Clinical Significance:
Recently established guidelines from the American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and/or the American Society of Clinical Oncology (ASCP) recommend testing for all newly diagnosed non-small cell, non-squamous lung carcinomas or such metastatic lung carcinomas that have not had a primary resection available for testing:

• EGFR, common variants (e.g., exon 19 LREA deletion, L858R, T790M, E709A, G719X, L861Q) [note: includes exon 20 insertion]
• BRAF V600E variant
• ALK 2p23 gene rearrangement
• ROS1 6q22 gene rearrangement
• RET 10q11 gene rearrangement
• cMET 7q31 amplification
• cMET Exon 14 skipping mutation gene analysis
• HER2 (ERBB2)  gene mutation analysis (Exon 20)
• PD-L1 immunohistochemistry, quantitative analysis on all non-small cell lung carcinomas (including squamous cell carcinomas)
• NTRK gene rearrangement by immunohistochemistry, quantitative analysis with reflex of positive cases to confirmatory RNA-based NGS analysis.

https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf

Specimen Requirements and Collection:
Formalin-fixed tissue containing a sufficient amount of tumor (generally at least several mm of tumor tissue submitted in the tissue block)

Methodology:
DNA isolation and extraction, library prep, fluorescent in-situ hybridization (FISH), immunohistochemistry (IHC), and next-generation sequencing (NGS)

Forms:
Molecular pathology requisition form

Transport:
Send formalin-fixed, paraffin-embedded (FFPE) tissue and cell block containing tumor at room temperature.  Also acceptable 10-unstained, 4-5 micron slides with 1 post H&E.  Please include a surgical pathology report

Unacceptable specimen:
Specimens fixed in alternative fixatives or metal fixatives (ex. B-plus).  Decalcified specimens.

CPT Codes
88381, 81210, 81235, 81403×2, 88360×2, 88377×4

Test reported:
Results are reported within 7-10 days