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Test ID 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


A 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 Requirements for Solid Tumor Next-Generation Sequencing. In this document, the sizes are given as 6 mm x 6 mm x 10 slides as preferred: approximate/equivalent to 360 mm(2) and the minimum as 4 mm x 4 mm x 10 slides: approximate/equivalent to 144 mm(2).

 

Preferred: Submit 2, if available, of the following specimens.

Acceptable: Submit at least one of the following specimens.

 

Specimen Type: Tissue block

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

 

Specimen Type: Tissue slide

Slides: 1 Hematoxylin and eosin-stained and 15 unstained

Collection Instructions:

Submit the followings slides:

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 15 slides from the same block.

Additional Information: 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 central nervous system 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.

Genetics Test Information

This test uses next-generation sequencing to evaluate for microsatellite instability (MSI) status, somatic mutations, and rearrangements (fusions and abnormal transcript variants) involving 160 genes associated with tumors of the central nervous system. This panel includes a DNA subpanel for the detection of sequence alterations in 89 genes and an RNA subpanel for the detection of rearrangements in 81 genes, including 104 known gene fusions and 29 known abnormal transcript variants. 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.

 

Of note, this test is performed to evaluate for somatic (ie, tumor-specific) mutations within the genes listed. Although germline (ie, inherited) alterations may be detected, this test cannot distinguish between germline alterations and somatic mutations with absolute certainty. Follow-up germline testing using non-neoplastic (normal) tissue can be performed for confirmation of suspected clinically relevant germline alterations. Germline testing should be performed along with genetic counseling.

Highlights

This next-generation sequencing tumor profiling assay interrogates targeted gene regions and rearrangements across 160 genes associated with central nervous system tumors to assess for the presence of somatic mutations and rearrangements, such as mutations in IDH1/2, TERT promoter, ATRX, TP53, H3-3A (previously H3F3A), H3C2/H3C3 (previously HIST1H3B/C), BRAF, FGFR1, NF1, and SMARCB1, and gene fusions including KIAA1549::BRAF, ZFTA::RELA (previously C11orf95::RELA), and EGFR transcript variants (eg, EGFR vIII).

 

Microsatellite instability (MSI) status is also determined (MSS, MSI-H) as part of this test and is often clinically actionable for determining the efficacy of immunotherapy in solid 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

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
Varies Ambient (preferred)
  Refrigerated 

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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
NONCP Neuro-Onc Expanded Panel 73977-1

 

Result ID Test Result Name Result LOINC Value
603048 Result Summary 50397-9
603049 Result 82939-0
603050 Interpretation 69047-9
603051 Additional Information 48767-8
603052 Specimen 31208-2
603053 Source 31208-2
603054 Tissue ID 80398-1
603055 Released By 18771-6

NY State Approved

Yes