ALPHARETTA, Ga. – March 18, 2019 – CSI Laboratories, a nationally renowned laboratory specializing in comprehensive cancer diagnostics, today announced that it has added the newly approved VENTANA PD-L1 (SP142) Assay as a companion diagnostic test for use in selecting triple-negative breast cancer (TNBC) patients for TENCENTRIQ® (atezolizumab).
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 (TNBC) 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.
“We are pleased to add this companion test to our diagnostic testing services, which will enable health care teams to treat TNBC patients with newer therapy options,” said Ron Ghafary, founder and CEO of CSI Laboratories. “We continue to focus on providing a superior client experience, exceptional and accurate lab results and quick turnaround to help our clients provide personalized cancer care to their patients.”