×

Biocept Expands Non-Small Cell Lung Cancer Diagnostic Capabilities for EGFR Mutations

SAN DIEGO, March 10, 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 detection testing utilizing a patient's blood-based liquid biopsy. This innovative diagnostic has the potential to help physicians identify which of their patients may be receptive to certain non-small cell lung cancer treatments.

The identification of these mutations in patients with advanced NSCLC can provide them with the opportunity to receive optimal targeted therapies, known as Tyrosine Kinase Inhibitors (TKIs). In the United States, there are two FDA-approved TKI therapies for patients with specific EGFR mutations: Erlotinib, marketed as Tarceva® by Genentech, Inc.; and Afatinib, marketed as Gilotrif® by Boehringher Ingelheim GmbH.

"At the time of recurrence or progression of non-small cell lung cancer, many patients may not have the option to have an assessment of EGFR mutation status because all of the original tissue biopsy material was consumed by the diagnostic testing conducted to identify the cancer. In other cases, patients may be too sick to undergo a surgical biopsy. For patient populations who are not candidates for tissue biopsy, there is a clear need for a test that enables physicians to better manage their cancer," said Raaj Trivedi, VP of Commercial Operations for Biocept. "With the addition of EGFR mutation testing to our NSCLC diagnostic capabilities, we believe we are addressing this unmet medical need by delivering diagnostic results that are comparable to those available through tissue biopsy from a simple blood test."

"With existing FDA-approved drugs on the market, every lung cancer patient should have the opportunity to have their sample tested to potentially qualify and benefit from one of these targeted therapies," said Veena Singh, M.D., Senior Medical Director of Biocept. "Our blood test, with its high level of both sensitivity and specificity, may help patients qualify for important therapeutic options when a tissue biopsy is not safe or practical. Testing for these mutations in blood is a safe and effective alternative to tissue biopsy for monitoring patients for both response and possible resistance to therapies."

Lung cancer is the leading cause of cancer-related death among men and women. According to data from the National Cancer Institute in 2013, an estimated 228,190 Americans will be diagnosed with lung cancer, and 159,480 would die from the disease. About 85 percent of lung cancers are non-small cell lung cancers (NSCLC), making it the most common type of lung cancer. EGFR gene mutations are present in the tumors of about 10 percent of NSCLC patients, with the majority of these gene mutations expressing EGFR in exon 19 deletions or exon 21 L858R substitutions.

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-GATM, OncoCEE-BRTM and OncoCEE-LUNGTM test, respectively for gastric, breast and lung cancer and plans to introduce additional CLIA validated tests for lung, colorectal, prostate and other solid tumors based on its proprietary technology platforms in the future.

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 improvement of outcomes, our impact on diagnostic strategies 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.

Reference

http://www.nejm.org/doi/full/10.1056/NEJMoa1406766

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.