ERBB2 (HER2) Gene Amplification status, FISH

ERBB2 (HER2) Gene Amplification status, FISH
WSLH Department: Cytogenetics
WSLH Test Code:883
CPT Code: 
Includes:FISH analysis of 40-80 cells for copy number of the ERBB2 (HER2) gene compared to copy number of chromosome 17 centromere
Methodology:**(CPT Code: 83950)** Fluorescence in situ hybridization performed on interphase nuclei from paraffin embedded tissue using DNA probes (PathVysion HER-2 DNA Probe Kit; Vysis, Inc) specific for the ERBB2(HER2)gene in 17q11.2-12 together with an internal control probe for the chromosome 17 centromere, 17p11.1-q11.1 alpha satellite DNA
Availability:Monday-Friday 7:45 AM - 4:30 PM, Saturday 7:45 AM - 12:00 PM
Turn-around Time:Approximately 4-8 days. (Reports are issued Monday-Friday 7:45 AM - 4:30 PM)
Recommended Uses:Detection of amplification of the ERBB2(HER2)gene. Aid in diagnosis of breast and gastric cancers.
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
Additional Tests Recommended: 
Additional Comments: 
Additional Tests Performed: 

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