New Company to Focus on Cancer Diagnostics

A new company dedicated to earlier detection of cancer and more precise staging, monitoring, and selection of therapy through the use of new in vitro diagnostics has been formed by Johnson & Johnson (New Brunswick, NJ, USA).

Called Veridex LLC, the company is initially developing two complementary product platforms, one a cellular diagnostic platform and the other a molecular diagnostic platform. CellSearch cellular assays identify, enumerate, and characterize circulating tumor cells (CTCs) directly from whole blood, while GeneSearch assays employ molecular technology to diagnose, stage, and more accurately characterize tumors. With the growing trend toward more personalized cancer care, these assays are expected to play a key role in supplying critical information to help oncologists in providing more individualized treatment.

The CellSearch system has been cleared by the U.S. Food and Drug Administration (FDA) for the prediction of progression-free and overall survival in patients with metastatic breast cancer and is expected to be available in the fall of 2004. In a clinical trial, investigators using the technology found that at disease recurrence, metastatic breast cancer patients with no CTCs had a median survival of more than 23 months, while patients with more than 50 cells had a median survival of only 3.8 months.

"CTCs have long been known in theory to exist in peripheral blood,” said Robert T. McCormack, Ph.D., general manager, cellular diagnostics, Veridex. "But the technology has never before been available to grasp this potential consistently. Now we have the automation and standardization to make a practical application.”

The GeneSearch technology is designed to determine the presence and tissue origin of cancer cells, as well as disease staging and holds promise for prognosis and for selecting therapy. Several applications are now under development, including an intraoperative assay for sentinel lymph node testing during breast cancer surgery. Another application is for the identification of a profile that specifies which patients with refractory leukemia are more likely to respond to tipifarnib, a drug under development for the treatment of hemtologic malignancies and other cancers.

"Veridex has the opportunity to make a real contribution to patients suffering from cancer by improving their diagnosis through a combination of cellular and gene-based testing,” said Mark Myslinski, general manager of Veridex. "This will offer predictive insight into the nature of an individual's particular cancer, enabling oncologists to prescribe treatment with more fundamental and valuable knowledge of the potential outcome.”