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
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 therapy. "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. http://www.veridex.com Contact: Jennifer Robinson, gabbegroup, 212-220-4444 / firstname.lastname@example.org Lorie Gawreluk, Veridex, 908-218-8287/ email@example.com
SOURCE Veridex, LLC
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