Agilent’s MMR IHC Panel pharmDx (Dako Omnis) Receives European IVDR Certification as a Companion Diagnostic Test for Colorectal Cancer
(NYSE:A) SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced that its MMR IHC Panel pharmDx (Dako Omnis) has received class C companion diagnostic (CDx) certification under EU in vitro diagnostic regulation (IVDR)1 as a CDx test for colorectal cancer. MMR IHC Panel pharmDx (Dako Omnis) is indicated as an aid to identify mismatch repair (MMR) deficient CRC patients eligible for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab). MMR IHC Panel
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How will the IVDR certification of Agilent’s MMR IHC Panel affect Agilent’s revenue forecasts and earnings guidance?
What impact will this companion diagnostic have on the market share and sales dynamics of Opdivo®/Yervoy® combination therapy versus competing immunotherapies?
How does Agilent’s certification timeline and product positioning compare to other diagnostic companies offering MMR testing in Europe, and what are the implications for reimbursement and pricing?