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FDA Clears Cellsearch(TM) Circulating Tumor Cell Test for Monitoring Metastatic Prostate Cancer Patients
Date:2/27/2008

ings demonstrate a strong indication that the baseline number of Circulating Tumor Cells (CTCs) is prognostic, and that the number of prostate CTCs is altered by the therapy." Dr. Nick Vogelzang, also of the Nevada Cancer Institute, continued, "We have compared CellSearch(TM) CTC test results to the standard clinical and biomedical parameters, such as prostate specific antigen (PSA) measured in MPC patients. A decrease in the number of CTCs is most often associated with patients successfully responding to therapy. Further analysis of CTCs may provide information as to the most efficacious treatments for specific individuals." These data will be presented at the 2008 American Association of Cancer Research (AACR) annual meeting in San Diego on April 12-16, 2008.

The CellSearch(TM) 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 a new class of diagnostic tools. The system's specificity, sensitivity and reproducibility allow for serial assessment of CTCs as early as the first cycle of treatment to help evaluate disease progression sooner.

The CellSearch(TM) 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. In November 2007, the CellSearch TM System was cleared as an aid in monitoring metastatic colorectal patients.

A prospective, multi-center clinical trial was conducted to validate the expanded clearance for CellSearch TM. The study, which took place in 65 clinical centers in the United States and Europe, involved 231 metastatic prostate cancer patients about to enter first- or later-line chemotherapy. Data showed that patients with less than five CTCs at baseline had significantly better survival rates versus patients with more than five CTCs. Data
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SOURCE Veridex, LLC
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