NEW YORK (GenomeWeb News) – Trovagene and US Oncology Research today announced a deal for the use of Trovagene's technology to determine whether KRAS mutations can be evaluated in urine to monitor pancreatic cancer patients.
The collaborative study aims to evaluate and monitor treatment response in patients who test positive or negative for the tumor marker CA 19-9. CT scans and CA 19-9 blood levels are the only two methods currently available for the clinical monitoring of metastatic pancreatic cancer tumor burden and therapy response. However, Trovagene said that between 11 and 17 percent of patients will not display elevated CA 19-9 even with high tumor load.
"For patients [who] test negative for CA 19-9, Trovagene's method to follow disease status could be distinctly beneficial," the company said.
It and US Oncology will start enrolling patients for the study in the first quarter. Up to 45 patients are expected to participate. In addition to the 11 US Oncology affiliated community cancer sites, academic research institutes specializing in cancer are expected to participate, the partners said.
"The study is designed to provide comprehensive qualitative and quantitative clinical results for our multiplexed KRAS NGS assay and is an important part of our strategic objective to integrate the use of our proprietary technology in clinical practice," Trovagene President and CEO Antonius Schuh said in a statement.
The San Diego-based company said the study supports its goal of demonstrating the clinical use of its cell-free DNA platform for detecting and monitoring cancer mutations in urine, and the agreement is the first multi-site study sponsored by Trovagene.
Financial and other terms of the deal were not disclosed.