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CSI Laboratories Begins Offering VENTANA PD-L1 (SP142) Assay as Companion Diagnostic Test for Triple Negative Breast Cancer as a Result of FDA Approval for TENCENTRIQ® (atezolizumab)

March 18, 2019

ALPHARETTA, Ga.--(BUSINESS WIRE)--Mar 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 therapeutic 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.”

For more information, please visit csilaboratories.com or contact Eric Diersen 678-248-8000.

ABOUT CSI LABORATORIES

CSI Laboratories is a specialized 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 (FISH), 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. For more information, please visit  www.csilaboratories.com.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190318005042/en/

CONTACT: Eric Diersen

678-248-8000

KEYWORD: UNITED STATES NORTH AMERICA GEORGIA

INDUSTRY KEYWORD: SURGERY HEALTH BIOTECHNOLOGY CLINICAL TRIALS ONCOLOGY PHARMACEUTICAL OTHER HEALTH FDA

SOURCE: CSI Laboratories

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PUB: 03/18/2019 07:30 AM/DISC: 03/18/2019 07:31 AM

http://www.businesswire.com/news/home/20190318005042/en