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HelpTest Code HERDN HER2, Breast, DCIS, Quantitative Immunohistochemistry, Manual 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
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: 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 tissue block from ductal carcinoma in situ or solid/intracystic papillary carcinoma breast carcinoma tissue.
Additional Information: 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)
Secondary ID
71498Useful 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
This FDA-approved test is most frequently used to evaluate HER2 overexpression in breast cancer
Disease States
- Breast cancer
Method Name
Ventana Pathway Immunoperoxidase Stain with Manual Quantitative Immunohistochemistry
Reporting Name
HER BreastDCIS IHC Manual 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.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.
Interpretation
Results are 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.
Cautions
The performance and quality of immunohistochemical stains in formalin-fixed, paraffin-embedded tissue depends critically on proper fixation.
Clinical Reference
1. Riber-Hansen R, Vainer B, Steiniche T: Digital image analysis: a review of reproducibility, stability and basic requirements for optimal results. Apmis 2012 April;120(4):276-289
2. Gavrielides MA, Gallas BD, Lenz P, et al: Observer variability in the interpretation of HER2/neu immunohistochemical expression with unaided and computer-aided digital microscopy. Arch Pathol Lab Med Feb;135(2):233-242
3. Cuadros M, Villegas R: Systematic review of HER2 breast cancer testing. Appl Immunohistochem Mol Morphol Jan 2009;17(1):1-7
4. Nassar A, Cohen C, Agersborg SS, et al: Trainable immunohistochemical HER2/neu image analysis: a multisite performance study using 260 breast tissue specimens. Arch Pathol Lab Med 2011 July;135(7):896-902
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
Report Available
4 to 6 daysSpecimen Retention Time
Until 1 week after results are reported. Material made at Mayo Clinic may be retained at Mayo Clinic indefinitely.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
88360
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| HERDN | HER BreastDCIS IHC Manual NO Reflex | Obsolete |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 71499 | Interpretation | 50595-8 |
| 71500 | Participated in the Interpretation | No LOINC Needed |
| 71501 | Report electronically signed by | 19139-5 |
| 71502 | Material Received | 81178-6 |
| MA027 | Tumor classification | 21918-8 |
| 71624 | Disclaimer | 62364-5 |
| 71838 | Case Number | 80398-1 |