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A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
FISH, HER-2/neu, Paraffin Block
Test Code14620
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.
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
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.