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ApoCell, Inc. announced that it has been awarded a two-year Small Business Innovation Research (SBIR) Phase II contract from the National Cancer Institute (NCI) for the further development of its ApoStream® technology as a point-of-care (POC) clinical device to isolate circulating tumor cells (CTCs) from human blood. The $1 million provided by the NCI under this Phase II program will cover 100% of the project costs. Isolating CTCs from a small sample of a patient's whole blood enables downstream biomarker and molecular analysis that can provide information for cancer diagnosis and treatment decisions.

Houston-based ApoCell was invited to apply for this latest grant after successfully completing its SBIR Phase I contract which included investigation and demonstration of the potential to use the ApoStream® technology in a POC setting.

CTCs have long been known to exist in cancer patients' blood and clinical correlations have been established between CTC counts and disease progression. These circulating cells represent an increasingly attractive target for clinicians seeking to assess a patient's disease state; however, the clinical promise of CTCs has yet to be fully realized because they are difficult to isolate using the commercially available technologies. ApoStream® utilizes antibody-independent dielectrophoresis (DEP) in a continuous flow process, to enrich significant quantities of intact CTCs from a wide range of cancer types, enabling more robust downstream analysis for greater understanding of each patient's disease. The company plans to commercially launch the technology for research-use-only in 2014 and as a point-of-care clinical device in 2016.

"This SBIR Phase II funding will significantly enhance our progress in developing ApoStream® as a point-of-care clinical device," said Darren Davis, president and CEO of ApoCell. "We believe the device, which uses an antibody-independent isolation process, can play a significant role in the evolution of personalized cancer treatment through the downstream analysis of a patient's CTCs."

Davis said the latest SBIR funding will support research and development efforts that include enhancing ApoStream®'s ease of use, overall system performance and further automation of quality control.

The SBIR Phase II funding will also support further research to demonstrate clinical utility through the detection of gene mutation in CTCs collected from the blood samples of non-small cell lung cancer patients. A study co-authored by investigators from University of Texas M.D. Anderson Cancer Center, and presented by poster at the 2013 ASCO annual meeting, utilized ApoStream® technology in isolating CTCs from 32 non-small cell lung cancer patients and 3 healthy volunteers to identify and characterize specific EGFR mutations, with the goal of determining the concordance of mutations between blood and tumor tissue.

A leader in molecular biomarker detection and analysis, ApoCell has been using ApoStream® technology since 2010 in its own laboratories and has incorporated it into 20 early and late stage clinical trials as part of the company's service offering.

For more information on ApoStream technology and ApoCell, visit www.apocell.com.

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