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Non-Small Cell Lung Cancer (NSCLC) HISTOPLUSSM: LUNG CANCER ASSAY HistoPlusSM: Lung Cancer Assay An increasing number of clinical studies have shown the importance of establishing the histologic subtype of non-small cell lung cancer (NSCLC) to guide the use of appropriate subtype-specific therapies for patients. Patients with tumors classified as squamous cell carcinoma may have adverse effects from treatment with bevacizumab or pemetrexed.1 The NCCN® Guidelines include additional molecular tests (EGFR mutation analysis, ALK gene rearrangements, ROS1 gene rearrangements) for selecting specific targeted therapies (erlotinib, crizotinib) for tumors classified as adenocarcinoma.2 What is HistoPlusSM: Lung Cancer Assay? HistoPlus: Lung Cancer assay is a gene expression assay using quantitative real-time PCR (qRT-PCR) for 57 genes expressed in NSCLC subtypes. This test can be used to distinguish adenocarcinoma from squamous cell cancer subtypes. An interobserver reproducibility study for NSCLC diagnosis found that there was only moderate agreement (kappa value = 0.55) among pathologists in standard H&E diagnosis of squamous cell carcinoma versus adenocarcinoma. Higher agreement was associated with differentiated tumors and pathology experience and expertise.3 In an internal comparative study of HistoPlus: Lung Cancer assay results versus standard H&E morphologic classification (performed at a CLIA certified reference laboratory), an agreement of 90.5% was observed between a consensus pathology diagnosis and subtype determination by gene expression, in differentiating squamous cell carcinoma from adenocarcinoma.4 Clinical Dilemma In current practice many lung tumor samples submitted for pathology evaluation are too small for ancillary IHC testing to determine the NSCLC subtypes. Standard morphologic classification (H&E) can produce disagreement between pathologists in providing a specific diagnosis of adenocarcinoma versus squamous cell carcinoma as determined in the VOILA study.3 Per the NCCN® guidelines, it is important to maintain adequate tissue for molecular testing. Therefore, pathology evaluation should limit the use of IHC studies in small tissue samples to preserve critical tissue.2 Clinical Application of HistoPlusSM: Lung Cancer Assay What can be done with problematic cases that cannot be histologically evaluated by standard H&E, with limited tissue to test by IHC, or samples with low tumor content? HistoPlus: Lung Cancer assay is a molecular test that aids in differentiating squamous cell carcinoma from adenocarcinoma in NSCLC.5,6 HistoPlus: Lung Cancer assay, in conjunction with morphological studies, helps further stratify neuroendocrine pulmonary neoplasms.6 HistoPlus: Lung Cancer assay complements standard histopathology and can be particularly useful in poorly differentiated tumors or tumors with limited cellularity. Methodology Quantitative real-time PCR (qRT-PCR) Specimen Requirement Options Formalin-fixed, paraffin-embedded tissue block (preferred) or Four unstained slides at 10 μM and one matching H&E slide (Air dry. Do not oven dry.) CPT Code(s): 81479 REFERENCES 1. Cagle, PT, and Dacic, S, Lung Cancer and the Future of Pathology. Arch Pathol Lab Med 2011; 135:293-5. 2. The NCCN Non-Small Cell Lung Cancer Clinical Practice Guidelines in Oncology (Version 2.2013). ©National Comprehensive Cancer Network, Inc. 2013. 3.Grilley-Olson, J, et al., Validation of Interobserver Agreement in Lung Cancer Assessment Hematoxylin-Eosin Diagnostic Reproducibility for Non-Small Cell Lung Cancer – The 2004 World Health Organization Classification and Therapeutically Relevant Subsets. Arch Pathol Lab Med 2013; 137:32-40. 4. Data sourced from studies at LabCorp’s Center for Molecular Biology and Pathology. 5. Wilkerson, MD, et al., Prediction of Lung Cancer Histological Types by RT-qPCR Gene Expression in FFPE Specimens. J Mol Diagn 2013; 15:485-97. 6.Miglarese, MR, et al., Evaluation of a Lung Cancer RNA Expression Subtyping Panel and Comparison with Histologic Diagnosis in Lung Tumor Samples from Multiple Data Sets Including The Cancer Genome Atlas (TCGA). J Clin Oncol 32:5s, 2014 (suppl; abstr 7566). HistoPlusSM is a service mark of Laboratory Corporation of America® Holdings. NCCN Guidelines® is a registered trademark of National Comprehensive Cancer Network, Inc. ©2014 Laboratory Corporation of America® Holdings. All rights reserved. onc-722-v3-0714 (Continued on back) www.integratedoncology.com