Agilent Technologies has announced that its PD-L1 IHC 28-8 pharmDx assay has received approval from the U.S. Food and Drug Administration (FDA) as a companion diagnostic tool to identify patients who may be suitable for immunotherapy.

The kit is now formally indicated for evaluating PD-L1 protein expression levels in patients with esophageal squamous cell carcinoma, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

This approval is based on the assay's demonstrated ability in multiple clinical trials to accurately identify patients suitable for specific immunotherapy regimens. For these cancer types, PD-L1 expression level is a key biomarker used by physicians to determine whether a patient may benefit from immunotherapy.

Agilent's companion diagnostic provides pathology laboratories with a standardized, clinically validated tool to quantify PD-L1 expression in tumor tissue samples.

The kit is a significant product for Agilent in the field of oncology diagnostics. Its core strength lies in providing a uniform and reliable testing standard for pathology laboratories worldwide, helping to ensure comparability of results across different regions and labs.

This supports clinicians in developing more precise treatment plans for patients. Previous data indicates this testing method has applications in various solid tumors, including lung cancer and melanoma, and demonstrates high reproducibility in terms of analytical sensitivity and specificity.

Agilent stated that this approval will help standardize the patient selection process for immunotherapy in these cancers, supporting global clinicians in making more accurate treatment decisions. The company also noted that the PD-L1 IHC 28-8 pharmDx assay is now available for order in the U.S. market.