Veridex, LLC Plans Fall Launch of the CellSearch(TM) System
New test helps physicians manage therapy for patients
with metastatic breast cancer
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 laboratories. 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: Jill S. Gabbe/Stephanie Hughes Koenig, gabbegroup (212) 220-4444 firstname.lastname@example.orgemail@example.com Mary Richardson, Veridex, LLC (908) 704-3652 Mrichar3@vrxus.jnj.com
SOURCE Veridex, LLC
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