Trovagene has entered into a clinical collaboration with Dana-Farber Cancer Institute to investigate the utility of quantitative urine-based mutation detection and the ability to monitor tumor mutation burden and treatment response over time in metastatic melanoma patients.

Urine samples will be collected from patients with locally advanced or metastatic melanoma known to harbor driver oncogene mutations. A Dana-Farber oncology team, led by Jason Luke, M.D., will conduct clinical studies designed to monitor oncogene mutations in study subjects based on urinary cell-free DNA as an analytical specimen. Studies will be designed to collect data regarding the clinical status of patients, treatment effect and long-term outcomes of therapy using Trovagene's non-invasive molecular diagnostic technology.

"While precision cancer treatments have made significant advances, current monitoring technologies are either invasive or do not provide specific genomic information to understand how the disease is responding to treatment at the molecular level," said Luke. "Based on study data that Trovagene has presented at medical meetings thus far, we are encouraged that urinary cell-free DNA has potential to offer a non-invasive solution for tracking oncogene mutations during and after treatment, and this may help physicians improve patient outcomes."

Trovagene is engaged in numerous collaborations designed to demonstrate the clinical utility of its precision cancer monitoring platform for the detection of mutational status in cancer patients, and the assessment of tumor dynamics and treatment response over time. To date, the company has processed over 1,000 patient samples under its collaborations, and is focused on developing the clinical evidence to support broad market adoption of its technology.

Antonius Schuh, Ph.D., CEO of Trovagene, said, "With this latest collaboration, we now are working with seven of the top cancer treatment centers in the U.S. to demonstrate the utility of our precision cancer monitoring platform and to integrate our assays into clinical practice. The Dana-Farber collaboration initially is focused on treatment of metastatic melanoma, and we are pleased to be working with Luke and his colleagues to gain greater perspective on how our non-invasive assays can impact the way this disease is managed."