Trovagene, Inc., a developer of cell-free molecular diagnostics, has received the key US Patent No. 8,501,924, covering "Nucleophosmin protein (NPM) mutants, corresponding gene sequences and uses thereof." The patent pertains to nucleic acid sequences encoding NPM mutants and methods of detecting them for diagnosing acute myeloid leukaemia (AML) and monitoring residual AML disease.

This is the second issued US patent directed to NPM mutants, and is part of a NPM-associated family of patents and applications for Trovagene. Previously, Trovagene announced issuance of US Patent 8,222,370, the first patent to issue in the US. Additional claims directed to detecting NPM mutations are pending in the US and abroad.

"While the NPM patent family is an asset that has value as an incremental revenue stream, Trovagene continues to develop its cell-free molecular diagnostic tests for cancer monitoring," states Antonius Schuh, Ph.D., chief executive officer of Trovagene.  "Currently, Trovagene has licensing programs with multiple organizations including Labcorp, Quest Labs, Genoptix, Duke University and others. We intend to continue to develop additional licensing relationships that can add supplemental value."

The National Comprehensive Cancer Network, which sets clinical standards for cancer treatment, has included testing for NPM mutations in their clinical practice guidelines. Mutation analysis of nucleophosmin-1 (NPM1) 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 is leveraging its patented technology for the detection of cell-free DNA and RNA, short nucleic acid fragments, originating from normal and diseased cell death that can be isolated and detected from urine.