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HelpTest Code HERGM HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual
Ordering Guidance
If ordering for diagnostic purposes: order PATHC / Pathology Consultation and then request the stains.
For specimens such as intestine, liver, colon, which do not contain metastatic adenocarcinoma from the stomach or esophagus, order H2MTF / HER2 Amplification, Miscellaneous Tumor, FISH, Tissue.
For breast cancer specimens, order HERBA / HER2, Breast, Quantitative Immunohistochemistry, Automated with HER2 FISH Reflex or HERBN / HER2, Breast, Quantitative Immunohistochemistry, Automated, No Reflex.
Shipping Instructions
Attach the green pathology address label included in the kit to the outside of the transport container.
Ship ambient.
Necessary Information
Include accompanying pathology report stating the final diagnosis. If not available, a preliminary diagnosis is acceptable only if it refers to invasive or metastatic gastric or esophageal adenocarcinoma.
Specimen Required
Only formalin-fixed, paraffin-embedded (FFPE) gastric or esophageal adenocarcinoma specimens will be accepted. Fixation in 10% neutral-buffered formalin is preferred. The performance and quality of immunohistochemical stains in 10% neutral-buffered FFPE tissue depends on proper fixation. It is recommended (not required) for surgical specimens to be fixed between 18 and 24 hours and biopsy specimens between 6 and 8 hours.
If being ordered for prognostic purposes:
Specimen Type: Gastric or esophageal adenocarcinoma
Supplies: Pathology Packaging Kit (T554)
Preferred: Paraffin-embedded tissue block containing invasive gastric or esophageal adenocarcinoma tissue
Additional Information: Paraffin blocks will be returned with final report.
Acceptable: Slides
Specimen Volume: 5
Collection Instructions: 5 Unstained sections, containing gastric or esophageal adenocarcinoma, on charged slides cut at 4 microns less than 1 month ago.
Useful For
Determining overexpression of HER2 protein of gastric and esophageal adenocarcinoma in formalin-fixed, paraffin-embedded tissue sections (with reflex to FISH testing)
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| H2GE | HER2, Gastroesophageal 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 Semi-Quantitative Immunohistochemistry
Reporting Name
HER Gastric/Esoph IHC + ReflexSpecimen Type
SpecialSpecimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| 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 have been associated with a shorter disease-free survival and shorter overall survival in gastric and gastroesophageal junction cancers, as well as breast, endometrial, and ovarian cancer.(1,2)
Reference Values
Reported as negative (0, 1+), equivocal (2+), and positive (3+)
Interpretation
Results are reported as positive (3+ HER2 protein expression), equivocal (2+), or negative (0 or 1+).
Equivocal (2+) cases will automatically reflex to FISH testing at an additional charge.
Cautions
No significant cautionary statements
Method Description
Testing is performed on formalin-fixed paraffin-embedded tissue sections using Ventana Pathway Immunoperoxidase HER2 (4B5) rabbit-monoclonal primary antibody and a proprietary detection system. No expression (HER2 score of 0), low expression (HER2 score of 1+), and high expression (HER2 score of 3+) controls are used.(Package insert: PATHWAY anti-HER-2/neu [4B5] Rabbit Monoclonal Primary Antibody; Ventana Medical Systems Inc 3/16/2012)
Scoring:
Scoring is performed for surgical and biopsy specimens according to the following article: Ruschoff J, Dietel M, Baretton G, et al: HER2 diagnostics in gastric cancer-guideline validation and development of standardized immunohistochemical testing. Virchows Arch 2010 Sep;457(3):299-307
Surgical Specimen:
Score of 0 is no reactivity or membranous reactivity (staining) in <10% of invasive tumor cells. Score of 1+ is faint/barely perceptible membranous reactivity (staining) in ≥10% of invasive tumor cells; cells are reactive (stained) only in part of their membrane. Score of 2+ is weak to moderate complete, basolateral, or lateral membranous reactivity (staining) in ≥10% of invasive tumor cells. Score of 3+ is strong complete, basolateral, or lateral membranous reactivity (staining) in ≥10% of invasive tumor cells.
Biopsy Specimen:
Score of 0 is no reactivity or no membranous reactivity (staining) in any invasive tumor cells. Score of 1+ is tumor cell cluster* with a faint/barely perceptible membranous reactivity (staining) irrespective of percentage of invasive tumor cells stained. Score of 2+ is tumor cell cluster with a weak to moderate complete, basolateral, or lateral membranous reactivity (staining) irrespective of percentage of invasive tumor cells stained. Score of 3+ is tumor cell cluster with a strong complete, basolateral, or lateral membranous reactivity (staining) irrespective of percentage of invasive tumor cells stained.
*Tumor cells cluster is defined as a cluster of 5 or more tumor cells by Ruschoff and colleagues (2010). There is no percentage cutoff in biopsy specimens for upper GI tract HER2 scoring.
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 |
|---|---|---|
| HERGM | HER Gastric/Esoph IHC + Reflex | Obsolete |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 70985 | Interpretation | 50595-8 |
| 70986 | Participated in the Interpretation | No LOINC Needed |
| 70987 | Report electronically signed by | 19139-5 |
| 70989 | Material Received | 81178-6 |
| MA019 | Tumor classification | 21918-8 |
| 71625 | Disclaimer | 62364-5 |
| 71839 | Case Number | 80398-1 |