Trovagene, Inc. has granted a worldwide, non-exclusive license to incorporate nucleophosmin protein (NPM1) into research and clinical testing services for acute myelogenous leukaemia (AML) to  Genoptix, Inc. (a Novartis Group Company).

Trovagene holds an exclusive worldwide license to US patent 8,222,370 and the corresponding group of US and foreign patent applications around NPM1. Terms of the agreement include upfront fees and royalty payments. Additional financial terms were not disclosed.

"Trovagene is pleased to add Genoptix to its list of worldwide licensees of the NPM1 marker," said Antonius Schuh,  chief executive officer for Trovagene.  "Genoptix is one of the leading haematopathology laboratories in the country, and understands NPM1's value as a prognostic marker for treatment planning and patient counselling." Testing for NPM1 mutations is recommended by the National Comprehensive Cancer Network, which sets clinical treatment standards for a wide variety of cancers.

Within the United States, Trovagene has granted non-exclusive sublicenses to offer mutation analysis of NPM1 as a laboratory service for the diagnosis and monitoring of patients with AML to Quest Diagnostics, LabCorp, Fairview Health Services and Invivoscribe Technologies; internationally, license holders include Münchner Leukamielabor GmbH (MLL) in Munich, Germany and Skyline Labs in the Netherlands. In addition, Trovagene has granted a co-exclusive license to manufacture and sell NPM1 mutation kits to Asuragen, Inc. and Ipsogen SA.

AML is a clinically heterogeneous disease that affects patients worldwide.  About 13,000 new cases per year occur in the U.S., and nearly 9,000 patients die from the disease annually. Chromosome analysis of leukaemia cells provides valuable prognostic information for physicians treating AML patients. Mutations involving the NPM1 gene are the most frequent molecular alteration in AML patients with normal chromosomes, accounting for nearly one-third of adult AML cases.  AML patients with isolated NPM1 mutations have been shown to have better responses to induction chemotherapy and a more favourable overall prognosis.

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.