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Trovagene, Inc., Announces Issuance of U.S. Patent for NPM Mutants to Diagnose and Monitor Acute Myeloid Leukemia
Date:7/18/2012

SAN DIEGO, July 18, 2012 /PRNewswire/ -- Trovagene, Inc. (Nasdaq:  TROV), a developer of transrenal molecular diagnostics, received notice of U.S. Patent 8,222,370, titled "Nucleophosmin protein (NPM) mutants, corresponding gene sequences and uses thereof."  This is the first U.S. patent issued around this mutation, and is part of a family of filed patents for Trovagene around NPM. Mutation analysis of nucleophosmin-1 (NPM1) is currently used for the diagnosis, stratification and monitoring of patients with acute myeloid leukemia (AML). 

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AML is a clinically heterogeneous disease with about 200,000 new cases per year worldwide. Subgrouping of AML patients using karyotypic abnormalities provides for more individualized patient prognosis. However, in almost half of AML cases the karyotype appears normal and provides no guidance for the physician. A discovery by Drs. Falini and Mecucci, at the Institute of Hematology at the University of Perugia in Italy, showed that many AML patients have mutations in the NPM1 gene, and these mutations are a marker for more favorable clinical outcomes.

The National Comprehensive Cancer Network (www.nccn.org), which sets clinical standards for cancer treatment, has included testing for NPM mutations in their clinical practice guidelines (NCCN Guidelines™ Version 2.2011 – Acute Myeloid Leukemia). NPM1 mutation analysis helps physicians to select more appropriate treatment strategies for AML patients. NPM1 testing may also be useful for monitoring the effectiveness of treatment, minimal residual disease monitoring and detecting relapse, and stratifying AML patients when enrolling in clinical trials.

Trovagene holds an exclusive worldwide license to the patent.  To date, the Company has granted nonexclusive sublicenses to offer mutation analysis of NPM1 as a laboratory service for the diagnosis, stratification and monitoring of patients with AML to Fairview Health Services of Minneapolis, MN, and to Munchner Leukamielabor GmbH (MLL) in Munich, Germany. In 2008, the Company granted nonexclusive license rights to Laboratory Corporation of America® Holdings (LabCorp®), InVivoScribe Technologies, and Warnex Medical Laboratories. Laboratories interested in obtaining a license should contact Trovagene directly.

About Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is developing its patented technology for the detection of transrenal DNA and RNA, short nucleic acid fragments, originating from normal and diseased cell death that cross the kidney barrier and can be detected in urine.

Trovagene has a dominant patent position as it relates to transrenal molecular testing. 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. In addition, it owns worldwide rights to nucleophosmin-1 (NPM1), an informative biomarker for acute myeloid leukemia (AML) and mutations in the SF3B1 gene, which have been shown to be associated with chemotherapy response in CLL (chronic lymphocytic leukemia) patients.

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 third party payer reimbursement; limited sales and marketing efforts and dependence upon third 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, 2011 and other periodic reports filed with the Securities and Exchange Commission.

Contact

Trovagene, Inc.
Keith McCormick
VP, Commercial Operations
+1 (858) 952-7640
kmccormick@trovagene.com
www.trovagene.com


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SOURCE Trovagene, Inc.
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