Test Code LAB20945 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.

Secondary ID

606162

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

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

Reject Due To

Specimens that have been decalcified (all methods)
Specimens that have not been formalin-fixed, paraffin-embedded
Bone marrow in EDTA

Reject

Clinical Information

Targeted cancer therapies are defined as antibody or small molecule drugs that block the growth and spread of cancer by interfering with specific cell molecules involved in tumor growth and progression. Multiple targeted therapies have been approved by the US Food and Drug Administration for the treatment of solid tumor malignancies. Molecular genetic profiling is often needed to identify targets amenable to targeted therapies and to minimize treatment costs and therapy-associated risks. Tumor mutational burden and microsatellite instability status are increasingly important biomarkers for determining effective immunotherapeutic treatment options for patients with solid tumors.(1,2)

In addition to providing therapeutic insight, molecular profiling of tumors often provides prognostic and diagnostic information. Next-generation sequencing is an accurate, cost-effective method to identify variants across numerous genes known to be associated with response or resistance to specific targeted therapies. This test is a single assay that uses formalin-fixed paraffin-embedded tissue or cytology specimens to assess for Tier I and Tier II variants in 515 genes known to be associated with solid tumors.(3)

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.

Method Description

Next-generation sequencing is performed to estimate tumor mutational burden and microsatellite instability status, somatic sequence variants, gene amplifications, homozygous gene deletions, gene fusions, and specific transcript variants in solid tumors. This test detects single nucleotide variants and small insertions and deletion within 515 genes, amplification of 96 genes, homozygous deletions in 133 genes, fusions involving 55 genes, and splice variants involving EGFR, AR, and MET.(Instruction manual: TruSight Oncology 500 High-Throughput. Illumina; 11/2020)

See Genes Interrogated by MayoComplete Solid Tumor Panel for details regarding genes interrogated by this test.

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

Day(s) Performed