Ki-67 IHC pharmDx
FDA premarket approval P210026 · Immunohistochemistry assay, antibody, Ki-67
Approval
- Applicant
- Agilent Technologies, Inc.
- Received
- June 30, 2021
- Decision date
- October 12, 2021 (APPR)
- Supplements
- 3, latest September 11, 2026
- Product code
- QQT – Immunohistochemistry Assay, Antibody, Ki-67
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.