FDA Clears Cellsearch(TM) Circulating Tumor Cell Test for Monitoring Metastatic Prostate Cancer Patients

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

Feb 27, 2008, 00:00 ET from Veridex, LLC

    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 findings demonstrate a strong indication
 that the baseline number of Circulating Tumor Cells (CTCs) is prognostic,
 and that the number of prostate CTCs is altered by the therapy." Dr. Nick
 Vogelzang, also of the Nevada Cancer Institute, continued, "We have
 compared CellSearch(TM) CTC test results to the standard clinical and
 biomedical parameters, such as prostate specific antigen (PSA) measured in
 MPC patients. A decrease in the number of CTCs is most often associated
 with patients successfully responding to therapy. Further analysis of CTCs
 may provide information as to the most efficacious treatments for specific
 individuals." These data will be presented at the 2008 American Association
 of Cancer Research (AACR) annual meeting in San Diego on April 12-16, 2008.
     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 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.
     The CellSearch(TM) 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. In November 2007, the CellSearch TM
 System was cleared as an aid in monitoring metastatic colorectal patients.
     A prospective, multi-center clinical trial was conducted to validate
 the expanded clearance for CellSearch TM. The study, which took place in 65
 clinical centers in the United States and Europe, involved 231 metastatic
 prostate cancer patients about to enter first- or later-line chemotherapy.
 Data showed that patients with less than five CTCs at baseline had
 significantly better survival rates versus patients with more than five
 CTCs. 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 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 investigating the disease."
     Dr. N. Vogelzang is the recipient of a research fellowship grant from
 Veridex for the purpose of supporting independent research in metastatic
 prostate cancer patients.
     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. For additional
 information, please visit www.veridex.com
     Linda Fedow, Veridex, LLC: (908) 218-8287
     Richard James, APCO Worldwide: (202) 478-3558