CellSearch System cleared for monitoring metastatic breast cancer

WARREN, N.J., Dec. 15, 2006 Veridex, a Johnson & Johnson company, today 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 breast cancer.

The CellSearch System identifies and counts circulating tumor cells (CTCs) in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast cancer earlier than the current standard of care. The results of serial testing for CTCs with the CellSearch System, in conjunction with other clinical methods for monitoring breast cancer, can help inform physicians' treatment decisions.

"The clearance of the CellSearch System as a routine monitoring diagnostic tool validates its efficacy as a critical part of the resources used to manage patients with metastatic breast cancer," said Mark Myslinski, General Manager, Veridex LLC. "With the CellSearch test, oncologists can clearly and consistently monitor the number of circulating tumor cells present in a patient's blood, an indication of disease progression."

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 the standard in a new class of diagnostic tools. The presence and number of CTCs in the blood provides valuable information to physicians for developing individual management programs for patients with metastatic breast cancer. The system's sensitivity, specificity and reproducibility allow for more rapid observation of CTCs as early as the first cycle of treatment helping to evaluate disease progression sooner.

According to the American Cancer Society, breast cancer claims approximately 40,000 lives each year, the vast majority of which are a result of recurrent metastatic disease. Metastatic breast cancer occurs when tumor cells spread to other lo

Contact: Steve Dnistrian
Veridex, LLC

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