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HER2 NEU BY FISH

Message
  • Please submit sample with AP Request Form located in Additional Information below.
  • Please send two tissue slides or paraffin block and one H&E slide with area of invasive tumor circled.  
  • Send tissue block/slides in a red pathology interoffice envelope to the Molecular Biology department at the Central Lab.


Test Code
None - Ordered in Soft Path


CPT Codes
88377

Includes
Includes Pathologist Interpretation


Preferred Specimen
Breast,Gastric, or EndometrialTissue


Transport Temperature

Room temperature



Specimen Stability

Room temperature; paraffin blocks are stable up to 10 years and 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



Batched once per day noted; set up on midnight shift
Report available following afternoon




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 (see Herceptin and Perjeta package inserts).




Performed By
Alverno Laboratories

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

Additional Information
AP Request Form

Last Updated: June 8, 2023


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.