SAN DIEGO, Nov. 28, 2017 /PRNewswire/ — Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, announces entering into a clinical study agreement with the University of California San Diego (UCSD) Medical Center. Led by recognized immune-oncology and precision medicine specialist Sandip Patel, M.D., Assistant Professor at UCSD School of Medicine, the 100-patient study is designed to clinically validate Biocept’s Target Selector™ PD-L1 assay for patients diagnosed with non-small cell lung cancer (NSCLC). Importantly, Biocept’s assay for PD-L1 will be evaluated using the two common antibody clones for PD-L1 detection, 28-8 and 22C3, which have the potential to offer high biomarker detection rates using liquid biopsy. The study’s primary endpoint is concordance between tissue biopsy and liquid biopsy for the detection of PD-L1 protein expression. Correlation between treatment response and PD-L1 status as detected using liquid biopsy will be examined as a secondary endpoint in the study.
“Liquid biopsies have revolutionized oncology and precision medicine with the ability to obtain important biomarker information to identify patients for targeted therapy,” said Dr. Patel. “In particular, identification of key driver mutations such as EGFR, ALK, and ROS1, among others, are crucial in advanced NSCLC, and liquid biopsy plays an important role in assessing for these targetable pathways. Equally important is PD-L1 staining in front-line NSCLC to assess for a 50% tumor-proportion score, which is key for the utilization of immunotherapy. To date, primarily tissue testing has been available to assess PD-L1 status, and this study attempts to broaden the use of liquid biopsies to encompass PD-L1 scoring, which is crucial in determining whether immunotherapy may be appropriate for a patient in a given disease setting.”
“Immunotherapy has become an important treatment strategy for patients diagnosed with cancer and we believe that our unique liquid biopsy assay for PD-L1 offers a solution for rapid and non-invasive detection of this critical biomarker,” said Biocept’s President and Chief Executive Officer Michael Nall. “We continue to evaluate our Target Selector™ platform in clinical studies in which the identification of clinically actionable biomarkers, like PD-L1 protein expression, can help guide treatment decisions resulting in improved patient outcomes. We are excited to initiate this study with Dr. Patel and the UCSD Medical Center.”
About PD-L1 Biomarker Expression Using Liquid Biopsy
PD-L1 immunohistochemistry (IHC) on tumor