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

Capable of detecting minute numbers of circulating cancer cells in 40 billion blood cells, the CellSearch test can help guide patient care decisions

WARREN, N.J., Nov. 20 /PRNewswire-USNewswire/ -- Veridex, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for the CellSearch(TM) System to be used as an aid in the monitoring of metastatic colorectal cancer. CellSearch is currently approved for monitoring metastatic breast cancer.

The CellSearch(TM) System identifies and counts circulating tumor cells (CTCs) in a blood sample to predict progression-free survival and overall survival in patients with metastatic colorectal or breast cancer, and can do so earlier than the current standard of care. The results of serial testing for CTCs with the CellSearch(TM) System, in conjunction with other clinical methods for monitoring, can help physicians assess disease progression, thereby guiding more informed care decisions earlier.

"We are very excited that we can now offer the CellSearch test to patients who have metastatic colorectal cancer," said Dr. Ravi Patel of the Comprehensive Blood and Cancer Center in Bakersfield, California, which will become the first clinical site in the U.S. to offer the test under the new indication. "CellSearch will have a very positive impact on the care of these patients, in the same way it has positively impacted the care of our patients with metastatic breast cancer over the last year."

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 the standard in 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.

According to the American Cancer Society, colorectal canc
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SOURCE Veridex, LLC
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