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Roche launches first companion diagnostic to identify triple-negative breast cancer patients eligible for treatment with Tecentriq

This launch represents an important step in Roche’s personalized healthcare strategy to fit treatments to patients who can benefit most from a specific medicine

9 Sept 2019
Georgina Wynne Hughes
Editorial Assistant

Product news

Roche has announced the expanded use of the VENTANA PD-L1 (SP142) Assay in triple-negative breast cancer (TNBC) for patients living in CE (Conformité Européene) markets where the Roche cancer immunotherapy medicine Tecentriq® is approved. It is the first companion diagnostic to aid in identifying triple-negative breast cancer patients eligible for treatment with Tecentriq (atezolizumab) plus chemotherapy (nab-paclitaxel). Assessment of PD-L1 biomarker status on tumor-infiltrating immune cells with the assay is essential for identifying those patients most likely to benefit from the treatment.

The announcement follows the U.S. Food and Drug Administration approval of the assay in March 2019 as the first companion diagnostic to identify triple-negative breast cancer patients eligible for the Tecentriq combination. A diagnosis of triple-negative breast cancer means that the three most common proteins associated with breast cancer growth – estrogen receptor, progesterone receptor and HER2/neu – are not expressed on the tumor.

“Until recently, the only treatment option for metastatic triple-negative breast cancer patients was chemotherapy,” said Thomas Schinecker, Head of Roche Diagnostics. “With our expanding menu of companion diagnostics and targeted cancer immunotherapies, Roche is proud to continue to deliver on our mission to make personalized healthcare a global reality, ensuring the right treatment for the right patient at the right time.”

The VENTANA PD-L1 (SP142) Assay was developed to enhance visual contrast of tumor-infiltrating immune cell staining. In triple-negative breast cancer, PD-L1 is primarily expressed on tumor-infiltrating immune cells rather than on tumor cells themselves.

Launched in 2016, the VENTANA PD-L1 (SP142) Assay is the primary diagnostic assay within the Tecentriq clinical development program and was used to enroll and stratify patients in Tecentriq clinical trials. It was the enrollment assay used in the IMpassion130 trial, the first positive phase III immunotherapy regimen study in triple-negative breast cancer. The assay was the first to evaluate patient PD-L1 biomarker status using immune cell staining and scoring within the tumor microenvironment.

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Point-of-CarePoint-of-Care Testing (POCT) or Near Patient Testing (NPT) products are available for urine, blood and other clinical chemistry analyses. POCT includes: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing (PT / INR), rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, food pathogens screening, hemoglobin diagnostics, infectious disease testing and cholesterol screening.Companion DiagnosticsCompanion diagnostics are tests, often <i>in vitro</i>, that are used to determine whether a therapeutic product will be safe and effective for use on an individual. They also identify which patients will benefit most from them. Companion diagnostic tests are often developed in conjunction with the pharmaceutical industry.Cancer DiagnosticsThere are a wide variety of diagnostic tests for cancer available, and this range continues to expand as our knowledge of cancer improves. Current diagnostic methods include biopsy, imaging and blood tests for known biomarkers. New methods in research development include liquid biopsies and cancer breathalyzers.Assay DevelopmentThe process of proving an assay to be sensitive with respect to the target is known as assay development. The assay should be able to characterize novel compounds and measure the potency of these compounds against a validated biological target.ChemotherapyImmunotherapyImmunotherapy is a treatment approach that utilizes the body�s immune system to fight diseases, especially cancer. It includes therapies such as monoclonal antibodies, checkpoint inhibitors, and CAR-T cell therapy. Immunotherapy is a rapidly growing area of research in oncology and autoimmune diseases. Browse our peer-reviewed product directory to find the best immunotherapy tools, compare products, check reviews, and get pricing directly from manufacturers.Breast CancerBreast cancer is a type of cancer that begins in the cells of the breast and can spread to other parts of the body. Early detection, accurate diagnosis, and targeted treatments are essential for improving patient outcomes. Browse our peer-reviewed product directory to find the best breast cancer research and diagnostic tools, compare products, check reviews, and get pricing directly from manufacturers.

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Roche launches first companion diagnostic to identify triple-negative breast cancer patients eligible for treatment with Tecentriq