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Patient Name: Test, Patient
Collection Date: 05/21/2007
Ordering Physician: Test, M.D.
Received Date: 05/23/2007
Treating Physician: Training
Report Date: 05/24/2007
Ordering Facility: Test Hospital
US LABS Ref #: AP07-0000W
Medical Record #: 000003
Date of Birth, Age: 01/27/1956, 51
Specimen ID #: 07-00001
Predictive/Prognostic Marker Analysis
Specimen Site: Lt Breast
Specimen ID #: 07-00001
ESTROGEN RECEPTOR* - IHC -
Reference Range
Favorable
Present/Positive
Unfavorable
Percent:
Intensity:
Strong (3)
Analysis:
PROGESTERONE RECEPTOR*
Reference Range
- IHC - Image
Favorable
Present/Positive
Unfavorable
Percent:
Intensity:
Strong (3)
Analysis:
HercepTest (HER2)* - IHC -
Reference Range
Not Over-Expressed 0 - 1+
Over-Expressed
Borderline
Over-Expressed
Analysis:
Electronically Signed by USLABS, M.D. on 5/24/2007 at US LABS
USLABS, M.D.
Associate Medical Director
Methodology
A monoclonal antibody (clone 1D5) that recognizes the Estrogen Receptor alpha is used to perform immunohistochemistry on routinely fixed (e.g., formalin,
Bouin's, or other acceptable fixative) paraffin embedded tissue. The percentage and intensity of stained tumor nuclei are determined either manually or by image
analysis. The performance characteristics of this analyte specific reagent (ASR) immunohistochemical stain used in this report has been determined by US LABS.
This test has not been cleared or approved by the U.S. Food & Drug Administration (FDA). The FDA has determined that such clearance or approval is not
necessary. This test is used for clinical purposes.
A monoclonal antibody (clone PR636) that recognizes the Progesterone Receptor is used to perform immunohistochemistry on routinely fixed (e.g., formalin, Bouin's, or other acceptable fixative) paraffin embedded tissue. The percentage and intensity of stained tumor nuclei are determined either manually or by image analysis. This test has not been cleared or approved by the U.S. Food & Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes.
HER-2 Receptor protein expression is analyzed using the DakoCytomation HercepTestTM kit. This assay is FDA cleared for in vitro diagnostic use for the determination of HER-2 protein over-expression in paraffin embedded, routinely fixed (e.g., formalin or Bouin's fixative) breast cancer tissue. Staining interpretation and scoring of the HercepTestTM are performed in accordance with the DakoCytomation HercepTestTM manual, 4th edition.
Test Hospital
2601 Campus Drive
2601 Campus Drive, Irvine, CA 92612
Irvine, CA 926127
949.450.0145 TEL 949.450.0147 Fax
800.710.1800 Client Services
www.uslabs.net
This document contains private and confidential health information protected by state and federal law. If you received this document in error, please call 800.710.1800.
Patient Name: Test, Patient
Collection Date: 05/21/2007
Ordering Physician: Test, M.D.
Received Date: 05/23/2007
Treating Physician: Training
Report Date: 05/24/2007
Ordering Facility: Test Hospital
US LABS Ref #: AP07-0000W
Medical Record #: 000003
Date of Birth, Age: 01/27/1956, 51
Specimen ID #: 07-00001
Intended Use
Although a favorable patient prognosis may be related to the expression of the Estrogen and/or Progesterone Receptors, prognosis may also be due to other
factors since expression of Estrogen Receptor is correlated with a more well-differentiated tumor, diploid DNA content and a lower proliferative index and is
inversely correlated with HER-2/neu and EGFR expression. Approximately 75% of invasive breast carcinoma will demonstrate expression of Estrogen Receptor.
On average, higher rates of Estrogen Receptor expression may be seen in post-menopausal patients. Primary breast carcinomas are more often Estrogen
Receptor positive than metastatic breast carcinomas, especially those from visceral metastases. Approximately, 60% of patients whose breast tumors express
Estrogen Receptor may respond to endocrine therapy, while less than 10% of those patients whose tumor lack Estrogen Receptor may respond. In univariate
analysis, moderate to strong staining in even 1% of the invasive tumor cells is associated with significant improvement of disease free survival as compared to
those patients whose tumors lack Estrogen Receptor expression (Harvey et al, JCO, 17:1474, 1999). Data suggests that the assessment of the Progesterone
Receptor is an independent predictor of benefit to endocrine therapy and that those patients whose tumor expresses both Estrogen and Progesterone Receptors
benefit the greatest from endocrine therapy. If only one receptor is expressed, the benefit of endocrine therapy may decrease by up to half (Bardou et al, JCO,
21:1973, 2003). Data also suggests that ductal carcinoma in-situ tumors which lack expression of Estrogen Receptor will not likely benefit from tamoxifen
therapy.
HER-2/neu is an oncogene that is over-expressed in 20-25% of primary breast carcinomas. The expected over-expression rate can vary based on the grade and type of breast cancer. Blocks submitted for immunohistochemistry should conform to the specifications set forth in the HercepTestTM package insert, otherwise an alternative testing methodology such as FISH should be used. Tumors showing intense (3+) over-expression of HER-2 may benefit from Trastuzimab therapy. Borderline results (2+) may show a reduced response rate to Trastuzimab therapy; therefore, assessment of the HER-2 gene status by FISH may provide additional therapeutic information.
Test Hospital
2601 Campus Drive
2601 Campus Drive, Irvine, CA 92612
Irvine, CA 92612
949.450.0145 TEL 949.450.0147 Fax
800.710.1800 Client Services
www.uslabs.net
This document contains private and confidential health information protected by state and federal law. If you received this document in error, please call 800.710.1800.

Source: http://www.uslabs.net/filebin/pdf/ER%20PR%20Her2.pdf

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