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Sep 13, 2016

Biocept to Collaborate with Renowned Clinical Investigator Dr. Shilpa Gupta to Study the Utility of Liquid Biopsy Testing in Bladder, Testicular and Prostate Cancers

Observational study aimed at supporting the clinical utility of Biocept’s tests for PD-L1
and Androgen Receptor expression

SAN DIEGO (September 13, 2016) – Biocept, Inc. (NASDAQ: BIOC), a molecular diagnostics company commercializing and developing blood-based liquid biopsies to provide information to physicians to improve the diagnosis and treatment of cancer, announces a research collaboration with Shilpa Gupta, M.D., Assistant Professor in the Division of Hematology, Oncology and Transplantation at Masonic Cancer Center, University of Minnesota, Minneapolis. Dr. Gupta is a genitourinary oncologist and the lead for the Phase 1 solid tumor program and is the principal investigator for several high-impact clinical trials in bladder and prostate cancer. The proposed study would observe the utility of Biocept’s patented Target Selector&#8482 liquid biopsy technology platform using circulating tumor cells (CTCs) to detect the expression of PD-L1 and androgen receptor (AR) expression in patients with bladder and prostate cancer.  The study will be conducted at Masonic Cancer Center.

“We are delighted to be working with Dr. Gupta, a leading expert in the field of genitourinary cancers, including bladder and prostate cancers and the role of targeted therapies and immunotherapy agents in these disease states,” said Veena Singh, M.D., Biocept’s Senior Vice President and Senior Medical Director.  “Dr. Gupta has been an active speaker at national and international forums discussing the role of novel therapeutics for personalized medicine in prostate cancer.” 

Dr. Gupta added, “PD-L1 is expressed in multiple cancer types and several therapies that target PD-1/PD-L1 are approved and being studied in a variety of tumors. However, the utility of PD-L1 in CTCs in bladder cancer and correlation with response to anti-PD1 therapies is unknown, and we propose to study the expression of PD-L1 in patients with bladder cancer at diagnosis and while on anti-PD-1/PD-L1 therapies.  AR is a known therapeutic target in prostate cancer but the utility of looking at AR expression in CTCs of patients with prostate cancer while on AR-directed therapies is unknown.  We are currently exploring AR as a therapeutic target in bladder cancer in a novel clinical trial using enzalutamide in combination with chemotherapy (NCT02300610). Our proposed study with Biocept would study AR expression in CTCs in patients with metastatic prostate and bladder cancer. We typically try to obtain tissue biopsies in patients with advanced bladder and prostate cancers, but these methods are invasive and can be expensive. 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 information for the use of these tests specifically in bladder and prostate cancers to help in clinical decision making.”

About Biocept

Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma.  The Company uses its proprietary liquid biopsy technology to provide physicians with information for treating and monitoring patients diagnosed with cancer. The Company's patented Target Selector&#8482 liquid biopsy technology platform captures and analyzes tumor-associated molecular markers in both CTCs and in plasma (ctDNA). With thousands of tests performed, the platform has demonstrated the ability to identify cancer mutations and alterations to inform physicians about a patient’s disease and therapeutic options. 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 diagnosis and treatment of cancer, the utility of our liquid biopsy technology platform to detect the expression of PD-L1 and AR expression in patients diagnosed with bladder and prostate cancers, and our ability to obtain additional clinical support for the use of our liquid biopsy technology platform , 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.

Investor Contact:

LHA
Jody Cain
Jcain@lhai.com
310-691-7100

Media Contact:
Trevelino/Keller
Colleen Murphy
cmurphy@trevelinokeller.com
404-214-0722, Ext. 109

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