Test Id : HERDN
Test down effective 10/29/2021 due to an unexpected technical issue related to a testing reagent. There are no alternative testing options available.
HER2, Breast, DCIS, Quantitative Immunohistochemistry, Manual 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 in ductal carcinoma in situ or solid/intracystic papillary carcinoma breast tissue
This FDA-approved test is most frequently used to evaluate HER2 overexpression in breast cancer
Method Name
A short description of the method used to perform the test
Ventana Pathway Immunoperoxidase Stain with Manual Quantitative Immunohistochemistry
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
c-neu Immunoperoxidase Stain
Her-2
HER2-Neu
HER2/Neu
HER2Neu
ISHER2DCISIHC
HER2 DCIS IHC stain, RST
c-erbB2 Immunoperoxidase Stain
Specimen Type
Describes the specimen type validated for testing
Special
Ordering Guidance
This test is only for ductal carcinoma in situ or solid/intracystic papillary carcinoma breast tissue. 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
Include accompanying pathology report stating the final diagnosis.
ORDER QUESTIONS AND ANSWERS
| Question ID | Description | Answers |
|---|---|---|
| MA027 | Tumor classification |
Ductal carcinoma in situ Solid/intracystic papillary carcinoma |
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 tissue block from ductal carcinoma in situ or solid/intracystic papillary carcinoma breast carcinoma tissue.
Additional Information: Paraffin blocks will be returned with final report.
Forms
If not ordering electronically, complete, print, and send an 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. The minimum volume is sufficient for one attempt at testing.
Entire block
Reject Due To
Identifies specimen types and conditions that may cause the specimen to 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 in ductal carcinoma in situ or solid/intracystic papillary carcinoma breast tissue
This FDA-approved test is most frequently used to evaluate HER2 overexpression in breast cancer
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.
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
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.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
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.
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- 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.
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 |
|---|---|---|
| HERDN | HER BreastDCIS IHC Manual 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.
|
|---|---|---|
| MA027 | Tumor classification | 21918-8 |
| 71499 | Interpretation | 50595-8 |
| 71500 | Participated in the Interpretation | No LOINC Needed |
| 71502 | Material Received | 81178-6 |
| 71501 | Report electronically signed by | 19139-5 |
| 71624 | Disclaimer | 62364-5 |
| 71838 | Case Number | 80398-1 |