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

ower survival rates. We believe, based on the clinical research, that identifying CTCs as soon as possible can lead to improved patient outcomes."

The CellSearch 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. They are then stained with additional bio-molecules and chemicals so that they can be positively identified as CTCs. The CellSearch test differs from the current standard of care because it can be used much earlier than traditional imaging (e.g., CT scans), and is not subject to the variation observed with other blood tests, called serum tumor markers.

In August 2004, a clinical study using the CellSearch 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 investigating the disease."

About Veridex

Veridex, LLC, a Johnson & Johnson company, develops cancer diagnostic products that will enable earlier disease detection as well as more accurate staging, monitoring and therapeutic selection. The company is initially developing two complementary product lines: CellSearch(TM) assays that identify, enumerate and characterize circulating tumor cells directly from whole blood; and Ge
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