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|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||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|
|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.
|Turn around times||10-14 days|
|Additional information||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|
|LDT or Mod FDA?||Yes|
|Last Updated||3/19/2013 10:19:49 AM|
If you have additional questions regarding this test, please call: 415-353-1667