Trovagene, Inc. (Nasdaq: TROV), a developer of transrenal molecular diagnostics, announced that it has entered into a clinical collaboration with The University of Texas MD Anderson Cancer Center to detect transrenal BRAF mutations in the urine of patients with advanced or metastatic cancers.
Researchers will use Trovagene's proprietary transrenal DNA (TrDNA) detection technology to evaluate BRAF mutation status in urine as compared to tissue biopsy. The study also calls for monitoring of mutation levels in the urine at planned intervals during and after treatment to assess outcomes including: response rate (RR); stable disease (SD); progression-free survival (PFS); and overall survival (OS). Results from patients who receive therapy that reflects their BRAF mutation status (e.g., BRAF inhibitors, MEK inhibitors) will be compared to outcomes for patients who receive standard-of-care therapy regardless of mutation status.
According to recent estimates, BRAF mutations are present in more than 20% of all cancers, and in 40% and 43% of all thyroid and skin cancer samples, respectively. Several targeted therapies for BRAF-mutated melanomas are already on the market and in development, including BRAF inhibitors vemurafenib (Zelboraf®) and dabrafenib; and trametinib, a MEK inhibitor.