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Trovagene, Inc., Grants License for NPM1 Marker to Quest Diagnostics for Acute Myelogenous Leukemia

9/13/2012
Trovagene, Inc. granted Quest Diagnostics, the world’s leading provider of diagnostic testing, information and services, a non-exclusive license to incorporate nucleophosmin protein (NPM1) into research and clinical testing services related to acute myelogenous leukemia (AML). 
 
SAN DIEGO, September 13, 2012  -- Trovagene, Inc. (NASDAQ: TROV), a developer of transrenal molecular diagnostics, announced it has granted Quest Diagnostics, the world’s leading provider of diagnostic testing, information and services, a non-exclusive license to incorporate nucleophosmin protein (NPM1) into research and clinical testing services related to acute myelogenous leukemia (AML). Trovagene holds an exclusive worldwide license to US patent 8,222,370 and the corresponding group of U.S. and foreign patent applications around NPM. Terms of the agreement include upfront fees and royalty payments on an annual basis. Additional terms were not disclosed.
 
"Trovagene continues to expand patient access to the NPM1 marker worldwide," said Charlie Rodi, Ph.D., chief technology officer for Trovagene. "Physicians need accurate tools to assess prognosis, select therapies and evaluate for bone marrow transplant. Use of this marker can help physicians more effectively treat patients with AML."
 
AML is a clinically heterogeneous disease that affects patients worldwide.  About 13,000 new cases a year occur in the U.S., and nearly 9,000 patients die from the disease annually. Chromosome analysis provides valuable prognostic information for physicians treating AML patients when abnormalities are present. However, in almost half of AML cases the chromosomes appear normal and provide no guidance for the physician. Many AML patients have mutations in the NPM1 gene.  These patients have been shown to have more favorable outcomes. Testing for NPM1 mutations is recommended by the National Comprehensive Cancer Network (www.nccn.org), which sets clinical treatment standards for a wide variety of cancers.
 
About Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is developing 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 is leveraging its intellectual property in oncogene mutations via out-licensing and use of Trovagene’s transrenal technologies to extend oncogene mutation detection using urine as a sample.  As a non-invasive and abundant sample, urine may overcome many of the cost and collection challenges presented by biopsy, as well as the volume limitations of blood.
Trovagene has a strong patent position as it 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) and mutations in the SF3B1 gene, which have been shown to be associated with chemotherapy response in chronic lymphocytic leukemia (CLL) patients.
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.  Investors should read the risk factors set forth in Trovagene's Form 10-K for the year ended December 31, 2011 and other periodic reports filed with the Securities and Exchange Commission.
Quest Diagnostics is a registered trademark of Quest Diagnostics. 
All other trademarks are the property of respective third parties.

Contact

Trovagene, Inc.
Keith McCormick
VP, Commercial Operations
+1 (858) 952-7640
kmccormick@trovagene.com
www.trovagene.com
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Amy Caterina
Investor Relations


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