FISH, HER-2/neu, Paraffin Block

Test Code
14620


CPT Codes
88377

Preferred Specimen
Formalin-fixed, paraffin-embedded tumor tissue block


Other Acceptable Specimens
5 micron (minimum 4 micron) sections collected on each of (x6) positively charged slides


Instructions
Invasive primary or metastatic breast or gastric cancer formalin-fixed, paraffin-embedded tissue or charged/+slides from formalin-fixed, paraffin-embedded tissue. Specimen MUST be fixed in 10% neutral buffered formalin. Cold ischemic time of less than 1 hour and fixation between 6 and 72 hours is recommended.
Pathology report must accompany paraffin block or slides.

Information required in this report includes: Physician identification, specimen identifiers (case and block number), specimen site and type, collection date, collection time, tissue processing used (routine or microwave), cold ishemic time, type of fixative, duration of fixation, pathologic diagnosis, and IHC score, if performed elsewhere.


Transport Temperature
Room temperature


Specimen Stability
Room temperature: See Collection Instructions
Refrigerated: See Collection Instructions
Frozen: See Collection Instructions


Methodology
Fluorescence in situ Hybridization (FISH)

FDA Status
The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Daily; Report available: 4 days


Reference Range
Interpretive report


Clinical Significance

HER-2 oncogene amplification in stage 2 lymph node positive breast cancer which aids in treatment selection and prognostication.





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.