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

Test Down Notes

Test down effective 10/29/2021 due to an unexpected technical issue related to a testing reagent. There are no alternative testing options available.


Ordering Guidance


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 fixative used, time to fixation, and 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.

Submission 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"

c. "Tissue was decalcified? Yes, No, or Unknown."

d. "Tumor type? Primary invasive breast carcinoma or metastatic breast carcinoma."

e. "Tumor classification? Invasive breast carcinoma, metastatic breast carcinoma, or micro-invasive breast carcinoma."

2. According to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 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 an Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763)

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

Disease States

  • Breast cancer

Reflex Tests

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

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

No specimen should be rejected.

Clinical Information

The HER2 (official gene name ERBB2) proto-oncogene encodes a membrane receptor with tyrosine kinase activity and homology to the epidermal growth factor receptor.

 

Amplification and overexpression of the HER2 gene in human breast, endometrial, ovarian, and other epithelial cancers have been associated with a shorter disease-free interval and shorter overall survival. Overexpression of HER2 protein is an indication for Herceptin therapy in patients with breast cancer.

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) Performed

Monday through Friday

Report Available

4 to 6 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been modified from the manufacturer's instructions. Its performance characteristics were 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

88361