Labcorp Launches FDA-Approved PD-L1 Companion Diagnostic for KEYTRUDA Ovarian Cancer Treatment

Key Takeaways

• Labcorp launches nationwide availability of Agilent’s PD-L1 IHC 22C3 pharmDx, the only FDA-approved companion diagnostic for platinum-resistant ovarian cancer patients eligible for KEYTRUDA
• The diagnostic enables precision medicine approach by identifying patients most likely to benefit from pembrolizumab immunotherapy treatment
• Launch expands access to personalized cancer treatment options for ovarian cancer patients across the United States

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BURLINGTON, N.C. — Labcorp (NYSE: LH) announced the nationwide launch of Agilent Technologies’ PD-L1 IHC 22C3 pharmDx companion diagnostic, marking a significant advancement in personalized ovarian cancer treatment. The FDA-approved test represents the only companion diagnostic specifically designed to identify patients with platinum-resistant ovarian cancer who may benefit from Merck’s KEYTRUDA® (pembrolizumab) immunotherapy.

Precision Medicine for Ovarian Cancer

The PD-L1 IHC 22C3 pharmDx test measures PD-L1 protein expression levels in tumor tissue, helping oncologists determine which patients are most likely to respond to KEYTRUDA treatment. This biomarker-driven approach represents a shift toward precision medicine in ovarian cancer care, where treatment decisions are based on individual tumor characteristics rather than a one-size-fits-all approach.

Platinum-resistant ovarian cancer affects thousands of patients annually and presents significant treatment challenges. The availability of this companion diagnostic through Labcorp’s extensive laboratory network ensures broader patient access to personalized treatment selection across the United States.

Market Impact and Clinical Significance

The launch strengthens Labcorp’s position in the growing companion diagnostics market, which plays an increasingly critical role in cancer treatment selection. For healthcare providers, the test offers evidence-based guidance for KEYTRUDA treatment decisions, potentially improving patient outcomes while optimizing healthcare resources.

KEYTRuda, Merck’s blockbuster immunotherapy drug, has demonstrated efficacy across multiple cancer types. The companion diagnostic approval specifically for platinum-resistant ovarian cancer expands treatment options for patients who have exhausted traditional chemotherapy approaches.

Healthcare Provider Access

Labcorp’s nationwide laboratory infrastructure enables healthcare providers to order the PD-L1 test through standard laboratory channels, streamlining the diagnostic process. The company’s established relationships with oncology practices and cancer centers facilitate rapid adoption of the new testing capability.

The diagnostic launch aligns with broader industry trends toward biomarker-guided cancer treatment, where molecular testing informs therapeutic decisions. This approach has shown promise in improving treatment outcomes while reducing unnecessary exposure to ineffective therapies.

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Frequently Asked Questions

What does this diagnostic test do for ovarian cancer patients?

The PD-L1 IHC 22C3 pharmDx test measures protein levels in tumor tissue to identify patients with platinum-resistant ovarian cancer who are most likely to benefit from KEYTRUDA immunotherapy treatment, enabling personalized treatment decisions.

When is this companion diagnostic available through Labcorp?

The FDA-approved PD-L1 companion diagnostic is now available nationwide through Labcorp’s laboratory network, allowing healthcare providers to order the test for eligible ovarian cancer patients immediately.

How does this compare to existing ovarian cancer treatment selection methods?

This represents the first and only FDA-approved companion diagnostic specifically for identifying platinum-resistant ovarian cancer patients eligible for KEYTRUDA, offering a more precise, biomarker-driven approach compared to traditional treatment selection methods.