Test Catalog

Test Id : HERBN

HER2, Breast, Quantitative Immunohistochemistry, Automated, No Reflex

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

Determining overexpression of HER2 protein on formalin-fixed, paraffin-embedded tissue sections without a reflex to FISH testing

 

This FDA-approved test is most frequently used to evaluate HER2 overexpression in breast cancer

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
HERBM HER Breast Semi Quant IHC Manual No No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Cases that are not able to be scanned for automated analysis due to technical issues will be changed to the manual process for analysis.

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

Ventana Pathway Immunoperoxidase Stain with Automated 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 Breast IHC Automated NO Reflex

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

c-neu Immunoperoxidase Stain

Her-2

HER2-Neu

HER2/Neu

HER2Neu

ISHER2IHC

HER2 IHC stain, RST

c-erbB2 Immunoperoxidase Stain

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Cases that are not able to be scanned for automated analysis due to technical issues will be changed to the manual process for analysis.

Specimen Type
Describes the specimen type validated for testing

Special

Ordering Guidance

For gastroesophageal cancer, order HERGM / HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual or HERGN / HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual, No Reflex.

Shipping Instructions

Attach the green pathology address label included in the kit to the outside of the transport container.

Necessary Information

1. Include accompanying pathology report stating the final diagnosis. If not available, a preliminary diagnosis is acceptable only if it refers to invasive or metastatic breast carcinoma.

2. Information regarding fixative used, time to fixation, and duration of fixation is required.

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

Supplies: Pathology Packaging Kit (T554)

Specimen Type:

Preferred: A paraffin-embedded tissue block containing breast cancer tissue that has been fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total of 6 to 72 hours and shipped at ambient temperature

Acceptable: 2 unstained sections, containing breast carcinoma, on charged slides cut at 4 microns less than 1 month ago and shipped at ambient temperature. Tissue on the slides should have been fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total of 6 to 72 hours.

Submission Container/Tube: Pathology Packaging Kit (T554)

Collection Instructions: Submit paraffin-embedded invasive or metastatic breast carcinoma tissue.

Additional Information:

1. When ordering this test, the following questions, as stated on the order form or presented electronically, must be answered:

a. "Was specimen fixed in 10% NB formalin w/in 1 hour? Yes, No, or Unknown"

b. "Was specimen fixed in 10% NB formalin 6-72 hours? Yes, No, or Unknown"

c. "Tissue was decalcified? Yes, No, or Unknown."

d. "Tumor type? Primary invasive breast carcinoma or metastatic breast carcinoma."

e. "Tumor classification? Invasive breast carcinoma, metastatic breast carcinoma, or micro-invasive breast carcinoma."

2. According to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, HER2 protein immunohistochemical test results are only valid for nondecalcified, paraffin-embedded specimens fixed in 10% neutral buffered formalin within 1 hour from surgical collection time and for a total time of 6 to 72 hours. Under- or overfixation may affect these results.

3. HER2 immunohistochemistry testing on intracystic papillary carcinoma and solid papillary carcinoma, without clearly stating invasive carcinoma, is not appropriate and will be canceled without processing.

4. Paraffin blocks will be returned with final report.

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Oncology Test Request (T729)

-Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

Entire block

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 on formalin-fixed, paraffin-embedded tissue sections without a reflex to FISH testing

 

This FDA-approved test is most frequently used to evaluate HER2 overexpression in breast cancer

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Cases that are not able to be scanned for automated analysis due to technical issues will be changed to the manual process for analysis.

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 in human breast, endometrial, ovarian, and other epithelial cancers have been associated with a shorter disease-free interval and shorter overall survival. Overexpression of HER2 protein is an indication for Herceptin therapy in patients with breast cancer.

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 strongly positive (3+) according to the interpretation guidelines for the FDA-approved Ventana Pathway HER2 (4B5) antibody.

Interpretation
Provides information to assist in interpretation of the test results

Results are reported as negative (0, 1+), equivocal (2+), and strongly positive (3+) according to the interpretation guidelines for the FDA-approved Ventana Pathway HER2 (4B5) antibody.

 

The scoring method using the Aperio digital pathology system was developed and validated in the Molecular Anatomic Pathology Laboratory, Department of Laboratory Medicine and Pathology, Mayo Clinic (see Method Description).

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 formalin-fixed, paraffin-embedded tissue depends critically on proper fixation.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Riber-Hansen R, Vainer B, Steiniche T: Digital image analysis: a review of reproducibility, stability and basic requirements for optimal results. Apmis 2012 April;120(4):276-289

2. Gavrielides MA, Gallas BD, Lenz P, et al: Observer variability in the interpretation of HER2/neu immunohistochemical expression with unaided and computer-aided digital microscopy. Arch Pathol Lab Med Feb;135(2):233-242

3. Cuadros M, Villegas R: Systematic review of HER2 breast cancer testing. Appl Immunohistochem Mol Morphol Jan 2009;17(1):1-7

4. Nassar A, Cohen C, Agersborg SS, et al: Trainable immunohistochemical HER2/neu image analysis: a multisite performance study using 260 breast tissue specimens. Arch Pathol Lab Med 2011 July;135(7):896-902

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

Testing is performed using FDA-approved Ventana Pathway HER2 (4B5) rabbit monoclonal primary antibody and a proprietary detection system.(Package insert: PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody)

 

Scoring is performed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as follows:

Score of 3+ is defined as circumferential membrane staining that is complete, intense and in greater than 10% of invasive tumor cells;

Score of 2+ is defined as weak to moderate complete membrane staining observed and  in greater than 10% of the invasive tumor cells; or circumferential membrane staining that is complete, intense and in less than or equal to 10% of invasive tumor cells;

Score of 1+ is defined as incomplete membrane staining that is faint or barely perceptible and in greater than 10% of the invasive tumor cells; or weak to moderate complete membrane staining observed and less than 10% of the invasive tumor cells;

Score of 0 is defined as no staining observed or membrane staining that is incomplete and is faint or barely perceptible and in less than or equal to 10% of the invasive tumor cells.(Wolff AC, Hammond ME, Hicks DG, et al. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. J Clin Oncol. 2018 Jul 10;36(20):2105-2122 doi: 10.1200/JCO.2018.77.8738)

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 Regional Manager. 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 cleared, approved, or is exempt by the US 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 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.

88361

LOINC® Information

Test Id Test Order Name Order LOINC Value
HERBN HER Breast IHC Automated NO Reflex In Process
Result Id Test Result Name Result LOINC Value
Result LOINC Value Tooltip
70975 Interpretation 50595-8
70976 Participated in the Interpretation No LOINC Needed
70977 Report electronically signed by 19139-5
70979 Material Received 81178-6
MA012 Fixed in 10% NB formalin w/in 1 hr 8100-0
MA013 Fixed in 10% NB formalin 6-72 hrs 8100-0
MA014 Tumor type 44638-5
MA015 Tumor classification 21918-8
MA047 Tissue was decalcified 8100-0
71622 Disclaimer 62364-5
71836 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 | 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