There are several key genes recurrently mutated in lung cancer. Genomic DNA is isolated from formalin fixed paraffin embedded tissue and the DNA sequence of targeted regions of the ALK, BRAF, CD274, EGFR, ERBB2, KRAS, and MET genes is determined using next-generation sequencing (NGS) technology.
disease state indication(s)
Non-Small Cell Lung Cancer (NSCLC)
Predictive, prognostic NCCN Guidelines for Non-Small Cell Lung Cancer (NSCLC) recommend EGFR and ALK testing (category 1), ROS1 and PD-L1 testing (category 2A) at a minimum, but strongly advise these be done in the context of broad molecular profiling as there are several driver mutations with targeted therapies available, under active investigation, or in development.
Capture-based, next-generation sequencing (NGS)
specimen type and requirements
Preferred: Two (2) formalin-fixed, paraffin-embedded tissue/fine needle aspirate (FFPE/FNA) blocks containing tumor tissue from recent surgery or biopsy or sixteen (16) 2x5 µm sections with accompanying H&E slide.
Acceptable Alternative: One (1) formalin-fixed, paraffin-embedded tissue/fine needle aspirate (FFPE/FNA) block containing tumor tissue from recent surgery or biopsy or eight (8) 2×5 µm sections with accompanying H&E slide.
Unacceptable: Specimens preserved in alternative (non-formalin) fixatives, decalcified specimens, fresh or frozen tissue.
Note: Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen.
DO NOT FREEZE.
Global (TC & PC): 12 days
medicare moldx cpt code
Laboratory developed test (LDT)
Global (TC & PC)