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 HER21, IGFR2, c-MET3 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.
About CELLSEARCH®System Technology
The CELLSEARCH® System was honored with a Prix Galien USA Award in 2009 for Best Medical Technology on the basis of the innovative nature of its development, applicability and future biomedical potential.
For further information, please refer to the CELLSEARCH® CXC Kit Instructions for Use at www.cellsearchruo.com. The application of the CELLSEARCH® System described in this study is for research use only, and not for use in diagnostic procedures. The performance characteristics, safety, and effectiveness for this application have not been established and are not cleared or approved by the FDA.
About Janssen Diagnostics
At Janssen Diagnostics we are passionate about the promise of precision medicine and its potential to improve outcomes for specific patients through targeted therapies.
We aspire to help doctors and researchers better identify, prevent or intervene earlier with diseases, or cure people with the right medicines for the right person, at the right time.
Being part of Janssen puts us in a strong position, enabling us to bridge Janssen’s extensive pharmaceutical knowledge-base and global capabilities, with our own heritage and talent in research technology, diagnostics and health information technology to deliver integrated solutions into the hands of healthcare providers.
The best way to further our aspirations in the personalized medicine space is to move away from the traditional business model and adopt a more open model that is based on developing the best technologies, either in-house or by partnering with those who own them, to ultimately improve patient outcomes in collaboration with our customers.
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1 Riethdorf, S., Muller, V., Zhang, L., Rau, T., Loibl, S., Komor, M., Roller, M., Huober, J., Fehm, T., Schrader, I., Hilfrich, J., Holms, F., Tesch, H., Eidtmann, H., Untch, M., von Minckwitz, G., Pantel, K., 2010. Detection and HER2 expression of circulating tumor cells: prospective monitoring in breast cancer patients treated in the neoadjuvant GeparQuattro trial. Clin. Cancer Res. 16:2634-2645.
2 De Bono, J., Attard, G., Adjei, A., Pollak, M., Fong, P., Haluska, P., Roberts, L., Melvin, C., Repollet, M., Chianese, D., Connely, M., Terstappen, L., Gualberto, A., 2007. Potential applications for circulating tumor cells expressing the insulin-like growth factor-I receptor. Clin. Cancer Res. 13:3611-3616.
3 Zhang, T., Boominathan, R., Foulk, B., Connelly, M.C., Rao, C., Kemeny, G., Hurwitz, H., Garcia-Blanco, M.A., Armstrong, A.J. Evaluation of a novel c-MET based circulating tumor cell (CTC) biomarker in patients with gastrointestinal malignancies. Poster presented at: 2015 Gastrointestinal Cancers Symposium; January 15, 2015; San Francisco, California