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Test Code NONCP Neuro-Oncology Expanded Gene Panel with Rearrangement, Tumor


Ordering Guidance


Multiple oncology (cancer) gene panels are available. For more information see Hematology, Oncology, and Hereditary Test Selection Guide.



Necessary Information


Pathology report (final or preliminary), at minimum containing the following information, must accompany specimen 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: tissue 360 mm(2)

-Minimum amount of tumor area: tissue 72 mm(2)

-If ordered in conjunction with CMAPT / Chromosomal Microarray, Tumor, Formalin-Fixed Paraffin-Embedded, the preferred amount of tissue is 430 mm(2), the minimum amount is 180 mm(2).

-These amounts are cumulative over up to 15 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. For the example in this document, 6 mm x 6 mm x 10 slides are preferred: approximate/equivalent to 360 mm(2) with the minimum acceptable of 4 mm x 4 mm x 10 slides: approximate/equivalent to 144 mm(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 15 unstained

Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 15 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 15 slides from the same block.

Additional information:

1. If the amount of tissue available is close to the minimum required, the ordering provider may be asked to prioritize between the DNA and RNA components of the assay.

2. Unused unstained slides will not be returned.


Forms

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

Useful For

Identifying mutations and rearrangements that may support a diagnosis or help determine prognosis for patients with CNS tumors

 

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

 

This test is not intended for use for hematological malignancies.

Method Name

Sequence Capture and Targeted Polymerase Chain Reaction (PCR)-Based Next-Generation Sequencing (NGS)

Reporting Name

Neuro-Onc Expanded Panel

Specimen Type

Varies

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

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

Reject Due To

Specimens that have been decalcified (all methods)
Specimens that have not been formalin-fixed, paraffin-embedded
Extracted nucleic acid (DNA/RNA)		 Reject

Clinical Information

Molecular biomarkers, including clinically relevant gene mutations (ie, sequence variants) and fusions, have been incorporated in the World Health Organization classification of central nervous system (CNS) tumors. This test evaluates targeted regions across 160 genes associated with a variety of adult and pediatric-type CNS tumors for the presence of somatic mutations and rearrangements (fusions and abnormal transcript variants) including, but not limited to, mutations in IDH1/2, TERT promoter, ATRX, TP53, H3-3A (previously H3F3A), H3C2/H3C3 (previously HIST1H3B/C), BRAF, FGFR1, NF1 and SMARCB1, and KIAA1549::BRAF and ZFTA::RELA (previously C11orf95::RELA) fusions, and EGFR transcript variants (eg, EGFR vIII).

 

See Targeted DNA Gene Regions Interrogated by Neuro-Oncology Panel and RNA Targeted Gene Fusions and Abnormal Transcript Variants for details regarding the targeted gene regions identified by this test.

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday through Friday

Report Available

12 to 20 days

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. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

81455