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Test Code MCBPP MayoComplete Bladder and Prostate 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.


Secondary ID

619604

Useful For

Primarily for determining if patients will respond to targeted therapy

 

Assessment of microsatellite instability for immunotherapy decisions

Highlights

This panel, performed on formalin-fixed, paraffin-embedded tumor or cytology slides, includes a curated list of 39 genes important for the clinical management of patients with prostate or bladder cancer.

 

It identifies alterations in the FGFR genes that may predict response to targeted therapies and 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 Bladder/Prostate 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.

 

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 bladder/prostate cancer: APC, AR, ARID1A, ATM, BARD1, BRCA1, BRCA2, BRIP1, CDH1, CDK12, CDKN2A, CHD1, CHEK1, CHEK2, CTNNB1, EGFR, ERBB2, ERCC2, FANCA, FANCC, FANCL, FGFR1, FGFR2, FGFR3, FOXA1, MLH1, MSH2, MSH6, PALB2, PMS2, PTEN, RAD51B, RAD51C, RAD51D, RAD54L, RB1, SPOP, TERT, and TP53. The results of this test can be useful for assessing prognosis and guiding treatment of individuals with bladder/prostate tumors. The 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.

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 determine microsatellite instability (MSI) status and evaluate the presence of a mutation in most coding regions of the APC, AR, ARID1A, ATM, BARD1, BRCA1, BRCA2, BRIP1, CDH1, CDK12, CDKN2A, CHD1, CHEK1, CHEK2, CTNNB1, EGFR, ERBB2, ERCC2, FANCA, FANCC, FANCL, FGFR1, FGFR2, FGFR3, FOXA1, MLH1, MSH2, MSH6, PALB2, PMS2, PTEN, RAD51B, RAD51C, RAD51D, RAD54L, RB1, SPOP, TERT, and TP53 genes. See Targeted Genes and Methodology Details for MayoComplete Bladder and Prostate Cancer Panel for details regarding the targeted gene regions identified by this test.(Unpublished Mayo method)

 

A pathology review and macro dissection to enrich for tumor cells is performed prior to slide scraping.

Day(s) Performed

Monday through Friday

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
MCBPP MayoComplete Bladder/Prostate Panel 105589-6

 

Result ID Test Result Name Result LOINC Value
619605 Result 82939-0
619606 Interpretation 69047-9
619607 Additional Information 48767-8
619608 Specimen 31208-2
619609 Tissue ID 80398-1
619610 Method 85069-3
619611 Disclaimer 62364-5
619612 Released By 18771-6

Forms

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