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.”
CSI Laboratories today announced the opening of our new flow cytometry laboratory in Jupiter, Florida.
The expansion enables CSI to further support pathologists and oncologists with quality and timely diagnostic results to help them meet the care needs of their patients.
The new facility complements the 65,000 square foot laboratory CSI operates in Alpharetta, Georgia, which provides a comprehensive suite of diagnostic services, including flow cytometry, cytogenetic analysis, fluorescence in-situ hybridization (FISH), immunohistochemistry, molecular genetics and consultations in the areas of hematopathology and surgical pathology.
“The opening of this new facility allows us to further our commitment to rapid turnaround of test results, which helps clinicians provide care for patients with acute leukemia,” said Ron Ghafary, founder and CEO of CSI Laboratories. “We are expanding our footprint to better serve the cancer community and this laboratory will become another cancer diagnostic center of excellence.”
Flow cytometry diagnostic tests performed by CSI utilize a 10-color platform that allows for better utilization of smaller specimens by providing more data per tube and enabling better management of downstream testing. CSI clients have the option to order both technical and professional components of the test. Pathologists who prefer to perform their own professional interpretation are provided access to patient cases through a secure, online portal. In addition to real-time, customized pathology reporting, clients are provided access to expert hematopathology consult services for difficult flow cytometry cases.
“It is always our goal to provide a superior client experience, exceptional quality lab results and quick turnaround,” said Ghafary. “Ultimately, we invested in this new laboratory, which integrates the best equipment with top medical professionals, to help our clients provide personalized cancer care to patients whose treatment relies on accurate results.”