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26258 Melanoma Targeted Gene Panel, Next-Generation Sequencing, Tumor (MELP)

Melanoma Targeted Gene Panel, Next-Generation Sequencing, Tumor (MELP)
Test Code: MELPSO
Synonyms/Keywords

​Melanoma,  Mutation Screening,  GST11,  GST13,  GST17,  Oncology panel,  Tumor panel,  BRAF,  GNA11,  GNAQ,  KIT,  NRAS,  Next Gen Sequencing Test,  NGS,  BRAF V600,  BRAF V600E,  BRAF V600K,  V600,  V600K,  V600E

Useful For

​Diagnosis and management of patients with melanoma

Simultaneously interrogating multiple gene targets including BRAF (eg, V600E and V600K), GNAQGNA11KIT and NRAS

Specimen Requirements

This assay requires at least 20% tumor nuclei.

-Preferred amount of tumor area with sufficient percent tumor nuclei: tissue144 mm(2)

-Minimum amount of tumor area: tissue 36 mm(2).

-These amounts are cumulative over up to 10 unstained slides and must have adequate percent tumor nuclei.

-Tissue fixation: 10% neutral buffered formalin, not decalcified

-The sizes are given as 4mm x 4mm x 10 slides as preferred: approximate/equivalent to 144 mm(2) and the minimum as 3mm x 1mm x 10 slides: approximate/equivalent to 36mm(2).

Preferred:

Specimen Type: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block with acceptable amount of tumor tissue.

 

Acceptable:

Specimen Type: Tissue slide

Slides: 1 stained and 10 unstained

Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 10 unstained, nonbaked slides with 5-micron thick sections of the tumor tissue.

Note: The total amount of required tumor nuclei can be obtained by scraping up to 10 slides from the same block.

Specimen Type: Cytology slide (direct smears or ThinPrep)

Slides: 1 to 3 slides

Collection Instructions: Submit 1 to 3 slides stained and cover slipped with a preferred total of 5000 nucleated cells or a minimum of at least 3000 nucleated cells.

Note: Glass coverslips are preferred; plastic coverslips are acceptable but will result in longer turnaround times.

Additional Information: Cytology slides will not be returned.

Collection Processing Instructions

​Pathology report (final or preliminary) at minimum containing the following information must accompany specimen in order for testing to be performed:

1. Patient name

2. Block number-must be on all blocks, slides and paperwork (can be handwritten on the paperwork)

3. Tissue collection date

4. Source of the tissue

Specimen Stability Information
Specimen TypeTemperature
​Varies ​ ​​Ambient (preferred)
​Frozen
​Refrigerated
Rejection Criteria
Specimens that have been decalcified (all methods) Specimens that have not been formalin-fixed, paraffin-embedded
Interference

​This test cannot differentiate between somatic and germline alterations. Additional testing may be necessary to clarify the significance of results if there is a potential hereditary risk. DNA variants of uncertain significance may be identified.

A negative (wild-type) result does not rule out the presence of a mutation that may be present but below the limits of detection of this assay (approximately 5%-10%). This test does not detect large single or multiexon deletions or duplications or genomic copy number variants.

Rare polymorphisms may be present that could lead to false-negative or false-positive results. Test results should be interpreted in the context of clinical findings, tumor sampling and other laboratory data. If results obtained do not match other clinical or laboratory findings, contact the laboratory for updated interpretation. Misinterpretation of results may occur if the information provided is inaccurate or incomplete.

Reliable results are dependent on adequate specimen collection and processing. This test has been validated on formalin-fixed, paraffin-embedded tissues; other types of fixatives are discouraged. Improper treatment of tissues, such as decalcification, may cause PCR failure. 

Performing Laboratory Information
Performing LocationDay(s) Test PerformedReport AvailableMethodology/Instrumentation
​Mayo Clinic Laboratories​Monday through Friday​12 to 20 days​Polymerase Chain Reaction (PCR)-Based Next Generation Sequencing
Reference Lab
Reference Range Information
Performing LocationReference Range
​Mayo Clinic Laboratories​An interpretive report will be provided.
Interpretation

​An interpretive report will be provided.

