Quantitative Pathology
Breast Biomarkers for HER2 and ER and PR receptors
HER2
HER2 in breast carcinoma is evaluated by the current CAP and National Comprehensive Cancer Network (NCCN-2006) recommended FDA approved immunohistochemical and FISH methods.
The first method, employs immunohistochemical study for HER2 with immunoreactivity determined by quantitative light microscopy. Tumors are classified as negative, indeterminate or positive dependent upon the extent and intensity of HER2 cytoplasmic membrane immunoreactivity. Negative and positive cases are reported accordingly. Indeterminate cases are reflexed to in-situ hybridization FISH analysis unless otherwise requested. Some cases may be indeterminate by FISH.
The second method, if specifically requested, employs FISH analysis alone, without immunohistochemistry. Specimen to submit: A paraffin block containing representative breast tumor and a copy of the pathology report with appropriate requisition. HER2 Reference: HER2 Testing in Breast Cancer: National Comprehensive Cancer Network Task Force Report and Recommendations. Journal of the National Comprehensive Cancer Network: 2006(July):4: S1-S22, (Supplement 3).
Estrogen and Progesterone Receptor Analysis in Tumor
Estrogen and Progesterone receptors in breast carcinoma, and other tumors known to express these hormone receptors, are evaluated by immunohistochemical study with quantitation. The immunoreactive tumor cells expressing estrogen or progesterone receptor activity are reported as a percent of the total number of tumor cells evaluated. Receptor reactivity is also reported as negative or positive, dependent on the expression observed. Specimen to submit: A paraffin block containing representative breast tumor and a copy of the pathology report with appropriate requisition.
Additional Breast Biomarkers Available: Assessment of Tumor DNA Ploidy and Cell Proliferation
Tumor DNA ploidy is determined by flow cytometry in formalin fixed, paraffin embedded tissue. Proliferation is analyzed by employing both DNA flow cytometry with calculation of S-phase fraction as well as use of MIB-1 (Ki-67) expression as determined by immunohistochemistry with quantitation. Specimen to submit: A paraffin block containing representative breast tumor and a copy of the pathology report with appropriate requisition.
Sample Reports: DNA Ploidy
Test List
Quantitative Pathology, General Info. (Edward J. Wilkinson, M.D.; Peter A. Drew, M.D.; Nicole Massoll, M.D.)
| Test Order Number: | ||
| Methodology: | Computer-assisted morphometry for quantitative immunohistochemistry and flow cytometry analyses. | |
| Specimen Requirements: | Paraffin block; formalin fixed tissue. | |
| Specimen Handling: | ||
| In-house turnaround time: | 2 to 5 days | |
| Reference Values: | Interpretive report with histogram | |
| CPT Code: |