Solid Tumors

Lung Targeted Profile

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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)

clinical use
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.

methodology/product platform
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.

turnaround time
Global (TC & PC): 12 days

cpt code(s)
81445 (x1)
In addition to the CPT Code(s) referenced, a microdissection service, CPT code 88381 (x1), may be medically indicated and separately billed when performing molecular diagnostic testing on solid tumor specimens.

medicare moldx cpt code
Not applicable


regulatory classification
Laboratory developed test (LDT)

ordering option
Global (TC & PC)