The approval has been given to VENTANA PD-L1 (SP142) Assay to identify triple-negative breast cancer (TNBC) patients eligible for treatment with the Roche cancer immunotherapy Tecentriq (atezolizumab) along with chemotherapy using Abraxane.

The proteins estrogen receptor, progesterone receptor and HER2/neu are most commonly associated with breast cancer growth. A triple-negative breast cancer is a condition where the three proteins are not expressed on the tumor.

Roche said that the assay is essential for identifying patients with triple-negative breast cancer, using PD-L1 biomarker assessment status on tumor-infiltrating immune cells rather than on tumor cells. The assay evaluates patient PD-L1 biomarker status using immune cell staining and scoring within the tumor microenvironment.

Roche Diagnostics CEO Michael Heuer said: “Triple-negative breast cancer is an aggressive disease that, until now, has had limited treatment options. 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 company claims that it has developed the VENTANA PD-L1 (SP142) Assay to improve visual contrast of tumor-infiltrating immune cell staining.

Roche has launched VENTANA PD-L1 (SP142) Assay in 2016 as the primary diagnostic assay for the Tecentriq clinical development program and was used in Tecentriq clinical trials.

The company offers VENTANA PD-L1 (SP142) Assay on the fully automated BenchMark ULTRA instrument using the OptiView DAB IHC Detection Kit with OptiView Amplification Kit.

Roche claimed that the assay was approved by the FDA and CE marked for use as a companion diagnostic in urothelial carcinoma and as a predictive assay in second-line non-small cell lung cancer with Tecentriq.

The company said that it has conducted IMpassion130, a phase III, multicenter, randomized, double-blind study to evaluate the efficacy, safety and pharmacokinetics of Tecentriq plus nab-paclitaxel.