Test Directory

HER2 –Other

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Updated Test Information:

Test Description
HER2 –Other
Synonym(s)

HER2 neu

General Information

Probes: HER2(17q12)/CEP 17 (17p11.2)


Disease(s): Endometrial cancer, salivary duct carcinoma, ovarian cancer, serous carcinomas and other various tumor types.

Specimen Requirements

Formalin fixed paraffin embedded (FFPE) tissue blocks or
2 unstained slides (4-5 microns thick sections)
1 H&E slide for pathology review (required)

Additional Processing Details

Transport to the testing lab at room temp is acceptable. Do not allow sample to overheat. Use cold pack for transport, making sure cold pack is not in direct contact with specimen

Required Information

Complete the Incyte Diagnostics hematology requisition with the patient's demographics and relevant clinical history. Label the specimen containers with patient's full name, second unique identifier, and specimen site/source.

Unacceptable Specimen Conditions

Specimen containers without two (2) patient identifiers, specimens submitted on non-positively charged slides, paraffin blocks that have been overheated or frozen, specimens without a H&E slide, slides or paraffin blocks with no tissue remaining, Samples fixed in fixative other than 10% neutral buffered formalin.

Department (code)

FISH

Methodology

Fluorescence in-Situ Hybridization (FISH)

Estimated TAT

3-5 working days from receipt

Testing Schedule

Monday-Friday

Retention

Blocks:10 years
H&E and IHC Slides: 10 years
IF Slides: 30 days

CPT Code(s)

88377x1 manual

Additional Information

Clinical Significance: HER2, a member of the epidermal growth factor receptor family, is a transmembrane protein with tyrosine kinase activity. Gene amplification and protein overexpression of HER2 have been found in a variety of tumors. This test provides HER2 amplification status to aid in determining anti-HER2 targeted therapies for patients. Scoring is performed using the following:

HER2 (Other) with Breast scoring uses the 2018 CAP/ASCO guidelines for breast cancer for HER2 evaluation. Breast scoring is recommended for indications such as endometrium cancer, salivary duct carcinoma, serous carcinoma, and ovarian cancer as well as other clinical indications without consensus guidelines.

HER2 (Other) with Gastric scoring uses the 2016 CAP/ASCP/ASCO consensus guidelines for gastric/gastroesophageal adenocarcinoma for HER2 evaluation.