Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is the identification and semi-quantification of Ki-67 protein expression level in breast cancer tissues by the GenASIs GoPth system as compared to manual reading of the same slides.
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 Ki-67 is a semi-quantitative immunohistochemical (IHC) assay to identify the Ki-67 protein expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Ki-67 test is indicated as an aid in the assessment of the protein status of breast cancer patients. While the p53 kit provides the antibody 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 analysis and review of immunohistochemically stained histologic slides.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with Breast Cancer #1 | IVD Study |
| |
| Women with Breast Cancer #2 | IVD Study |
| |
| Women with Breast Cancer #3 | IVD Study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Women with Breast Cancer | Procedure | IVD Study |
|
| Measure | Description | Time Frame |
|---|---|---|
| IVD study of Ki67 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 Ki67 antibody at least 85%. | 1 Day |
| IVD study of Ki67 IHC samples: Repeatability & Reproducibility of analysis | Repeatability & Reproducibility tests of system analysis of antibody expressions. R&R acceptance criteria of Ki67 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 80%. | 1 Day |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Women having breast cancer aged 21 and up
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |