The presence of any of 59 possible EGFR mutations in exons 18-21 (including the T790M mutation in exon 20) is identified by real-time polymerase chain reaction.
disease state indication(s)
Non-Small Cell Lung Cancer (NSCLC)
Somatic mutations of the epidermal growth factor receptor (EGFR) gene are associated with more favorable response to EGFR-specific tyrosine kinase inhibitors such as erlotinib, afatinib and gefitinib in advanced non-small cell lung cancer (NSCLC)
Molecular / Polymerase chain reaction (PCR)
specimen type and requirements
Preferred: One (1) or two (2) formalin-fixed, paraffin-embedded (FFPE) blocks containing tumor tissue from most recent surgery or biopsy.
Acceptable Alternative: Four (4) unstained slides at 2×5 µm thickness, plus 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: 7 days
medicare moldx cpt code
Laboratory developed test (LDT)