ERBB2 (HER2) Gene Amplification status, FISH

WSLH Department: Cytogenetics
WSLH Test Code: 883
Availability: Monday-Friday 7:45 AM - 4:30 PM, Saturday 7:45 AM - 12:00 PM
Turn-around Time: Approximately 4-8 days, with an average of 4 days. (Reports are issued Monday-Friday 7:45 AM - 4:30 PM)
Recommended Uses: Detection of amplification of the ERBB2 (HER2) gene. Aids in diagnosis of breast and gastric cancers.
Additional Tests Performed:
Patient Preparations:
Specimen Requirements: Paraffin embedded tissue: Five 4-micron sections of tissue containing tumor on immunohistochemistry slides, the middle section stained with H&E.
Specimen Handling & Transport: Store and transport specimens at room temperature.
Collection Kit/Container:
Collection Instructions: Specimens should be placed in 10% neutral phosphate-buffered formalin within one hour of biopsy or resection (cold ischemia time) and remain in fixative for at least six hours and up to 72 hours (formalin fixation time) at room temperature.
Unacceptable Conditions: Specimens processed in fixatives other than 10% neutral buffered formalin. No tumor in tissue. Decalcified specimens. Tissue fixed for less than 6 hours or greater than 72 hours. Cold ischemia time greater than 1 hour.
Requisition Form: Cytogenetics Lab Neoplasia Diagnosis Form #132
Required Information: Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), reason for referral, clinician name and UPIN/NPI, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label.
Results Include: Ratio of ERBB2 (HER2) to chromosome 17 centromere signals. Results are interpreted utilizing the current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP)
Limitations: Prolonged cold ischemia time or over- or under-fixation may impact signal quality and/or signal intensity, leading to false negative results (PMIDs: 19734848, 24992176).
Additional Tests Recommended:
Additional Comments:
Methodology: Fluorescence in situ hybridization (FISH) on interphase nuclei (nuc ish) is performed with the FDA approved Vysis PathVysion HER2 DNA Probe Kit procedure using the ERBB2 probe together with an internal control probe for the chromosome 17 centromere. A manual scoring system is used to evaluate tumor cells and determine the average number of ERBB2 signals per cell and 17 centromere signals per cell. Assays are run with the Vysis ProbeChek control slides (normal and cut-off) to ensure assay quality.
Includes: FISH analysis of 40-80 cells for copy number of the ERBB2 (HER2) gene compared to copy number of chromosome 17 centromere
CPT Code: 83950
Price: For pricing information, please call 608-262-0402.
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