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Biocept and Insight Genetics Collaborate to Advance Non-Small Cell Lung Cancer Diagnosis and Treatment

SAN DIEGO and NASHVILLE, Tenn., Jan. 8, 2015 (GLOBE NEWSWIRE) -- Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in biomarker analysis of cell-free circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs); and Insight Genetics, a leading molecular diagnostic assay development company, today announced their collaboration to generate an enhanced diagnostic for the expression and mutation of ALK, a major therapeutic target in the treatment of non-small cell lung cancer.

As part of the initial collaboration, Biocept and Insight Genetics will evaluate the combination of both companies' platform technologies to enhance detection of ALK status in NSCLC patients. Biocept's proprietary technology will be used to capture and analyze CTCs and ctDNA. Insight Genetics will then utilize its technical expertise and proprietary evaluation methods to determine ALK expression, and whether the gene has mutated over the course of cancer treatment.

The initial aim of this collaboration is to better identify and monitor patients who may benefit from existing ALK-based therapies as well as those that may benefit from second-generation therapies based on inhibitor resistance mechanisms.

"Biocept's ability to perform a 'liquid biopsy' on these NSCLC patients by capturing and analyzing CTCs and ctDNA using a simple blood draw rather than relying on solid tumor biopsy gives us a distinct collaborative advantage with leading industry partners. We are excited to explore the potential of such an agreement with Insight Genetics, combining the power of our capture platform with Insight's specific molecular testing content," said Michael Nall, president and CEO of Biocept. "Since the launch of OncoCEE-LU™, our first CLIA-validated assay for lung cancer in late 2014, we continue to focus on building our lung franchise and expanding our offering to both biopharmaceutical collaborators and clinicians. Insight Genetics is an ideal collaborator as we both seek to bring our unique expertise in CTC capture and ALK analysis to advance our respective testing capabilities."

"As the field of ALK-based therapies continues to grow with second- and third-generation molecules, the concept of looking at both DNA and RNA from CTCs is a diagnostic approach Insight has been interested in exploring for some time. Biocept, as a leader in CTC and ctDNA capture and analysis, is well positioned to help us pursue this diagnostic innovation," said Stephan Morris, M.D., scientific founder & chief scientific officer of Insight Genetics.

"The ability to obtain information about a tumor through a simple, blood-based test is appealing in that it can not only qualify patients for targeted therapies, but also aid in the monitoring of these patients for changes in a tumor as disease progresses," Morris added. "By combining our existing expertise in ALK testing with Biocept's liquid biopsy technologies, we are poised to expand our mutual efforts in profiling and monitoring ALK positive patients and mechanisms of resistance identified with this patient cohort."

ALK is incorporated into the testing guidelines utilized by oncologists when making treatment decisions in NSCLC patients. ALK positive patients now have targeted treatment options with two key drugs that have been approved by the FDA: the first is Pfizer's Xalkori (Crizotinib) and the second is Novartis's Zykadia (ceritinib), and others are in development.

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 testing for breast cancer, gastric cancer and lung cancer, and plans to introduce CLIA-validated tests in the future for colorectal, prostate and other solid tumors based on its proprietary technology platforms.

About Insight Genetics

Insight Genetics is dedicated to improving the lives of cancer patients through advanced molecular diagnostics that enable precision in cancer care. The company specializes in the discovery, development and commercialization of companion diagnostics that detect specific cancer biomarkers and assist in guiding the effective diagnosis and treatment of cancer. Insight Genetics is an ISO 9001:2008 and CLIA-certified laboratory who partners with leading academic researchers, pharmaceutical and biotechnology companies, clinical reference laboratories, and IVD kit manufacturers to create new standards of care for cancer patients worldwide. Visit www.insightgenetics.com for more information.

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 Biocept and Insight Genetics believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, they 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 the ability to develop next generation versions of certain current testing methods in which liquid biopsies could be used, the ability to market any resulting joint platform to pharmaceutical and biotech companies, and any impacts on diagnostic strategies, 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 the companies' 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. Neither Biocept nor Insight Genetics 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 the companies' filings with the SEC, 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.