Duke Obtains License to Trovagene’s Leukemia Dx

Trovagene granted Duke University and Duke University Health Systems a nonexclusive license to incorporate nucleophosmin protein (NPM1) into research and clinical testing services for acute myelogenous leukemia (AML).

Mutations in an NPM1 gene are characteristic of 30% to 40% of the cases of AML, according to Trovagene. NPM1 is a protein involved in regulation of ribosome biogenesis, cell division, cell death, and other important processes, the firm explains.

“Use of NPM1 is part of the NCCN guidelines for the treatment of AML,” says Antonius Schuh, Ph.D., CEO. “Clinical and academic laboratories are increasingly interested in licensing this assay so they can offer it directly to their physicians for use in patient care.”

Within the U.S., 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 Quest Diagnostics, LabCorp, Fairview Health Services, and Invivoscribe Technologies. Internationally, license holders include Münchner Leukamielabor 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 and Ipsogen.

Trovagene, which changed its name from Xenomics in 2010, made its AML test available to clinicians in August of 2007. Less than three months later, the firm granted Asuragen co-exclusive, worldwide rights to incorporate NPM1 technology into Asuragen’s molecular diagnostic products. The following year, Xenomics granted Warnex Medical Laboratories a nonexclusive license in Canada to offer NPM1 testing.