title: Clinical Utility of a Plasma Protein Classifier for Indeterminate Lung Nodules.
abstract: Evaluation of indeterminate pulmonary nodules is a complex challenge. Most are benign but frequently undergo invasive and costly procedures to rule out malignancy. A plasma protein classifier was developed that identifies likely benign nodules that can be triaged to CT surveillance to avoid unnecessary invasive procedures. The clinical utility of this classifier was assessed in a prospective-retrospective analysis of a study enrolling 475 patients with nodules 8-30 mm in diameter who had an invasive procedure to confirm diagnosis at 12 sites. Using this classifier, 32.0 % (CI 19.5-46.7) of surgeries and 31.8 % (CI 20.9-44.4) of invasive procedures (biopsy and/or surgery) on benign nodules could have been avoided. Patients with malignancy triaged to CT surveillance by the classifier would have been 24.0 % (CI 19.2-29.4). This rate is similar to that described in clinical practices (24.5 % CI 16.2-34.4). This study demonstrates the clinical utility of a non-invasive blood test for pulmonary nodules.
authors.affiliation: Pulmonary, Allergy, and Critical Care Division, Perelman School of Medicine, University of Pennsylvania/Abramson Research Center, 3615 Civic Center Boulevard, Suite 1016E, Philadelphia, PA, 19104, USA.
authors.forename: Anil
authors.initials: A
authors.lastname: Vachani
authors.affiliation: Henry Ford Hospital, 2799 W. Grand Blvd., Detroit, MI, 48202, USA.
authors.forename: Zane
authors.initials: Z
authors.lastname: Hammoud
authors.affiliation: Integrated Diagnostics, 818 Stewart St., Suite 1101, Seattle, WA, 98101, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Springmeyer
authors.affiliation: Greater Baltimore Medical Center, 6569 North Charles Street, Suite 701, Baltimore, MD, 21204, USA.
authors.forename: Neri
authors.initials: N
authors.lastname: Cohen
authors.affiliation: Sylvester Comprehensive Cancer Center, University of Miami Hospital & Clinics, 1550 NW 10th Avenue, Fox Building, Suite 308, Office 314, Miami, FL, 33136, USA.
authors.forename: Dao
authors.initials: D
authors.lastname: Nguyen
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, Lahey Hospital & Medical Center, 41 Mall Road, Burlington, MA, 01805, USA.
authors.forename: Christina
authors.initials: C
authors.lastname: Williamson
authors.affiliation: University of Cincinnati, 231 Albert Sabin Way, Cincinnati, OH, 45267-0562, USA.
authors.forename: Sandra
authors.initials: S
authors.lastname: Starnes
authors.affiliation: Integrated Diagnostics, 818 Stewart St., Suite 1101, Seattle, WA, 98101, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Hunsucker
authors.affiliation: Integrated Diagnostics, 818 Stewart St., Suite 1101, Seattle, WA, 98101, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Law
authors.affiliation: Integrated Diagnostics, 818 Stewart St., Suite 1101, Seattle, WA, 98101, USA.
authors.forename: Xiao-Jun
authors.initials: XJ
authors.lastname: Li
authors.affiliation: Integrated Diagnostics, 818 Stewart St., Suite 1101, Seattle, WA, 98101, USA.
authors.forename: Alexander
authors.initials: A
authors.lastname: Porter
authors.affiliation: Integrated Diagnostics, 818 Stewart St., Suite 1101, Seattle, WA, 98101, USA. pkearney@indidx.com.
authors.forename: Paul
authors.initials: P
authors.lastname: Kearney
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000097:blood*; D001798:Blood Proteins / Q000378:metabolism*; D001999:Bronchoscopy; D002289:Carcinoma, Non-Small-Cell Lung / Q000097:blood* / Q000175:diagnosis / Q000473:pathology; D005260:Female; D006801:Humans; D061705:Image-Guided Biopsy; D008175:Lung Neoplasms / Q000097:blood* / Q000175:diagnosis / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D003074:Solitary Pulmonary Nodule / Q000097:blood* / Q000175:diagnosis / Q000473:pathology; D014057:Tomography, X-Ray Computed; D047368:Tumor Burden
chemical_list: D014408:Biomarkers, Tumor; D001798:Blood Proteins
keywords: Biomarker; Clinical utility; Lung cancer; Lung nodule; Prospective; Xpresys lung