Audit of the autoantibody test, EarlyCDT®-lung, in 1600 patients: an evaluation of its performance in routine clinical practice

Lung Cancer. 2014 Jan;83(1):51-5. doi: 10.1016/j.lungcan.2013.10.008. Epub 2013 Oct 22.


Objectives: 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.

Keywords: Autoantibodies; Biomarkers; Blood test; Clinical test; Early detection; Lung cancer; Tumor-associated antigens.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Autoantibodies / blood
  • Biomarkers / blood
  • Carcinoma, Non-Small-Cell Lung / diagnosis*
  • Carcinoma, Non-Small-Cell Lung / epidemiology
  • Diagnostic Tests, Routine
  • Early Detection of Cancer
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Female
  • Humans
  • Lung Neoplasms / diagnosis*
  • Lung Neoplasms / epidemiology
  • Male
  • Middle Aged
  • Practice Guidelines as Topic
  • Quality Assurance, Health Care
  • United States


  • Autoantibodies
  • Biomarkers