Home
HelpEpic Test Code NONCM Neuro-Oncology Gene Panel, Mutations Only, 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 288 mm(2)
-Minimum amount of tumor area: tissue 36 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 this test, at least 6 mm x 6 mm areas on 8 unstained slides is preferred: this is approximately equivalent to 288 mm(2). The minimum acceptable area is 6 mm x 6 mm on 1 unstained slides: approximately equivalent to 36 mm(2). For specimen preparation guidance, see Tissue Requirement for Solid Tumor Next-Generation Sequencing.
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 Hematoxylin and eosin-stained and 15 unstained
Collection Instructions:
Submit the following slides:
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: Unused unstained slides will not be returned.
Useful For
Identifying mutations that may support a diagnosis or help determine prognosis for patients with central nervous system tumors
Identifying specific mutations 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 and somatic mutations involving 89 genes associated with tumors of the central nervous system. See Targeted DNA Gene Regions Interrogated by Neuro-Oncology Panel 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 and somatic alterations 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.
This test only evaluates MSI status and somatic mutations; this test does not evaluate for rearrangements (fusions and abnormal transcript variants).
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.
Special Instructions
Method Name
Sequence Capture Next-Generation Sequencing (NGS)
Reporting Name
Neuro-Onc Panel, Mutations OnlySpecimen Type
VariesSpecimen Minimum Volume
See Specimen Required
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| 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), have been incorporated in the World Health Organization classification of central nervous system (CNS) tumors. Additionally, there are clinically available targeted therapies for patients with certain CNS tumor types harboring specific mutations. This test evaluates targeted regions across 89 genes associated with a variety of adult and pediatric-type CNS tumors for the presence of somatic mutations 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.
See Targeted DNA Gene Regions Interrogated by Neuro-Oncology Panel for details regarding the targeted gene regions identified by this test.
Reference Values
An interpretive report will be provided.
Interpretation
The interpretation of molecular biomarker analysis includes an overview of the results and the associated diagnostic, prognostic, and therapeutic implications.
Cautions
This test does not include evaluation of rearrangements (fusions and abnormal transcript variants).
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.
Variants of uncertain significance may be identified.
A negative result does not rule out the presence of a variant that may be present below the limits of detection of this assay. The analytical sensitivity of this assay for sequence reportable alterations is 5% mutant allele frequency with a minimum coverage of 500X in a sample with 20% or more tumor content.
Point mutations and small insertion/deletion mutations will be detected in 89 genes. This test may detect single exon deletions but does not detect multi-exon deletions, duplications, or genomic copy number variants in any of the genes tested
The presence or absence of a variant may not be predictive of response to therapy in all patients.
Rare alterations (ie, polymorphisms) may be present that could lead to false-negative or false-positive results.
Test results should be interpreted in the context of clinical, tumor sampling, histopathological, and other laboratory data. If results obtained do not match other clinical or laboratory findings, contact the laboratory for discussion. 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 fixatives are discouraged. Improper treatment of tissues, such as decalcification, may cause polymerase chain reaction failure.
Genes may be added or removed based on updated clinical relevance. Refer to the Targeted DNA Gene Regions Interrogated by Neuro-Oncology Panel for the most up to date list of genes included in this test.
Supportive Data
Performance Characteristics
The limit of detection for calling a somatic variant (single nucleotide variants [SNV] and deletions-insertions [delins]) is 5% variant allele frequency (VAF) and having at least 500x deduplicated coverage.
Verification studies demonstrated concordance between this test and the reference method for detection of SNV and delins is 99.7% (699/701) and 96.6% (226/234) of variants, respectively. Concordance for the detection of delins was 98.9% (186/188) in variants 1 to 10 base pairs (bp) in size, 95.8% (23/24) in variants 11 to 50 bp in size, and 88.9% (8/9) in variants 51 to 200 bp in size.
Microsatellite instability (MSI) evaluation is accurate at a tumor purity of at least 10% for colorectal tumors and 20% for other tumor types. During verification studies, 98% (200/204) concordance for MSI status was observed between this test and the reference method.
To ensure accuracy, this test will be performed on cases estimated by a pathologist to have at least 20% tumor cells.
Day(s) Performed
Monday through Friday
Report Available
12 to 20 daysSpecimen Retention Time
FFPE tissue block: Unused portions of blocks will be returned 10 to 14 days after testing is complete; FFPE tissue slides: Unused slides are stored indefinitely and not returnedPerforming Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
81455