Additional Information:
If requested indeterminate results will be reflexed for Her2/neu FISH testing. A separate report will be issued.
CPT Code(s):
- 88361
- FISH Reflex: 88368 x 2
Specimen Requirements:
A paraffin block containing representative breast tumors
Fixation: 10% formalin
Storage/Transport: Ship specimens at 20° – 25° C to protect them from excessive heat. Include a surgical pathology report.
- Frozen
- Ambient: Indefinitely
Use:
This test is used to determine if Herceptin therapy is warranted in invasive breast tumors. Interpretation of breast tumors is based on the 2007 ASCO/CAP guidelines. If requested, indeterminate results and triple negative cases can be reflexed for Her2Neu FISH testing. A separate report will be issued.
Methodology:
Immunohistochemistry and image quantitation using ACIS III
Reported:
Immunohistochemistry is reported within 7 days. If FISH is required and requested, the additional report will be provided within an additional 2 – 7 days.
Reference Values:
- 0.0 – 1.7 Negative: No staining or weak, incomplete membrane staining in any portion of the invasive tumor or weak complete membrane staining in less than 10% of the cells
- 1.8 – 2.9 Indeterminate: Complete membrane staining that is non-uniform or weak but with obvious circumferential distribution in at least 10% of the tumor cells; or intense complete staining in 305 or less of the tumor cells
- ≥ 3.0 Positive: Uniform intense membrane staining of more than 30% of invasive tumor
Interpretation Data:
Breast: The HercepTest™ is interpreted using quantitative analysis using the DAKO ACIS III instrument. The assay is performed on paraffin-embedded tissue using the FDA-approved staining method (polyclonal antibody and LSAB detection system).