Raritan, N.J., August 4, 2015 — Janssen Diagnostics today announced that a clinical trial involving the company’s CELLSEARCH® System has been recognized by the editors of Clinical Cancer Research1 as being among the most significant studies to appear in the journal in its 20 year history. The study revealed the prevalence of circulating tumor cells (CTCs) in most major cancers2, and established the analytical accuracy, reproducibility, and linearity of the CELLSEARCH® System in capturing CTCs. This research demonstrated that the CELLSEARCH® System could be used as a reliable tool to investigate CTCs and their clinical utility. The trial, “Tumor cells circulate in the peripheral blood of all major carcinomas but not in healthy subjects or patients with nonmalignant diseases,” was published in 20043 and ignited interest in the clinical use of CTC testing.
The FDA cleared the CELLSEARCH® System for use in the management of individuals with metastatic breast cancer, and subsequently expanded this clearance for use in the management of individuals with metastatic prostate* and colorectal cancers. To date, the CELLSEARCH®System remains as the only CTC test to earn FDA clearance for use in patient management, and has also earned approval by the China FDA for the management of individuals with metastatic breast cancer.
CTCs are cancer cells that have detached from the tumor and entered the bloodstream. The highly sensitive and selective CELLSEARCH®System can detect CTCs via a routine blood test. The trial referenced in Clinical Cancer Research demonstrated that these rare cells are not present in individuals without cancer. The value of capturing and counting CTCs continues to evolve as more research data is gathered about the utility of these markers in monitoring disease progression and potentially guiding more precise and personalized cancer therapy.
“Studies have repeatedly demonstrated the accuracy of CTC enumeration to predict survival in patients with metastatic breast, prostate and colorectal cancers,” notes Mark C. Connelly, Ph.D., Scientific Director, Janssen Diagnostics and one of the investigators involved in the trial published in Clinical Cancer Research. “The CELLSEARCH® System can help detect changes in disease progression at any time which can help oncologists and their patients make more informed clinical decisions.”
Clinical data from 28 independent prospective studies involving more than 4,700 patients have validated the clinical performance and value of CELLSEARCH® System CTC testing as a reliable prognostic factor for progression-free survival and overall survival both before and after therapy initiation. Data obtained with the CELLSEARCH® System have been published in more than 100 peer-reviewed publications.
Intended Use: The CELLSEARCH® Circulating Tumor Cell Kit is intended for the enumeration of CTC of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood. The presence of CTC in the peripheral blood is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast, colorectal or prostate* cancer. The test is intended to be used as an aid in the monitoring of patients with metastatic breast, colorectal or prostate cancer. Serial testing for CTC should be used in conjunction with other clinical methods for monitoring metastatic breast, colorectal and prostate cancer. Evaluation of CTC at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival.
*Metastatic prostate cancer patients in this study were defined as having two consecutive increases in the serum marker PSA above a reference level, despite standard hormonal management. These patients are commonly described as having androgen-independent, hormone-resistant, or castration-resistant prostate cancer.
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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1Anderson, K.C., Potash, J., 2015. Clinical Cancer Research: The 20th Anniversary. Clin. Cancer Res., 2015;21:3
2These include metastatic breast, colorectal, prostate, lung, gastric, pancreatic, and ovarian cancers
3Allard, W.J., Matera, J., Miller, M.C., Repollet, M., Connelly, M.C., Rao, C., Tibbe, A.G.J., Uhr, J.W., Terstappen, L.W.M.M., 2004. Tumor cells circulate in the peripheral blood of all major carcinomas but not in healthy subjects or patients with nonmalignant diseases. Clin. Cancer Res., 10; 6897