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Test 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.

Highlights

This panel, performed on formalin-fixed, paraffin-embedded tumor or cytology slides, includes a curated list of 49 genes important for the clinical management of patients with gynecologic tumors, including endometrial, ovarian, and sex-cord stromal tumors. This includes molecular classification of gynecologic tumors based on current guidelines and World Health Organization recommendations.(1) It also assesses DNA damage response genes associated with therapeutic eligibility to poly(adenosine diphosphate-ribose) polymerase inhibitors.

 

This test evaluates mismatch repair genes and microsatellite instability (MSI) status (MSS, MSI-H), as this is often clinically actionable for determining the efficacy of immunotherapy in solid tumors.

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 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.

Day(s) Performed

Monday through Friday

Report Available

12 to 20 days

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

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

NY State Approved

Yes

Forms

If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.