Trovagene completes PCR assay development for detection of K-RAS mutations

Trovagene, Inc. (Pink Sheets:   TROV.PK), a developer of trans-renal molecular diagnostics, announced today that the Company has successfully completed the analytical development of digital PCR assays for the detection of the most prevalent K-RAS mutations, which are, according to recent estimates, observed in more than 90% of pancreatic cancers, and in 23% of all solid tumors. The Company intends to establish and validate the performance of these assays for the detection of K-RAS mutations in the urine of pancreatic cancer patients.

Earlier published work by scientific collaborators of the Company has demonstrated that K-RAS mutations can be more reliably detected in urine, when compared to plasma or biopsy material. Next generation digital PCR platforms now enable the design of oncogene mutation assays which are compatible with the throughput and reliability requirements of a clinical-diagnostic laboratory at acceptable cost levels.

Dr. Riccardo Dalla-Favera, Director of the Institute of Cancer Genetics at Columbia University Medical Center and a member of the Company's Scientific Advisory Board, comments: "The ability to detect K-RAS mutations in urine holds the promise of a non-invasive method for the early detection of pancreatic cancer, which is currently not available to clinicians and patients."

"The detection of oncogene mutations from urine could eventually lead to a comprehensive platform for monitoring minimal residual disease and progression of disease in oncology, and also for the early detection of cancer," stated Antonius Schuh, Ph.D., Trovagene's CEO. "Clinical utility of and clinical need for such a platform would be highly significant," he added.

The Company plans to enter into collaborative agreements, providing access to patient samples, with leading endocrine oncology clinical sites in the U.S. by June 2012.