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J Mol Diagn. 2014 Mar;16(2):267-72. doi: 10.1016/j.jmoldx.2013.11.008. Epub 2014 Jan 9.

Gene expression ratio test distinguishes normal lung from lung tumors in solid tissue and FNA biopsies.

Author information

  • 1Thoracic Surgery Oncology Laboratory and the International Mesothelioma Program, Division of Thoracic Surgery, Brigham and Women's Hospital, Boston, Massachusetts; Department of Surgery, Harvard Medical School, Boston, Massachusetts.
  • 2Department of Medicine, Harvard Medical School, Boston, Massachusetts; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.
  • 3Department of Pathology, Harvard Medical School, Boston, Massachusetts.
  • 4Thoracic Surgery Oncology Laboratory and the International Mesothelioma Program, Division of Thoracic Surgery, Brigham and Women's Hospital, Boston, Massachusetts; Department of IT Research Computing, Harvard Medical School, Boston, Massachusetts.
  • 5Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts; Department of Radiology, Brigham and Women's Hospital, Boston, Massachusetts.
  • 6Thoracic Surgery Oncology Laboratory and the International Mesothelioma Program, Division of Thoracic Surgery, Brigham and Women's Hospital, Boston, Massachusetts; Department of Surgery, Harvard Medical School, Boston, Massachusetts. Electronic address: rbueno@partners.org.

Abstract

Lung cancer is the leading cause of cancer-related deaths worldwide. Prognosis and survival are dependent on cell type, early detection, and surgical treatment. Hence, optimal screening strategies and new therapies are urgently required. Although surveillance with low-dose computed tomography can reduce lung cancer mortality by 20%, the number of false-positive detections is significant. Tissue diagnosis aids in the identification of benign nodules, reducing the number of false positive detections. To determine whether molecular testing of fine-needle aspirations (FNAs) can reduce false-positive detections, we developed a gene expression-based test that distinguishes normal from cancerous lung tissues. The test first was applied to published microarray data, showing overall sensitivity and specificity values of 95% (95% CI, 90%-98%) and 100% (95% CI, 40%-100%), respectively. Subsequently, it was validated on 30 solid and ex vivo FNA lung cancer tumor samples and matched normal lung specimens using real-time PCR. The validation test was 93% (95% CI, 78%-99%) sensitive and 100% (95% CI, 88%-100%) specific for the detection of tumor versus normal lung on solid samples, whereas FNA specimens yielded a sensitivity of 91% (95% CI, 72%-99%) and a specificity of 94% (95% CI, 70%-100%). This study supports the hypothesis that the gene-ratio approach reliably distinguishes normal lung from cancerous tissues in FNA samples and can be optimized to diagnose benign nodules.

Copyright © 2014 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

PMID:
24412526
[PubMed - in process]
PMCID:
PMC3937535
[Available on 2015/3/1]
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