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HelpTest 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.
Method Name
Sequence Capture and Targeted Next-Generation Sequencing (NGS)
Reporting Name
MayoComplete Solid Tumor PanelSpecimen Type
VariesSpecimen Minimum Volume
See Specimen Required
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Ambient (preferred) | ||
| Refrigerated | |||
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.
Clinical Reference
1. Subbiah V, Solit DB, Chan TA, Kurzrock R. The FDA approval of pembrolizumab for adult and pediatric patients with tumor mutational burden (TMB) ≥10: a decision centered on empowering patients and their physicians. Ann Oncol. 2020;31(9):1115-1118. doi:10.1016/j.annonc.2020.07.002
2. Marcus L, Lemery SJ, Keegan P, Pazdur R. FDA Approval Summary: Pembrolizumab for the treatment of microsatellite instability-high solid tumors. Clin Cancer Res. 2019;25(13):3753-3758. doi:10.1158/1078-0432.CCR-18-4070
3. Li MM, Datto M, Duncavage EJ, et al. Standards and guidelines for the interpretation and reporting of sequence variants in cancer: A joint consensus recommendation of the Association for Molecular Pathology, American Society of Clinical Oncology, and College of American Pathologists. J Mol Diag. 2017;19(1):4-23. doi:10.1016/j.jmoldx.2016.10.002
4. Mikhail FM, Biegel JA, Cooley LD, et al. Technical laboratory standards for interpretation and reporting of acquired copy-number abnormalities and copy-neutral loss of heterozygosity in neoplastic disorders: a joint consensus recommendation from the American College of Medical Genetics and Genomics (ACMG) and the Cancer Genomics Consortium (CGC). Genet Med. 2019;21(9):1903-1916. doi:10.1038/s41436-019-0545-7
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
Varies
Report Available
14 to 21 daysForms
If not ordering electronically, complete, print, and send a Oncology Test Request (T729) with the specimen.
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