Agilent MMR IHC Panel pharmDx Receives FDA Approval as Companion Diagnostic Test for Colorectal Cancer

Agilent's MMR IHC Panel pharmDx has received FDA approval as a companion diagnostic test for colorectal cancer, aiding in identifying patients eligible for Bristol Myers Squibb's Opdivo treatment. The test is approved for exclusive use with Agilent's Dako Omnis automated staining solution.

Agilent Technologies Inc. (NYSE: A) has received significant attention this week as its MMR IHC Panel pharmDx (Dako Omnis) has been approved by the U.S. Food and Drug Administration (FDA) as a companion diagnostic test for colorectal cancer. This approval is a significant milestone in the ongoing effort to improve colorectal cancer care.

The MMR IHC Panel pharmDx is designed to identify mismatch repair deficient (dMMR) colorectal cancer (CRC) patients who are eligible for treatment with Bristol Myers Squibb's Opdivo (nivolumab) alone or in combination with Yervoy (ipilimumab). The panel is specifically developed and validated to detect the loss of function of any of the four MMR proteins (MLH1, PMS2, MSH2, and MSH6) in formalin-fixed paraffin-embedded (FFPE) colorectal cancer tissue.

"This approval marks an important step forward in the ongoing effort to improve colorectal cancer care," stated Nina Green, vice-president and general manager of Agilent’s Clinical Diagnostics Division. "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."

The MMR IHC Panel pharmDx 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. Agilent partnered with Bristol Myers Squibb to develop this diagnostic assay, highlighting the collaborative efforts between the two companies in developing and gaining approval for such diagnostic tools.

The approval of the MMR IHC Panel pharmDx is expected to support better tumor control and potentially improve progression-free survival for patients with colorectal cancer. This advancement underscores Agilent's commitment to innovation in clinical diagnostics and its role in enhancing the precision of cancer treatment.

References:
[1] https://www.nasdaq.com/articles/agilent-mmr-ihc-panel-pharmdx-gets-fda-approval-companion-diagnostic-test-colorectal
[2] https://www.marketscreener.com/news/agilent-mmr-ihc-panel-pharmdx-dako-omnis-receives-fda-approval-as-a-companion-diagnostic-test-for-ce7c51d2df8bf22d
[3] https://www.agilent.com/about/newsroom/presrel/2025/20aug-25026.html
[4] https://www.biospace.com/press-releases/agilent-mmr-ihc-panel-pharmdx-dako-omnis-receives-fda-approval-as-a-companion-diagnostic-test-for-colorectal-cancer