Labcorp Expands Access to FDA-Approved Ovarian Cancer Diagnostic

Event summary

  • Labcorp launched nationwide availability of Agilent's PD-L1 IHC 22C3 pharmDx, the only FDA-approved companion diagnostic for identifying platinum-resistant ovarian cancer patients eligible for Merck's KEYTRUDA.
  • The diagnostic supports KEYTRUDA and KEYTRUDA QLEX, the first FDA-approved PD-1 inhibitors for this patient population.
  • Labcorp participated in Agilent's Early Validation Program to ensure rapid testing availability following FDA approval in February 2026.
  • Approximately 80% of ovarian cancer patients experience recurrence, with limited treatment options for platinum-resistant cases.

The big picture

Labcorp's move underscores the growing importance of companion diagnostics in precision oncology, particularly for hard-to-treat cancers like platinum-resistant ovarian cancer. The launch follows the FDA's February approval of KEYTRUDA for this indication, highlighting the strategic alignment between diagnostic providers and pharmaceutical companies in expanding treatment options for rare cancer subtypes. The nationwide availability of the diagnostic could significantly improve patient outcomes by enabling faster identification of eligible candidates for KEYTRUDA therapy.

What we're watching

Adoption Pace
How quickly clinicians will integrate the diagnostic into treatment protocols for platinum-resistant ovarian cancer patients.
Market Impact
Whether Labcorp's nationwide availability will drive broader adoption of KEYTRUDA in this indication.
Competitive Dynamics
The pace at which other diagnostics providers may develop competing tests for similar indications.

Related topics

Biotechnology