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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 Clinical Cancer Genomics Laboratory (CCGL)
In House Availability Test performed once a week, with DNA extraction set up on Mondays and Wednesdays, test run on Tuesday or Wednesday, day shift only
Method Fluorescence in-situ hybridiztion (FISH)
Collection Instructions Testing should be ordered only on surgical excision samples. Biopsy material is not appropriate. Blocks selected for MSI PCR testing must contain both tumor and normal tissue. If only tumor is present on the block, select an additional block with normal tissue

Areas of tumor must contain at least 50% tumor cells. The lab can remove adjacent non-tumor tissue, so the entire slide does not need 50% tumor cells, just the area with tumor. Contact the laboratory (415-514-1035, AGCLab@ucsf.edu) if the specimen suitability is uncertain. Label slides with pathology case number and block identification.

Complete an Applied Genomics Laboratory requisition and submit it with samples.

Click here for requisition form
Container type glass slides
Sample type Formalin-fixed, paraffin-embedded tissue. Tissue block or unstained slides. If sending unstained slides, we require five (5) 10-micron tissue sections on uncharged glass slides. One adjacent H&E stained slide should be included.
Preferred volume 3 unstained and 1 H&E stained sections
UCSF Rejection Criteria All required slides not included. Insufficient tumor or normal tissue present on slide as determined by pathologist. Slides not labeled or not accompanied by completed requisition form (if not ordered directly through Department of Pathology).
Processing notes Contact CCGL at 415-502-3252 and inform them that a sample is available for pickup and your location.
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
Stability Formalin-fixed, paraffin-embedded tissues are stable indefinitely at room temperature
Turn around times 7-10 days
Additional information An interpretation of this test by a laboratory physician will automatically be performed and billed for separately.

The test was validated by the UCSF Clinical Cancer Genomics Laboratory (CCGL) to confirm performance characteristics, in compliance with current guidelines for clinical implementation
LOINC code 42783-1
LDT or Mod FDA? Yes
Last Updated 10/1/2015 8:55:09 AM
Entry Number 347
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