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FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer
Date:11/20/2007

er claims approximately 55,000 lives each year, the vast majority of which are a result of recurrent metastatic disease. Metastatic colorectal cancer occurs when tumor cells spread to other locations in the body and grow. Although there are several options for the treatment of metastatic colorectal cancer, oncologists often have to wait several months before they can determine if a specific treatment is beneficial to the patient. The CellSearch(TM) System helps physicians to predict disease progression and patient survival any time during therapy through its ability to locate minute numbers of circulating tumor cells in the approximately 40 billion cells contained in a 7.5 ml sample of blood - an achievement never before documented in any diagnostic tool.

The CellSearchTM 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.

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 the United States and Europe, involved 430 metastatic colorectal patients about to enter first- or second-line therapy. Data showed that patients with less than three CTCs at baseline had significantly better survival rates versus patients with more than three CTCs - an overall finding consistent with metastatic breast cancer patients. Data also showed that CTCs are a strong independent predictor of progression-free survival and overall survival, and that the combination of CTC analysis and radiological assessment may provide the most accurate assessment of prognosis.

"Clinical research validates the significance of circulating, cancer tumor cells," said Robert McCormack, Ph.D., Vice President of Medical and Scientific Affairs, Veridex. "Elevated CTCs in the blood stream are associated with l
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SOURCE Veridex, LLC
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