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news.Veridex has announced that FDA has granted an expanded clearance for the CellSearch System to be used as an aid in the monitoring of metastatic colorectal cancer. CellSearch is currently approved for monitoring metastatic breast cancer.
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A prospective, multi-center clinical trial was conducted to validate the expanded clearance for CellSearch. The study, which took place in 55 clinical centers in US and Europe, involved 430 metastatic colorectal patients about to enter first- or second-line therapy. Data showed that patients with less than three circulating tumor cells (CTCs) at baseline had significantly better survival rates versus patients with more than three CTCs.
According to the company, the CellSearch system is the first diagnostic test to automate the detection and enumeration of CTCs, cancer cells that detach from solid tumors and enter the blood stream, and is the standard in a new class of diagnostic tools.
The CellSearch system was originally cleared by the FDA in January 2004 as a diagnostic tool for identifying and counting CTCs in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast cancer.