SAN DIEGO, Jan. 12, 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 test that targets a region of the gene that includes T790M, a biomarker that identifies therapy-resistant tumors utilizing its proprietary Selector technology. This test will be performed at the Company's CLIA-certified and CAP-accredited laboratory and is the first of several assays the company will launch based on its proprietary Selector platform. The launch of Selector technology for ctDNA biomarker analysis from plasma in non-small cell lung cancer (NSCLC) expands Biocept's existing test menu of commercialized blood based assays for CTC capture and analysis for breast, gastric and lung cancers. The Selector technology was developed and validated by scientists at Biocept.
Approximately 20 percent of the NSCLC cases diagnosed each year are identified as EGFR-mutant, a correlation which has led to a number of targeted therapies focused on the patient population whose tumor has this mutation. These targeted therapies are known as Tyrosine Kinase Inhibitors, or TKIs. TKIs have been shown to be effective at shrinking tumors for a time, however, many patients ultimately develop resistance to EGFR-targeted TKIs because of secondary mutations such as T790M. Evaluating and monitoring for these secondary mutations in a clinical setting utilizing a blood sample could enhance the way treatment is managed. In addition to better informing clinicians when and how to treat NSCLC with TKIs, there are promising new therapies in clinical testing that target resistance alterations like T790M.
"Monitoring for EGFR resistance mutations in ctDNA from patients being treated with TKIs has the potential to dramatically change how physicians treat patients," said Veena Singh, M.D., Biocept SVP and Senior Medical Director. "High concordance when comparing tissue to blood samples demonstrates the feasibility of using this strategy in a clinical setting."
"In addition to being a noninvasive method to collect tumor related samples, blood testing could overcome the frequent obstacle of lack of sufficient tissue for molecular testing as well as issues with tumor heterogeneity. We believe these are significant advantages to our technology when testing gene mutations such as T790M," Singh said.
"We are excited to launch our first test using our proprietary Selector technology," said Lyle Arnold Ph.D., Biocept SVP and Chief Scientific Officer. "Physicians and researchers know us as a leader in CTC capture and analysis. With Selector, we can help patients by analyzing molecular biomarkers in blood from both CTCs and ctDNA found in plasma. The significant sensitivity of Selector allows us to identify these rare cancer mutations shed by the tumor into the blood, even when a large excess of normal DNA is present."
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-BR™ test for breast cancer, OncoCEE-GA™ test for gastric cancer and OncoCEE-LU™ for non-small cell lung cancer and plans to introduce CLIA validated tests for melanoma, colorectal, prostate and other solid tumors based on its proprietary technology platforms over the coming months.
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