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HER2 by FISH : 1001051
MessagePlease provide most recent Pathology report.
Test Code
MDFCPHER2F or 1001051
Alias/See Also
Breast Cancer; Breast Carcinoma; c-erb-b2 Amplification Test (FISH); FISH for Breast Cancer; FISH with HER-2/neu Gene; FISH with HER2/neu Gene; FISH, HER-2/neu Amp.; FISH, HER2/neu Amp; HER-2/neu Amplification Test (FISH); HER2/neu Amplification Test (FISH); Gastric Tissue; Gastric Cancer; Gastric Carcinoma
CPT Codes
88271x2, 88275
Instructions
Tissue.
Transport Container
Paraffin embedded formalin fixed tissue that has been fixed in 10% neutral buffered formalin, within 1 hour of biopsy or resection procedure, for at least 6 hours and no longer than 72 hours. Two unstained slides, with tissue of 4 microns in thickness are needed for processing, accompanied by a circled H & E clearly indicating the area to be examined.
Record the time of removal of the tissue and the time of immersion of the tissue in fixative on the requisition.
Record the time of removal of the tissue and the time of immersion of the tissue in fixative on the requisition.
Transport Temperature
Paraffin embedded tissue block: Ambient or on ice pack in summer. Slides: Ambient.
Specimen Stability
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Decalcified tissue specimen.
Methodology
Fluorescence in situ hybridization (FISH)
Setup Schedule
Monday - Friday
Report Available
Up to 7 days
Limitations
Laboratory test results should always be considered in the context of clinical observations. This FISH test is performed using a modification of the Vysis FDA approved Her2/neu Probe Kit. This test was developed and its performance characteristics determined
by med fusion. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational
for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.
by med fusion. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational
for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.
Reference Range
An interpretive report will be provided.
Clinical Significance
The PathVysion HER-2 DNA Probe Kit is an FDA approved kit. Results are intended for use as an adjunct to existing clinical and pathologic information currently used as prognostic factors in stage II, node-positive breast cancer patients. Detection of HER-2 amplification is based on counting fluorescent signals for LSI HER-2 and CEP17 in a minimum of 20 interphase nuclei of invasive carcinoma cells. The PathVysion Kit can also be used as an aid to predict disease-free and overall survival in the same cohort of patients when treated with adjuvant cyclophosphamide, doxorubicin and 5-fluorouracil (CAF) chemotherapy.
Performing Laboratory
med fusion
