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FDA Approves Roche's PD-L1 Test for Bladder Cancer

NEW YORK (360Dx) – Roche on Tuesday said that its PD-L1 assay was approved by the US Food and Drug Administration as a complementary diagnostic for patients with locally advanced or metastatic urothelial carcinoma who are being considered for treatment with AstraZeneca's immunotherapy Imfinzi (durvalumab).

The Ventana PD-L1 (SP263) assay is now available in the US for use on the Ventana BenchMark Ultra instrument. It evaluates a patient's PD-L1 status using tumor and immune cell staining and scoring within the tumor microenvironment, and provides clinicians with information to help them make treatment decisions.

PD-L1 is a protein involved in the suppression of the immune system, and understanding its expression in tumors could help with identifying those patients who are most appropriate for treatment with an immunotherapy.

According to Roche, about 79,000 Americans will be diagnosed with bladder cancer this year, and about 17,000 will die from the disease.

The company said that it is pursuing regulatory approval of the Ventana PD-L1 assay for use with other cancers in the US and other geographies.