Trovagene, Inc. announced the presentation of results from two clinical studies at the 2015 Gastrointestinal Cancer Symposium (also known as ASCO GI) held in San Francisco, CA. Results demonstrate the ability of the Company's Precision Cancer MonitoringSM platform to detect and quantitate KRAS mutations at diagnosis and longitudinally in cell-free DNA (cfDNA) obtained from colorectal and pancreatic cancer patients. In this study, archived, matched plasma and urine samples, stored between 3-5 years prior to circulating tumor DNA extraction, from 20 Stage I-IV colorectal cancer patients with known KRAS mutations in tumor tissue were used in a retrospective setting for a blinded pilot study.

The majority of patients in the study underwent surgery for primary tumor and/or liver metastases and received neo-adjuvant or adjuvant therapy. The company's platform technology, specifically its quantitative KRAS mutation assay, was used to analyze patient specimens and compare KRAS mutational status in urine, blood, and tissue samples, and to monitor KRAS burden in response to therapy. Results showed high concordance in KRAS detection between plasma and tissue, and between urine and tissue.

Dynamic changes in KRAS mutational burden were highly correlated to response from both surgical and chemotherapeutic treatment. By tracking the mutational status of advanced colorectal cancer patients post-surgery, clinicians can rapidly determine the surgery outcome and monitor the effectiveness of a subsequent therapy, said study investigator, Lucie Benesova, Ph.D., science director at the Center for Applied Genomics of Solid Tumors, Genomac Research Institute in Prague, Czech Republic. Trovagene's assay has potential to provide this information, which can be critical in selecting the best follow up care for patients that have undergone this procedure.