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Test Code H2UR HER2 Amplification Associated with Urothelial Carcinoma, FISH, Tissue


Ordering Guidance


This test is only for primary or metastatic urothelial tumors.

 

-For breast tumors, order H2BR / HER2 Amplification Associated with Breast Cancer, FISH, Tissue.

-For gastroesophageal tumors, order H2GE / HER2 Amplification Associated with Gastroesophageal Cancer, FISH, Tissue.

-For all other tumor types, order H2MT / HER2 Amplification, Miscellaneous Tumor, FISH, Tissue.



Shipping Instructions


Advise Express Mail or equivalent if not on courier service.



Necessary Information


1. A pathology report is required in order for testing to be performed. Acceptable pathology reports include working drafts, preliminary pathology or surgical pathology reports.

2. A reason for testing must be provided. If this information is not provided, an appropriate indication for testing may be entered by Mayo Clinic Laboratories.

3. The pathology report must include type of fixation used as well as the time of fixation (recommended: >6 hours and <72 hours).



Specimen Required


Submit only 1 of the following specimens:

 

Specimen Type: Tissue

Preferred: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. Blocks prepared with alternative fixation methods may be acceptable; provide fixation method used.

 

Acceptable: Slides

Collection Instructions: Four consecutive, unstained, 5 micron-thick sections placed on positively charged slides, and 1 hematoxylin and eosin-stained slide.


Useful For

Guiding therapy for patients with primary or metastatic urothelial tumors, as patients with HER2 amplification may be candidates for therapies that target the human epidermal growth factor receptor 2 (HER2) protein (eg, trastuzumab [Herceptin], pertuzumab)

 

Confirming the presence of HER2 amplification in cases with 2+ (low level) or 3+ (high level) HER2 protein overexpression by immunohistochemistry, and for certain histologic subtypes with aberrant patterns of HER2 expression seen by immunohistochemistry (eg, micropapillary carcinoma).

Testing Algorithm

This test does not include a pathology consult. If a pathology consult is requested, PATHC / Pathology Consultation should be ordered and the appropriate FISH test will be ordered and performed at an additional charge.

 

Note: in accordance to criteria set forth in the 2013 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline for breast cancer, reflex testing will not be performed using an alternative chromosome 17 probe when the FISH result is equivocal.

 

A charge and CPT code is applied for each probe set hybridized, analyzed, and reported.

Method Name

Fluorescence In Situ Hybridization (FISH)

Reporting Name

HER2, Urothelial Tumor, FISH,Tissue

Specimen Type

Tissue

Specimen Minimum Volume

Two consecutive, unstained, 5-micron-thick sections placed on positively charged slides and 1 hematoxylin and eosin-stained slide.

Specimen Stability Information

Specimen Type Temperature Time Special Container
Tissue Ambient (preferred)
  Refrigerated 

Reference Values

An interpretative report will be provided.

Day(s) Performed

Monday through Friday

Report Available

6 to 8 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. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

88377

LOINC Code Information

Test ID Test Order Name Order LOINC Value
H2UR HER2, Urothelial Tumor, FISH,Tissue 96893-3

 

Result ID Test Result Name Result LOINC Value
603107 Result Summary 50397-9
603108 Interpretation 69965-2
603109 Result 62356-1
GC034 Reason for Referral 42349-1
603110 Specimen 31208-2
603111 Source 85298-8
603112 Tissue ID 80398-1
603113 Fixative 8100-0
603114 Method 85069-3
603115 Additional Information 48767-8
603116 Disclaimer 62364-5
603117 Released By 18771-6

Forms

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