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her2 gene amplification: (138-3870 and 138-3872)
Clinical Indication:

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

 HER2
Methodology:

Fluorescent 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, fixed within 6-48 hours)) 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.

Specimen Preparation: Slide preparations

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

Stability: Indefinite

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

Used as a predictive and prognostic tumor marker
Reference Range:

Reported as  ERBB2 copy-number relative to chromosome 17(CEP17)ERRB2?CEP17 ratio.

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

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

 
CPT 4 Code:

 88368x2
Review 2/12/2013 by T. Friloux, 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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