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HelpTest ID: MCGYN MayoComplete Gynecological Cancer 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
Specimen Required
This assay requires at least 20% tumor nuclei.
-Preferred amount of tumor area with sufficient percent tumor nuclei: tissue 216 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 Requirement 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:
Specimen Type: Tissue block
Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block with acceptable amount of tumor tissue.
Acceptable:
Specimen Type: Tissue slide
Slides: 1 Stained and 10 unstained
Collection Instructions: Submit 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 slide (direct smears or ThinPrep)
Slides: 1 to 3 Slides
Collection Instructions: Submit 1 to 3 slides stained and coverslipped with a preferred total of 5000 nucleated cells or a minimum of at least 3000 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.
Useful For
Predicting patients' prognosis and response to targeted therapy
Assessment of microsatellite instability for immunotherapy decisions
Genetics Test Information
This test uses targeted next-generation sequencing to determine microsatellite instability (MSI) status and evaluate for somatic mutations within the AKT1, APC, ARID1A, ARID1B, ATM, ATR, ATRX, BAP1, BARD1, BRAF, BRCA1, BRCA2, BRIP1, CDC42, CDK12, CDKN2A, CTNNB1, DICER1, EIF1AX, EPCAM, ERBB2, FBXW7, FOXL2, GNAS, KRAS, L1CAM, MED12, MLH1, MSH2, MSH6, NBN, NF2, NRAS, PALB2, PIK3CA, PIK3R1, PMS2, POLE, PPP2R1A, PTEN, RAD51C, RAD51D, RB1, SMARCA2, SMARCA4, SMARCB1, STK11, TP53, and TRAF7 genes. See Targeted Genes and Methodology Details for MayoComplete Gynecological Panel for details regarding the targeted gene regions evaluated by this test.
This test is performed to evaluate for somatic mutations within solid tumor samples. This test does not assess for germline alterations within the genes listed.
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.
Method Name
Sequence Capture Next-Generation Sequencing (NGS)
Reporting Name
MayoComplete GYN PanelSpecimen Type
VariesSpecimen Minimum Volume
See Specimen Required
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Ambient (preferred) | ||
| Refrigerated | |||
Clinical Information
Molecular genetic profiling identifies targets amenable to targeted therapies, minimizing treatment costs and therapy-associated risks. Microsatellite instability (MSI) status is an increasingly important biomarker for determining effective immunotherapeutic treatment options for patients with solid tumors.
This test uses formalin-fixed paraffin-embedded tissue or cytology slides to assess for somatic mutations in the following genes known to be associated with gynecologic cancer: AKT1, APC, ARID1A, ARID1B, ATM, ATR, ATRX, BAP1, BARD1, BRAF, BRCA1, BRCA2, BRIP1, CDC42, CDK12, CDKN2A, CTNNB1, DICER1, EIF1AX, EPCAM, ERBB2, FBXW7, FOXL2, GNAS, KRAS, L1CAM, MED12, MLH1, MSH2, MSH6, NBN, NF2, NRAS, PALB2, PIK3CA, PIK3R1, PMS2, POLE, PPP2R1A, PTEN, RAD51C, RAD51D, RB1, SMARCA2, SMARCA4, SMARCB1, STK11, TP53, and TRAF7, as well as MSI status. The results of this test can be useful for molecular classification, assessing prognosis, and guiding treatment of individuals with gynecologic tumors, including endometrial, ovarian, and sex-cord stromal tumors. The data can also be used to help determine clinical trial eligibility.
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. WHO Classification of Tumours Editorial Board, eds. Female genital tumours. 5th ed. World Health Organization; 2020. WHO Classification of Tumours. Vol 4
2. Strom SP. Current practices and guidelines for clinical next-generation sequencing oncology testing. Cancer Biol Med. 2016;13(1):3-11. doi:10.28092/j.issn.2095-3941.2016.0004
3. Spurr L, Li M, Alomran N, et al. Systematic pan-cancer analysis of somatic allele frequency. Sci Rep. 2018;8(1):7735. Published 2018 May 16. doi:10.1038/s41598-018-25462-0
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
4. Cancer Genome Atlas Research Network; Kandoth C, Schultz N, et al: Integrated genomic characterization of endometrial carcinoma [published correction appears in Nature. 2013 Aug 8;500(7461):242]. Nature. 2013;497(7447):67-73. doi:10.1038/nature12113
5. Cancer Genome Atlas Research Network. Integrated genomic analyses of ovarian carcinoma [published correction appears in Nature. 2012 Oct 11;490(7419):298]. Nature. 2011;474(7353):609-615
Day(s) Performed
Monday through Friday
Report Available
12 to 20 daysTest 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
88381-Microdissection, manual
81457
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| MCGYN | MayoComplete GYN Panel | 105592-0 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 619623 | Result | 82939-0 |
| 619624 | Interpretation | 69047-9 |
| 619625 | Additional Information | 48767-8 |
| 619626 | Specimen | 31208-2 |
| 619627 | Tissue ID | 80398-1 |
| 619628 | Method | 85069-3 |
| 619629 | Disclaimer | 62364-5 |
| 619630 | Released By | 18771-6 |
Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.
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