Clarient and Biocept Commercialize Test for Circulating Tumor Cells

(Aliso Viejo, CA, USA) a GE Healthcare Company, will collaborate on the commercialization of a blood test for CTCs in breast cancer patients, which includes the determination of HER2 status.

Biocept will perform the test in its laboratories, and results will be interpreted by Clarient’s 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.

The blood test, called OncoCEE-BR, will be marketed and sold by Clarient to community hospitals, pathologists, and medical oncologists. Biocept plans to include estrogen receptor/progesterone receptor status determination, as well as additional biomarkers on the test in the future.

According to Biocept executive chairman David Hale, the combination of OncoCEE-BR and Clarient's marketing and pathology capabilities will accelerate the education of doctors about the need for CTC analysis for patients with breast cancer. He stated, "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."

Biocept’s OncoCEE-BRTM test is expected to have application in several clinical settings, including determination of whether a patient's HER2 status changed from the original diagnosis or surgery, especially in cases where a biopsy is difficult to obtain. In addition, the test will confirm the patient's 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. 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.

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Biocept, Inc.
Clarient Inc.