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Alternative Name
Melanoma Targeted Profile
Methodology
Molecular
Test Description

There are several key genes recurrently mutated in melanoma. Genomic DNA is isolated from formalin fixed paraffin embedded tissue and the DNA sequence of targeted regions of the BRAF, CD274, CDK4, HRAS, KIT, KRAS, NF1, and NRAS genes is determined using next-generation sequencing (NGS) technology.

Clinical Significance

For predictive purposes.

NCCN Guidelines for Melanoma strongly encourage testing for gene mutations that impact treatment options in metastatic melanoma. The Cancer Genome Atlas (TCGA) Network identified four main molecular subtypes of cutaneous melanoma:

  • mutant BRAF
  • mutant RAS (KRAS, NRAS, HRAS)
  • mutant NF1
  • triple wild-type (enriched in KIT mutations)
Specimen Requirements
  • Tissue (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.
Storage and Transportation

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. DO NOT FREEZE.

CPT Code(s)*
81445x1
Turnaround Time

12 Days

New York Approved
Yes
Level of Service
Global

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.