First Urine-Based Molecular Diagnostic Test for Transrenal Cancer Mutation Monitoring

Trovagene, Inc. has announced successful development of its first molecular diagnostic test capable of detecting KRAS mutations from a urine specimen. Transfer of the transrenal KRAS test to the company’s CLIA lab is expected to be completed in December 2012 with commercial availability expected in January 2013.

“Our scientific team has developed the first commercially viable process for quantitative detection of KRAS mutations in transrenal DNA isolated from a simple urine specimen,” said Charlie Rodi, Ph.D., chief technology officer of Trovagene. “This represents a breakthrough in cancer monitoring, and will provide oncologists and surgeons with the ability to frequently check mutation status before, during, and after therapy.”

Cell-free nucleic acids originate from both normal and diseased cells, circulate through the bloodstream, cross the kidney barrier, and can be detected in urine as transrenal DNA. As interest in this technology grows among leading academic cancer centers, Trovagene continues to engage with new collaborators to develop a series of transrenal molecular diagnostic tests to detect and monitor cancer mutations. Trovagene's initial oncogene mutation tests will include KRAS, BRAF and PIK3CA. Potential uses of this non-invasive technology include monitoring for recurrence of disease, determining response to therapy and disease detection.

Solid tumors represent more than 90% of all cancers, and approximately 24% of these are KRAS mutation positive. Based on current cancer incidence rates in the US, each year an estimated 360,000 newly diagnosed patients are expected to have KRAS mutation-positive cancers.

“Over the next six months, we plan to introduce a variety of assays that may offer significant clinical benefits for physicians and patients, as well as potential savings for the healthcare system,” stated Antonius Schuh, Ph.D., chief executive officer of Trovagene. “The ability to test, detect and confirm cancer mutation status non-invasively represents an enabling technology that can be used across a variety of clinical applications.”