Agilent MMR IHC Panel pharmDx (Dako Omnis) Receives FDA Approval as a Companion Diagnostic Test for Colorectal Cancer

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[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":1000,"height":404,"url":"https://media.zenfs.com/en/business-wire.com/28490e8b68a273c6604589bb68e58b73"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/AsCEane.Mon8vpASSd5RVQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTM4ODtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/28490e8b68a273c6604589bb68e58b73","width":960,"height":388},"lightbox":{"url":"https://s.yimg.com/ny/api/res/1.2/3UElkKKA7VMK7Gc5O2LKRA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIwMDA7aD04MDg7Y2Y9d2VicA--/https://media.zenfs.com/en/business-wire.com/28490e8b68a273c6604589bb68e58b73","width":1000,"height":404}},"lazy":false},{"type":"text","content":"SANTA CLARA, Calif., August 20, 2025--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced that its MMR IHC Panel pharmDx (Dako Omnis) has received FDA approval as a companion diagnostic (CDx) test for colorectal cancer. This test aids in identifying mismatch repair deficient (dMMR) colorectal cancer (CRC) patients who are eligible for treatment with Bristol Myers Squibb’s Opdivo® (nivolumab) alone or Opdivo (nivolumab) in combination with Yervoy® (ipilimumab). The MMR IHC Panel pharmDx (Dako Omnis) is approved for exclusive use with the Agilent Dako Omnis automated staining solution.","length":607,"tagName":"p"},{"type":"text","content":"The mismatch repair (MMR) pathway corrects DNA replication errors to maintain genomic stability1. Dysfunction in key MMR proteins (MLH1, PMS2, MSH2, and MSH6) causes MMR deficiency, leading to elevated mutations, tumorigenesis, and neoantigen accumulation—features that make dMMR tumors more responsive to immunotherapy due to enhanced immune recognition2.","length":356,"tagName":"p"},{"type":"text","content":"MMR IHC Panel pharmDx (Dako Omnis) is an immunohistochemical (IHC) panel specifically developed and validated to detect the loss of function of any of the four MMR proteins in formalin-fixed paraffin-embedded (FFPE) colorectal cancer tissue. Agilent’s panel is the only FDA-approved companion diagnostic IHC panel to diagnose colorectal cancer patients eligible for treatment with Opdivo alone or in combination with Yervoy.","length":424,"tagName":"p"},{"type":"text","content":""This approval marks an important step forward in the ongoing effo...

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