PERFORMED ON (Case #, Block):
Laterality:
    Right
    Left

History:
       Ductal Carcinoma In Situ (DCIS)
       Lobular Carcinoma In Situ (LCIS)
       Invasive Ductal Carcinoma
       Invasive Lobular Carcinoma
       

ESTROGEN RECEPTOR (ER):
       Interpretation:
        POSITIVE
        NEGATIVE
        OTHER:
       Not performed
       Pending
       Percentage of cells with nuclear immunoreactivity: %
       Intensity of staining:
        Absent
        Weak
        Medium
        Strong
       Antibody clone: (ER2-123 AND 1D5 COCKTAIL)

PROGESTERONE RECEPTOR (PR):
       Interpretation:
        POSITIVE
        NEGATIVE
        OTHER:
       Not performed
       Pending
       Percentage of cells with nuclear immunoreactivity: %
       Intensity of staining:
        Absent
        Weak
        Medium
        Strong
       Antibody clone: (PGR 1294)

HER-2/NEU IHC (HercepTest):
       Interpretation:
        NEGATIVE (Score )
        EQUIVOCAL (Score )
        POSITIVE (Score )
        OTHER:
       Not performed
       Pending
       Antibody clone: Her-2/neu

Reference range for Her-2/neu IHC:
Positive: ≥ 3
Equivocal: 1.8-2.9
Negative: <1.8

HER-2/NEU FISH:
       Interpretation:
        NOT AMPLIFIED
               Average number of HER2 gene copies per cell:
               Average number of chromosome 17 per cell:
               Amplification Ratio:
        EQUIVOCAL
               Average number of HER2 gene copies per cell:
               Average number of chromosome 17 per cell:
               Amplification Ratio:
        AMPLIFIED:
               Average number of HER2 gene copies per cell:
               Average number of chromosome 17 per cell:
               Amplification Ratio:
        HER2 Genetic Heterogeneity is present. (See comment)
        OTHER:
       Not performed
       Pending
       Name of assay: Abbott Pathvysion

Reference range for Her-2/neu FISH:
Positive for amplification: >2.2
Equivocal for amplification: 1.8-2.2
Negative for amplification: <1.8

Comments:


Comment for triple negative breast cancer: The Her2/neu value is determined to be . This value indicates no significant expression of the Her2/neu protein. Molecular analysis for Her-2/neu gene amplification will be performed by fluorescence in situ hybridization (FISH). Results will be reported as an addendum.
Comment for equivocal Her-2/neu IHC: The Her2/neu value is determined to be . This value may not correlate with increased copy number of the Her2/neu protein. Molecular analysis for Her-2/neu gene amplification will be performed by fluorescence in situ hybridization (FISH). Results will be reported as an addendum.
ER/PR and/or Her-2/neu IHC, invasive: COMMENT: Examination of microscopic sections from the referred block confirms the presence of carcinoma in the regions evaluated. Testing was performed on a corresponding level using the FDA approved immunohistochemical assay(s) and the reactivity quantitated by image analysis.
TEST DESCRIPTION: Sample(s) were fixed in for no less than six hours and not exceeding 48 hours prior to processing. Testing was performed on the carcinoma using the DAKO ER/PR PharmDx kit FDA approved immunohistochemical assay(s). The reactivity was analyzed by image analysis. Appropriate positive and negative external and internal controls were acceptable. The performance characteristics were validated by the University of Florida Pathology Laboratories.
Reference range for ER/PR IHC:
Positive: Equal to or greater than 1%
Negative: Less than 1%
Reference range for Her-2/neu IHC:
Positive: equal to or greater than 3
Equivocal: 1.8 to 2.9
Negative: less than 1.8
ER/PR and/or Her-2/neu IHC, DCIS: COMMENT: Examination of microscopic sections from the referred block confirms the presence of in the regions evaluated. Testing was performed on a corresponding level using the FDA approved immunohistochemical assay(s) and the reactivity quantitated by image analysis.
TEST DESCRIPTION: Sample(s) were fixed in for no less than six hours and not exceeding 48 hours prior to processing. Testing was performed on the using the DAKO ER/PR PharmDx kit FDA approved immunohistochemical assay(s). The reactivity was analyzed by image analysis. Appropriate positive and negative external and internal controls were acceptable. The performance characteristics were validated by the University of Florida Pathology Laboratories.
Reference range for ER/PR IHC:
Positive: Equal to or greater than 1%
Negative: Less than 1%
Reference range for Her-2/neu IHC:
Positive: equal to or greater than 3
Equivocal: 1.8 to 2.9
Negative: less than 1.8
Her-2/neu FISH: COMMENT: Examination of microscopic sections from the referred block confirms the presence of carcinoma in the regions evaluated. FISH analysis was performed on a corresponding level. The result is expressed as the ratio of Her-2/neu gene copies/chromosome 17. Clinical correlation of these results in conjunction with Her-2/neu immunohistochemical studies, and clinical findings may be of value in determining further therapy.
TEST DESCRIPTION: Fluorescence in situ hybridization (FISH) for the detection of the Her-2/neu gene amplification in paraffin embedded tissue was performed using the Abbott Pathvysion FDA approved assay. FISH analysis was performed on the carcinoma. Using fluorescent microscopy, enumeration was performed on the Her-2/neu gene, located at locus (17p11.2-q12) on chromosome 17, and the alpha satellite DNA sequence, located at the centromeric region of chromosome 17 (17p11.1-q11.1). Gene amplification is based on the ratio of Her-2/neu to chromosome 17 in the tumor tissue. External positive controls were acceptable. FISH Probes: Orange LSI HER-2/neu; Green Chromosome 17: CEP 17. The performance characteristics were validated by the University of Florida Pathology Laboratories.
Reference range:
Positive for amplification: HER2 gene copy greater than 6 or ratio greater than 2.2
Equivocal for amplification: HER2 gene copy 4 to 6 or ratio 1.8 to 2.2
Negative for amplification: HER2 gene copy less than 4 or ratio less than 1.8
COMMENT: HER2 amplification is seen in % of the invasive tumor cells analyzed. The amplified cells are present .
If a specific cluster of amplified cells is present: In the cluster of amplified cells the average number of HER2 signals per cell is , average number of chromosome 17 signals per cell is , and the amplification ratio is: . (The area is histologically distinctive)
If the examination was performed on a needle core biopsy: COMMENT: The evaluation may not be representative of the entire tumor and it might be desirable to perform FISH testing on a resection sample.



REFERENCE(S):
       Hammond, E.H.; et al. ASCO/CAP Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer (unabridged Version). Arch Pathol Lab Med. 2010. 134: e48-e72
       Wolff AC, Hammond ME, Schwartz JN et. al.; American Society of Clinical Oncology/College of American Pathologists. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med. 2007;131(1):18-43.
       Hofmann M, Stoss O, Shi D, et al. Assessment of a HER2 scoring system for gastric cancer: results from a validation study. Histopathology. 2008 Jun;52(7):797-805. Epub 2008 Apr 18.
       Path Vysion her-2/neu DNA probe kit (package insert). Downers Grove, III; Vysis, Inc; 2003.