FDA has approved the Ventana PD-L1 (SP142) assay from Roche Diagnostics, Indianapolis, as the first companion diagnostic to aid in identifying triple-negative breast cancer patients eligible for treatment with the Roche cancer immunotherapy Tecentriq (atezolizumab) plus chemotherapy. Use of the assay to assess a patient’s PD-L1 biomarker status on tumor-infiltrating immune cells is essential for identifying those most likely to benefit from the treatment.

A diagnosis of triple-negative breast cancer means that the three most common proteins associated with breast cancer growth¾estrogen receptor, HER2/neu, and progesterone receptor¾are not expressed on the tumor.

“Triple-negative breast cancer is an aggressive disease that, until now, has had limited treatment options,” explains Michael Heuer, CEO of Roche Diagnostics. “This assay plays a pivotal role in helping physicians identify patients that can benefit from Tecentriq therapy, providing better patient care. At Roche, we build on our capacity to research both targeted medicines and companion diagnostics under one roof, so we can provide the right treatment to the right patient at the right time.”

The Ventana PD-L1 (SP142) assay was developed to enhance visual contrast of tumor-infiltrating immune cell staining. In triple-negative breast cancer, PD-L1 is expressed primarily on tumor-infiltrating immune cells rather than on tumor cells themselves.

Launched in 2016, the assay is the primary diagnostic assay within the Tecentriq clinical development program and was used to enroll and stratify patients in the Tecentriq clinical trials. The assay was the first to evaluate patient PD-L1 biomarker status using immune cell staining and scoring within the tumor microenvironment.

The Ventana PD-L1 (SP142) assay is available on the fully automated BenchMark Ultra instrument and uses the OptiView amplification kit and the OptiView DAB immunohistochemistry detection kit. The assay performs specific staining of tumor cells and immune cells, and was previously CE marked and approved by FDA for use as a companion diagnostic in urothelial carcinoma and as a predictive assay for the treatment of second-line non-small cell lung cancer with Tecentriq.

For further information, visit Roche Diagnostics.