Risk assessment of indeterminate lung nodule characterization by a novel plasma-protein multiplexed assay in current smokers: Results of a clinical experience program

Abstract

Background: To reduce overdiagnosis and overtreatment of non-cancerous pulmonary nodules found on chest imaging, an accurate non-invasive and easily administered test is needed to assist in the detection and diagnosis of cancers in a cost-effective manner at an early stage, when curative interventions are still possible.Objective: To assess the results of a novel, plasma-based multiplexed protein assay in a clinical experience program.Methods: Fifty-four consecutive plasma samples were evaluated in a CLIA-certified laboratory using the novel blood test. All samples were from patients who are current smokers, aged 25 years and older, and have an indeterminate pulmonary nodule 0.4 to 3 cm in diameter. Results:The mean patient age was 65.5 years and the mean nodule size was 1.0 cm. 26 patients were male (52% female). Of the 54 tests, the assay results for 23 individuals were determined to be in the lower risk of malignancy range (score ≤49). 42 patients had a pre-test probability in the intermediate risk range as calculated by the VA Clinical Model. Of those patients, the assay characterized 22 as having a lower risk of malignancy (52%). Conclusion:The risk stratification of individuals with an indeterminate pulmonary nodule appears to be enhanced by identifying benign nodules compared to current methods in clinical practice. We hypothesize patients with benign disease may benefit the most from this assay by avoiding unnecessary subsequent overtreatment such as lung biopsy or bronchoscopy, while improving patient quality of care and reducing associated risks and costs from these procedures. Providers and their patients in whom they suspect lung cancer may consider using this novel assay prior to proceeding with more aggressive interventions.