MMR IHC Panel pharmDx (Dako Omnis)

FDA premarket approval P250004 · Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay

PMA numberP250004

Approval

Applicant
Agilent Technologies, Inc.
Received
February 18, 2025
Decision date
August 15, 2025 (APPR)
Supplements
1, latest September 11, 2026
Product code
QNH – Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

Official FDA PMA record

Approval order statement

For In Vitro Diagnostic Use.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) alone or OPDIVO (nivolumab) in combination with YERVOY® (ipilimumab).