×

Biocept Launches Clinical Research Services for Biomarker Detection in Circulating Tumor DNA

SAN DIEGO, April 28, 2014 (GLOBE NEWSWIRE) -- Biocept, Inc. (Nasdaq:BIOC), a molecular diagnostics company specializing in oncology biomarker detection and monitoring through circulating tumor cells (CTCs) and cell-free circulating tumor DNA, today announced the launch of its clinical research services offering.

This service will be performed at Biocept's CLIA-certified, CAP-accredited laboratory and will include blood-based biomarker testing services for research and development activities, including clinical trial screening and testing. Biocept will provide clinical trial and drug development support services for targeted therapeutics developed by the pharmaceutical industry. This testing can include identification of appropriate patients for trial inclusion and detection and monitoring of therapeutic response for specific cancer therapies.

"We are excited to launch our services for pharmaceutical research, development and clinical trials," said Michael Nall, Biocept President and CEO. "This offering to pharma is a natural extension of the work we are doing in our clinical lab. Many of the biomarker tests we are currently validating for referring physicians are also well suited for pharma and research projects. The validation efforts in which we are already investing will enable us to create a comprehensive biomarker test menu that will benefit an expanded group of end users – community oncologists, academic researchers and pharmaceutical developers, to name a few."

The number of therapeutic biomarkers Biocept can target is growing rapidly. The Company has performed studies to demonstrate its ability to analyze many of these biomarkers on tumor DNA from both intact CTCs and cell-free circulating tumor DNA from plasma.

"The next logical step in expanding our service offering to a broader audience is through the extension of our capabilities beyond referring physicians to pharmaceutical companies and academia. All of these groups stand to benefit from our ability to identify key biomarkers from simple blood samples. Our ability to capture and analyze genomic changes both in intact CTCs as well as cell-free tumor DNA will allow our pharmaceutical partners to achieve the sensitive detection of driver and drug resistance mutations," said Farideh Bischoff, Vice President, Translational Research and Clinical Development at Biocept.

Some of the key programs for the clinical research offering include:

  • ALK and ROS1 translocations on CTCs, with a focus on NSCLC
  • MET copy number analysis on CTCs, with a focus on non-small cell lung cancer (NSCLC) and gastrointestinal (GI) cancers
  • Her2 copy number analysis on CTCs, with a focus on breast cancer and GI cancer
  • ER protein expression on CTCs, with a focus on breast cancer
  • AR, PTEN and MYC copy number and loss of gene regions in CTCs, with a focus on prostate cancer
  • EGFR mutation analysis on cell-free tumor DNA, with a focus on NSCLC
  • KRAS mutation analysis on cell-free tumor DNA, with a focus on NSCLC and colon cancer

In addition to these assays, Biocept will offer key tumor activating mutation and resistance marker analysis in blood samples for use when tissue based biopsy samples may not be feasible.

About Biocept, Inc.

Biocept, Inc., headquartered in San Diego, California, 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-BRTM test for breast cancer and plans to introduce CLIA validated tests for lung, colorectal, prostate and other solid tumors based on its proprietary technology platforms over the coming months.

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 anticipated product introductions and their capabilities, and anticipated expansion of our service 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, including without limitation the possibility that we will not successfully make new product introductions or service offering expansions, our need to grow our business and our operations, our need for capital, and the effects of reimbursement limitations and other health care statutory and regulatory initiatives. 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.comSource:Biocept, Inc.