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Test Code HERBN HER2, Breast, Quantitative Immunohistochemistry, Automated, No Reflex


Advisory Information


For gastroesophageal cancer, order HERGM / HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual or HERGN / HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual, No Reflex.



Shipping Instructions


Attach the green pathology address label included in the kit to the outside of the transport container.



Necessary Information


1. Include accompanying pathology report stating the final diagnosis. If not available, a preliminary diagnosis is acceptable only if it refers to invasive or metastatic breast carcinoma.

2. Information regarding duration of fixation is required.



Specimen Required


Supplies: Pathology Packaging Kit (T554)

Specimen Type:

Preferred: A paraffin-embedded tissue block containing breast cancer tissue that has been fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total of 6 to 72 hours and shipped at ambient temperature

Acceptable: 2 unstained sections, containing breast carcinoma, on charged slides cut at 4 microns less than 1 month ago and shipped at ambient temperature. Tissue on the slides should have been fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total of 6 to 72 hours.

Container/Tube: Pathology Packaging Kit (T554)

Collection Instructions: Submit paraffin-embedded invasive or metastatic breast carcinoma tissue.

Additional Information:

1. When ordering this test, the following questions, as stated on the order form or presented electronically, must be answered:

a."Was specimen fixed in 10% NB formalin w/in 1 hour? Yes, No, or Unknown"

b."Was specimen fixed in 10% NB formalin 6-72 hours? Yes, No, or Unknown"

2. According to the College of American Pathologists (CAP)/American Society of Clinical Oncology (ASCO) guidelines, HER2 protein immunohistochemical test results are only valid for nondecalcified, paraffin-embedded specimens fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total time of 6 to 72 hours. Under- or overfixation may affect these results.

3. HER2 immunohistochemistry testing on intracystic papillary carcinoma and solid papillary carcinoma, without clearly stating invasive carcinoma, is not appropriate and will be canceled without processing.

4. Paraffin blocks will be returned with final report.


Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

Pathology Test Request Form (T246) (http://www.mayomedicallaboratories.com/it-mmfiles/pathology-request-form.pdf)

Oncology Test Request Form (T729) (http://www.mayomedicallaboratories.com/it-mmfiles/oncology-request-form.pdf)

Useful For

Determining overexpression of HER2 protein on formalin-fixed, paraffin-embedded tissue sections without a reflex to FISH testing

 

This FDA-approved test is most frequently used to evaluate HER2 overexpression in breast cancer

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HERBM HER Breast Semi Quant IHC Manual No No

Testing Algorithm

Cases that are not able to be scanned for automated analysis due to technical issues will be changed to the manual process for analysis.

Method Name

Ventana Pathway Immunoperoxidase Stain with Automated Quantitative Immunohistochemistry

Reporting Name

HER Breast IHC Automated NO Reflex

Specimen Type

Special

Specimen Minimum Volume

Entire block

Specimen Stability Information

Specimen Type Temperature Time
Special Ambient (preferred)
  Refrigerated 

Reject Due To

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

NA

Reference Values

Reported as negative (0, 1+), equivocal (2+), and strongly positive (3+) according to the interpretation guidelines for the FDA-approved Ventana Pathway HER2 (4B5) antibody.

Day(s) and Time(s) Performed

Monday through Friday

Analytic Time

2 days

Performing Laboratory

Mayo Medical Laboratories in Rochester

CPT Code Information

88361

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HERBN HER Breast IHC Automated NO Reflex In Process

 

Result ID Test Result Name Result LOINC Value
70975 Interpretation 50595-8
70976 Participated in the Interpretation No LOINC Needed
70977 Report electronically signed by 19139-5
70979 Material Received 81178-6
MA012 Fixed in 10% NB formalin w/in 1 hr In Process
MA013 Fixed in 10% NB formalin 6-72 hrs In Process
MA014 Tumor type In Process
MA015 Tumor classification In Process
71622 Disclaimer 62364-5
71836 Case Number In Process

Test Classification

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.