Trovagene is developing its patented technology for the detection of transrenal DNA and RNA, short nucleic acid fragments, originating from normal and diseased cell deaths that cross the kidney barrier and can be detected in urine. The company is leveraging its intellectual property through out-licensing agreements.
The company today announced that it has received a milestone payment from Ipsogen S.A., a subsidiary of Qiagen N.V. (Nasdaq: QGEN). 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 payment was triggered by issuance of U.S. Patent 8,222,370 that is part of a family of patents filed by Trovagene around nucleophosmin protein that cover NPM1 mutations in 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. But in nearly half the cases, the chromosomes appear normal and provide no guidance to doctors. However, 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 that these mutations are a marker for more favorable clinical outcomes.
The National Comprehensive Cancer Network, which sets clinical standards for cancer treatment, has now included testing for NPM mutations in their clinical practice guidelines. To date, it has granted nonexclusive sublicenses to offer mutation analysis of NPM1 as a laboratory service to Laboratory Corporation of America Holdings, InVivoScribe Technologies, Warnex Medical Laboratories, Fairview Health Services of Minneapolis, Minnesota, and Munchner Leukamielabor GmbH in Munich, Germany. The company also has granted co-exclusive licenses to manufacture and sell NPM1 mutation assays to Ipsogen and Asuragen, Inc.
For additional information about Trovagene and its intellectual property, please visit the company's website at www.trovagene.com
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