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Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

Breast Carcinoma

Ki-67 IHC MIB-1 pharmDx (Dako Omnis)

IVD

Code GE020

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.

The assay is a modular IHC assay for 60 tests. The assay has been tailored especially with EnVision FLEX visualization system on Dako Omnis. Important components making up the assay (to be ordered separately) are listed below. For a complete list of materials required to run the assay, refer to the Instructions for Use.

Ki-67 IHC pharmDx (GE02021-5) for Dako Omnis containing Monoclonal Mouse Anti-Ki-67, Clone MIB-1, RTU (Dako Omnis) with Negative Control Reagent

EnVision FLEX, High pH (Dako Omnis) (GV80011-2) or EnVision FLEX Mini Kit, High pH (Dako Omnis) (GV82311-2)

EnVision FLEX Target Retrieval Solution, Low pH (50x) (GV80511-2)

Hematoxylin (Dako Omnis) (GC80811-2) or equivalent

Wash Buffer (20x) (Dako Omnis) (GC80711-2)

Clearify™ Clearing Agent (GC81030-6)

Dako Omnis Sulfuric Acid, 0.3 M (GC20330-2)

The assay requires low pH Target Retrieval Solution for heat-induced epitope retrieval.
For In Vitro Diagnostic Use.

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