MMR IHC Panel pharmDx (Dako Omnis)
MMR IHC Panel pharmDx (Dako Omnis)* is a qualitative immunohistochemical (IHC) assay intended for use in the assessment of mismatch repair (MMR) proteins (MLH1, PMS2, MSH2, and MSH6) in formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue using EnVision FLEX visualization system on Dako Omnis automated staining instrument. MMR IHC Panel pharmDx (Dako Omnis) consists of MLH1 IHC pharmDx (Dako Omnis), PMS2 IHC pharmDx (Dako Omnis), MSH2 IHC pharmDx (Dako Omnis), and MSH6 IHC pharmDx (Dako Omnis), which must be used together to identify MMR deficient CRC patients.
MMR IHC Panel pharmDx (Dako Omnis) is indicated as an aid to identify MMR deficient CRC patients eligible for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab).
MMR IHC Panel pharmDx (Dako Omnis) is a modular IHC assay consisting of four MMR primary antibodies to MLH1, PMS2, MSH2, MSH6, and two negative control reagent (NCR) antibodies. Each antibody vial is individually packaged and contains 12 mL of ready-to-use reagent sufficient for 60 tests:
– MLH1 IHC pharmDx (Dako Omnis), Clone ES05, Code GE079
– PMS2 IHC pharmDx (Dako Omnis), Clone EP51, Code GE087
– MSH2 IHC pharmDx (Dako Omnis), Clone FE11, Code GE085
– MSH6 IHC pharmDx (Dako Omnis), Clone EP49, Code GE086
– MMR Negative Control Reagent, Mouse (Dako Omnis), Code GE101
– MMR Negative Control Reagent, Rabbit (Dako Omnis), Code GE102
The MMR IHC Panel pharmDx (Dako Omnis) assay has been tailored for use with the EnVision FLEX visualization system on Dako Omnis automated staining instrument. The following main components, which must be ordered separately in addition to the MMR IHC Panel pharmDx (Dako Omnis) assay, are required:
-Target Retrieval Solution, pH 9 (50x) (Dako Omnis) (Code GC309)
-EnVision FLEX+ Mouse LINKER (Dako Omnis) (Code GV821)
-EnVision FLEX+ Rabbit LINKER (Dako Omnis) (Code GV809)
-EnVision FLEX, High pH (Dako Omnis) (Code GV800), or EnVision FLEX Mini Kit, High pH (GV823)
MMR IHC Panel pharmDx (Dako Omnis) is subject to an exclusive trademark license to Agilent Technologies, Inc. OPDIVO® and YERVOY® are trademarks owned by Bristol-Myers Squibb.
For more details about MMR IHC Panel pharmDx (Dako Omnis), refer to the region-specific Instructions For Use (IFU) corresponding to the relevant antibody components of assay.
Reg status: For In Vitro Diagnostic Use
* MMR IHC Panel pharmDx (Dako Omnis) is approved for exclusive use with the Agilent Dako Omnis automated staining solution (GI100), at present, the MMR IHC Panel pharmDx (Dako Omnis) is not approved for use on the following members of the Dako Omnis Family of Instruments, the Dako Omnis 110, Dako Omnis 165, and Dako Omnis 165 Duo instruments.
MMR IHC Panel pharmDx (Dako Omnis) is indicated as an aid to identify MMR deficient CRC patients eligible for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab).
MMR IHC Panel pharmDx (Dako Omnis) is a modular IHC assay consisting of four MMR primary antibodies to MLH1, PMS2, MSH2, MSH6, and two negative control reagent (NCR) antibodies. Each antibody vial is individually packaged and contains 12 mL of ready-to-use reagent sufficient for 60 tests:
– MLH1 IHC pharmDx (Dako Omnis), Clone ES05, Code GE079
– PMS2 IHC pharmDx (Dako Omnis), Clone EP51, Code GE087
– MSH2 IHC pharmDx (Dako Omnis), Clone FE11, Code GE085
– MSH6 IHC pharmDx (Dako Omnis), Clone EP49, Code GE086
– MMR Negative Control Reagent, Mouse (Dako Omnis), Code GE101
– MMR Negative Control Reagent, Rabbit (Dako Omnis), Code GE102
The MMR IHC Panel pharmDx (Dako Omnis) assay has been tailored for use with the EnVision FLEX visualization system on Dako Omnis automated staining instrument. The following main components, which must be ordered separately in addition to the MMR IHC Panel pharmDx (Dako Omnis) assay, are required:
-Target Retrieval Solution, pH 9 (50x) (Dako Omnis) (Code GC309)
-EnVision FLEX+ Mouse LINKER (Dako Omnis) (Code GV821)
-EnVision FLEX+ Rabbit LINKER (Dako Omnis) (Code GV809)
-EnVision FLEX, High pH (Dako Omnis) (Code GV800), or EnVision FLEX Mini Kit, High pH (GV823)
MMR IHC Panel pharmDx (Dako Omnis) is subject to an exclusive trademark license to Agilent Technologies, Inc. OPDIVO® and YERVOY® are trademarks owned by Bristol-Myers Squibb.
For more details about MMR IHC Panel pharmDx (Dako Omnis), refer to the region-specific Instructions For Use (IFU) corresponding to the relevant antibody components of assay.
Reg status: For In Vitro Diagnostic Use
* MMR IHC Panel pharmDx (Dako Omnis) is approved for exclusive use with the Agilent Dako Omnis automated staining solution (GI100), at present, the MMR IHC Panel pharmDx (Dako Omnis) is not approved for use on the following members of the Dako Omnis Family of Instruments, the Dako Omnis 110, Dako Omnis 165, and Dako Omnis 165 Duo instruments.
