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Biocept, Inc. Announces Availability of Its New Breast Cancer Test, OncoCEE-BR™ Utilizing Circulating Tumor Cells (CTCs)
Date:7/28/2011

he status and aggressiveness of a patient's disease, and help guide clinical management of that patient.  OncoCEE-BR™ provides real-time information on a tumor via a simple blood test to evaluate CTCs as compared to a surgical biopsy.  This means that a tumor can be monitored and analyzed utilizing CTC analysis on an ongoing basis during therapy which may permit the early identification of emerging treatment resistance.  In addition, expression of HER2 has been detected in CTCs in metastic breast cancer patients whose primary tumors from surgery or biopsy were HER2 negative [Munzone, et al, Clin. Cancer Res. 2011].  In fact, preliminary reports suggest that breast cancer patients who were CTC HER2-positive and primary tumor HER2-negative responded to Herceptin® therapy [Meng et al, PNAS 2004]; larger prospective clinical studies are in process.

More than 200,000 new cases of breast cancer will be reported in the US in 2011.  Approximately 20% of breast cancer patients are HER2 positive by primary tissue diagnosis, and thus candidates for HER2-targeted therapy.  Due primarily to tumor heterogeneity, the false-negative rate for the HER2 test, particularly by immunohistochemistry (IHC), is estimated to be 10-15% or higher; the HER2 FISH test, which Biocept performs on CTCs, is considered a "gold standard".

"We believe that OncoCEE-BR™ may be an important tool for clinicians in the assessment of a breast cancer patient's prognosis and treatment options," said Executive Chairman David F. Hale.  "It can complement tumor tissue analysis, offering the opportunity to "cross-check" those results.  In situations where tissue is not available, for example at time of recurrence, or when monitoring therapy to determine its effectiveness, it can provide a real-time evaluation of the cancer at the cellular level."   Mr. Hale continued, "Clinical studies are being conducted to examine the effects of HER2 tar
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