Test Name: HERCEPT TEST (Her-2/neu)

Methodology: IHC

Test Description

HercepTest™ is an FDA-approved semi-quantitative immunohistochemical assay for determination of HER2 protein (c-erbB-2 oncoprotein) overexpression in gastroesophageal adenocarcinoma cells from formalin-fixed, paraffin-embedded tissue samples. In our laboratory this immunohistochemical assessment is combined with FISH evaluation of the status of Her-2/neu gene, and both results are reported to aid in clinical decision. Positive or negative results provide a basis for Herceptin® (trastuzumab) treatment selection. Decision regarding Herceptin® treatment should be made within the context of the patient’s clinical history.

Specimen Requirements

A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type or one (1) unbaked, unstained slide cut at 4-5 microns for H&E staining (required) and two to three (2-3) positively charged unstained slides cut at 3-4 microns for each test/antibody ordered.

Storage and Transport

Use cold pack during transport of paraffin blocks and unstained slides. Cold pack should not be placed in direct contact with the specimen during shipping

Specimen Rejection Criteria

Click here to reference the specimen rejection criteria.

Turn Around Time (TAT): 2-3 Days

CPT Codes*: 88341, 88342, 88360

*The CPT codes provided with our Test Descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.