Test Catalog

Test Id : HERGN

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HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual, No Reflex

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Determining overexpression of HER2 protein of gastric and esophageal adenocarcinoma in formalin-fixed, paraffin-embedded tissue sections (no reflex to FISH testing)

Method Name
A short description of the method used to perform the test

Ventana Pathway Immunoperoxidase Stain with Manual Semi-Quantitative Immunohistochemistry

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

HER Gastric/Esoph IHC NO Reflex

Aliases
Lists additional common names for a test, as an aid in searching

c-neu Immunoperoxidase Stain

HER2GE

ISHER2GEIHC

HER2 Gastric/Esophageal IHC stain, RST

c-erbB2 Immunoperoxidase Stain

Specimen Type
Describes the specimen type validated for testing

Special

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 H2BR / 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.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
MA021 Tumor classification Primary G/E adenocarcinoma including intramucosal only
Metastatic adenocarcinoma G/E origin
Suspicious for G/E adenocarcinoma

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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)

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

No specimen should be rejected.

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Special Ambient (preferred)
Refrigerated

Useful For
Suggests clinical disorders or settings where the test may be helpful

Determining overexpression of HER2 protein of gastric and esophageal adenocarcinoma in formalin-fixed, paraffin-embedded tissue sections (no reflex to FISH testing)

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+)

Interpretation
Provides information to assist in interpretation of the test results

Results are reported as positive (3+ HER2 protein expression), equivocal (2+), or negative (0 or 1+)

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

No significant cautionary statements

Clinical Reference
Recommendations for 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. 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

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

88360

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
HERGN HER Gastric/Esoph IHC NO Reflex Obsolete
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
MA021 Tumor classification 21918-8
70990 Interpretation 50595-8
70991 Participated in the Interpretation No LOINC Needed
70992 Report electronically signed by 19139-5
70994 Material Received 81178-6
71626 Disclaimer 62364-5
71840 Case Number 80398-1

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports