Trovagene to Study Trans-Renal KRAS Mutation Detection in Pancreatic Cancer Study will compare detection of KRAS mutations in urine to their detection in biopsy samples

SAN DIEGO, July 3, 2012 /PRNewswire/ -- Trovagene, Inc. (Nasdaq:  TROV), a developer of trans-renal molecular diagnostics, announced today that they will be collaborating with The University of Texas MD Anderson Cancer Center on the detection of transrenal KRAS mutations in the urine of patients with pancreatic cancer.

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According to recent estimates KRAS mutations are present in more than 90% of pancreatic cancers (1-3), and in 23% of all cancer tissue samples examined by the Sanger Centre (4). An earlier publication in this field used a complicated two-stage PCR assay to detect KRAS mutations in the urine of patients with pancreatic carcinomas (5). Recently, Trovagene successfully completed the analytical development of digital PCR assays for the detection of the most prevalent KRAS mutations, including ones that account for approximately 95% of the KRAS mutations found in pancreatic adenocarcinomas, the most common form of pancreatic cancer. 

Matthew H. Katz, MD, FACS, who will lead the study for MD Anderson, said, "We are pleased to begin this study to detect KRAS mutations in the urine of patients with pancreatic cancer. We will also determine the KRAS mutation status from biopsies taken from the same patients. This will allow an early comparison of mutation detection using biopsy, which samples only a portion of a tumor, with detection using urine, a systemic sampling of the patient."

"The reliable detection and quantification of both KRAS mutations and wild type molecules from urine could eventually lead to a sensitive method for staging tumors before treatment and detecting minimal residual disease after treatment," said Dr. Charlie Rodi, chief technology officer at Trovagene. He added, "The volume of urine that can be collected far outstrips what is available by biopsy or even through blood collection; this may significantly improve detection. In addition, urine is a truly non-invasive sample that could greatly simplify patient monitoring in the future."

  1. Almoguera C, Shibata D, Forrester K, et al. Most human carcinomas of the exocrine pancreas contain mutant c-K-ras genes (1998) Cell  53: 549-554.
  2. Smit V, Boot A, Smits A, et al. KRAS codon 12 mutations occur very frequently in pancreatic adenocarcinomas(1988) NAR  16(16): 7773-7782.
  3. Zhang C, Guo W, Wu J, et al. Differential high-resolution melting analysis for the detection of K-ras codons 12 and 13 mutations in pancreatic cancer (2011) Pancreas 40(8): 1283-1288.
  4. Prevalence of KRAS mutations in various cancers. Sanger COSMIC site. http://www.sanger.ac.uk/perl/genetics/CGP/cosmic?action=bygene&ln=KRAS&start=1&end=189&coords=AA:AA  
  5. Botezatu I, Serdyuk O, Potapova G, et al. Genetic analysis of DNA excreted in urine: a new approach for detecting specific genomic DNA sequences from cells dying in an organism (2000) Clinical Chemistry 46(8): 1078-1084.

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 has a dominant 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 CLL (chronic lymphocytic leukemia) 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.

Contacts
Trovagene, Inc.
Keith McCormick
VP, Commercial Operations
+1 (858) 952-7640
kmccormick@trovagene.com
http://www.trovagene.com

SOURCE Trovagene, Inc.



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