CELLSEARCH® System chosen as platform for new research on PD-L1 and Circulating Tumor Cells

PRESS RELEASE

Raritan, N.J., July 8, 2015, -- Janssen Diagnostics today announced that its CELLSEARCH

®

System technology was used in new research demonstrating the ability to detect PD-L1 expression on circulating tumor cells (CTCs). The results of this research appear in the article, “Frequent Expression of PD-L1 on Circulating Breast Cancer Cells,” published online in

Molecular Oncology

, and demonstrate that PD-L1 positive CTCs were found in 11 out of 16 (68.8%) patients with circulating tumor cells. This particular application of the CELLSEARCH

System is for research purposes only and has not been cleared by the US Food and Drug Administration. This publication potentially adds a new important application to the research use of the CELLSEARCH

System to characterize CTCs for PD-L1. In performing their research, the investigators selected the CELLSEARCH

System as an automated technical platform that has demonstrated consistent, reproducible results.

The importance of immune checkpoint regulators in oncology is becoming more widely understood and has given rise to the development of immunotherapies for cancer treatment. PD-L1 is an immune checkpoint regulator targeted by a number of approved and developmental oncology therapies. These results indicate that CTC analysis for PD-L1 expression is feasible and when confirmed, could open up the opportunity to predict response to certain therapies in future, larger studies using a blood test rather than tissue biopsy. In a research setting, the CELLSEARCH

System offers the ability to capture CTCs via a routine blood test.

“I believe we have demonstrated that CTC characterization for PD-L1 expression is feasible using a CTC platform. This paves the way for the utilization of a CTC/PD-L1 assay in future clinical trials to explore whether it can stratify patients according to response, and potentially predict the efficacy of immune checkpoint blockade,” comments study investigator Catherine Alix-Panabières, Ph.D., Director of the Laboratory of Rare Human Circulating Cells, University Medical Centre of Montpellier, University of Montpellier EA2415, Montpellier, France.

CTCs have the potential to allow real-time, dynamic monitoring of tumor characteristics without the need for repeated invasive biopsies. It was demonstrated earlier that CTC expression of key biomarkers such as HER2, IGFR, c-MET and other proteins can be monitored successfully. This publication in

Molecular Oncology

underscores the potential of CELLSEARCH

CTC testing to also become an important tool in cancer immunotherapy.