title: Audit of the autoantibody test, EarlyCDT®-lung, in 1600 patients: an evaluation of its performance in routine clinical practice.
abstract: OBJECTIVE
  EarlyCDT(®)-Lung may enhance detection of early stage lung cancer by aiding physicians in assessing high-risk patients through measurement of biological markers (i.e., autoantibodies). The test's performance characteristics in routine clinical practice were evaluated by auditing clinical outcomes of 1613 US patients deemed at high risk for lung cancer by their physician, who ordered the EarlyCDT-Lung test for their patient.
  
  
  METHODS
  Clinical outcomes for all 1613 patients who provided HIPAA authorization are reported. Clinical data were collected from each patient's treating physician. Pathology reports when available were reviewed for diagnostic classification. Staging was assessed on histology, otherwise on imaging.
  
  
  RESULTS
  Six month follow-up for the positives/negatives was 99%/93%. Sixty-one patients (4%) were identified with lung cancer, 25 of whom tested positive by EarlyCDT-Lung (sensitivity=41%). A positive EarlyCDT-Lung test on the current panel was associated with a 5.4-fold increase in lung cancer incidence versus a negative. Importantly, 57% (8/14) of non-small cell lung cancers detected as positive (where stage was known) were stage I or II.
  
  
  CONCLUSIONS
  EarlyCDT-Lung has been extensively tested and validated in case-control settings and has now been shown in this audit to perform in routine clinical practice as predicted. EarlyCDT-Lung may be a complementary tool to CT for detection of early lung cancer.
authors.affiliation: National Jewish Health, Denver, CO, USA.
authors.forename: James R
authors.initials: JR
authors.lastname: Jett
authors.affiliation: Oncimmune USA LLC, De Soto, KS, USA.
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Peek
authors.affiliation: Oncimmune USA LLC, De Soto, KS, USA.
authors.forename: Lynn
authors.initials: L
authors.lastname: Fredericks
authors.affiliation: Oncimmune USA LLC, De Soto, KS, USA.
authors.forename: William
authors.initials: W
authors.lastname: Jewell
authors.affiliation: Oncimmune USA LLC, De Soto, KS, USA.
authors.forename: William W
authors.initials: WW
authors.lastname: Pingleton
authors.affiliation: University of Nottingham, Nottingham, UK; Oncimmune Ltd., Nottingham, UK. Electronic address: John.Robertson@nottingham.ac.uk.
authors.forename: John F R
authors.initials: JF
authors.lastname: Robertson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001323:Autoantibodies / Q000097:blood; D015415:Biomarkers / Q000097:blood; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis* / Q000453:epidemiology; D003955:Diagnostic Tests, Routine; D055088:Early Detection of Cancer; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic; D011785:Quality Assurance, Health Care; D014481:United States
chemical_list: D001323:Autoantibodies; D015415:Biomarkers
keywords: Autoantibodies; Biomarkers; Blood test; Clinical test; Early detection; Lung cancer; Tumor-associated antigens