Trovagene has entered into a clinical collaboration with City of Hope to conduct studies to determine the clinical utility of detecting and monitoring EGFR mutations in lung cancer patients using Trovagene's Precision Cancer MonitoringSM platform.

"Tracking various alterations in the EGFR oncogene, particularly emergence of the T790M mutation, has potential to improve therapeutic strategies for treating patients with non-small cell lung cancer," said Mihaela Cristea, MD, lead investigator and associate professor, City of Hope Lung Cancer and Thoracic Oncology programme. "We look forward to evaluating Trovagene's molecular diagnostics for the monitoring of circulating tumour DNA found in both urine and blood, with the goal of delivering highly personalised cancer treatment to improve patient outcomes."

The clinical study is expected to enroll 75 patients with lung cancer. Primary objectives of the study include evaluating concordance between urinary circulating tumour DNA (ctDNA), blood ctDNA, and tumor tissue for determining EGFR mutational status. Additionally, the study investigators will evaluate the quantitative and qualitative performance of longitudinal EGFR mutation monitoring using both urine and blood specimens, as they relate to response to therapy over time. Exploratory objectives include evaluating the feasibility of identifying the TKI-resistant mutation, T790M, in urinary and blood ctDNA at the time of progression.

"Enabling physicians to detect the emergence of problematic mutations in real-time is a key benefit of our Precision Cancer Monitoring platform, and one such mutation is EGFR T790M, which drives treatment resistance in non-small cell lung cancer patients," said Mark Erlander, chief scientific officer of Trovagene. "We are pleased to be working with City of Hope, a world-class institution, to demonstrate the utility of our T790M assay in a setting where timely information can potentially lead to better treatment decisions and outcomes. This is an important part of our strategy to realise the full potential of our platform, as we partner with major cancer treatment centres in the US. to obtain clinical utility data and to integrate our technology into clinical practice."

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 tumour dynamics and treatment response over time. To date, the company has processed more than 3,000 patient samples under these collaborations, and is developing the clinical evidence to support broad market adoption of its technology.