Outreach CPTs
CPTModifier
(if needed)
QuantityDescriptionComments
​81445​1
​88381​1
Synonyms/Keywords

​Melanoma,  Mutation Screening,  GST11,  GST13,  GST17,  Oncology panel,  Tumor panel,  BRAF,  GNA11,  GNAQ,  KIT,  NRAS,  Next Gen Sequencing Test,  NGS,  BRAF V600,  BRAF V600E,  BRAF V600K,  V600,  V600K,  V600E

Ordering Applications
Ordering ApplicationDescription
​COM​MelanomaGenePanel, NextGen, Tum
​Cerner​Melanoma, NextGen, Tumor (MELP)
​Centricity​Melanoma, NextGen, Tumor (MELP)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements

This assay requires at least 20% tumor nuclei.

-Preferred amount of tumor area with sufficient percent tumor nuclei: tissue144 mm(2)

-Minimum amount of tumor area: tissue 36 mm(2).

-These amounts are cumulative over up to 10 unstained slides and must have adequate percent tumor nuclei.

-Tissue fixation: 10% neutral buffered formalin, not decalcified

-The sizes are given as 4mm x 4mm x 10 slides as preferred: approximate/equivalent to 144 mm(2) and the minimum as 3mm x 1mm x 10 slides: approximate/equivalent to 36mm(2).

Preferred:

Specimen Type: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block with acceptable amount of tumor tissue.

 

Acceptable:

Specimen Type: Tissue slide

Slides: 1 stained and 10 unstained

Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 10 unstained, nonbaked slides with 5-micron thick sections of the tumor tissue.

Note: The total amount of required tumor nuclei can be obtained by scraping up to 10 slides from the same block.

Specimen Type: Cytology slide (direct smears or ThinPrep)

Slides: 1 to 3 slides

Collection Instructions: Submit 1 to 3 slides stained and cover slipped with a preferred total of 5000 nucleated cells or a minimum of at least 3000 nucleated cells.

Note: Glass coverslips are preferred; plastic coverslips are acceptable but will result in longer turnaround times.

Additional Information: Cytology slides will not be returned.

Collection Processing

​Pathology report (final or preliminary) at minimum containing the following information must accompany specimen in order for testing to be performed:

1. Patient name

2. Block number-must be on all blocks, slides and paperwork (can be handwritten on the paperwork)

3. Tissue collection date

4. Source of the tissue

Specimen Stability Information
Specimen TypeTemperature
​Varies ​ ​​Ambient (preferred)
​Frozen
​Refrigerated
Rejection Criteria
Specimens that have been decalcified (all methods) Specimens that have not been formalin-fixed, paraffin-embedded
Interference

​This test cannot differentiate between somatic and germline alterations. Additional testing may be necessary to clarify the significance of results if there is a potential hereditary risk. DNA variants of uncertain significance may be identified.

A negative (wild-type) result does not rule out the presence of a mutation that may be present but below the limits of detection of this assay (approximately 5%-10%). This test does not detect large single or multiexon deletions or duplications or genomic copy number variants.

Rare polymorphisms may be present that could lead to false-negative or false-positive results. Test results should be interpreted in the context of clinical findings, tumor sampling and other laboratory data. If results obtained do not match other clinical or laboratory findings, contact the laboratory for updated interpretation. Misinterpretation of results may occur if the information provided is inaccurate or incomplete.

Reliable results are dependent on adequate specimen collection and processing. This test has been validated on formalin-fixed, paraffin-embedded tissues; other types of fixatives are discouraged. Improper treatment of tissues, such as decalcification, may cause PCR failure. 

Useful For

​Diagnosis and management of patients with melanoma

Simultaneously interrogating multiple gene targets including BRAF (eg, V600E and V600K), GNAQGNA11KIT and NRAS

Reference Range Information
Performing LocationReference Range
​Mayo Clinic Laboratories​An interpretive report will be provided.
Interpretation

​An interpretive report will be provided.

For more information visit:
Performing Laboratory Information
Performing LocationDay(s) Test PerformedReport AvailableMethodology/Instrumentation
​Mayo Clinic Laboratories​Monday through Friday​12 to 20 days​Polymerase Chain Reaction (PCR)-Based Next Generation Sequencing
Reference Lab
For billing questions, see Contacts
Outreach CPTs
CPTModifier
(if needed)
QuantityDescriptionComments
​81445​1
​88381​1
For most current information refer to the Marshfield Laboratory online reference manual.