TrovaGene Inc. has signed a worldwide exclusive license for an assay that detects Hairy Cell Leukemia (HCL).

A recent discovery, published in the June 16, 2011, New England Journal of Medicine by Dr. Brunangelo Falini and colleagues, 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.

"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. "This new test for the diagnosis of Hairy Cell Leukemia (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. There are about 2,000 new cases of HCL diagnosed annually in the U.S. and Europe. Most patients are successfully treated with cladribine or pentostatin with 80% 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 (CBC) but may include bone marrow testing. The name stems from the hairy appearance of the abnormal B lymphocytes under a microscope, visible in about 85% of HCL cases.