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HelpTest 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.
Day(s) Performed
Monday through Friday
Report Available
4 to 14 daysPerforming 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 |
|---|---|---|
| HERDM | HER BreastDCIS IHC Manual + Reflex | Obsolete |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 70980 | Interpretation | 50595-8 |
| 70981 | Participated in the Interpretation | No LOINC Needed |
| 70982 | Report electronically signed by | 19139-5 |
| 70984 | Material Received | 81178-6 |
| MA017 | Tumor classification | 21918-8 |
| 71623 | Disclaimer | 62364-5 |
| 71837 | Case Number | 80398-1 |