Trovagene, Inc., has announced the results of its clinical study evaluating the capacity of the company’s Precision Cancer Monitoring technology to detect and quantify KRAS mutations in the blood and urine of patients suffering from advanced colorectal cancer.
The results, developed in collaboration with Genomac International, were presented by Mark Erlander, Ph.D., Trovagene’s Chief Scientific Officer, during the EORTC-NCI-AACR International Symposium on Molecular Targets and Therapeutics Meeting in Barcelona, Spain, and showed that alterations in mutational signals found in patient’s blood and urine can be used to monitor the presence of colorectal cancer.
“We have previously shown that our highly sensitive and quantitative assay technology is suitable for monitoring patients with BRAF-associated malignancies,” Mark Erlander, Ph.D., chief scientific officer of Trovagene said in a press release. “With these new results, we have demonstrated the applicability of our platform for the monitoring of KRAS mutations in colorectal cancer patients. Additional data analysis from this study is expected to become available in mid-2015, which should support the commercial adoption of our Precision Cancer Monitoring solution in this clinical setting.”
The researchers used stored plasma and urine samples from 20 untreated, advanced colorectal cancer patients that tested positive for known KRAS mutations and used Trovagene’s quantitative KRAS mutation assay to analyze the samples and evaluate the status of KRAS mutations in urine, blood, and tissue samples. Most patients analyzed in the study had surgery and received neo-adjuvant or adjuvant therapy.
The results demonstrated there was a high correlation between the assay’s outcome and tumor mutational status. Of all the plasma DNA samples and urine samples analyzed, 95% and 92%, respectively, revealed a KRAS mutation concordant with tumor tissue.
Trovagene’s assay was able to show a marked link between blood and urine samples, with an analytical sensitivity of 7 copies per ~100,000 genome equivalents.
“Our proven ability to monitor KRAS mutations in colorectal cancer is another step forward for our technology, and is also the first of several major cancer indications in which we anticipate to demonstrate clinical utility with our assay platform in the coming year,” explained Antonius Schuh, Ph.D., chief executive officer of Trovagene. “We have multiple ongoing studies that are on track to yield clinical results in 2015 for the detection and monitoring of driver mutations in pancreatic, colorectal, lung and skin cancers. We look forward to presenting and publishing these data as they become available.”