GNAQ exon 5
CTNNB1 exon 3
KIT exons 2, 9-11, 13-15, 17 and 18
NRAS exons 2-4
BRAF exons 11 and 15
Melanoma Mutation Panel by NGS
Oncomine genomic profiling
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Molecular testing of metastatic melanoma is currently the standard of care for guiding the use FDA-approved targeted therapies such as BRAF, MEK and KIT inhibitors. In addition, more investigational clinical actions are often employed for patients with metastatic melanoma including the use FDA-approved drugs for an off-label indication and enrollment in clinical trials. This assay is designed to provide comprehensive molecular results relevant for both standard of care and emerging/investigational clinical actions. This DNA and RNA based, next-generation sequencing test targets 50 genes to detect substitution and insertion/deletion mutations (35 genes), gene amplifications (19 genes), and gene fusions (21 genes). Detectable variants relevant for melanoma include, but are not limited to, mutations of BRAF, NRAS, KIT, MAP2K1, CTNNB1, GNAQ and GNA11; amplification of CCND1 and KIT; and rearrangements of BRAF, NTRK1, ROS1, ALK and RET. A complete list of sequenced regions, genes assessed for amplification and detectable fusion transcripts is available below.
Interpretive Report Provided
* Reference ranges may change over time. Please refer to the original patient report when evaluating results.
For formalin-fixed, paraffin-embedded tissue, a block containing an area with a high percentage of neoplastic cells (for micro-/macro-dissection) is preferred. Unstained, UNBAKED slides (5-8, 10-micron slides; 10-15 if few neoplastic cells are present) with associated H&E stained slide are also acceptable. Decalcified tissue or other fixatives will be accepted and the assay attempted, however these may result in failed testing due to degraded nucleic acid. Both blocks and slides should be stored at room temperature. A Diff-Quik or Papanicolaou stained aspirate smear (preferable containing a high percentage and overall amount of neoplastic cells) is also acceptable. Store at room temperature.