FISH, HER2/neu with Reflex to IHC : 19859

Message
Please provide most recent Pathology report.

Test Code
MDFCPHER2FRI or 19859

CPT Codes
88377

Includes
If HER2 is equivocal, HER2 (HercepTest®), IHC, with Interpretation will be performed at an additional charge (CPT code(s): 88360).

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. Five 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.

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); If reflex, Immunohistochemistry (IHC)

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.

Reference Range
HER2 FISH result Negative (Not amplified):  LSI HER2/CEP17 ratio < 2.0 (average HER2 copy number < 4.0 signals/cell)

HER2 FISH result Positive (Amplified):   LSI HER2/CEP17 ratio > 2.0 (average HER2 copy number > 4.0 copies/cell)

HER2 FISH result requiring additional workup:   LSI HER2/CEP17 ratio > 2.0 (average HER2 copy number < 4.0 signals/cell) or LSI HER2/CEP17 ratio < 2.0 (average HER2 copy number > 4.0 and < 6.0) or LSI HER2/CEP17 ratio < 2.0 (average HER2 copy number > 6.0 signals/cell)

An interpretive report will be provided.

Performing Laboratory
med fusion and PBM



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.