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TrovaGene, Inc., Achieves Intellectual Property Milestone Under License Agreement with Ipsogen


8/29/2012 10:00:34 AM

SAN DIEGO, Aug. 29, 2012 /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV), a developer of transrenal molecular diagnostics, today announced that it has received a milestone payment from Ipsogen S.A., a subsidiary of the QIAGEN group. This payment comes from a co-exclusive license agreement to manufacture and sell diagnostic kits for the detection of nucleophosmin protein (NPM1) mutations in patients with acute myeloid leukemia (AML). The milestone payment was triggered by issuance of U.S. Patent 8,222,370, titled "Nucleophosmin protein (NPM) mutants, corresponding gene sequences and uses thereof." This patent is part of a family of filed patents for Trovagene around NPM that cover the diagnostic use of NPM1 mutations in AML.

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

"Trovagene is continuing to expand its commercial activity through its CLIA lab offerings and through external licensing opportunities," said Antonius Schuh, chief executive officer of Trovagene. "Ipsogen and Qiagen are leaders in the field of molecular diagnostics, and we are pleased to be partnering with them to help patients with AML."

AML is a clinically heterogeneous disease with about 200,000 new cases per year worldwide. Subgrouping of AML patients using chromosomal abnormalities provides for more individualized patient prognosis. However, in almost half of AML cases the chromosomes appear normal and provide no guidance for the physician. A discovery by Drs. Brunangelo Falini and Cristina 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 GuidelinesTM 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 US patent 8,222,370 and the corresponding group of U.S. and foreign patent applications. To date, Trovagene has granted nonexclusive sublicenses to offer mutation analysis of NPM1 as a laboratory service for the diagnosis and monitoring of patients with AML to Fairview Health Services of Minneapolis, MN; Münchner Leukamielabor GmbH (MLL) in Munich, Germany; Laboratory Corporation of America® Holdings (LabCorp®); InVivoScribe Technologies; and Warnex Medical Laboratories; and co-exclusive licenses to manufacture and sell NPM1 mutation assays to Ipsogen S.A. and Asuragen, Inc.

Laboratories interested in obtaining a license for testing NPM1 mutations for AML patients 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 is leveraging its intellectual property in oncogene mutations via out-licensing and use of Trovagene's transrenal technologies to extend oncogene mutation detection using urine as a sample. As a non-invasive and abundant sample, urine may overcome many of the cost and collection challenges presented by biopsy, as well as the volume limitations of blood.

Trovagene has a strong 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 chronic lymphocytic leukemia (CLL) 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

SOURCE Trovagene, Inc.



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