FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer

Capable of detecting minute numbers of circulating cancer cells in 40

billion blood cells, the CellSearch test can help guide patient care


Nov 20, 2007, 00:00 ET from Veridex, LLC

    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 cancer claims
 approximately 55,000 lives each year, the vast majority of which are a
 result of recurrent metastatic disease. Metastatic colorectal cancer occurs
 when tumor cells spread to other locations in the body and grow. Although
 there are several options for the treatment of metastatic colorectal
 cancer, 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 through its ability to locate
 minute numbers of circulating tumor cells in the approximately 40 billion
 cells contained in a 7.5 ml sample of blood - an achievement never before
 documented in any diagnostic tool.
     The CellSearchTM 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.
     A prospective, multi-center clinical trial was conducted to validate
 the expanded clearance for CellSearch. The study, which took place in 55
 clinical centers in the United States and Europe, involved 430 metastatic
 colorectal patients about to enter first- or second-line therapy. Data
 showed that patients with less than three CTCs at baseline had
 significantly better survival rates versus patients with more than three
 CTCs - an overall finding consistent with metastatic breast cancer
 patients. Data also showed that CTCs are a strong independent predictor of
 progression-free survival and overall survival, and that the combination of
 CTC analysis and radiological assessment may provide the most accurate
 assessment of prognosis.
     "Clinical research validates the significance of circulating, cancer
 tumor cells," said Robert McCormack, Ph.D., Vice President of Medical and
 Scientific Affairs, Veridex. "Elevated CTCs in the blood stream are
 associated with lower 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 GeneSearch(TM) assays that use molecular technology
 to diagnose, stage and more accurately characterize tumors.