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Biocept Launches Selector(TM), a Blood Based Test for EGFR Mutations for Non-Small Cell Lung Cancer Patients

SAN DIEGO, Jan. 12, 2015 (GLOBE NEWSWIRE) -- Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in biomarker analysis of circulating tumor DNA (ctDNA) and Circulating Tumor Cells (CTCs), today announced the launch of its EGFR mutation test that targets a region of the gene that includes T790M, a biomarker that identifies therapy-resistant tumors utilizing its proprietary Selector technology. This test will be performed at the Company's CLIA-certified and CAP-accredited laboratory and is the first of several assays the company will launch based on its proprietary Selector platform. The launch of Selector technology for ctDNA biomarker analysis from plasma in non-small cell lung cancer (NSCLC) expands Biocept's existing test menu of commercialized blood based assays for CTC capture and analysis for breast, gastric and lung cancers. The Selector technology was developed and validated by scientists at Biocept.

Approximately 20 percent of the NSCLC cases diagnosed each year are identified as EGFR-mutant, a correlation which has led to a number of targeted therapies focused on the patient population whose tumor has this mutation. These targeted therapies are known as Tyrosine Kinase Inhibitors, or TKIs. TKIs have been shown to be effective at shrinking tumors for a time, however, many patients ultimately develop resistance to EGFR-targeted TKIs because of secondary mutations such as T790M. Evaluating and monitoring for these secondary mutations in a clinical setting utilizing a blood sample could enhance the way treatment is managed. In addition to better informing clinicians when and how to treat NSCLC with TKIs, there are promising new therapies in clinical testing that target resistance alterations like T790M.

"Monitoring for EGFR resistance mutations in ctDNA from patients being treated with TKIs has the potential to dramatically change how physicians treat patients," said Veena Singh, M.D., Biocept SVP and Senior Medical Director. "High concordance when comparing tissue to blood samples demonstrates the feasibility of using this strategy in a clinical setting."

"In addition to being a noninvasive method to collect tumor related samples, blood testing could overcome the frequent obstacle of lack of sufficient tissue for molecular testing as well as issues with tumor heterogeneity. We believe these are significant advantages to our technology when testing gene mutations such as T790M," Singh said.

"We are excited to launch our first test using our proprietary Selector technology," said Lyle Arnold Ph.D., Biocept SVP and Chief Scientific Officer. "Physicians and researchers know us as a leader in CTC capture and analysis. With Selector, we can help patients by analyzing molecular biomarkers in blood from both CTCs and ctDNA found in plasma. The significant sensitivity of Selector allows us to identify these rare cancer mutations shed by the tumor into the blood, even when a large excess of normal DNA is present."

About Biocept, Inc.

Biocept, Inc., headquartered in San Diego, Calif., is a commercial-stage oncology diagnostics company focused on providing information on patients' tumors to physicians using its proprietary technology platform to help improve individual patient treatment. Biocept has developed proprietary technology platforms for capture and analysis of circulating tumor DNA, both in circulating tumor cells (CTCs) and in plasma (cell free tumor DNA). A standard blood sample is utilized to provide physicians with important prognostic and predictive information to enhance individual treatment of their patients with cancer. Biocept currently offers its OncoCEE-BR™ test for breast cancer, OncoCEE-GA™ test for gastric cancer and OncoCEE-LU™ for non-small cell lung cancer and plans to introduce CLIA validated tests for melanoma, colorectal, prostate and other solid tumors based on its proprietary technology platforms over the coming months.

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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 improvement of outcomes, our impact on diagnostic strategies and planned future product offerings, 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 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 Securities and Exchange Commission, which can be accessed over the Internet at the SEC's website located at www.sec.gov.

CONTACT: Investor Contact: The Ruth Group David Burke (646) 536-7009 dburke@theruthgroup.com Media Contact: The Ruth Group Melanie Sollid-Penton (646) 536-7023 msollid@theruthgroup.com

Source:Biocept, Inc.