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Test ID GISTP Gastrointestinal Stromal Tumor (GIST) Targeted Gene Panel, Next-Generation Sequencing, Tumor

Useful For

Diagnosis and management of patients with gastrointestinal stromal tumors

 

This test is not useful for assessment of hematologic malignancies or germline alterations.

Genetics Test Information

This test uses targeted next-generation sequencing to evaluate for somatic alterations within the KIT (exon 2, 9, 10, 11, 13, 14, 15, 17, 18) and PDGFRA (exons 12, 14, 15, 18) genes. See Targeted Gene Regions Interrogated by Solid Tumor Targeted Cancer Gene Panel by Next-Generation Sequencing in Special Instructions for details regarding the targeted gene regions identified by this test.

 

This test is performed to evaluate for somatic alterations within solid tumor samples. This test is not intended for use for hematological malignancies. Additionally, this test does not assess for germline alterations within the genes listed.

Additional Tests

Test ID Reporting Name Available Separately Always Performed
SLIRV Slide Review in MG No, (Bill Only) Yes

Testing Algorithm

When this test is ordered, slide review will always be performed at an additional charge.

Method Name

Polymerase Chain Reaction (PCR)-Based Next-Generation Sequencing

Reporting Name

GIST Panel, Tumor

Specimen Type

Varies


Advisory Information


For KIT Asp816Val allelic variant analysis in mast cell disease, refer to KITAS / KIT Asp816Val Mutation Analysis, Qualitative PCR, Varies.



Necessary Information


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 Required


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

-For specimen preparation guidance, see Tissue Requirement for Solid Tumor Next-Generation Sequencing in Special Instructions. In this document, 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 minimum of 5000 total nucleated cells, minimum of 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.


Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Ambient (preferred)
  Frozen 
  Refrigerated 

Reference Values

An interpretative report will be provided.

Day(s) and Time(s) Performed

Monday through Friday; Varies

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

81272-KIT (v-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog) (eg, gastrointestinal stromal tumor [GIST], acute myeloid leukemia, melanoma), gene analysis, targeted sequence analysis (eg, exons 8, 11, 13, 17, 18)

81314-PDGFRA (platelet-derived growth factor receptor alpha polypeptide) (eg, gastrointestinal stromal tumor [GIST]), gene analysis, targeted sequence analysis (eg, exons 12, 18)

88381-Microdissection, manual

LOINC Code Information

Test ID Test Order Name Order LOINC Value
GISTP GIST Panel, Tumor In Process

 

Result ID Test Result Name Result LOINC Value
54862 Result 82939-0
54863 Result Summary 50397-9
54864 Interpretation 69047-9
54865 Additional Information 48767-8
54867 Specimen 31208-2
54868 Source 31208-2
54869 Tissue ID 80398-1
54870 Released By 18771-6

NY State Approved

Yes

Forms

If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.