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ERBB2 (HER2/neu) Gene Amplification by FISH with Reflex, Tissue

ERBB2 FISH
Example Reports
Amplified
Not Amplified

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Additional Technical Information

Ordering Recommendation

Aid in prediction of response to HER2-directed therapy in patients with breast carcinoma or gastroesophageal adenocarcinoma. Use to confirm equivocal HercepTest (2+) immunohistochemistry (IHC) result.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Tumor tissue.

Specimen Preparation

Formalin fix (10 percent neutral buffered formalin) and paraffin-embed tissue. Fixative duration: 6-72 hours.  Protect paraffin block from excessive heat. Transport block or 7 unstained (4 micron thick sections) positively charged slides in a tissue transport kit (ARUP supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787 (kit recommended but not necessary). (Min 4 slides)

Storage/Transport Temperature

Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.

Unacceptable Conditions

Paraffin block with no tumor tissue remaining. Specimens fixed in any fixative other than 10 percent neutral buffered formalin. Decalcified specimens.  Specimens with fixation delayed for more than one hour. Tissue fixed or less than 6 hours of greater than 72 hours.

Remarks

Include surgical pathology report.
If multiple specimens (blocks or slides) are sent to ARUP, they must be accompanied by one of the following: an order comment indicating that the ARUP pathologist should choose the specimen most appropriate for testing (e.g., "Choose best block"), or individual orders for each sample submitted. A Pathologist Block Selection Fee (ARUP test code 3002076) will be added to orders that utilize the first option. If multiple specimens are sent to ARUP without a request for pathologist block/slide selection or individual orders, they will be held until clarification is provided.

Stability

Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Methodology

Fluorescence in situ Hybridization (FISH)

Performed

Mon-Fri

Reported

3-9 days

Reference Interval

Interpretive Data

Refer to report. ARUP uses the most recent ASCO/CAP interpretation criteria for evaluating ERBB2 (HER2) status.

Compliance Category

FDA

Note

Breast tissue results of FISH group 2, 3, or 4 will be reflexed to ERBB2 (HER2/neu) (HercepTest) with Interpretation by Immunohistochemistry, Tissue (ARUP test code 0049174). Additional charges apply. Gastric and other non-breast tissue with indeterminate results will be reflexed to an alternate probe in an effort to resolve amplification status. Additional charges apply.

Hotline History

N/A

CPT Codes

88377, if reflexed add 88360 or 88377

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Components

Component Test Code* Component Chart Name LOINC
0049241 ERBB2 (HER2) by FISH 42783-1
3005658 Sample Adequacy
3005659 Fixative Used
3005660 Time from Bx to Fixative
3005661 Duration of Fixation
3005662 ERBB2 Reference Number
3005663 ERBB2 Tissue Source
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • c-erbB2 FISH
  • CEP17
  • ERRB2 FISH
  • HER-2/neu FISH
  • Her-2/neu Gene Amplification or Overexpression
  • HER2/CEP17 Ratio
ERBB2 (HER2/neu) Gene Amplification by FISH with Reflex, Tissue