HER2 Amplification by FISH, Breast Cancer

Message

Please submit online AP Request Form

Test Code

H2FHB

CPT Codes
88377

Includes

Includes Pathologist Interpretation

Preferred Specimen

Formalin-fixed, paraffin-embedded breast cancer tissue

Instructions

Please send two (2) tissue slides or paraffin block, AND one (1) H&E slide with area of invasive tumor circled. Include a copy of the AP Request form in a red pathology interoffice envelope to the Molecular Biology department at the Central Lab.

Transport Temperature

Room temperature

Specimen Stability

Room temperature paraffin blocks are stable up to 10 years.
Cut slides are stable up to 60 days.

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Absence of tumor cells or decalcified specimens will be rejected.

Methodology

Fluorescence In Situ Hybridization (FISH)

Setup Schedule

M, Th

Report Available

Report available within 7 days of receipt at the performing laboratory.

Reference Range

Negative for HER2 amplification

Clinical Significance

HER2 IQFISH pharmDx is indicated as an aid in the assessment of breast and gastric cancer patients for whom Herceptin (trastuzumab) treatment is being considered, and for breast cancer patients for whom Perjeta (pertuzumab) treatment is being considered.

Performed By
Alverno Laboratories

Performing Laboratory
Alverno Central Lab
NMB15 (Molecular Biology, FISH)

Last Updated: March 25, 2025

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.