HER-2/neu FISH, Gastric, Paraffin

CPT: 88377
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Test Details

Synonyms

  • Gastric Biopsy

Use

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

Limitations

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.

Methodology

Fluorescence in situ hybridization (FISH)

Specimen Requirements

Specimen

Tumor (formalin-fixed, paraffin-embedded)

Volume

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

Container

Paraffin block transport pouch or slide mailer.

Collection

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.

References

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.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
483340 HER-2/CEP17 FISH, Gastric 483341 HER-2/neu FISH, Gastric 31150-6
483340 HER-2/CEP17 FISH, Gastric 483326 HER-2/CEP17 Ratio 49683-6
483340 HER-2/CEP17 FISH, Gastric 483349 Avg Num Her-2 signals/nucleus: 74860-8
483340 HER-2/CEP17 FISH, Gastric 483359 Avg Num CEP17 probes/nucleus: 74861-6
483340 HER-2/CEP17 FISH, Gastric 483308 Fixation Time N/A
483340 HER-2/CEP17 FISH, Gastric 483309 Fixative N/A
483340 HER-2/CEP17 FISH, Gastric 483361 Methodology: 49549-9
483340 HER-2/CEP17 FISH, Gastric 483004 Director Review N/A

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The LOINC® codes are copyright © 1994-2018, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf