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HelpOrder 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
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 ReflexSpecimen Type
SpecialSpecimen Minimum Volume
Entire block
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Special | Ambient (preferred) | |
| Refrigerated | ||
Reject Due To
No specimen should be rejected.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.
Method Description
Testing is performed using FDA-approved Ventana Pathway HER2 (4B5) rabbit monoclonal primary antibody and a proprietary detection system.(Package insert: PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody)
Scoring is performed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as follows:
Score of 3+ is defined as circumferential membrane staining that is complete, intense and in greater than 10% of invasive tumor cells;
Score of 2+ is defined as weak to moderate complete membrane staining observed and in greater than 10% of the invasive tumor cells; or circumferential membrane staining that is complete, intense and in less than or equal to 10% of invasive tumor cells;
Score of 1+ is defined as incomplete membrane staining that is faint or barely perceptible and in greater than 10% of the invasive tumor cells; or weak to moderate complete membrane staining observed and less than 10% of the invasive tumor cells;
Score of 0 is defined as no staining observed or membrane staining that is incomplete and is faint or barely perceptible and in less than or equal to 10% of the invasive tumor cells.(Wolff AC, Hammond ME, Hicks DG, et al. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. J Clin Oncol. 2018 Jul 10;36(20):2105-2122 doi: 10.1200/JCO.2018.77.8738)
Day(s) Performed
Monday through Friday
Performing Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
88361