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 News Release - July 14, 2015

Biocept Launches Diagnostic Assay for BRAF Mutations in Patients with Melanoma

New test provides physicians with a liquid biopsy option to reach informed treatment decisions for patients with mElanoma and other tumors

SAN DIEGO--(Healthcare Sales & Marketing Network)--Biocept, Inc. (BIOC), a molecular diagnostics company commercializing and developing liquid biopsies to improve the detection and treatment of cancer, today announced the launch of its proprietary, quantitative assay targeting BRAF mutations utilizing a patient's blood sample. This diagnostic assay has the potential to help physicians identify patients who might benefit from currently available targeted therapies. In addition, due to the high sensitivity of detecting BRAF mutations, Biocept’s test can be used for monitoring patients for response to treatment and for progression of disease during the course of therapy.

About half of all patients with mElanoma have changes (mutations) in the BRAF gene. These changes cause the gene to make an altered BRAF protein that signals the mElanoma cells to grow and divide quickly. Drugs such as Vemaurafenib (Zelboraf™) from Genentech and Dabarafenib (Tafinlar™) from Novartis target these mutations. BRAF gene mutations also have been demonstrated to have important implications in other solid tumors such as colon and lung cancers.

In addition to its new biomarker test for mElanoma, Biocept has commercialized blood-based tests for breast, lung and gastric cancer biomarkers. All Biocept blood-based tests provide options for healthcare providers and researchers when a tissue biopsy is not available or unsafe to perform, or when additional information is desired.

“Analysis of BRAF mutations from a blood sample allows rapid diagnosis of the BRAF V600E and V600K status in patients with advanced mElanoma and could enable therapy improvement for patients who were previously found to be negative through tissue biopsy due to tumor heterogeneity,” said Veena Singh, M.D., Biocept’s Senior Vice President and Senior Medical Director. “Our test is highly specific and sensitive and can therefore detect even low levels of mutant BRAF. This test holds promise as a therapeutic monitoring tool for patients with advanced mElanoma.”

“Due to their high sensitivity, our mutation tests offer a great advantage in assessing patients with advanced disease and provide a new tool for following patients who are likely to be at high risk for disease recurrence,” said Lyle Arnold, Ph.D., Biocept’s Senior Vice President of Research & Development and Chief Scientific Officer. “The addition of BRAF to our test menu expands the spectrum of both tumor types and relevant biomarkers we are able to detect in blood with our proprietary methods. We look to cover all guidelines-listed biomarkers that aid medical decision making and that have potential companion diagnostic value.”

Biocept plans to launch additional biomarkers for mElanoma and other solid tumors this year that physicians can use when making treatment decisions.

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 assays for mElanoma, OncoCEE-GA™ for gastric cancer, OncoCEE-BR™ for breast cancer and OncoCEE-LU™ for non-small cell lung cancer, and plans to introduce CLIA-validated tests for colorectal, 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 the potential of our diagnostic assays to help physicians identify patients who might benefit from currently available targeted therapies, 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.


Source: Biocept

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