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 locations in the body and grow. Although there are many options for the treatment of metastatic breast cancer, 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 if treatment is effective at any time during therapy through its ability to locate one circulating tumor cell in the 40 billion cells contained in a 7.5 ml sample of blood – an achievement no other diagnostic approach has been able to accomplish.

The CellSearchTM System was 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.

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About Veridex

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 complementary product lines: CellSearch™ assays that identify, enumerate and characterize circulating tumor cells directly from whole blood; and GeneSearch™ assays that use molecular technology to diagnose, stage and more accurately characterize tumors. www.veridex.com


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