TrovaGene, Inc. Announces Clinical Collaboration With Dana-Farber Cancer Institute

SAN DIEGO, June 16, 2014 /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV) today announced that it has entered into a clinical collaboration with Dana-Farber Cancer Institute to investigate the utility of quantitative urine-based mutation detection and the ability to monitor tumor mutation burden and treatment response over time in metastatic melanoma patients.

Under the agreement, urine samples will be collected from patients with locally advanced or metastatic melanoma known to harbor driver oncogene mutations. A Dana-Farber oncology team, led by Jason Luke, M.D., will conduct clinical studies designed to monitor oncogene mutations in study subjects based on urinary cell-free DNA as an analytical specimen. Studies will be designed to collect data regarding the clinical status of patients, treatment effect, and long-term outcomes of therapy using Trovagene's non-invasive molecular diagnostic technology.

"While precision cancer treatments have made significant advances, current monitoring technologies are either invasive or do not provide specific genomic information to understand how the disease is responding to treatment at the molecular level," said Dr. Luke. "Based on study data that Trovagene has presented at medical meetings thus far, we are encouraged that urinary cell-free DNA has potential to offer a non-invasive solution for tracking oncogene mutations during and after treatment, and this may help physicians improve patient outcomes."

Trovagene is engaged in numerous collaborations designed to demonstrate the clinical utility of its precision cancer monitoring platform for the detection of mutational status in cancer patients, and the assessment of tumor dynamics and treatment response over time. To date, the company has processed over 1,000 patient samples under its collaborations, and is focused on developing the clinical evidence to support broad market adoption of its technology.

Added Antonius Schuh, Ph.D., chief executive officer of Trovagene, "With this latest collaboration, we are now working with seven of the top cancer treatment centers in the United States to demonstrate the utility of our precision cancer monitoring platform and to integrate our assays into clinical practice. The Dana-Farber collaboration is initially focused on treatment of metastatic melanoma, and we are pleased to be working with Dr. Luke and his colleagues to gain greater perspective on how our non-invasive assays can impact the way this disease is managed."

About Dana-Farber Cancer Institute

Dana-Farber Cancer Institute, a principal teaching affiliate of Harvard Medical School, is world-renowned for its leadership in adult and pediatric cancer treatment and research. Designated as a comprehensive cancer center by the National Cancer Institute (NCI), it is one of the largest recipients among independent hospitals of NCI and National Institutes of Health grant funding. For more information, go to www.dana-farber.org.

About Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is leveraging its proprietary technology for the detection and monitoring of cell-free DNA and RNA 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 Contacts

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