February 28, 2008 - Veridex LLC said the FDA has granted an expanded clearance for the CellSearch System to be used as an aid in the monitoring of metastatic prostate cancer (MPC) patients.
The CellSearch System currently is cleared for monitoring metastatic breast and metastatic colorectal cancer patients.
The system reportedly identifies and counts circulating tumor cells (CTCs) in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast, colorectal or prostate cancer. The results of serial testing for CTCs with the CellSearch System provide additional information to the oncologist and do so earlier than other currently approved diagnostic modalities, according to Veridex.
According 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 is designed to help physicians to predict disease progression and patient survival any time during therapy.
The CellSearch System is one of the first diagnostic tests to automate the detection and enumeration of CTCs, cancer cells that detach from solid tumors and enter the blood stream. 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, said the company.
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, said the company.
For more information: www.veridex.com