Agilent Technologies, Inc.

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Bullish +75

Labcorp introduces US FDA-approved companion diagnostic to identify patients with ovarian cancer eligible for Keytruda

🔬 Labcorp has announced the nationwide availability of Agilent Technologies' PD-L1 IHC 22C3 pharmDx, a new companion diagnostic test for ovarian cancer patients.

✅ This is the only FDA-approved test specifically designed to identify patients with platinum-resistant ovarian cancer who may be eligible for treatment.

💊 The test supports access to Keytruda and Keytruda Qlex, which are the first FDA-approved PD-1 inhibitors authorized as a complete treatment regimen for this condition.

📉 Approximately 80% of individuals with ovarian cancer experience recurrence after initial therapy, often developing resistance to platinum-based chemotherapy.

⏳ Patients with platinum-resistant ovarian cancer previously faced limited treatment options and poor survival outcomes due to the incurable nature of the disease.

💡 Clinical approval for these therapies has been found to reduce the risk of disease progression and improve overall survival rates for eligible patients.

🤝 Labcorp's chief scientific officer, Dr. Marcia Eisenberg, stated that the diagnostic helps clinicians connect struggling patients with therapies offering new hope.

📜 The FDA approved Keytruda, Keytruda Qlex, and the companion diagnostic in February of this year following regulatory review.

🏭 Prior to nationwide launch, Labcorp participated in Agilent Technologies' Early Validation Programme to ensure rapid testing availability.

🎓 Through standardized training and readiness activities, Labcorp prepared its laboratories to expand access to the diagnostic quickly.

🌐 Labcorp is described as a global leader providing innovative laboratory services to doctors, hospitals, pharmaceutical companies, researchers, and patients.

🏥 The company's mission includes helping medical professionals make confident decisions and advancing science through diagnostics and drug development capabilities.

Bullish Signals
  • Labcorp has introduced the only US FDA-approved companion diagnostic, Agilent Technologies' PD-L1 IHC 22C3 pharmDx, for identifying patients with platinum-resistant ovarian cancer eligible for Keytruda.
  • The partnership enables clinicians to quickly identify patients who may benefit from newly approved treatments, reducing risk of disease progression and improving overall survival.
  • Labcorp participated in Agilent Technologies' Early Validation Programme to support rapid testing availability nationwide following the FDA's February approval.
  • This launch expands nationwide access to a therapy offering new hope for individuals with platinum-resistant ovarian cancer who previously had limited treatment options.
Risk Factors
  • Approximately 80% of individuals with ovarian cancer experience recurrence after initial therapy, highlighting the severe unmet medical need despite new diagnostic approvals.
  • The disease is incurable, and current treatment options offer limited and short-lived benefits for patients suffering from platinum-resistant ovarian cancer.
  • Many patients develop resistance to platinum-based chemotherapy, leading to a critical lack of viable treatment options before these new therapies become accessible.
Full Analysis
Labcorp has announced the nationwide availability of Agilent Technologies' PD-L1 IHC 22C3 pharmDx, a US FDA-approved companion diagnostic designed to identify patients with platinum-resistant ovarian cancer who may be eligible for Merck's Keytruda. This diagnostic tool is significant because it is the only one currently approved by the US Food and Drug Administration specifically for this purpose within the context of ovarian cancer treatment. The availability allows clinicians to quickly and accurately pinpoint patients who can benefit from these targeted therapies, addressing a critical gap in care where approximately 80% of individuals with ovarian cancer experience recurrence after initial therapy, often developing resistance to platinum-based chemotherapy with limited options remaining. Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) represent the first FDA-approved PD-1 inhibitors available as part of a complete treatment regimen for eligible patients with platinum-resistant ovarian cancer. Clinical findings indicate that these treatments reduce the risk of disease progression and improve overall survival, offering new hope for a challenging form of cancer that is currently incurable and offers limited benefits with current options. Following the FDA's approval in February, which included Keytruda, Keytruda Qlex, and the PD-L1 IHC 22C3 pharmDx diagnostic, Labcorp participated in Agilent Technologies' Early Validation Programme to ensure rapid testing readiness through standardized training and other preparatory activities. Dr. Marcia Eisenberg, Ph.D., chief scientific officer at Labcorp, emphasized the critical nature of this development by stating that platinum-resistant ovarian cancer remains incurable with existing treatments providing only short-lived benefits, making it one of the most difficult conditions to manage. She noted that by making the companion diagnostic available nationwide, Labcorp is helping clinicians rapidly identify eligible patients and connect them with a therapy that offers new hope. Labcorp, described as a global leader in innovative and comprehensive laboratory services, aims to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions, advancing science to improve health and lives through its unparalleled diagnostics and drug development capabilities. This expansion follows the February regulatory approval, positioning the company to immediately support broader access to these life-extending treatments across the United States.