Woman donating blood
Woman donating blood and doctor holding the needle while it fills

Molecular diagnostics company Biocept announced today it will collaborate with Shilpa Gupta, Ph.D., of the University of Minnesota to observe the performance of the company’s liquid biopsy platform to detect the expression of PD-L1 and androgen receptor (AR) in patients diagnosed with bladder and prostate cancers.

Biocept’s Target Selector™ platform for prostate cancer is based on the analysis of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) found in a patient’s blood sample. The company also offers testing for AR and plans to validate testing for phosphatase and tensin homolog (PTEN) gene deletions by fluorescence in situ hybridization (FISH).

“Tissue sample collection and cystoscopy are the standard methods for detecting bladder and prostate cancers, and these methods are invasive and can be expensive,” said Dr. Gupta, who is an assistant professor in the University of Minnesota’s Hematology Oncology and Transplantation Division. “Biocept's liquid biopsy tests have shown high concordance with tissue biopsies in detecting genetic mutations associated with multiple cancers, and this study is aimed at providing additional clinical support for the use of these tests specifically in bladder and prostate cancers.”

According to Biocept, the Target Selector platforms are designed to provide both biomarker detection as well as disease monitoring, requiring only a blood sample. Target Selector’s CTC offering is based on an internally developed and patented, microfluidics-based capture and analysis platform, whereas the company’s patent-pending Target Selector ctDNA technology is designed to enable mutation detection and is applicable to nucleic acid derived from CTCs or other sample types, such as blood plasma.

The collaboration with Dr. Gupta comes just three months after the company expanded its testing assays to the fast growing immuno-oncology area. The test, which is used to detect and monitor PD-L1 protein expression, was developed by Biocept scientists in collaboration with David Rimm, M.D, Ph.D., a professor of pathology and medicine at Yale University School of Medicine and a scientific advisor to Biocept. 

“Immunotherapy is among today's most promising approaches to improving the outcomes of patients with cancer and shows even greater potential in the future as drugs currently in development come to market,” said Michael Nall, Biocept's president and CEO.  “We believe Biocept has one of the few, if not the only, commercial, CLIA-validated, blood-based test for detecting PD-L1 expression. Our test provides a new option for physicians to qualify patients for approved immuno-oncology therapies and for companies in developing these breakthrough therapies.”

In addition to its newly launched PD-L1 testing, Biocept has developed tests on its Target Selector platform for HER2 negative and HER2 positive testing for breast cancer, non-small-cell lung cancer, small-cell lung cancer, gastric cancer, colorectal cancer, and melanoma.It also offers diagnostics for the c-MET signaling pathway for a variety of cancers, and a blood-based diagnostic for determining hormonal status for patients with metastatic breast cancer.

The San Diego-based company completed an initial public offering in early 2014 and its proprietary microfluidics and cell capture technologies have been awarded 12 separate patents.

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