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Trovagene, Inc., Achieves Intellectual Property Milestone Under License Agreement With Ipsogen

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 Guidelines TM 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.

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