ERBB2 (HER2/neu) Gene Amplification by FISH with Reflex, Tissue

Casandra

Casandra Test Code AR56396Version 1 (DRAFT)

Performing Lab

Lab ARUP LaboratoriesLab Test ID 2008603CPT Codes 88360, 88377

ERBB2 (HER2/neu) Gene Amplification by FISH with Reflex, Tissue

Also known as: ERBB2 FISH

Clinical Use

Order Test

Use

This test aids in predicting the response to HER2-directed therapy in patients with breast carcinoma or gastroesophageal adenocarcinoma. It is used to confirm equivocal HercepTest (2+) immunohistochemistry (IHC) results. This test is vital in assessing the HER2 status, which is crucial for planning treatment strategies in relevant cancer patients.

Special Instructions

Include a surgical pathology report with the submission. If multiple specimens (blocks or slides) are sent, an order comment or individual orders for each sample must accompany them. A Pathologist Block Selection Fee will be added if the pathologist chooses the specimen. Unclear submissions will be held until clarification is provided.

Limitations

The test cannot be performed if the paraffin block has no tumor tissue remaining, if specimens are fixed in any fixative other than 10 percent neutral buffered formalin, or if specimens are decalcified. Specimens with fixation delayed for more than one hour or those fixed for less than 6 hours or more than 72 hours are also unacceptable.

Test Details

FDA Approved

New York Approved

Methodology

Chromosomal / Cytogenetics (FISH)

Biomarkers

Chromosome CEP17

Chromosome

HER2 Signal Number • Copy Number Alteration • Categorical (e.g., Positive / Negative / Indeterminate)

CEP17 Signal Number • Copy Number Alteration • Categorical (e.g., Positive / Negative / Indeterminate)

ERBB2

Gene

ERBB2/CEP17 Ratio • Copy Number Alteration • Categorical (e.g., Positive / Negative / Indeterminate)

LOINC Codes

Order Codes

42783-1

Result Codes

42783-1

Result Turnaround Time

3-9 days

Specimen

Tissue (FFPE)

Volume

Not provided

Minimum Volume

Min 4 slides

Collection Instructions

Formalin fix (10 percent neutral buffered formalin) and paraffin-embed tissue. Fixative duration: 6-72 hours.

Storage Instructions

Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.

Causes for Rejection

Paraffin block with no tumor tissue remaining. Specimens fixed in any fixative other than 10 percent neutral buffered formalin. Decalcified specimens. Specimens with fixation delayed for more than one hour. Tissue fixed or less than 6 hours of greater than 72 hours.