDT test. All demographic data including age, smoking status was collected and tabulated. In addition, lung nodule clinical characteristics were obtained and tabulated. Statistical analyses were performed using frequency tables and chi-square tests, with a significance level set at p < 0.05 in efforts to determine clinical significance between higher risk nodules and demographic characteristics. Results: There was a total of 91 patients (40 males and 51 females with any average age of 64 +/- 11.4 years). The Likely benign/Reduced risk classification was found to be statistically significant with specific nodule characteristics, including non-spiculated morphology (p < 0.001) and sub-centimeter size (p< 0.001). Patients less than 70 years old were statistically more likely to be classified as Reduced Risk/Likely Benign lesion (p< 0.011). Additionally, history of non-smoking was also statistically associated with Likely benign/Reduced risk category (p < 0.018). Conclusions: Blood based proteomic testing such as NodifyLung has demonstrated the ability to help further classify low to moderate risk pulmonary nodules with clinical significance. The ability to discriminate between higher and lower risk nodules can further aid in clinical decision making. Blood based proteomic testing is an additional tool that may be used in lung cancer screening/nodule clinics. Association of Nodify XL2 results with demographic characteristics. Indeterminate n (%) Reduced Risk/Likely Benign n (%) p Value Age Group < 70 11 (47.8) 52 (76.5) 0.01084 70 or more 12 (52.2) 16 (23.5) Smoking Current/Former 22 (95.7) 49 (72.1) 0.01817 Never smoker 1 (4.3) 19 (27.9) Nodule Size <10mm 2 (8.7) 38 (55.9) 0.000081 10mm or more 21 (91.3) 30 (44.1) Spiculated Yes  19 (82.6) 17 (25.0) <0.0001 No 4 (17.4) 51 (75.0) Statistical test: Chi Square. “n” represents sample size. “(%)” corresponds to row percentages.