Lung Carcinoma Molecular
Analysis
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, 81403x2,
88360x2, 88377x4
Test
reported:
Results are reported within 7-10 days
