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Test Code MCRSP MayoComplete Targeted RNA Sequencing 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 diagnoses



Specimen Required


This assay requires at least 10% tumor nuclei.

-Preferred amount of tumor area with sufficient percent tumor nuclei: tissue 144 mm(2)

-Minimum amount of tumor area: tissue 36 mm(2)

-These amounts are cumulative over up to 10 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 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 slides

Slides: 1 Hematoxylin and eosin-stained and 10 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 10 slides from the same block.

Additional Information: Unused unstained slides will not be returned.

 

Specimen Type: Cytology slides (direct smears or ThinPrep)

Slides: 1 to 3 Slides

Collection Instructions: Submit 1 to 3 slides stained and coverslipped with a total of 5000 nucleated cells (preferred) or at least 3000 nucleated cells (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 gene fusions that help in the diagnosis of solid tumors

 

Secondarily, for identifying gene fusions that have therapeutic or prognostic significance

Genetics Test Information

This test uses next-generation sequencing to evaluate 1445 genes for the presence of somatic gene fusions, known abnormal transcript variants in the MET and EGFR genes, and BCOR exon 15 internal tandem duplications. See Targeted Fusion Genes for MayoComplete Targeted RNAseq Panel for details regarding the targeted gene regions evaluated by this test.

 

This test is performed to evaluate for somatic gene fusions within solid tumor samples. It does not assess for germline alterations.

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.

Reporting Name

MayoComplete Targeted RNAseq 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.

Supportive Data

Performance Characteristics:

Validation studies demonstrated that concordance between this test, and the reference method, for detection of gene fusions, BCOR in-tandem duplications, and splice variants within MET and EGFR is 96.6% (256/265). No gene fusions were detected in 14 normal tissues, and no gene fusions were detected in the negative control sample (100% specificity).

 

To ensure that this assay detects fusions based on the established sensitivity, this test will be performed on cases that are estimated by a pathologist to have at least 10% tumor cells.

Day(s) Performed

Monday through Friday

Report Available

12 to 20 days

Specimen Retention Time

Tissue blocks: Unused portions of blocks will be returned; Tissue slides: Unused slides are stored for at least 5 years; Extracted RNA: 3 months

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

81456

LOINC Code Information

Test ID Test Order Name Order LOINC Value
MCRSP MayoComplete Targeted RNAseq Panel 95123-6

 

Result ID Test Result Name Result LOINC Value
623361 Result 82939-0
623362 Interpretation 69047-9
623363 Additional Information 48767-8
623364 Specimen 31208-2
623365 Tissue ID 80398-1
623366 Method 85069-3
623367 Disclaimer 62364-5
623368 Released By 18771-6