Test ID MCSTP MayoComplete Solid Tumor 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

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. Pathologic diagnosis (final or preliminary)

Specimen Required

This assay requires at least 20% tumor nuclei. However, 40% tumor is preferred.

-Preferred amount of tumor area: 720 mm(2) tissue on up to 20 unstained slides

-Minimum amount of tumor area: 192 mm(2) tissue on up to 20 unstained slides

-Tissue fixation: 10% neutral buffered formalin, not decalcified

-For this test, at least 6 mm x 6 mm areas on 20 unstained slides is preferred: this is approximately equivalent to 720 mm(2). The minimum acceptable area is 3.1 mm x 3.1 mm on 20 unstained slides: approximately equivalent to 192 mm(2).

Preferred:

Specimen Type: Tissue block

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

Acceptable:

Specimen Type: Tissue slide

Slides: 1 stained and 20 unstained

Collection Instructions: Submit 1 hematoxylin and eosin (H and E) stained slide and 20 unstained, nonbaked 5-micron thick sections

Note: The total amount of required tumor can be obtained by scraping up to 20 slides from the same block.

Specimen Type: Cytology slides (direct smears or ThinPrep)

Slides: 2 to 6 slides

Collection Instructions: Submit 2 to 6 stained and coverslipped slides with a preferred total of 10,000 nucleated cells or a minimum of at least 6000 nucleated cells

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

Assisting in tumor profiling for diagnosis, predicting prognosis, and identifying targeted therapies for the treatment and management of patients with solid tumors

Identifying somatic alterations including single nucleotide variants, small deletions/insertions, gene amplifications, homozygous gene deletions, fusions, and splice variants in genes known to be associated with the tumorigenesis of solid tumors

Assessment of microsatellite instability and tumor mutational burden status

Genetics Test Information

This test uses targeted next-generation sequencing to estimate tumor mutational burden and detect microsatellite instability, sequence variants, gene amplifications, homozygous gene deletions, fusions, and specific transcript variants in solid tumors. This panel includes a DNA subpanel for the detection of sequence alterations in 515 genes, amplification of 96 genes, homozygous deletion of 133 genes, as well as an RNA subpanel for the detection of fusions involving 55 genes and specific splice variants involving EGFR, AR, and MET. Sequence variants and copy number changes are concomitantly interpreted to evaluate for complete inactivation of 31 tumor suppressor genes. See Genes Interrogated by MayoComplete Solid Tumor Panel for details regarding genes interrogated by this test.

Note: This test is performed to evaluate for somatic (ie, tumor-specific) alterations 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 whole blood can be performed for confirmation of suspected clinically relevant germline alterations. Germline testing should be performed along with genetic counselling.

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 to ensure specimen adequacy.

Special Instructions

Method Name

Sequence Capture and Targeted Next-Generation Sequencing (NGS)

Reporting Name

MayoComplete Solid Tumor Panel

Specimen Type

Varies

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

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

Reference Values

An interpretive report will be provided.

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

81459

88381-Microdissection, manual

LOINC Code Information

Test ID	Test Order Name	Order LOINC Value
MCSTP	MayoComplete Solid Tumor Panel	73977-1

Result ID	Test Result Name	Result LOINC Value
610425	Result	82939-0
610426	Interpretation	69047-9
610427	Additional Information	48767-8
610428	Clinical Trials	82786-5
610429	Variants of Uncertain Significance	93367-1
610430	Specimen	31208-2
610431	Tissue ID	80398-1
610432	Method	85069-3
610433	Disclaimer	62364-5
610434	Released By	18771-6

NY State Approved

Yes

Day(s) Performed