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Test Code MCSRC MayoComplete Comprehensive Sarcoma Panel, Next-Generation Sequencing, 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

5. Diagnosis, potential diagnosis, or differential diagnosis



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)

-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 Sold Tumor Next-Generation Sequencing. In this document, the sizes are given as 4 mm x 4 mm x 10 slides as preferred: approximate/equivalent to 144 mm(2) and the minimum as 3 mm x 1 mm x 10 slides: approximate/equivalent to 36 mm(2).

 

Preferred: Submit 3, if available, or 2 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

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 10 slides from the same block.

Additional Information: Unused unstained slides will not be returned.

 

Specimen Type: Cytology slide (Diff-Quik or Pap stained direct smears or ThinPrep )

Slides: 2 to 6 Slides

Collection Instructions: Submit 2 to 6 slides, stained and coverslipped, with a total of 10,000 nucleated cells (preferred) or 2 slides with at least 2000 nucleated cells per slide (minimum).

Note: Glass coverslips are preferred; plastic coverslips are acceptable but will result in longer turnaround times.

Additional Information: Cytology slides will not be returned. An image of the slides will be stored per regulatory requirements.


Useful For

Primarily for identifying mutations/gene fusions that help in the diagnosis of specific soft tissue and bone tumors (sarcoma)

 

Secondarily for identifying variants that have therapeutic or prognostic significance

 

Assessing microsatellite instability for immunotherapy decisions

Highlights

This test evaluates formalin-fixed, paraffin-embedded tumor or cytology slides, for somatic mutations and gene fusions, to assist in the diagnosis and management of patients with sarcoma.

 

This test detects BCOR internal tandem duplications of exon 15, and splice variants for EGFR and MET genes.

 

Microsatellite instability (MSI) status is determined (microsatellite stable, MSI-High) 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.

 

This test includes DNA mutation and RNA fusion analyses. A reflex test is added only when there is insufficient specimen for both test components. Indicate the preferred order of testing on the paperwork. If the specimen is insufficient to perform all portions of testing, the lab will use this prioritization to select the appropriate reflex test ID, reducing communication delays. If additional tests are ordered on same specimen, include them in the prioritization preferences.

Method Name

Sequence Capture and Targeted Next-Generation Sequencing (NGS)

Reporting Name

MayoComplete Sarcoma Panel

Specimen Type

Varies

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time
Varies Ambient (preferred)
  Refrigerated 

Reject Due To

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

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

81457

81456

 

LOINC Code Information

Test ID Test Order Name Order LOINC Value
MCSRC MayoComplete Sarcoma Panel 95124-4

 

Result ID Test Result Name Result LOINC Value
617849 Result 82939-0
617850 Interpretation 69047-9
617851 Additional Information 48767-8
617852 Specimen 31208-2
617853 Tissue ID 80398-1
617854 Method 85069-3
617855 Disclaimer 62364-5
617856 Released By 18771-6

Forms

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

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
MCSMP MayoComplete Sarcoma Mutation Panel Yes No
MCRSP MayoComplete Targeted RNAseq Panel Yes No