Biocept Launches its First Liquid Biopsy Diagnostic Test for Colorectal Cancer

New test uses patient’s blood sample to detect KRAS, predictive biomarker for solid tumor cancers

SAN DIEGO--()--Biocept, Inc. (NASDAQ: 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 Target Selector™ assay targeting KRAS mutations utilizing a patient's blood sample. Testing for this predictive biomarker will help physicians identify patients who might benefit from targeted therapies currently available to treat solid tumor cancers. In addition, the high sensitivity of Biocept’s Target Selector™ allows the test to be used for monitoring patients for response to treatment and progression of disease during the course of therapy.

“The ability to detect KRAS mutations could be vital in helping to diagnose these patients earlier in the diseases’ progression. The high sensitivity of our mutation test also offers an advantage in monitoring patients at high risk for disease recurrence without the use of invasive tissue biopsies.”

KRAS mutations occur in approximately 40% of patients with colorectal cancer, and have been identified in high frequency in lung, pancreatic and other solid tumor cancers. Mutations in the KRAS gene have been shown to be predictive to resistance to anti-EGFR monoclonal antibodies, such as Vectibix® (panitumumab) from Amgen Inc. and Erbitux® (cetuximab) from Eli Lilly and Company.

“Understanding a patient’s KRAS status is required to prequalify that patient for specific antibody-based targeted therapies,” said Veena Singh, MD, Biocept’s Senior Vice President and Senior Medical Director. “Additionally, disease recurrence or progression in a patient treated with an anti-cancer agent can indicate an evolution in the tumor’s mutational landscape and a change in a patient’s biomarker status. Our liquid biopsy, using a simple blood draw, enables a physician to monitor a patient’s KRAS status over time to identify these changes and respond accordingly.”

“Patients with solid tumor cancers such as lung, colorectal and pancreatic can exhibit few symptoms until the disease reaches an advanced stage,” said Lyle Arnold, Biocept’s Senior Vice President of Research and Development and Chief Scientific Officer. “The ability to detect KRAS mutations could be vital in helping to diagnose these patients earlier in the diseases’ progression. The high sensitivity of our mutation test also offers an advantage in monitoring patients at high risk for disease recurrence without the use of invasive tissue biopsies.”

About Biocept

Biocept, Inc. is a commercial-stage molecular diagnostics company that utilizes proprietary technology platforms and a standard blood sample to provide physicians with important prognostic and predictive information to enhance the 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 lung cancer, colorectal cancer, gastric cancer, breast cancer and melanoma, and 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 improvement of diagnosis outcomes and monitoring of patients, the pediatric nature of the KRAS gene, 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.

Contacts

Investor Contact:
LHA
Jody Cain
310-691-7100
jcain@lhai.com

Biocept, Inc.