FDA Grants Expanded Clearance for CellSearch™ System
Veridex, a Johnson & Johnson company that develops cancer diagnostic products, recently announced that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for the CellSearch™ System to be used as an aid in the monitoring of metastatic prostate cancer patients. The CellSearch™ System currently is cleared for monitoring metastatic breast and metastatic colorectal cancer patients.
"I am extremely pleased that we now can offer this test to patients with metastatic prostate cancer," said Dr. Louis Fink, director Core Laboratory Sciences for Nevada Cancer Institute. "We have been evaluating the clinical utility of the CellSearch™ System in patients with metastatic prostate cancer since January 2007. Our findings demonstrate a strong indication that the baseline number of Circulating Tumor Cells (CTCs) is prognostic, and that the number of prostate CTCs is altered by the therapy."
Dr. Nicholas Vogelzang, director of Nevada Cancer Institute, continued, "We have compared CellSearch™ CTC test results to the standard clinical and biomedical parameters, such as prostate specific antigen (PSA) measured in MPC patients. A decrease in the number of CTCs is most often associated with patients successfully responding to therapy. Further analysis of CTCs may provide information as to the most efficacious treatments for specific individuals." Dr. Vogelzang is the recipient of a research fellowship grant from Veridex for the purpose of supporting independent research in metastatic prostate cancer patients.
This data will be presented at the 2008 American Association of Cancer Research annual meeting in San Diego on April 12-16, 2008.
VIEW IMAGEAccording to the American Cancer Society, prostate cancer claims approximately 27,000 lives each year, the vast majority of which are a result of recurrent metastatic disease. Metastatic prostate cancer occurs when tumor cells spread to other locations in the body and grow. Currently, oncologists often have to wait several months before they can determine if a specific treatment is beneficial to the patient. The CellSearch™ System helps physicians to predict disease progression and patient survival any time during therapy.
The CellSearch™ System does this by identifying and counting CTCs in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast, colorectal or prostate cancer, and can do so earlier than the current standard of care. The results of serial testing for CTCs with the CellSearch™ System provide additional information to the oncologist and does so earlier than other currently approved diagnostic modalities, thereby allowing the oncologist to make more-informed patient care decisions.
The CellSearch™ System is the first diagnostic test to automate the detection and enumeration of CTCs, cancer cells that detach from solid tumors and enter the blood stream, and is a new class of diagnostic tools. The system's specificity, sensitivity and reproducibility allow for serial assessment of CTCs as early as the first cycle of treatment to help evaluate disease progression sooner.
The CellSearch™ System was originally cleared by the FDA 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. In November 2007, the CellSearch™ System was cleared as an aid in monitoring metastatic colorectal patients.