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.
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."
- 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.
- Smit V, Boot A, Smits A, et al. KRAS codon 12 mutations occur very frequently in pancreatic adenocarcinomas(1988) NAR 16(16): 7773-7782.
- 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.
- 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
- 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.
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SOURCE Trovagene, Inc.