NEW ORLEANS, June 5 /PRNewswire-FirstCall/ -- Veridex, LLC, a Johnson &
Johnson company, today announced plans for a fall 2004 launch of the
CellSearch(TM) System, a new cancer diagnostic technology that identifies and
counts circulating tumor cells in a blood sample to predict progression free
survival and overall survival in patients with metastatic breast cancer. The
announcement was made at the opening of the annual American Society of
Clinical Oncology meeting.
The CellSearch(TM) System is the first of its kind to automate the
detection and enumeration of circulating tumor cells in peripheral blood, and
will serve as the standard in a new class of diagnostic tools. The
announcement comes after the recent FDA notification of market clearance in
the U.S. for the CellSearch(TM) Epithelial Cell Kit.
In 2004, there will be more than 80,000 patients with metastatic breast
cancer in the United States. Metastatic breast cancer occurs when tumor cells
spread to other locations in the body and grow. Although there are many
options for the treatment of metastatic breast cancer, physicians often have
to wait up to three months before they can determine if a specific treatment
is beneficial to the patient. The CellSearch(TM) system will help physicians
to predict whether treatment is effective much earlier than currently possible
and to determine the best treatment options for individual patients.
The CellSearch(TM) System works by detecting cancer cells that detach from
solid tumors and enter the blood stream. The presence and number of these
cancer cells in blood provides valuable information to physicians for
predicting response to therapy in patients with metastatic breast cancer.
"This represents an important landmark for patients," said Mark Myslinski,
general manager, Veridex. "The technology has never before been available to
consistently advance the potential of circulating tumor cells -- and as the
first in a new class of diagnostic tools, the CellSearch(TM) System will
finally provide oncologists and patients with critical real-time information
regarding their disease and the management of their treatment."
The CellSearch(TM) Epithelial Cell kit was cleared according to the FDA
"de novo" classification process whereby the test was first determined to be
safe and effective, and then directed to be listed with the U.S. Federal
register as the standard for this type of test.
Daniel F. Hayes M.D., a breast cancer expert at the University of Michigan
Comprehensive Cancer Center, has been one of the lead investigators in
development of the assay and in the performance of the pivotal clinical trial
on which the FDA decision was based. Dr. Hayes stated that "The
CellSearch(TM) System may significantly enhance the ability of medical
oncologists to determine the best treatment options for patients with
metastatic breast cancer, and this assay could potentially result in improved
patient quality of life. Additional studies will further define its role in
the management of patients with metastatic disease."
The CellSearch(TM) System was developed in collaboration with Immunicon
Corporation in Huntingdon Valley, PA.
The CellSearch(TM) System is expected to become available in the fall of
2004, launching at comprehensive cancer centers and central diagnostic
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.
Contact: Jill S. Gabbe/Stephanie Hughes Koenig, gabbegroup
Mary Richardson, Veridex, LLC
SOURCE Veridex, LLC