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

Advanced technology capable of detecting minute numbers of circulating cancer cells in a blood sample; the CellSearch(TM) test can help guide patient care decisions

RARITAN, N.J., Feb. 27 /PRNewswire/ -- 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 prostate cancer (MPC) patients. The CellSearch(TM) System currently is cleared for monitoring metastatic breast and metastatic colorectal cancer patients.

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 breast, colorectal or prostate cancer, and can do so earlier than the current standard of care. The results of serial testing for CTCs with the CellSearch(TM) System provide additional information to the oncologist and does so earlier than other currently approved diagnostic modalities, thereby allowing the oncologist to make more-informed patient care decisions.

According to the American Cancer Society, prostate cancer claims approximately 27,000 lives each year, the vast majority of which are a result of recurrent metastatic disease. Metastatic prostate cancer occurs when tumor cells spread to other locations in the body and grow. Currently, 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.

"I am extremely pleased that we now can offer this test to patients with metastatic prostate cancer," said Dr. Louis Fink of the Nevada Cancer Institute in Las Vegas, Nevada. "We have been evaluating the clinical utility of the CellSearch(TM) System in patients with metastatic prostate cancer since January 2007. Our find
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SOURCE Veridex, LLC
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