HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Determining overexpression of HER2 protein of gastric and esophageal adenocarcinoma in formalin-fixed, paraffin-embedded tissue sections
Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)
|Test ID||Reporting Name||Available Separately||Always Performed|
|FH2GE||HER2 Amp, Gastroesophageal FISH||Yes||No|
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
Cases that are equivocal (2+) by immunohistochemical stain will reflex to HER2 FISH at an additional charge.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
US Food and Drug Administration (FDA)-Approved Ventana Pathway Immunoperoxidase Stain
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
HER2 Gastric/Esophageal IHC, Manual
c-neu Immunoperoxidase Stain
c-erbB2 Immunoperoxidase Stain
c-erbB2 Immunoperoxidase Stain
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
If being ordered for diagnostic purposes, you must order a surgical pathology consultation test (5439) and then request the stain.
If being ordered for prognostic purposes:
Preferred: Paraffin-embedded tissue block containing invasive gastric or esophageal adenocarcinoma tissue that has been fixed in 10% neutral buffered formalin shipped at ambient temperature
Acceptable: 2 unstained sections, containing gastric or esophageal adenocarcinoma, on charged slides cut at 4 microns <1 month ago and shipped at ambient temperature. Tissue on the slides should be fixed in 10% neutral buffered formalin.
Container/Tube: Surgical Pathology Packaging Kit (Supply T554)
1. Submit paraffin-embedded gastric or esophageal adenocarcinoma tissue.
2. 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.
3. Attach the green pathology address label included in the kit to the outside of the transport container.
1. Only paraffin-embedded (FFPE) gastric or esophageal adenocarcinoma specimens will be accepted. Fixation in 10% neutral buffered formalin is preferred. For breast cancer specimens, order 81504 HER2, Breast, Quantitative Immunohistochemistry, Automated.
2. 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.
3. Paraffin blocks will be returned with final report.
Forms: If not ordering electronically, submit a Pathology/Cytology Request Form (Supply T246) with the specimen.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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 Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Reported as negative (0, 1+), equivocal (2+), and positive (3+)
Results are reported as positive (3+ HER2 protein expression), equivocal (2+), or negative (0 or 1+).
Equivocal (2+) cases will automatically reflex to FH2GE/60620 HER2 Amplification Associated with Gastroesophageal Cancer, FISH, Tissue at an additional charge.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
The performance and quality of immunohistochemical stains in 10% neutral buffered formalin-fixed, paraffin-embedded 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.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Pergam M, Slamon D: Biological rationale for HER2/neu (c-erbB2) as a target for monoclonal therapy. Semin Oncol 2000;27(5):13-19
2. Gravalos C, Jimeno A: HER2 in gastric cancer: a new prognostic factor and a novel therapeutic target. Ann Oncol 2008 Sep;19(9):1523-1529
3. Meza-Junco J, Au HJ, Sawyer MB: Transtuzumab for gastric cancer. Expert Opin Biol Ther 1009;9(12):1543-1551
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. (Package insert: PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody). No expression (HER2 score of 0), low expression (HER2 score of 1+) and high expression (HER2 score of 3+) controls are used.
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 Sep;457(3):299-307
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.
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.
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
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
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual
88360-Morphometric analysis, tumor immunohistochemistry (eg, Her-2/neu, estrogen receptor/progesterone receptor), quantitative or semiquantitative, each antibody; manual
HER2 Amplification Associated with Gastroesophageal Cancer, FISH, Tissue
88271 x 2-Molecular cytogenetics (eg, FISH), each probe (if appropriate)
88274-Interphase in situ hybridization (if appropriate)
88291-Cytogenetics and molecular cytogenetics, interpretation and report (if appropriate)
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|20329||Ref Path/Phys Address||In Process|
|20334||SP Signing Pathologist:||N/A|
|20335||*Previous Report Follows*||N/A|