Agilent Receives FDA Approval for PD-L1 Test in Esophageal and Gastric Cancers

Agilent Technologies announced it has received U.S. Food and Drug Administration (FDA) approval for its PD-L1 IHC 28-8 pharmDx assay. The diagnostic test is now approved to identify patients with esophageal squamous cell carcinoma (ESCC), gastric cancer, gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma who may be eligible for treatment with Bristol Myers Squibb's OPDIVO® (nivolumab) or OPDIVO QVANTIG®.

The new approval expands the use of the PD-L1 IHC 28-8 pharmDx assay, which serves as a companion diagnostic. It aids pathologists and clinicians in determining PD-L1 protein expression in a patient's tumor tissue. The level of PD-L1 expression, measured by the Combined Positive Score (CPS), can help predict a patient's response to PD-1 inhibitor therapy.

The test is intended for use exclusively with the Agilent Autostainer Link 48, an advanced automated staining solution for histopathology laboratories. A CPS score of ≥ 1 is considered when assessing patient eligibility for OPDIVO® or OPDIVO QVANTIG®, which are immunotherapies used in cancer treatment.

Gastric and esophageal cancers represent a significant global health burden, and their treatment is often challenging. PD-1 and PD-L1 targeted immunotherapies, such as OPDIVO®, have improved treatment outcomes in various cancer types. Accurate biomarker testing is crucial for maximizing the benefits of these therapies.