Veridex, LLC Plans Fall Launch of the CellSearch(TM) System

New test helps physicians manage therapy for patients

with metastatic breast cancer

Jun 05, 2004, 01:00 ET from Veridex, LLC

    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
     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
                (212) 220-4444
                Mary Richardson, Veridex, LLC
                (908) 704-3652