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.
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
SOURCE Veridex, LLC