HER-2/neu FISH, Gastric, Paraffin

CPT: 88377
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Test Details


  • Gastric Biopsy


Qualitative determination of HER-2/neu gene amplification; prognostic information regarding risk of recurrence and disease-related death; predict response to therapies, including targeted immunotherapy


Use of fixatives other than 10% formalin, fixation times less than six hours or greater than 48 hours may not yield reliable results.

Results of the HER-2/neu FISH assay should always be used in conjunction with other information available from the clinical evaluation of the patient and other prognostic factors, such as tumor size, histologic grade, nodal status, patient's age, hormone receptor status, and other known risk factors.


Fluorescence in situ hybridization (FISH)

Specimen Requirements


Tumor (formalin-fixed, paraffin-embedded)


One paraffin block or four unstained, positively charged tissue slides cut at 4 to 5 microns and dried overnight at 56°C.


Paraffin block transport pouch or slide mailer.


FFPE tissue, preserved in 10% neutral buffered formalin, fixed for 18 to 24 hours. Extended fixation time might increase the incubation time required for pepsin digestion. ASCO/CAP 2013 guidelines recommend fixation time between 6 and 72 hours for breast tissue; however, special ASCO/CAP guidelines have not been established for gastric cancer samples.

Storage Instructions

Maintain specimen at room temperature.

Causes for Rejection

Fixative other than neutral buffered formalin; quantity not sufficient for analysis; tumor other than gastric tumor

Clinical Information

Special Instructions

Direct any questions regarding this test to oncology customer service at 800-345-4363.


Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): A phase 3, open-label, randomized controlled trial. Lancet. 2010 Oct 16; 376(9742):687-697.
Hofmann M, Stoss O, Shi D, et al. Assessment of a HER2 scoring system for gastric cancer: Results from a validation study. Histopath. 2008 Jun; 52(7):797-805.

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