Practical Clinical Benefits of Trovagene's Urine-Based Liquid Biopsy Platform Demonstrated in Field Experience Analysis

Consistent with prior clinical study results, non-invasive laboratory test is effective in determining mutational status

Oct 08, 2015, 16:05 ET from Trovagene, Inc.

SAN DIEGO, Oct. 8, 2015 /PRNewswire/ -- Trovagene, Inc., (NASDAQ:   TROV) a developer of cell-free molecular diagnostics, today announced the presentation of results from a field experience analysis featuring the use of its Precision Cancer MonitoringSM (PCM) platform to accurately identify mutational status, which can be critical for physicians to determine appropriate therapy for patients. Mark Erlander, Ph.D. chief scientific officer of Trovagene is delivering the results today in an oral presentation titled CLIA Laboratory Testing of Urinary BRAF V600E DNA mutations: Application in the Management of Patients with Histiocytic Diseases at the 3rd Annual Erdheim-Chester International Medical Symposium, MD Anderson Cancer Center in Houston, Texas.

"The ability to quickly and accurately determine BRAF mutational status is very important to our patients with histiocytic disease when assessing therapeutic options," stated Filip Janku, M.D. Ph.D., of the University of Texas MD Anderson Cancer Center. "In patients that test positive for the mutation, the use of a BRAF inhibitor can offer a prolonged benefit that significantly improves their quality of life. We are encouraged by the recent advances in molecular diagnostic testing that can enable fast, accurate and non-invasive testing for our patients."

"These data again demonstrate the ability of our urinary liquid biopsy platform to determine and monitor mutational status in patients when tissue biopsy is either inconclusive or unavailable," stated Antonius Schuh, Ph.D., chief executive officer of Trovagene. "We are pleased to support the underserved histiocytic patient population for whom determining BRAF mutational status can be critical for therapeutic selection and improving treatment outcomes."   

In October 2014, results from a blinded prospective clinical study were first published in the medical journal Cancer Discovery demonstrating that analysis of circulating tumor DNA from urine provides a convenient and reliable method to detect the presence of the BRAF V600E mutation and to monitor mutational load repeatedly for assessment of treatment response.

Trovagene's PCM BRAF V600E Mutation Detection Test is now available to healthcare providers for patient testing. Physicians interested in utilizing this test should contact Client Services at 888-391-7992. For more information, please visit www.trovagene.com/BRAF.

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 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, 2014 and other periodic reports filed with the Securities and Exchange Commission.

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Ian Stone

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Trovagene, Inc.


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SOURCE Trovagene, Inc.



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