title: 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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Pathology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA.
authors.forename: Marcello
authors.initials: M
authors.lastname: DiStasio
authors.affiliation: Department of Pathology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA.
authors.forename: Yigu
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA.
authors.forename: Deepa
authors.initials: D
authors.lastname: Rangachari
authors.affiliation: Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA.
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Costa
authors.affiliation: Department of Pathology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA.
authors.forename: Yael K
authors.initials: YK
authors.lastname: Heher
authors.affiliation: Department of Pathology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA. Electronic address: pvanderl@bidmc.harvard.edu.
authors.forename: Paul A
authors.initials: PA
authors.lastname: VanderLaan
mesh_terms: D000077548:Anaplastic Lymphoma Kinase; D002289:Carcinoma, Non-Small-Cell Lung / Q000235:genetics*; D004252:DNA Mutational Analysis; D004273:DNA, Neoplasm / Q000032:analysis*; D066246:ErbB Receptors / Q000235:genetics; D005240:Feasibility Studies; D005260:Female; D005820:Genetic Testing / Q000592:standards / Q000706:statistics & numerical data*; D006801:Humans; D017404:In Situ Hybridization, Fluorescence; D008175:Lung Neoplasms / Q000235:genetics*; D008297:Male; D058990:Molecular Targeted Therapy; D017410:Practice Guidelines as Topic; D011505:Protein-Tyrosine Kinases / Q000235:genetics; D011518:Proto-Oncogene Proteins / Q000235:genetics; D016283:Proto-Oncogene Proteins p21(ras) / Q000235:genetics; D020794:Receptor Protein-Tyrosine Kinases / Q000235:genetics; D012189:Retrospective Studies; D013048:Specimen Handling / Q000592:standards / Q000706:statistics & numerical data*; D013997:Time Factors; D057188:Workflow
chemical_list: D004273:DNA, Neoplasm; C117307:KRAS protein, human; D011518:Proto-Oncogene Proteins; D000077548:Anaplastic Lymphoma Kinase; D066246:ErbB Receptors; D011505:Protein-Tyrosine Kinases; C062333:ROS1 protein, human; D020794:Receptor Protein-Tyrosine Kinases; D016283:Proto-Oncogene Proteins p21(ras)
keywords: Pathology; Practice Guidelines; Process Improvement; Quality; Send-out testing