OncoCEE-BR™ -Enumerated CTCs with HER2 by FISH...Now Available- July 2011!

Biocept, Inc., an advanced diagnostic CLIA-certified service laboratory developing novel tests for the oncology community, today announced the availability of OncoCEE-BR™ for breast cancer, a test designed to detect circulating tumor cells (CTCs) found in the blood of patients with this disease, and assess their HER2/neu status by fluorescence in situ hybridization (FISH) performed on the detected CTCs.  OncoCEE-BR™ is intended as an adjunct to current standard testing methods for breast cancer, and especially in clinical settings where it may not be possible to obtain a tissue biopsy. CTC analysis, including biomarker analysis such as HER2 gene amplification, may provide a more complete picture of a patient’s cancer. 

The OncoCEE-BR^TMtest includes: 1) enumeration of CTCs (their actual number, per an 8 ml blood sample), and 2) determination of the HER2/neu status of the detected CTCs by FISH.  Clinical studies have demonstrated poorer outcomes for patients with elevated or increasing numbers of CTCs.  The detection of HER2/neu amplification in tissue biopsy samples indicates eligibility for HER2-targeted therapies like trastuzumab (e.g., Herceptin®).  Biocept intends to add ER/PR status determination to the test, and potentially other biomarkers, in the future.  OncoCEE-BR^TMis the only commercially available test that combines CTC enumeration with their cytogenetic characterization.  It requires a unique blood draw tube and sample shipping container, which are provided by Biocept upon request.

The results from an OncoCEE-BR^TMtest may provide oncologists, pathologists and patients with a greater understanding of the aggressiveness of a patient’s disease, and guide clinical management of that patient.  OncoCEE-BR™ provides real-time information on a tumor’s features via a simple blood test as compared to a surgical biopsy.  The convenience of a blood test means that a tumor, via its CTCs, can be monitored and analyzed on an ongoing basis, which may permit 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 will be 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”.