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HER2 mutation DETECTION: (138-3870 and 138-3872)
Clinical Indication:

 Gene amplification of ERBB2(HER2/neu)
Test Mnemonic:

 HER2
Methodology:

 Fluorescence in situ hybridization (FISH)
Performed:

 Molecular Diagnostics Laboratory
Turnaround Time:

 7-14 days
Specimen Requirements: Patient Preparation: Tumor sample

Collect: Formalin fixed (10 percent neutral buffered formalin) and paraffin embedded tissue sections (prepared in Surgical Pathology).  Transport 5 unstained 5-10 micron slides (Minimum is 3 slides) with a matching HE slide marked tumor area. Tumor cell smear/cell block (prepared in Cytopathology) or blood samples may be used when there are enough tumor cells in the sample.

Specimen Preparation: Slides are prepared by Surgical Pathology

Storage/Transport: Protect specimens from excessive heat. Ship in cooled container during summer months. Transport are room temperature or refrigerated.

Causes for Rejection: Sections not mounted on +ve charge slides. Incomplete and/or incorrect identification.
Clinical Information:

Used as predictive and prognostic tumor marker
Reference Range:

Report ERBB2 copy-number relative to chromosome 17 (CEP17)ERBB2/CEP17 ration.

If the ratio is <2, ERBB2 gene amplification is not observed.

If the ration is >2, ERBB2 gene amplification is observed.
Note:

 
CPT 4 Code:

88368x2
Review 1/31/13by T. Friloux and Dr. Dong

When ordering tests for which Medicare or Medicaid reimbursement will be sought, physicians should only order tests that are medically necessary for the diagnosis or treatment of the patient.  Components of the organ or disease panels may be ordered individually.  The diagnostic information must substantiate all tests ordered and must be in the form of an ICD-9 code or its verbal equivalent.

 

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