20 March 2019 - - US-based cancer diagnostics specialist laboratory CSI Laboratories has added the newly approved Ventana PD-L1 (SP142) Assay as a companion diagnostic test for use in selecting triple-negative breast cancer patients for Tencentriq (atezolizumab), the company said.

Tencentriq was granted accelerated approval for use in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 on March 8, 2019.

The indication is approved under accelerated approval based on progression-free survival and continued approval may be contingent on verification and description of clinical benefit in confirmatory trials, according to the FDA.

CSI is one of the first reference laboratories to offer the new companion test.

The new assay is used to determine PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥ 1% of the tumor area.

CSI Laboratories is a specialised cancer diagnostics laboratory focused specifically on meeting the unique needs and challenges of pathologists and community hospitals.

CSI Laboratories offers flow cytometry, cytogenetic analysis, fluorescence in-situ hybridization, immunohistochemistry, molecular genetics, and consultations in the areas of hematopathology and surgical pathology. 

CSI Laboratories is a CLIA-certified and CAP-accredited laboratory located in Alpharetta, GA.

CSI Laboratories is independently owned and operated by medical professionals and has provided expert diagnostic testing to pathologists across the United States since 1997.