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The purpose of the study is the identification and quantification of proteins expression level in breast cancer tissues.
The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ER/PR IHC stained samples.
The anti ER/PR Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the progesterone (PR) and estrogen (ER) expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the ER/PR test is indicated as an aid in the assessment of the hormones status of breast cancer patients. While the ER/PR kit provides the antibodies that offer direct visualization and semi-quantification of the protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the review of immunohistochemically stained histologic slides.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer patients | Breast cancer patients |
| |
| women with breast cancer | women with breast cancer |
| |
| Cancer patients | Cancer patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast Cancer patient | Procedure | Samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| IVD study of ER/PR IHC samples: Accuracy of analysis | Comparison tests (accuracy) between manual and automatic analysis of antibody expressions. The results from the automatic counting from the clinical studies will be compared to the manual counting analysis. Accuracy of the study will be declared "Success" if Positive, Negative and Overall agreement with manual count of the ER & PR antibody at least 90%. | 1 Day |
| IVD study of ER/PR IHC samples: Repeatability & Reproducibility of analysis | Repeatability & Reproducibility tests of system analysis of antibody expressions. R&R acceptance criteria of ER/PR are related to the average agreement for between runs, between days and between systems R&R part of the study will be declared "Success" if Positive and Negative average agreement will be at least 85%. | 1 Day |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer patients
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| Name | Affiliation | Role |
|---|---|---|
| Sheila Dobin | Section Chief, Cytogenetics | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scott & White Hospital,, | Temple | Texas | 76508 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Cancer patients | Procedure | Samples |
|
| D017437 |
| Skin and Connective Tissue Diseases |