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Test Code MCKCP MayoComplete Kidney 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

Identifying specific mutations to assist in tumor diagnosis/classification

 

Assisting in the clinical management of patients with renal cell carcinoma

 

Assessment of microsatellite instability for immunotherapy decisions

Method Name

Sequence Capture Next-Generation Sequencing (NGS)

Reporting Name

MayoComplete Kidney Cancer 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, except for cytology slides
Extracted nucleic acid (DNA/RNA)
Reject

Clinical Information

Molecular genetic profiling is often needed to identify targets amenable to targeted therapies and to minimize 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.

 

Renal cell carcinoma is being increasingly subtyped based on underlying molecular alterations. Some kidney tumor types are defined by molecular alterations based on the recent World Health Organization classification of tumors.(1) In addition, the identification of pathognomonic alterations may help classify poorly differentiated tumors, and those associated with hereditary predisposition syndromes. It is important to note that this assay does not distinguish between germline and somatic alterations.

 

This test uses formalin-fixed paraffin-embedded tissue or cytology slides to assess for somatic mutations involving the following genes known to be associated with kidney cancer: ATRX, BAP1, BRAF, CDKN2A, FH, FLCN, KRAS, MET, MITF, MLH1, MSH2, MSH6, MTOR, NF2, PBRM1, PMS2, PTEN, RB1, SDHA, SDHB, SDHC, SDHD, SETD2, SMARCB1, ELOC (TCEB1), TERT, TP53, TSC1, TSC2, and VHL, as well as MSI status. The results of this test can be useful for assessing prognosis and guiding treatment of individuals with kidney tumors. These data can also be used to help determine clinical trial eligibility for patients with alterations in genes not amenable to current US Food and Drug Administration-approved targeted therapies.

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

Forms

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