First-in-Class Test Can Predict Progression-Free and Overall Survival of Patients with Metastatic Breast Cancer

Simple blood test may help doctors make critical treatment decisions earlier

Aug 18, 2004, 01:00 ET from Veridex, LLC

    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
 previously possible.
     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
 metastatic disease."
     Immunicon Corp. of Huntingdon Valley, PA, developed the CellSearch(TM)
 System under a Development, License and Supply Agreement with Veridex.
     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.
      Jennifer Robinson, gabbegroup, 212-220-4444 /
      Lorie Gawreluk, Veridex, 908-218-8287/