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HelpOrder Code HERDM HER2, Breast, DCIS, Quantitative Immunohistochemistry, Manual with HER2 FISH 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
This test is only for ductal carcinoma in situ or solid/intracystic papillary carcinoma breast tissue. 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
Include accompanying pathology report stating the final diagnosis.
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: 5 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.
Collection Instructions:
1. Submit paraffin-embedded ductal carcinoma in situ or solid intracystic papillary carcinoma breast carcinoma tissue.
2. 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 in ductal carcinoma in situ or solid/intracystic papillary carcinoma breast tissue with a reflex to FISH testing if the specimen is equivocal (2+)
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| H2BR | HER2, Breast Tumor, FISH, Tissue | Yes | No |
Testing Algorithm
Cases that are equivocal (2+) by immunohistochemical stain will reflex to HER2 amplification by FISH at an additional charge.
Method Name
Ventana Pathway Immunoperoxidase Stain with Manual Quantitative Immunohistochemistry
Reporting Name
HER BreastDCIS IHC Manual + ReflexSpecimen Type
SpecialSpecimen Minimum Volume
Entire specimen
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 ASCO/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. [published online ahead of print May 30, 2018]. J Clin Oncol. doi: 10.1200/JCO.2018.77.8738.)
Day(s) Performed
Monday through Friday
Performing Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
88360