ERBB2 (HER2) Gene Amplification status, FISH

ERBB2 (HER2) Gene Amplification status, FISH
WSLH Department: Cytogenetics
WSLH Test Code:883
CPT Code:83950
Price:For pricing information, please call 608-262-0402.
Includes:FISH analysis of 40-80 cells for copy number of the ERBB2 (HER2) gene compared to copy number of chromosome 17 centromere
Methodology:Specimens subject to ERBB2 testing should be fixed in 10% neutral buffered formalin for at least 6 hours and no longer than 72 hours. 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.
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.
Contraindications: 
Specimen Requirements:Paraffin embedded tissue: Five 4-micron sections of tissue containing tumor on immunohistochemistry slides, the middle section stained with H&E.
Collection Kit/Container: 
Patient Preparation: 
Collection Instructions:FFPE tissue: Tissue specimen should be fixed in 10% neutral buffered formalin for 6-72 hours.
Specimen Handling and Transport:Store and transport specimens at room temperature.
Unacceptable Conditions:FFPE tissue specimen must not be de-calcified.
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. ERBB2(HER2)gene not amplified/ERBB2(HER2)gene amplified/ERBB2(HER2)gene status equivocal
Limitations: 
Additional Tests Recommended: 
Additional Comments: 
Additional Tests Performed: 

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