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Highly Sensitive and Quantitative Analytical Performance is Translational for Clinical Utility of Cell-Free Tumor DNA Diagnostics
Date:8/26/2014

WASHINGTON, Aug. 26, 2014 /PRNewswire/ -- Trovagene, Inc. (NASDAQ:  TROV) presented data at the Next Generation Dx Summit; Moving Assays to the Clinic with an oral presentation entitled "Targeted Detection and Monitoring of Cell Free Tumor DNA in Urine." In this presentation Trovagene reported the analytical component of its Precision Cancer Monitoring (PCM) platform and results from several studies demonstrating high clinical sensitivity for the detection of tumor DNA mutations from urine samples of cancer patients.  The PCM platform uses a proprietary urinary DNA extraction process and mutant tumor DNA enrichment methodologies coupled to next generation sequencing and proprietary bio-informatic analyses.  The PCM platform enables translational studies for the demonstration of high clinical sensitivity, quantitative assessment of mutational copy levels and subsequent utility for urinary-based cell-free tumor DNA diagnostics.

Specifically, the analytical component of the PCM platform is compatible with highly degraded DNA, a common characteristic of both plasma and urine-based cell-free tumor DNA.  The compatibility of the PCM platform with highly degraded DNA was demonstrated by targeting extremely short DNA fragments and achieving single copy tumor mutation detection, as reported for KRAS mutations within the oral presentation.  High analytical sensitivity and the ability to obtain large amounts of cell-free DNA from patient urinary samples increases the ability to observe a single mutant tumor DNA fragment within a large background of non-mutated cell free DNA.  This results in significantly enhanced clinical sensitivity for the detection of tumor mutations from urine samples of cancer patients.  In addition, a bio-informatic approach was described, demonstrating quantitative output for tracking of changes in tumor mutation copy numbers in a patient over time.

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SOURCE Trovagene, Inc.
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