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Test 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.


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 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

Method Name

Ventana Pathway Immunoperoxidase Stain with Manual Semi-Quantitative Immunohistochemistry

Reporting Name

HER Gastric/Esoph IHC + Reflex

Specimen Type

Special

Specimen 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+)

Day(s) Performed

Monday through Friday

Report Available

4 to 14 days

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