Agilent Expands Cancer Diagnostic Use in the United States

Agilent Technologies announced on September 18, 2017, that the U.S. Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 28-8 pharmDx diagnostic test for new indications. The test can now be used for the diagnosis of urothelial carcinoma (UC), the most common type of bladder cancer, and squamous cell carcinoma of the head and neck (SCCHN).

The test was previously approved for melanoma and non-small-cell lung cancer (NSCLC). Developed in collaboration with Bristol-Myers Squibb (BMS), the PD-L1 IHC 28-8 pharmDx test offers a broader utility with more clinically validated tumor indications than any other commercially produced PD-L1 assay on the U.S. market.

The PD-L1 IHC 28-8 pharmDx test enables physicians in the USA to identify which patients with locally advanced or metastatic UC and recurrent or metastatic SCCHN, who have disease progression on or after platinum-based chemotherapy, are most likely to benefit from treatment with Opdivo (nivolumab). While the test is not required for treatment, these latest indications provide pathologists with a clinically validated tool to determine tumor PD-L1 status in patients with these difficult-to-treat diseases.

Data from clinical trials suggest that tumor PD-L1 expression, as detected by PD-L1 IHC 28-8 pharmDx, may be associated with an enhanced survival benefit from Opdivo treatment. Agilent's Dako brand of pathology diagnostics aims to deliver results that pathologists can trust, based on rigorous analytical and clinical validation.