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

also showed that CTCs are a strong independent predictor of progression-free survival and overall survival, and that the combination of CTC analysis and prostate specific antigen (PSA) assessment may provide the most accurate assessment of prognosis.

"Continued clinical studies validate the significance of circulating tumor cells, and now extend that significance to patients with metastatic prostate cancer," said Robert McCormack, Ph.D., Vice President of Medical and Scientific Affairs, Veridex. "Elevated CTCs in the blood stream are associated with shorter progression-free and overall survival rates."

The CellSearch(TM) test works by using antibodies that are joined to microscopic iron particles, called ferrofluid. These antibody/ferrofluid combinations attach very specifically to CTCs. Powerful magnets then "pull" the CTCs out of the blood sample and they are then stained with additional bio-molecules and chemicals so that they can be positively identified as CTCs. The CellSearch(TM) test differs from the current standard of care because it can accurately predict prognosis much earlier than the prostate specific antigen serum tumor marker test.

In August 2004, a clinical study using the CellSearch(TM)test in metastatic breast cancer patients was published in The New England Journal of Medicine. The authors of this study concluded: "The very short median progression-free survival in patients with elevated circulating tumor cells at the first follow-up visit suggests that these patients are receiving ineffective therapy." In addition, as recently as November 2006, a metastatic breast cancer study was published in Clinical Cancer Research where the authors concluded: "The results reported here indicate that the evaluation of CTCs is an accurate measure of treatment efficacy." Additionally, the authors said: "The ability to serially quantitate and interrogate CTCs in patients with breast cancer makes possible new ways of managing and invest
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SOURCE Veridex, LLC
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