On August 4, 2015, Janssen Diagnostics reported that a clinical trial involving the company’s CELLSEARCH System has been recognized by the editors of Clinical Cancer Research as being among the most significant studies to appear in the journal in its 20 year history (Press release, Johnson & Johnson, AUG 4, 2015, View Source [SID:1234506996]).

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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.