Molecular Testing Turnaround Time for Non-Small Cell Lung Cancer in Routine Clinical Practice Confirms Feasibility of CAP/IASLC/AMP Guideline Recommendations: A Single-center Analysis

Clin Lung Cancer. 2017 Sep;18(5):e349-e356. doi: 10.1016/j.cllc.2017.03.001. Epub 2017 Mar 14.

Abstract

Introduction: Molecular testing to identify targetable driver mutations is the standard of care for patients with advanced-stage non-small cell lung cancer. Recent guideline recommendations by the College of American Pathologists (CAP), International Association for the Study of Lung Cancer (IASLC), and Association for Molecular Pathology (AMP) established a benchmark turnaround time (TAT) target of 10 working days for results to be available to the treating oncologist and ≤ 3 days for specimens to arrive at a commercial testing laboratory if testing is not performed in-house.

Methods and materials: To provide insights regarding the pre-testing, post-testing, and testing intervals that constitute the overall TAT target, we performed a detailed workflow analysis. A total of 157 lung cancer specimens were sent out for molecular testing at a commercial vendor from a single academic medical center during the calendar year 2015.

Results: Overall, 128 specimens (81.5%) met the recommended 10-working day TAT, with a median total TAT of 9 weekdays (mean ± standard deviation, 9.17 ± 4.15 days). The pre-testing interval was ≤ 3 days for 146 specimens (93.0%), and the post-testing reporting interval was < 1 day for 116 cases (73.9%). The TAT variance was not related to intrinsic specimen characteristics.

Conclusion: Overall, the findings indicated that the CAP/IASLC/AMP TAT guideline recommendations are feasible for most lung cancer specimens when a streamlined system is in place.

Keywords: Pathology; Practice Guidelines; Process Improvement; Quality; Send-out testing.

MeSH terms

  • Anaplastic Lymphoma Kinase
  • Carcinoma, Non-Small-Cell Lung / genetics*
  • DNA Mutational Analysis
  • DNA, Neoplasm / analysis*
  • ErbB Receptors / genetics
  • Feasibility Studies
  • Female
  • Genetic Testing / standards
  • Genetic Testing / statistics & numerical data*
  • Humans
  • In Situ Hybridization, Fluorescence
  • Lung Neoplasms / genetics*
  • Male
  • Molecular Targeted Therapy
  • Practice Guidelines as Topic
  • Protein-Tyrosine Kinases / genetics
  • Proto-Oncogene Proteins / genetics
  • Proto-Oncogene Proteins p21(ras) / genetics
  • Receptor Protein-Tyrosine Kinases / genetics
  • Retrospective Studies
  • Specimen Handling / standards
  • Specimen Handling / statistics & numerical data*
  • Time Factors
  • Workflow

Substances

  • DNA, Neoplasm
  • KRAS protein, human
  • Proto-Oncogene Proteins
  • Anaplastic Lymphoma Kinase
  • ErbB Receptors
  • Protein-Tyrosine Kinases
  • ROS1 protein, human
  • Receptor Protein-Tyrosine Kinases
  • Proto-Oncogene Proteins p21(ras)