SAN DIEGO, Sept. 25, 2013 /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, announced the issuance of U.S. Patent 8,501,924, "Nucleophosmin protein (NPM) mutants, corresponding gene sequences and uses thereof." The patent pertains to nucleic acid sequences encoding NPM mutants and methods of detecting them for diagnosing acute myeloid leukemia (AML) and monitoring residual AML disease. This is the second issued U.S. patent directed to NPM mutants, and is part of a NPM-associated family of patents and applications for Trovagene. Previously, Trovagene announced issuance of U.S. Patent 8,222,370, the first patent to issue in the U.S. Additional claims directed to detecting NPM mutations are pending in the U.S. and abroad.
"While the NPM patent family is an asset that has value as an incremental revenue stream, Trovagene continues to develop its cell-free molecular diagnostic tests for cancer monitoring," states Antonius Schuh, Ph.D., chief executive officer of Trovagene. "Currently, Trovagene has licensing programs with multiple organizations including Labcorp, Quest Labs, Genoptix, Duke University and others. We intend to continue to develop additional licensing relationships that can add supplemental value."
The National Comprehensive Cancer Network (www.nccn.org), which sets clinical standards for cancer treatment, has included testing for NPM mutations in their clinical practice guidelines. Mutation analysis of nucleophosmin-1 (NPM1) helps physicians to select more appropriate treatment strategies for AML patients. NPM1 testing may also be useful for monitoring the effectiveness of treatment, minimal residual disease monitoring and detecting relapse, and stratifying AML patients when enrolling in clinical trials.
About Trovagene, Inc.
Headquartered in San Diego, California, Trovagene is leveraging its patented technology for the detection of cell-free DNA and RNA, short nucleic acid fragments, originating from normal and diseased cell death that can be isolated and detected from urine. Trovagene has a strong intellectual property asset as it relates to cell-free DNA and RNA testing in urine. 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.
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 fourth party payer reimbursement; limited sales and marketing efforts and dependence upon fourth 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, 2012 and other periodic reports filed with the Securities and Exchange Commission.
Chief Financial Officer
SOURCE Trovagene, Inc.