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
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."
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.
SOURCE Veridex, LLC