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TrovaGene, Inc. Announces Pharmaceutical Collaboration for Oncogene Mutation Detection Study



10/16/2013 8:59:25 AM

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SAN DIEGO, Calif., Oct. 16, 2013 /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, today announced that it will collaborate with a pharmaceutical company to evaluate Trovagene's proprietary, urine-based, cell-free DNA technology for the detection of certain epidermal growth factor receptor (EGFR) mutations associated with lung cancer.

(Logo: http://photos.prnewswire.com/prnh/20120620/LA28014LOGO)

"We are pleased to launch a pharmaceutical clinical study collaboration to further evaluate the use of cell-free DNA in urine as a systemic sample for monitoring of individual patients' mutational status," said Antonius Schuh, Ph.D., chief executive officer of Trovagene. "The ability to non-invasively monitor real-time EGFR mutations changes in lung cancer patients represents the potential to obtain greater guidance for treatment decisions."

Lung cancer is the most prevalent cancer in the United States, with more than 225,000 new cases diagnosed annually. EGFR mutations are present in 10 to 35 percent of lung cancers, and these mutations frequently occur during the course of therapy, affecting response to treatment and/or prognosis.

"This study will help us further evaluate Trovagene's technology as an alternative for mutation monitoring in lung cancer, where tissue biopsies are often challenging to obtain," said Mark Erlander, chief scientific officer of Trovagene.

Trovagene is committed to a clinical study program with the objective to demonstrate that cell-free DNA specimens from urine samples provide an effective and reliable alternative to monitoring patients' therapeutic response and the emergence of drug-resistance mutations, thereby offering the potential to improve outcomes and patient care.

About Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is leveraging its patented technology for the detection of cell-free DNA and RNA, short nucleic acid fragments, originating from normal and diseased cell death that can be isolated and detected from urine. Trovagene has a strong intellectual property asset as it relates to cell-free DNA and RNA testing in urine. It has U.S. and European patent applications and issued patents that cover testing for HPV and other infectious diseases, cancer, transplantation, prenatal and genetic testing.

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; 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, 2012 and other periodic reports filed with the Securities and Exchange Commission.

Contact:

Trovagene, Inc.

Amy Caterina
Investor Relations
Trovagene, Inc.
858-952-7593
acaterina@trovagene.com

SOURCE Trovagene, Inc.



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