The MMR IHC Panel pharmDx helps identify patients eligible for immunotherapy treatment with Bristol Myers Squibb’s Opdivo alone or in combination with Yervoy.
Agilent Technologies has received US Food and Drug Administration (FDA) approval for its MMR IHC Panel pharmDx (Dako Omnis) as a companion diagnostic test for colorectal cancer, the company announced. The test identifies mismatch repair deficient (dMMR) colorectal cancer patients who are eligible for treatment with Bristol Myers Squibb’s Opdivo (nivolumab) alone or Opdivo in combination with Yervoy (ipilimumab).
The immunohistochemical panel is approved for exclusive use with the Agilent Dako Omnis automated staining solution and represents the only FDA-approved companion diagnostic IHC panel to diagnose colorectal cancer patients eligible for treatment with these specific immunotherapy regimens.
The test detects the loss of function of any of the four mismatch repair proteins (MLH1, PMS2, MSH2, and MSH6) in formalin-fixed paraffin-embedded colorectal cancer tissue. The mismatch repair pathway corrects DNA replication errors to maintain genomic stability, and dysfunction in these key proteins causes MMR deficiency, leading to elevated mutations and neoantigen accumulation that make dMMR tumors more responsive to immunotherapy.
Partnership Drives Development
Agilent partnered with Bristol Myers Squibb to develop the MMR IHC Panel pharmDx, highlighting collaborative efforts between the companies in developing diagnostic assays for patient selection in specific treatments.
“This approval marks an important step forward in the ongoing effort to improve colorectal cancer care,” says Nina Green, vice president and general manager of Agilent’s Clinical Diagnostics Division, in a release. “Our new CDx product offers healthcare providers an additional tool to identify mismatch repair deficiency in patients, complementing existing options and enhancing the ability to tailor immunotherapy treatments.”
Green adds that by providing more choices, the company aims to support better tumor control and potentially improve progression-free survival.
Clinical Laboratory Impact
The approval provides clinical laboratories with a standardized, automated approach to MMR testing for colorectal cancer patients. The test’s integration with the Dako Omnis platform offers laboratories a streamlined workflow for identifying patients who may benefit from specific immunotherapy treatments.
The companion diagnostic designation means laboratories using this test will play a direct role in treatment decisions for colorectal cancer patients, as the FDA has determined that the safe and effective use of the corresponding therapeutic products depends on the use of this specific diagnostic test.
Agilent generated revenue of $6.51 billion in fiscal year 2024 and employs approximately 18,000 people worldwide.
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