SAN DIEGO—TrovaGene Inc., a developer of transrenalmolecular diagnostics to facilitate personalized medicine, has signed aworldwide exclusive license for an assay that detects Hairy Cell Leukemia(HCL).
A recent discovery, published in the June 16 issue of the NewEngland Journal of Medicine by Dr.Brunangelo Falini and colleagues at the University of Perugia in Italy, showedthat a specific mutation in the BRAF gene was present in all patients with HCLin the study. TrovaGene holds exclusive rights to the discovery and will offernonexclusive licenses for its diagnostic application.
The results of such a test will also help physicians tomonitor 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 thediagnosis and treatment of leukemia and lymphoma," said Dr. Tom Adams, chairmanof TrovaGene, in a press release. "This new test for the diagnosis of HCL basedon the identification of a specific BRAF gene mutation is unique in that itrepresents an objective, reproducible, specific and sensitive DNA-based testfor the diagnosis of HCL. It also provides an immediate therapeutic indicationfor the use of available anti-B-RAF drugs." HCL is a cancer of the bone marrow resulting in accumulationof abnormal B lymphocytes in the blood. The name stems from the hairyappearance of the abnormal B lymphocytes under a microscope, visible in about85 percent of HCL cases.
About 2,000 new cases of HCL diagnosed annually in theUnited States and Europe. Most patients are successfully treated withcladribine or pentostatin, with 80 percent of patients achieving a completeresponse. 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 hasfocused on development of tests using its patented technology to detecttransrenal DNA and RNA, short nucleic acid fragments from normal and diseasedcell death that cross the kidney barrier and can be detected in urine.
TrovaGene has a dominant patent position as relates totransrenal molecular testing. It has U.S. and European patent applications andissued patents that cover testing for HPV and other infectious diseases,cancer, transplantation, prenatal and genetic testing. In addition, it ownsworldwide rights to nucleophosmin-1 (NPM1), an informative biomarker for acutemyeloid leukemia (AML).
