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| Device | Ki-67 IHC pharmDx |
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| Generic Name | Immunohistochemistry assay, antibody, Ki-67 |
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| Applicant | Agilent Technologies, Inc.
5301 Stevens Creek Boulevard
Santa Clara, CA 95051 |
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| PMA Number | P210026 |
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| Date Received | 06/30/2021 |
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| Decision Date | 10/12/2021 |
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| Product Code |
QQT |
| Advisory Committee |
Pathology |
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| Clinical Trials | NCT03155997
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval of Ki-67 IHC MIB-1 pharmDx (Dako Omnis)For In Vitro Diagnostic Use.Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is a qualitative immunohistochemical (IHC) assay using monoclonal mouse anti-Ki-67, Clone MIB-1, intended for use in the detection of Ki-67 protein in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue using the EnVision FLEX visualization system on Dako Omnis.Ki-67 protein expression in breast carcinoma is determined by using the Ki-67 pharmDx Score, which is the overall percentage of viable tumor cells in the invasive cancer component showing Ki-67 nuclear staining. The specimen should be considered to have Ki-67 expression if Ki-67 pharmDx Score is ? 20.Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is indicated as an aid in identifying patients with early breast cancer at high risk of disease recurrence for whom adjuvant treatment with Verzenio® (abemaciclib) in combination with endocrine therapy is being considered. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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