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Genoptix Announces FDA Cleared Test to Identify Circulating Tumor Cells

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Genoptix, Inc. has announced it will be one of two national laboratories to offer the CellSearch™ System, 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, a platform commercially available from Veridex, LLC, a Johnson & Johnson company, designed to enable 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 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," Dr. Nerenberg said.

"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."