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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.

Regarding clinical sensitivity of the PCM platform, results from a blinded retrospective study of urine samples from colorectal cancer patients were reported, which demonstrated both high sensitivity and concordance to tissue biopsies for the detection of specific KRAS mutations in urine.  Summary results from other blinded, prospective clinical studies demonstrated high clinical sensitivity for the detection of BRAF V600E mutations, with highly significant correlation between treatment responses and changes in measured levels of BRAF V600E over time from urine samples of patients with various metastatic cancer types. 

"The reported strong analytical performance of our precision monitoring platform is enabling translation to high clinical sensitivity and quantitative monitoring of tumor mutations from urine samples of cancer patients," stated Mark Erlander, Ph.D., chief scientific officer of Trovagene. "We continue to conduct clinical studies using our PCM platform through our numerous collaborations with academic medical centers and integrated healthcare networks to demonstrate utility of cell-free tumor diagnostics and to improve the standard of care for cancer patients."

About Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is leveraging its proprietary technology for the detection and monitoring of cell-free DNA in urine.  The company's technology detects and quantitates oncogene mutations in cancer patients for improved disease management. Trovagene's precision cancer monitoring platform is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property including multiple issued patents and pending patent applications globally.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on Trovagene's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or fourth party payer reimbursement; limited sales and marketing efforts and dependence upon fourth parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any medical diagnostic tests under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Trovagene does not undertake an obligation to update or revise any forward-looking statement.  Investors should read the risk factors set forth in Trovagene's Form 10-K for the year ended December 31, 2013 and other periodic reports filed with the Securities and Exchange Commission.

Trovagene ContactsInvestor RelationsMedia RelationsDavid Moskowitz and Amy Caterina

Investor RelationsIan Stone

Account DirectorTrovagene, Inc.Canale Communications, Inc.858-952-7593619-849-5388ir@trovagene.comian@canalecomm.comLogo - http://photos.prnewswire.com/prnh/20120620/LA28014LOGO


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SOURCE Trovagene, Inc.
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