Roche has introduced Ventana PD-L1 (SP142) assay in CE markets as first companion diagnostic to identify triple-negative breast cancer (TNBC) patients eligible for treatment with Tecentriq (atezolizumab).
Ventana PD-L1 (SP142) assay is claimed to be the first companion diagnostic to assist in identifying TNBC eligible for treatment with Tecentriq plus chemotherapy (nab-paclitaxel).
Evaluation of PD-L1 biomarker status on tumour-infiltrating immune cells with the assay is crucial to identify those patients expected to benefit from the treatment.
The present announcement follows the US Food and Drug Administration approval of the assay in March this year, as the first companion diagnostic to identify TNBC patients eligible for the Tecentriq combination.
Ventana PD-L1 (SP142) assay
The company has developed the Ventana PD-L1 assay to optimise visual contrast of tumour-infiltrating immune cell staining. PD-L1 will mainly express on tumour-infiltrating immune cells rather than on tumour cells themselves.
Ventana PD-L1 (SP142) assay, which was introduced in 2016, is the primary diagnostic assay within the Tecentriq clinical development programme. It was used to recruit and stratify patients in Tecentriq clinical trials.
Ventana PD-L1 is the enrolment assay used in the IMpassion130 trial, the first positive phase III immunotherapy regimen study in TNBC.
It is the first assay to assess patient PD-L1 biomarker status using immune cell staining and scoring within the tumour microenvironment.
Available on the fully automated BenchMark IHC/ISH series instruments, the Ventana PD-L1 (SP142) assay uses the OptiView DAB IHC detection kit with OptiView amplification kit.
The assay carries out specific staining of tumour cells and immune cells. It was earlier approved by the FDA and CE marked for use as a companion diagnostic in urothelial carcinoma (UC) and as a predictive assay in non-small cell lung cancer (NSCLC) with Tecentriq.
Roche Diagnostics head Thomas Schinecker said: “Until recently, the only treatment option for metastatic triple-negative breast cancer patients was chemotherapy.
“With our expanding menu of companion diagnostics and targeted cancer immunotherapies, Roche is proud to continue to deliver on our mission to make personalised healthcare a global reality, ensuring the right treatment for the right patient at the right time.”
In June this year, Roche and GE Healthcare have introduced new Navify Tumor Board 2.0 solution for more personalised treatment decisions in cancer care.
