Healthcare Industry News:  circulating tumor cells 

Diagnostics Oncology FDA

 News Release - July 10, 2006

Genoptix Announces FDA Cleared Test to Identify Circulating Tumor Cells

Test Helps Physicians and Patients Fight Metastatic Breast Cancer Sooner

SAN DIEGO, July 10 (HSMN NewsFeed) -- Genoptix, Inc., a provider of personalized medicine oncology services, today announced it will be one of two national laboratories to offer the CellSearch(TM) System, the only FDA cleared test that identifies circulating tumor cells (CTCs) in patients with metastatic breast cancer.

"CellSearch is an important diagnostic tool designed to help oncologists and their patients fight cancer," said Dr. Tina Nova, President and CEO of Genoptix. "The system's analysis of circulating tumor cells in the blood provides valuable insight into cancer regression and progression that oncologists can use to develop personalized treatment strategies for individual patients. The CTC test is also a great complement to the other prognostic and predictive peripheral blood assays that Genoptix provides to community oncologists."

CellSearch, an advanced diagnostic platform commercially available from Veridex, LLC, a Johnson & Johnson company, enables the capture, identification and classification of rare CTCs. It is capable of detecting as low as one CTC in 7.5 mL of whole blood, and with a high specificity at five or more CTCs, it virtually eliminates false positives.

"The sensitivity, specificity and reproducibility of CellSearch allows for more rapid observation of changes of CTCs as early as the first cycle of treatment to help evaluate patient progression earlier," said Dr. Mike Nerenberg, Genoptix Vice President of Medical Affairs.

In addition to providing prognostic information on individual patients prior to initiation of therapy, CellSearch may be used after a new therapy is begun. A fall in CTC levels, as determined by CellSearch at the first follow-up visit, suggests appropriate response to therapy.

"Early information about changes in CTCs may help physicians evaluate the effectiveness of therapy much earlier than using conventional radiologic methods. In the future, this may become the preferred method for deciding when to change therapy, thus avoiding unnecessary side effects that are caused by ineffective therapy," Dr. Nerenberg said.

For more information about CellSearch, visit, or call 800.755.1605.

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(TM) assays that identify, enumerate and characterize circulating tumor cells directly from whole blood; and GeneSearch(TM) assays that use molecular technology to diagnose, stage and more accurately characterize tumors.

About Genoptix

Genoptix, Inc. (, headquartered in Carlsbad, CA, provides Personalized Medicine Services to hematologists and oncologists that combine proprietary and exclusive tests with advanced clinical techniques for comprehensive evaluation of individual patients. To inquire about services or partnerships, contact Mike Nerenberg, M.D. at (760) 268-6200 or

This press release contains forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements. Actual results may differ materially from those projected. Genoptix disclaims, however, any intent or obligations to update these forward-looking statements.

Source: Genoptix

Issuer of this News Release is solely responsible for its content.
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