Biocept to Collaborate on Biopharma Company Clinical Trial by Identifying Biomarkers Found in Cerebral Spinal Fluid for Patients with Lung Cancer that has Spread to the Brain

SAN DIEGO, March 21, 2016 /PRNewswire/ -- Biocept, Inc. (NASDAQ: BIOC), a molecular diagnostics company commercializing and developing liquid biopsies to improve the detection and treatment of cancer, announces a collaboration on a biopharmaceutical company clinical trial analyzing biomarkers using both circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) from cerebrospinal fluid (CSF). The trial is being conducted in patients with non-small cell lung cancer (NSCLC) whose disease has spread to the brain or membranes surrounding the brain and spinal cord, known as leptomeningeal disease. 

"Our technology has the high sensitivity required to detect biomarkers using both CTCs and ctDNA in fluids beyond blood, including CSF," said Biocept President and CEO Michael W. Nall. "This is particularly significant as collecting tissue in patients with leptomeningeal disease through a standard invasive surgical biopsy is impossible in most cases due to the risk associated with a brain biopsy. As newer targeted therapies for these cancers become available, the ability to conduct molecular analysis on CSF using liquid biopsy will become increasingly important." 

Brain metastases and leptomeningeal disease are prevalent in patients with solid tumors, including those with NSCLC. Radiation therapy has been used to control the symptoms of these patients, due to the inability of the majority of available therapeutic drugs to penetrate the blood-brain barrier, the body's natural defense system. However, new therapeutic molecules in development are demonstrating the ability to penetrate the blood-brain barrier more effectively, thus providing the potential for new therapeutic options.  

"Finding effective treatments for patients with brain metastases and leptomeningeal disease is a critical unmet medical need because of the inability of most drugs to cross the blood-brain barrier," said Veena Singh, M.D., Senior Vice President and Senior Medical Director of Biocept. "The data from this trial could provide further clinical validation of Biocept's liquid biopsy tests to detect and monitor important biomarkers in CSF." 

Marileila Varella Garcia, Ph.D., Professor in the Division of Medical Oncology at the University of Colorado School of Medicine and Biocept Scientific Advisor, said, "Biocept's capability to analyze both intact tumor cells and fragments of tumor DNA in CSF affords a more comprehensive analysis of biomarkers for emerging DNA, RNA and proteomic targeted therapies. The detection of these biomarkers could help to qualify patients for treatment with both new and existing therapies, which could lead to improved patient outcomes."

About Biocept
Biocept, Inc. is a commercial-stage molecular diagnostics company that utilizes a proprietary technology platform and a standard blood sample to provide physicians with important prognostic and predictive information to enhance individual treatment of patients with cancer. Biocept's patented technology platform captures and analyzes circulating tumor DNA, both in CTCs and in ctDNA. Biocept currently offers assays for gastric cancer, breast cancer, lung cancer, colorectal cancer and melanoma, and plans to introduce CLIA-validated assays for prostate cancer and other solid tumors in the near term. For additional information, please visit www.biocept.com.

Forward-Looking Statements Disclaimer Statement
This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements as to our ability to improve the detection and treatment of cancer, our ability to analyze biomarkers in fluids beyond blood (including CSF), new therapeutic molecules having the ability to penetrate the blood-brain barrier, our ability to obtain data that provides clinical validation of our liquid biopsy tests to detect and monitor important biomarkers in CSF, our impact on diagnostic strategies, our ability to enhance individual cancer treatments and our plans to introduce CLIA-validated assays for prostate cancer and other solid tumors in the near term, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC's website located at www.sec.gov.

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