Janssen Diagnostics today announced 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. 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.