TEST CATALOG ORDERING & RESULTS SPECIMEN HANDLING CUSTOMER SERVICE EDUCATION & INSIGHTS
Test Catalog

Test ID: HERGN    
HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual, No Reflex

Method Description Describes how the test is performed and provides a method-specific reference

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 > or =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 > or =10% of invasive tumor cells. Score of 3+ is strong complete, basolateral, or lateral membranous reactivity (staining) in > or =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.

PDF Report Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

4 to 6 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Until 1 week after results are reported. Materials made at Mayo Clinic may be retained at Mayo Clinic indefinitely.

Performing Laboratory Location Indicates the location of the laboratory that performs the test

Rochester