Days Set Up
Monday – Friday
Analytic Time

6-13 days

MiChart Code
Melanoma NGS Panel
Soft Order Code
NGMEL

Test Updated:

Synonyms

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
AKT1
ERBB3
ERBB4
ERG
ESR1
ETV1
ETV4
ETV5
FGFR1
FGFR2
FGFR3
FGFR4
(HER2)
ERBB2
ALK
AR
AXL
BRAF
CCND1
CDK4
CDK6
CTNNB1
DDR2
EGFR
EGFRvIII
GNA11
GNAQ
MYCN
NRAS
NTRK1
NTRK2
NTRK3
PDGFRA
PIK3CA
PPARG
RAF1
RET
ROS1
MYC
MTOR
HRAS
IDH1
IDH2
JAK1
JAK2
JAK3
KIT
KRAS
MAP2K1
MAP2K2
MET
SMO

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Find a Requisition

All specimens should be accompanied by a requisition.

Submitting Specimens

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MLabs provides all the supplies necessary for the collection of specimens.

Test FAQ

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Test Overview

Test Methodology

Next-Generation Sequencing

Test Usage

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.

Reference Range

Interpretive Report Provided

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Specimen Requirements

Collection Onsite

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.

Collection Offsite

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.

Normal Volume
Formalin-fixed, paraffin-embedded tissue; Diff-Quik stained aspirate smear, Papanicolaou stained aspirate smear. Extracted DNA is also acceptable if extracted in a CLIA certified laboratory.
Minimum Volume
 

Billing Information

CPT Code
81445, 88381-TC
Pro Fee Code
 
LOINC
 

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Our High Standard

Quality that sets us apart

As the reference laboratory division of Michigan Medicine's Department of Pathology, MLabs shares the institution's commitment to applying established quality principles to clinical laboratory testing. Like other large organizations in complex, consequential fields, we rely on an established approach to monitor quality throughout the testing process.