Biocept and Clarient Announce Collaboration on First Test for Circulating Tumor Cells and HER2 Status in Breast Cancer Patients

SAN DIEGO, Aug. 24, 2011 /PRNewswire/ -- Biocept, Inc., a privately-held CLIA-certified laboratory testing company, focused on the detection and analysis of circulating tumor cells (CTCs) in cancer patients, and Clarient, Inc. (a GE Healthcare Company) today announced a collaboration on the commercialization of a proprietary blood test for CTCs in breast cancer patients, which includes the determination of HER2 status.  Clarient and Biocept will market and sell Biocept's new OncoCEE-BR™ CTC test to community hospitals, pathologists and medical oncologists.  Biocept will perform the test in its laboratories, and results will be interpreted by Clarient's highly respected pathology group (Clarient Pathology Services, Inc.).   The test includes CTC enumeration and HER2 status of the detected CTCs by fluorescence in situ hybridization (FISH); it is the first commercially available CTC test to include analysis of a specific treatment-associated biomarker.  

David Hale, Executive Chairman of Biocept, said, "We are very excited about this collaboration with Clarient, and feel there is real synergy between our two companies.  We believe the combination of the technical advantages of the OncoCEE-BR™ test, and Clarient's highly regarded marketing and pathology capabilities, will enable the rapid education of the physician community about the benefits of CTC analysis for patients with breast cancer."  He continued, "We think a blood-based, CTC-directed HER2 test, which can be performed when a treatment decision arises, has high potential, and expect that it will be used to support other laboratory and clinical information to provide physicians with the most current information on a tumor to help select the most appropriate course of therapy."

The OncoCEE-BR™ test includes enumeration of CTCs as well as the determination of HER2 status by FISH.  Biocept intends to add ER/PR status determination to the test, and potentially other biomarkers, in the future.  OncoCEE-BR™ is the only commercially available CTC test that combines enumeration and cytogenetic characterization.

Ron Andrews, CEO of Clarient, said, "Establishing the ability to perform molecular characterization of peripheral cancer cells from a blood sample takes us one step closer to making cancer a chronic disease.  Biocept's OncoCEE™ platform supports our mission of personalized medicine and care for cancer patients."

Biocept's OncoCEE-BR™ test is expected to have application in several clinical settings, including:

• At the time of recurrence, and especially in cases where a biopsy may be difficult to obtain, to determine if the patient's HER2 status has changed from the original diagnosis or surgery.
• Confirmation of HER2 status at the time of original diagnosis or surgery, where tumor tissue analysis was negative for HER2 amplification.  Biocept has demonstrated detection of HER2-amplified CTCs in patients with HER2 negative primary tumors, a finding reported by other groups in the scientific literature.  This suggests that the pathologist may have examined a part of the tumor that was not HER2 amplified for a variety of reasons including tumor heterogeneity, and that treatment with HER2-targeted agents may be justified.  This could be a life-changing event for a breast cancer patient.

About Biocept, Inc.

Biocept Laboratories, headquartered in San Diego, California, is an advanced diagnostic CLIA-certified laboratory services company specializing in the capture, detection, enumeration and molecular analysis of circulating tumor cells (CTCs). Biocept is dedicated to positively impacting the lives of cancer patients through the development of innovative diagnostic products and services. Biocept utilizes innovative and proprietary technologies to deliver clinically relevant and actionable information to physicians that enable better patient care. This includes clinical assessments of CTCs, both prognostic and diagnostic, which may provide physicians with information highly relevant for the treatment of their patients with cancer.

About Clarient

Clarient combines innovative diagnostic technologies with world class pathology expertise to assess and characterize cancer. Clarient's mission is to become the leader in cancer diagnostics by dedicating itself to collaborative relationships with the healthcare community to translate cancer discovery and research into better patient care. Clarient's principal customers include pathologists, oncologists, hospitals, and biopharmaceutical companies. The rise of individualized medicine as the new direction in oncology has created the need for a centralized resource providing leading diagnostic technologies, such as flow cytometry and molecular testing. Clarient is that resource, having created a state-of-the-art commercial cancer laboratory providing advanced oncology testing and diagnostic services. Clarient's customers are connected to its Internet-based portal, PATHSITE® that delivers high-resolution images and critical interpretive reports based on its diagnostic testing. Clarient also develops and markets new, proprietary "companion" diagnostic markers for therapeutics in breast, prostate, lung, ovarian, and colon cancers, and leukemia/lymphoma.

www.Clarientinc.com

Biocept's CEE™ Platform

Biocept is developing the proprietary CEE™ (cell enrichment and extraction) platform, and a family of specialized CTC tests (OncoCEE™), which will be provided as a service to physicians and patients, as well as pharmaceutical and biotechnology companies through Biocept's CLIA-certified, CAP-accredited laboratory.  The CEE™ platform is comprised of micro-fluidic capture channels and associated instrumentation, an antibody capture cocktail, and CEE-Enhanced™ staining technology, with biomarker assays being performed on CTCs captured in the channels.

About OncoCEE™

The OncoCEE™ platform, developed by Biocept, has demonstrated that it can consistently and accurately capture extremely rare cells from blood, like CTCs, which may be present in only 1 of every 50-100 billion blood cells. Biocept obtains patient samples via a simple blood draw, or "liquid biopsy", instead of relying on traditional biopsy methods or surgical procedures.  Biocept differentiates its "liquid biopsy" CTC analysis by combining CTC enumeration and diagnostic (e.g., HER2 status) biomarker analyses, information not currently available through commercial laboratories using existing technologies for CTC testing.  Other methods to capture, detect and enumerate CTCs rely only on the expression of the epithelial cell adhesion (EpCAM) molecule and cytokeratins, and do not include molecular biomarker analysis.  This approach may exclude CTCs that have undergone intrinsic modifications of their phenotype, such as the epithelial-to-mesenchymal transition (EMT).   EMT may represent a possible explanation for many patients who, despite an aggressive disease, are found negative for the presence of CTCs.  OncoCEE™ captures epithelial (i.e., EpCAM positive) CTCs and mesenchymal-like CTCs.  Additionally, the OncoCEE™ platform enables evaluation of diagnostic biomarkers by techniques like immunocytochemistry, fluorescence in situ hybridization (FISH) and mutation analysis.  An example is HER2 status, which Biocept determines by FISH.  HER2 status is diagnostic of a potential response to HER2-targeted agents such as Herceptin® and Tykerb®.

SOURCE Biocept, Inc.