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Lab Manual for Moffitt-Long and Mount Zion

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HER2/neu FISH

Item Value
Approval req'd? No
Available Stat? No
Utilization Guidelines Tests with long turn-around times (ie. Molecular based tests and Microarrays) should only be requested on an inpatient if the result is going to affect the inpatient management.

If the patient will likely be discharged before the result will be available, the test should be requested after discharge. (NOTE: UCSF Medical Center is not reimbursed for inpatient testing).

An exception to the above may be appropriate if there is a possibility the patient will not survive to be discharged and the information is important for diagnosis and/or family decisions/management (ie. recurrence risk).
Test code ERBB2; Her2/NEU
Test group Oncology FISH
Performed by Medical Genomics - Molecular Diagnostics
In House Availability Run 1x per week, Tuesday, day shift only
Method Fluorescence in-situ hybridiztion (FISH)
Collection Instructions For UCSF Samples (from remote sites) Click here for sample collection instructions

For NON-UCSF Samples Click here for Requisition form & Account set-up instructions. Note we only do institutional billing.
Container type glass slides
Sample type Formalin-fixed, paraffin-embedded tissue on three (3) unstained slides (5 microns thick) on charged glass. One adjacent hematoxylin and eosin stained (H&E) slide should also be included. Slides should be labeled with pathology case number and block identification
Preferred volume 3 unstained and 1 H&E stained sections
UCSF Rejection Criteria All required slides not included. Insufficient tumor present on slide as determined by pathologist. Slides not labeled or not accompanied by completed requisition form.
Processing notes Store slides at room temperature. Transport to CB, Molecular Diagnostics
Units Ratio
Normal range Normal range for breast tumors without amplification in this laboratory is an ERBB-2:chromosome 17 ratio of <1.8. ERBB-2 amplification is defined as a ratio of > 2.2. A ratio of 1.8-2.2 is interpreted as equivocal.

This test is most useful as an adjunct to immunohistochemical analysis of ERB-B2 protein expression (Herceptest) to clarify the interpretation of 1+ and 2+ results.
Synonyms ERBB2; Herceptin
Turn around times 10-14 days
Additional information An interpretation of this test by a laboratory physician will automatically be performed and billed for separately.

Note: This test was developed and its performance characteristics determined by the Clinical Laboratories at the Medical Center at UC San Francisco. It has not been cleared or approved by the U.S. Food and Drug Administration
CPT coding 88368 x2
LOINC code 42783-1
LDT or Mod FDA? Yes
Last Updated 1/22/2014 8:59:44 AM
Entry Number 347

If you have additional questions regarding this test, please call: 415-353-1667

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