Journal of Clinical Oncology Article Highlights CellSearch(TM) Circulating Tumor Cell Test in Treatment of Metastatic Colorectal Cancer

Data Support Prognostic Value of Circulating Tumor Cells

RARITAN, N.J., July 25 /PRNewswire/ -- An international, prospective clinical trial found the number of circulating tumor cells (CTCs) is a strong indicator of progression-free and overall survival among metastatic colorectal cancer patients, according to a report published in the July 1 issue of the Journal of Clinical Oncology.

The study, conducted in the US, the Netherlands, and the United Kingdom, found that metastatic colorectal cancer patients with fewer than three circulating tumor cells in their bloodstream had significantly better overall survival than patients with more than three CTCs.

"Given the variety of cancer drugs available today, the ability to monitor CTCs in conjunction with radiological assessment may help physicians and patients make more informed and timely treatment decisions," said lead investigator and author Steven J. Cohen, M.D.*, Attending Physician at Fox Chase Cancer Center. "Obtaining measurements of CTCs for patients with metastatic colorectal cancer beginning a new therapy can provide additional information about their prognosis, and may also be followed serially to assist with clinical management."

These findings were included in a report titled, "Relationship of Circulating Tumor Cells to Tumor Response, Progression-Free Survival, and Overall Survival in Patients with Metastatic Colorectal Cancer," which summarizes data from a prospective trial involving 430 colorectal cancer patients at 55 clinical centers using the CellSearch System to count CTCs. Researchers counted the number of circulating tumor cells in the peripheral blood of patients at baseline and after starting first-, second-, or third-line therapy.

The CellSearch(TM) System is the first diagnostic test to automate the process of identifying and counting circulating tumor cells (CTCs) in a blood sample. This system helps physicians to predict disease progression and patient survival any time during therapy through its ability to locate minute numbers of circulating tumor cells in the approximately 40 billion cells contained in a 7.5 ml sample of blood - an achievement never before documented in any diagnostic tool.

"Clinical studies continue to validate the significance of circulating tumor cells in treating patients with metastatic breast, colorectal or prostate cancer," said Robert McCormack, Ph.D., Vice President of Medical and Scientific Affairs, Veridex. "This study demonstrates the clinical value of circulating tumor cells in predicting progression-free and overall survival rates."

According to the American Cancer Society, colorectal cancer claims approximately 55,000 lives each year, the vast majority of which are a result of recurrent metastatic disease. Metastatic colorectal cancer occurs when tumor cells spread to other locations in the body and grow. Although there are several options for the treatment of metastatic colorectal cancer, oncologists often have to wait several months before they can determine if a specific treatment is beneficial to the patient.

The U.S. Food and Drug Administration (FDA) first cleared The CellSearch(TM) System in January 2004 as a diagnostic tool for identifying and counting CTCs in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast cancer. The FDA has since granted expanded clearance for the CellSearch(TM) System as an aid in monitoring metastatic colorectal and metastatic prostate cancer patients.

*Dr. S. Cohen is a paid consultant for Veridex, LLC.

About Veridex

Veridex, LLC, a Johnson & Johnson company, is an organization dedicated to providing physicians with high-value in vitro diagnostic oncology products. Veridex's products may significantly benefit patients through earlier disease detection and may enable personalized strategies to help improve patient management and outcomes. For more information, please visit www.veridex.com.

CONTACT: CONTACTS: Jessica Giangaspero, of Veridex, LLC, +1-908-218-8124;
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