TrovaGene licenses Hairy Cell Leukemia assay
October 2011

SAN DIEGO—TrovaGene Inc., a developer of transrenal molecular diagnostics to facilitate personalized medicine, has signed a worldwide exclusive license for an assay that detects Hairy Cell Leukemia (HCL).  
A recent discovery, published in the June 16 issue of the New England Journal of Medicine by Dr. Brunangelo Falini and colleagues at the University of Perugia in Italy, showed that a specific mutation in the BRAF gene was present in all patients with HCL in the study. TrovaGene holds exclusive rights to the discovery and will offer nonexclusive licenses for its diagnostic application.  
The results of such a test will also help physicians to monitor effectiveness of treatment and disease relapse, says TrovaGene.
"We are pleased to enter into this collaboration with Dr. Falini and his colleagues as we continue to build our franchise in the diagnosis and treatment of leukemia and lymphoma," said Dr. Tom Adams, chairman of TrovaGene, in a press release. "This new test for the diagnosis of HCL based on the identification of a specific BRAF gene mutation is unique in that it represents an objective, reproducible, specific and sensitive DNA-based test for the diagnosis of HCL. It also provides an immediate therapeutic indication for the use of available anti-B-RAF drugs."
HCL is a cancer of the bone marrow resulting in accumulation of abnormal B lymphocytes in the blood. The name stems from the hairy appearance of the abnormal B lymphocytes under a microscope, visible in about 85 percent of HCL cases.  
About 2,000 new cases of HCL diagnosed annually in the United States and Europe. Most patients are successfully treated with cladribine or pentostatin, with 80 percent of patients achieving a complete response. Patients who relapse often respond successfully to retreatment. Monitoring for relapse is typically performed by routine complete blood count, but may include bone marrow testing.  
Headquartered in San Diego, California, TrovaGene has focused on development of tests using its patented technology to detect transrenal DNA and RNA, short nucleic acid fragments from normal and diseased cell death that cross the kidney barrier and can be detected in urine.  
TrovaGene has a dominant patent position as relates to transrenal molecular testing. It has U.S. and European patent applications and issued patents that cover testing for HPV and other infectious diseases, cancer, transplantation, prenatal and genetic testing. In addition, it owns worldwide rights to nucleophosmin-1 (NPM1), an informative biomarker for acute myeloid leukemia (AML).

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