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Sep 3, 2015

Biocept and Insight Genetics to Present ALK Expression Study Data on Liquid Biopsy Platform at the IASLC World Conference on Lung Cancer

Detection of ALK biomarker expression in circulating tumor cells could provide a new method to identify and monitor patients with ALK+ lung cancer

SAN DIEGO--(BUSINESS WIRE)-- Biocept, Inc. (NASDAQ: BIOC), a molecular diagnostics company commercializing and developing biomarkers in liquid biopsies to improve the detection and treatment of cancer, and Insight Genetics, Inc., a privately held molecular diagnostics company with expertise in developing assays to detect ALK and other lung and breast cancer markers, today announced the presentation of study data at the International Association for the Study of Lung Cancer's (IASLC) 16th Annual World Conference on Lung Cancer in Denver. "Detection of Aberrant ALK Expression from Circulating Tumor Cells for Accurate Monitoring of ALK Driven Non-Small Cell Lung Cancer" will be presented on September 7, 2015, and will describe the detection of RNA-based targets using Biocept's proprietary liquid biopsy platform.

Earlier this year, Biocept and Insight Genetics announced a collaboration to combine platform technologies to study RNA-based biomarker detection in circulating tumor cells (CTCs). Data demonstrate that Biocept's proprietary CTC capture technology is compatible for detecting RNA-based targets such as ALK, which is a known driver of non-small cell lung cancer (NSCLC). Using Insight Genetics' proprietary ALK detection assay, the two companies have been able to demonstrate the feasibility of performing RNA-based detection of ALK in both cell lines and patient samples. These studies demonstrate that Biocept's proprietary CTC capture technology, coupled with Insight Genetics' RNA-based biomarker detection assays, could provide a viable strategy to accurately monitor biomarker status in NSCLC patient populations. Biocept has previously demonstrated the ability to detect and quantify ALK translocations at the DNA level.

"These data further support Biocept's ability to scale our liquid biopsy platform across a number of different biomarkers," said Biocept's Senior Vice President and Chief Scientific Officer Lyle Arnold, PhD. "Biocept has already demonstrated the ability to validate biomarkers based on protein expression, as well as DNA copy number and mutations. The addition of RNA expression to the list increases our potential for discovery and clinical utility."

"Through our collaboration of combining Biocept's CTC capture platform and Insight Genetics' ALK qPCR assay, we have been able to successfully detect ALK fusions from blood, something only dreamed about just a few years ago," said Stephan W. Morris, MD, Insight Genetics' Scientific Founder and Chief Scientific Officer. "Our collaboration will now build upon these initial data with the goal of making clinical testing from liquid biopsies a standard of care."

About the World Conference on Lung Cancer

The World Conference on Lung Cancer is the world's largest meeting dedicated to lung cancer and other thoracic malignancies. More than 7,000 delegates come from more than 100 countries to discuss the latest developments in thoracic malignancy research. Attendees include surgeons, medical oncologists, radiation oncologists, pulmonologists, radiologists, pathologists, epidemiologists, basic research scientists, nurses, allied health professionals, advocates and patients.

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 technology platform captures and analyzes circulating tumor DNA, both in CTCs and in plasma (ctDNA). Biocept currently offers biomarker assays for lung, breast, colorectal and gastric Cancers, as well as melanoma. The company plans to introduce CLIA-validated assays for prostate and other solid tumors in the near term.

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 accurately monitor biomarker status in NSCLC patient populations, our ability to continue to scale our liquid biopsy platform across a number of different biomarkers, our ability to make clinical testing from liquid biopsies standard of care, and planned future 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 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.

Investors:
LHA
Jody Cain, 310-691-7100
jcain@lhai.com

Source: Biocept, Inc.

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