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Test Code HER2A HER2 TEST

Important Note

Outside clients submit a manual order. This test is subject to reflex testing, see Laboratory Reflex Testing Policy, you have the option to decline reflex testing if you believe it is not medically necessary. if result is 2+ HER2 Amplification Associated with Breast Cancer, FISH, Tissue will be sent to Mayo Medical Laboratory.

Additional Codes

Primary ID

Epic Code

Mayo Access ID

HER2A

 LAB12 N/A

 

Specimen Information

ontainer

Specimen

Temperature

Collect Vol

Submit Vol

Minimum Vol
Sterile Container* Tissue Submit container on ice N/A N/A N/A
10% Neutral buffered formalin** Tissue Ambient N/A N/A N/A
Paraffin-embedded tissue block** Tissue Ambient N/A N/A N/A

*University of Vermont Medical Center Surgery: Submit fresh tissue in a sterile container on ice within 60 minutes.

**10% neutral buffered formalin fixed tissue or paraffin-embedded tissue block (6 - 72 hours exposure to formalin; delay of no more than 60 minutes between removal from patient and placement into formalin; please note

  1. Date and time tissue was removed from patient
  2. Date and time tissue was added to formalin or provide fixation delay time and total  fixation time

Test Schedule / Analytical Time / Test Priority

Weekly / Greater than 50% of routine Surgical Pathology specimens are completed within 2 working days / Not available STAT

Method

Immunohistochemical Assay

CPT(s)

Description CPT
Morphometric Analysis, tumor immunochemistry, each single ab stain procedure 88360
Professional 88360.26

 

Reference Range

0-1+ negative for Her2 protein overexpression,

2-3+ positive for Her2 protein overexpression, (See Reference Ranges for clarification).

A 3+ Her2Test result has an approximate 95% correlation with gene amplification studies. A 2+ result is also considered positive; however 2+ tumors have much lower Trastuzamab (Herceptin). All new breast cancers are tested using insitu hybridization to evaluate.

Section

Pathology

Performing Location

University of Vermont Medical Center

Is the UVMMC lab NY State Certified to perform this testing?  Yes/No

Yes

Test Note

HER2/neu  (4B5) Immunoperoxidase

The HER-2 assay is a FDA approved standardized immunohistochemical (IHC) assay.  It is a rabbit monoclonal antibody intended for the semi-quantitative detection of HER2 antigen in sections of formalin-fixed, paraffin embedded normal and neoplastic tissue.  It is indicated as an aid in the assessment of breast cancer patients for whom Herceptin treatment is considered.   IHC assay is an excellent first line HER2 assay that is scored as 0-3+ with 0 and 1+ considered  a negative result for protein over expression and   3+ considered as positive measure the HER2 protein over expression intumors. 2+ is considered equivocal.  
 

HER2 Dual ISH DNA Probe is intended to determine HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17.  The HER2 and Chromosome 17 probes are detected using two color chromogenic in situ hybridization (ISH) in formalin fixed, paraffin embedded human breast cancer tissue.   It is also indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab)  treatment is being considered.  

 

A HER2 IHC assay and Dual ISH DNA Probe Cocktail Assay will automatically be performed using the HER2 antibody and Inform HER2 Dual ISH DNA Probe Cocktail Assay on all confirmed invasive breast carcinomas at the time of diagnostic core biopsy.  If there is no adequate tumor tissue in the core biopsy, these assays will be performed on excisional biopsy specimens.

 

Providers may decline the reflex testing by checking the box on the Surgical Pathology requisitions.  The test may be ordered on cases which do not fulfill the criteria below if the provider feels the test is medically necessary.  Under these circumstances, the provider must still submit a written order for the HER-2 to  Surgical Pathology via fax (802-847-4155) or mail (ACC EP2, Main Campus). 

 

Criteria for reflex performance of the HER2 and HER2 Dual ISH DNA Probe on breast carcinomas:

  1. Tumors present in a core biopsy or resection specimens.
  2. All invasive adenocarcinomas are included providing sufficient quantity is present for assay performance and interpretation.

If there are questions or concerns relating to whether the test has been ordered, please contact Surgical Pathology office at (802)-847-3566.  If there are questions concerning the application of the assay or interpretation of the assay, please contact Dr. Donald Weaver through Provider Access Service or (802) 847-3566. 

 

Note: At the request of the Provider HER2 may be performed on gastric adenocarcinomas.  This is not a reflex test.