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Test ID CAPN Solid Tumor Targeted Cancer Gene Panel by Next Generation Sequencing

Useful For

Identifying solid tumors that may respond to targeted therapies by assessing multiple gene targets simultaneously

 

Identifying specific mutations within genes known to be associated with response or resistance to specific cancer therapies

 

Identifying mutations that may help determine prognosis for patients with solid tumors

 

Assisting in establishing a diagnosis (eg, KIT and PDGFRA alterations for gastrointestinal stromal tumors)

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

(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)

Reporting Name

Solid Tumor Targeted Cancer Panel

Specimen Type

Varies

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

(http://www.mayomedicallaboratories.com/it-mmfiles/oncology-request-form.pdf)

 

Pathology report must accompany specimen in order for testing to be performed.

  

Preferred:

Specimen Type: Tissue

Container/Tube: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block.

Additional Information: At least 20% tumor is required for this assay. The amount of tissue needed is dependent on a variety of preanalytical factors (eg, cellularity, ischemic time, fixation). In general, the minimum specimen adequacy for this test is approximately a 6 mm(2) area of tissue (can be over multiple slides) or 5,000 total cells.

 

Acceptable:

Specimen Type: Tissue

Container/Tube: Slides

Specimen Volume: 1 stained and 10 unstained

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

Additional Information: At least 20% tumor is required for this assay. The amount of tissue needed is dependent on a variety of preanalytical factors (eg, cellularity, ischemic time, fixation). In general, the minimum specimen adequacy for this test is approximately a 6 mm(2) area of tissue (can be over multiple slides) or 5,000 total cells.

 

Acceptable:

Specimen Type: Cytology

Container/Tube: Cytology slide (Direct smears or ThinPrep)

Specimen Volume: 1-2 slides (stained and coverslipped) with a minimum of 5,000 total nucleated cells

Collection Instructions: Submit 1-2 slides stained and coverslipped.

Additional Information: At least 20% tumor is required for this assay. The amount of cells needed is dependent on a variety of preanalytical factors (eg, cellularity, ischemic time, fixation), but the minimum specimen requirement is 5000 total nucleated cells if using cytology slides. Cytology slides will not be returned.

Specimen Minimum Volume

Formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or 1 slide stained with hematoxylin and eosin and 10 unstained, non-baked slides with 5-microns thick sections of the tumor tissue with at least 6 mm(2) area of tissue (can be over multiple slides) and 20% tumor nuclei, 1 stained and coverslipped cytology slide with at least 5,000 total nucleated cells and at least 20% tumor cells.

Specimen Stability Information

Specimen Type Temperature Time
Varies Ambient (preferred)
  Frozen 
  Refrigerated 

Clinical Information

Targeted cancer therapies are defined as antibody or small molecule drugs that block the growth and spread of cancer by interfering with specific cell molecules involved in tumor growth and progression. Multiple targeted therapies have been approved by the United States Food and Drug Administration (FDA) for treatment of specific cancers. Molecular genetic profiling is often needed to identify targets amenable to targeted therapies and to minimize treatment costs and therapy-associated risks.

 

Next generation sequencing has recently emerged as an accurate, cost-effective method to identify mutations across numerous genes known to be associated with response or resistance to specific targeted therapies. CAPN / Solid Tumor Targeted Cancer Gene Panel by Next Generation Sequencing is a single assay that uses formalin-fixed paraffin-embedded tissue to assess for common mutations in 50 genes known to be associated with cancer. The results of this test can be useful for assessing prognosis and guiding treatment of individuals with solid tumors. These data can also be used to help determine clinical trial eligibility for patients with mutations in genes not amenable to current FDA-approved targeted therapies.

 

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.

Reference Values

An interpretive report will be provided.

Cautions

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.

 

This test is not intended for use for hematological malignancies.

 

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 multi-exon 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, please contact the laboratory for updated interpretation. Misinterpretation of results may occur if the information provided is inaccurate or incomplete.

Day(s) Performed

Monday through Friday; Varies

Report Available

12 days

Performing Laboratory

Mayo Medical 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

81445 – Targeted genomic sequence analysis panel, solid organ neoplasm

Slide Review

88381-Microdissection, manual

NY State Approved

Yes