Circulating Tumor Cells Prove To Be Key Predictors of Survival in Newly Diagnosed Metastatic Breast Cancer Patients

Homogenous test group reinforces value of information gleaned through simple blood test -


Veridex LLC, a Johnson & Johnson company, today announced that a study published in the Journal of Clinical Oncology (March
1, 2005) found that the presence of circulating tumor cells (CTCs) in the blood of patients newly diagnosed with metastatic
breast cancer is highly predictive of progression-free, overall survival, and is associated with significant prognostic
information. Further, the results indicate that the company's CellSearch™ System, which was used to identify and enumerate
CTCs - cancer cells that detach from solid tumors and enter the bloodstream - may one day allow for design of tailored
treatments earlier than ever before possible.


Researchers worked with an 83-patient subset of the 177 patients with metastatic breast cancer who were involved in a
multi-institution, double blind study recently published in The New England Journal of Medicine (August 19, 2004). In order
to obtain the most directly comparable results possible, the subset was limited to patients whose cancer had recurred but who
had not yet received any treatment, thereby eliminating complicating factors such as differences among prior therapies, or
stage and timing of treatments. Patients were tested for a CTC count prior to initial therapy, then approximately every four
weeks and were followed clinically out to 18 months.


Patients with five or more CTCs per 7.5mL (the equivalent of one blood draw) at baseline and first follow-up (four weeks)
ultimately had significantly shorter progression-free survival and overall survival. Patients with five or more CTC had a
median PFS of 4.9 months and a median OS of 14.2 months OS prior to the administration of therapy versus patients with fewer
than five CTCs prior to therapy (median PFS of 9.5 months and more than 18 months OS). At first follow-up after the
administration of the first cycle of therapy, patients with five or more CTC had a median PFS of 2.1 months and 11.1 months
OS versus patients with less than five CTC had median PFS of 8.9 months and more than 18 months OS.


"By studying a subpopulation of patients who are at precisely the same point in their illness, without having to take into
account a variety of outside factors, we could have a clear picture of the biology of metastatic breast cancer and the role
that CTCs played," said lead author Massimo Cristofanilli, M.D., associate professor in the Department of Medical Oncology at
the University of Texas M. D. Anderson Cancer Center. "Our findings with this homogenous group of patients reinforce the
value of this technology in identifying patients who might be resistant to a particular therapy and those who could benefit
from early treatment change or a more investigational approach."


The CellSearch™ Circulating Tumor Cell Test requires only a simple blood draw from a patient, but its sensitivity and
specificity allow physicians to observe true changes in CTCs that are greater than or less than the five CTC cutoff. This
information may help physicians predict, with a high degree of certainty, progression-free and overall survival in individual
patients both before and following a single cycle of therapy, develop individual patient treatment strategies and counsel and
advise patients appropriately.


"Scientists have long believed that circulating tumor cells held a wealth of information, but there was no method to
efficiently and objectively evaluate and utilize them for decision making in routine medical practice," said Robert T.
McCormack, Ph.D., general manager, Cellular Diagnostics for Veridex, LLC. "We're pleased that this study has shown that our
technology will go a long way toward addressing an unmet need in the cancer field and could change the course of treatment
for many critically ill patients."


Immunicon Corp., of Huntingdon Valley, PA, developed the CellSearch™ System under a Development, License and Supply Agreement
with Veridex, LLC.


About Veridex, LLC


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™ assays that identify, enumerate and characterize circulating tumor cells directly from whole
blood; and GeneSearch™ assays that use molecular technology to diagnose, stage and more accurately characterize tumors. For
more information, visit veridex.