Healthcare Industry News:  Cladribine 

Diagnostics Licensing Oncology

 News Release - September 7, 2011

TrovaGene, Inc., Announces Worldwide Exclusive Licensing of Assay for Hairy Cell Leukemia

SAN DIEGO--(Healthcare Sales & Marketing Network)-- TrovaGene, Inc. (Pink ), 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, 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.

About TrovaGene, Inc.

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).

TrovaGene is currently in the process of auditing its financial statements and preparing a Form 10 registration statement so that it can report on a current basis with the Securities and Exchange Commission. A filing is anticipated during the third quarter of 2011. More complete current information about TrovaGene will be contained in the filing.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on TrovaGene's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any medical diagnostic tests under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. TrovaGene does not undertake an obligation to update or revise any forward-looking statement.

Source: TrovaGene

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