WARREN, N.J., Aug. 18 /PRNewswire/ -- Veridex, LLC, a Johnson & Johnson
company, today announced that The New England Journal of Medicine (351;
781-791, 2004, August 19) published the results of a prospective study showing
that the number of circulating tumor cells (CTCs) in 7.5mL of blood taken from
women with metastatic breast cancer can predict progression-free and overall
survival. CTCs are cancer cells that detach from solid tumors and enter the
bloodstream. Knowing the number of CTCs in the blood may pave the way for
oncologists to make critical decisions about patients' treatment earlier than
The multi-institutional, double-blind trial used the Veridex
CellSearch(TM) System, a diagnostic technology that is the first of its class
to automate the detection and enumeration of CTCs. The CellSearch(TM) System
was cleared according to the FDA "de novo" classification process whereby the
test was first determined to be safe and effective, then listed with the U.S.
Federal Register as a new device. It is expected to become commercially
available in the fall of 2004.
The study enrolled 177 metastatic breast cancer patients who were about to
either start initial therapy or change to a new course of therapy. Patients
were tested for a CTC count before therapy, and then again at the first
follow-up approximately three to four weeks later. Patients with five or more
CTCs per 7.5mL (the equivalent of one blood draw) ultimately had significantly
shorter progression-free survival and overall survival than patients with
fewer than five CTCs. Further, the percentage of patients with more than 5
CTCs was reduced from 49 percent (87 women) to just 30 percent (49 women) at
first follow up -- an indication that a number of patients responded to
"The results showed the presence of circulating tumor cells to be the
strongest independent predictor of progression-free and overall survival,"
said lead author Massimo Cristofanilli, M.D., Associate Professor in the
Department of Breast Medical Oncology at The University of Texas M. D.
Anderson Cancer Center in Houston.
While CTCs have been documented since 1869, and discussed in over 1,500
publications, the technology has not been available until now to fully
understand their value.
"For the first time, oncologists now have a powerful diagnostic tool,
designed for mainstream clinical practice, that automates and standardizes the
collection and detection of CTCs," said Robert T. McCormack, Ph.D., general
manager, cellular diagnostics, Veridex. "The CellSearch(TM) System addresses
a significant unmet need by providing more accurate information -- earlier
than ever before possible -- to enable more informed treatment decisions. It
is important to note that the CellSearch(TM) test is not for use with early
breast cancer or for screening purposes."
Currently patients go through several rounds of treatment before it is
known whether or not the therapy is working. According to Daniel F. Hayes,
M.D., Clinical Director of the Breast Oncology Program at the University of
Michigan Comprehensive Cancer Center and the study's senior author, "One of
the most problematic aspects of managing cancer is determining the fine lines
dividing an effective course of therapy from one that is futile. The
CellSearch(TM) System may significantly advance our ability to more accurately
define those lines and more effectively manage cancer therapy; we are planning
further studies to precisely define the role of monitoring CTCs in women with
Immunicon Corp. of Huntingdon Valley, PA, developed the CellSearch(TM)
System under a Development, License and Supply Agreement with 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 complimentary 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.
Jennifer Robinson, gabbegroup, 212-220-4444 / firstname.lastname@example.org
Lorie Gawreluk, Veridex, 908-218-8287/ email@example.com
SOURCE Veridex, LLC