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TrovaGene, Inc. Obtains Exclusive License to Novel Mutations Associated with Prognosis and Chemotherapy Response in Leukemia

SAN DIEGO, Jan. 3, 2012 /PRNewswire/ -- TrovaGene, Inc. (Pink Sheets: TROV), a developer of trans-renal molecular diagnostics,  today announced that it has obtained an exclusive worldwide license to mutations of the SF3B1 splicing factor, which have been shown to be associated with disease progression and chemotherapy response in patients suffering from chronic lymphocytic leukemia (CLL).

The findings have been published in the Dec 22 issue of BLOOD, the journal of the American Society of Hematology, in an article titled "Mutations of the SF3B1 splicing factor in chronic lymphocytic leukemia: association with progression and fludarabine-refractoriness" (Rossi D. et al., Blood 118:6904-6908, 2011). A US patent application is pending.

Research results suggest that SF3B1 mutations represent important incremental diagnostic markers beyond TP53 disruptions and NOTCH1 mutations in CLL patients, and may also provide a therapeutic target for SF3B1 inhibitors, which are currently in pre-clinical development. Gianluca Gaidano and Davide Rossi at the Amedeo Avogadro University (Novara, Italy), lead the research team, in collaboration with their colleague Roberto Foa at the Sapienza University (Rome, Italy) that discovered the SF3B1 mutations.

"Since CLL is the most frequent type of leukemia in adults, the discovery of SF3B1 mutations in this disease will affect a large number of patients worldwide. In particular, SF3B1 mutations may contribute to the early identification of patients destined to fail standard treatment, who instead might benefit from more aggressive therapeutic strategies. Future goals in SF3B1 research include the development of a robust molecular assay for diagnosis, and the exploitation of SF3B1 as a therapeutic target for this leukemia," stated Gianluca Gaidano.

TrovaGene has been building a franchise of proprietary markers in hematological oncology, including mutations in the nucleophosmin gene (NPM1), which are today widely used in the diagnosis of acute myeloid leukemia (AML), and the BRAF V600E mutation for diagnostic use in hairy cell leukemia (HCL).

"We believe that SF3B1 mutations have the potential to become key components of standard diagnostic panels with clinical utility in the management of patients suffering from CLL," states Antonius Schuh, TrovaGene's Chief Executive Officer. "We plan to offer laboratory-developed tests to detect SF3B1 mutations and to identify opportunities for the development of in-vitro diagnostic products incorporating our proprietary markers."

About TrovaGene, Inc.
Headquartered in San Diego, California, TrovaGene has focused on the development of its patented technology for the detection of transrenal DNA and RNA, short nucleic acid fragments, originating 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. TrovaGene 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 has filed a Form 10 with the SEC. More complete current information about TrovaGene is 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.

Venanzio Ciampa
+1 (212) 217 9065

SOURCE Trovagene, Inc.
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