Solid Tumors

The presence of any of 21 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)

clinical use
Therapy selection/monitoring
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).

methodology/product platform
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: Two (2) 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.

turnaround time
Global: 7 days

cpt code(s)
81235 (x1)

medicare moldx cpt code
Not applicable

regulatory classification
FDA approved/cleared

ordering option
Global