Biocept and Clarient Announce Launch of Proprietary Circulating Tumor Cell (CTC) Blood Test for HER2 Status in Breast Cancer Patients

SAN DIEGO & ALISO VIEJO, Calif.--(BUSINESS WIRE)--

Biocept, Inc., a privately-held laboratory services company focused on Circulating Tumor Cells (CTCs), and Clarient, Inc., a GE Healthcare Company, announced today the US commercial launch of Biocept's proprietary breast cancer CTC test, OncoCEE-BR™, which is performed on a blood sample. OncoCEE-BR detects CTCs, which are typically very rare, and determines the patient's HER2 status by FISH (fluorescence in situ hybridization). Clarient and Biocept, Inc. will market and sell the OncoCEE-BR CTC test to hospitals, pathologists and medical oncologists. Biocept will perform the test in its laboratory and results will be interpreted and reported by Clarient's highly respected pathology group (Clarient Pathology Services, Inc.). Biocept and Clarient entered into an agreement to cooperate on the commercialization of OncoCEE-BR in the second half of 2011.

Dave Daly, Chief Commercial Officer of Clarient, said, “Clarient and GE are committed to innovation and improving health care for millions of cancer patients. We believe Biocept's OncoCEE-BR is a unique and important test for our oncology portfolio, and will help the oncology community progress towards more personalized cancer care. Our collaboration with Biocept demonstrates Clarient's ability to identify, and develop partnerships with, cutting-edge technology companies, enabling the delivery of new and powerful tools to assist clinicians in diagnosing and treating patients.”

OncoCEE-BR is a significant advance over current commercial CTC testing, with improved sensitivity, enumeration results and diagnostic biomarker analyses (e.g., HER2 status). Competitive CTC tests rely on the expression of the epithelial cell adhesion (EpCAM) molecule and cytokeratins for CTC capture, detection and enumeration. This approach may exclude CTCs that have undergone intrinsic modifications of their phenotype, such as the epithelial-to-mesenchymal transition (EMT), thought to be critical for metastasis. EMT may represent a possible explanation for many patients who, despite an aggressive disease, are found negative for the presence of CTCs. OncoCEE™ captures and detects EpCAM and cytokeratin negative CTCs, which are more mesenchymal-like. Additionally, the OncoCEE platform enables evaluation of treatment-associated biomarkers, like HER2 status, which often qualifies patients as candidates for HER2-targeted agents such as Herceptin® and Tykerb®.

David Hale, Executive Chairman of Biocept, said, “We are very pleased to be launching the OncoCEE-BR test with Clarient/GE, and hope to enhance the strong relationships they have built in the cancer community. With the advent of new and better therapies for breast cancer, to win the fight against this disease we need better information about its particular attributes in each individual patient. Improved breast cancer testing is one way to achieve this. We and Clarient/GE are equally dedicated to this approach.” He continued, “We think our blood-based, CTC HER2 test, which because of its convenience can be performed whenever a treatment decision arises, will make an important contribution to patient care. We 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, and improve patient outcomes.”

About Biocept, Inc.

Biocept, Inc. is a laboratory services company with an advanced CLIA-certified, CAP-accredited testing facility specializing in the development of assays for 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 specialized, 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 predictive for specific therapies, which may provide physicians with information highly relevant for the treatment of their patients with cancer.

About Clarient, Inc.

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. For more information, visit www.clarientinc.com.

Herceptin® and Tykerb® are proprietary product names of Genentech USA, Inc. and GlaxoSmithKline, respectively.