Clinical OMICs - Issue 7 - (Page 25)

Trovagene provides oncologists who want to fully utilize genomics in clinical practice a means to precisely monitor oncogenic mutations. cision cancer monitoring technology that can identify and quantify DNA mutations of interest in urine. Trovagene's precision cancer monitoring technology provides oncologists with a whole body molecular view of the patient enabling physicians to make treatment decisions in real-time, by detecting mutations through cell-free DNA in urine. Using urine specimens, patients are able to provide large amounts of sample material, frequently, which can improve the chances for detecting and monitoring mutations driving the cancer and disease progression. Trovagene's technology can allow treatment decisions to be made more quickly, personalized to the patient's mutational status, without invasive testing. Oncologists are provided with precise, actionable information before and throughout treatment regarding oncogene mutation status, disease progression, and recurrence. Trovagene's clinical tests are sample agnostic, meaning they can detect cell-free DNA and oncogene mutations in multiple sample types, including blood, tissue, and urine. This allows physicians added flexwww.clinicalomics.com ibility when deciding how to screen and monitor patients throughout their treatment. However, Trovagene believes urine is the most effective sample due to the benefits it provides patients and physicians, since it is a simpler, noninvasive, and more costeffective process overall that requires no special refrigeration or transportation. While cell-free DNA has a short half-life in blood, it builds up in urine until excreted, so the probability of finding the small amounts of mutated DNA may be higher. A decade of scientific work by Trovagene validates this novel approach, including a significant number of peer reviewed publications covering the detection of nucleic acids in urine. Clinical study results presented at the American Association for Cancer Research (AACR) annual meeting and at the American Society of Clinical Oncology (ASCO) convention demonstrate the effectiveness of this new technology. All datasets thus far demonstrate high levels of concordance between tissue biopsy and urinary cell-free DNA mutations, as well as the ability to monitor response to treatment using urinary cell-free DNA over time. Notably, patients with mul- tiple types of advanced cancer were included in these studies indicating the technology's ability to work in various systemic cancers that are being treated differently. Trovagene also recently presented data from a study with MD Anderson Cancer Center and Memorial SloanKettering Cancer Center at the ASCO meeting. The poster presentation, titled, "Detection of BRAF mutations in urine and plasma cell-free DNA: Application to the diagnosis and management of histiocytic disorder," demonstrates that oncogene mutation load in urinary cell-free DNA, as determined using the company's precision cancer monitoring technology, is significantly correlated with treatment response. Trovagene's plan is to continue to broaden its test offerings through the expansion of additional mutation coverage, as well as to demonstrate the clinical and health economic benefits through validation studies. Collaborations with leading institutions, including MD Anderson Cancer Center, USC Norris Cancer Center, and Memorial Sloan-Kettering Cancer Center, are currently under way to evaluate the clinical and health outcome benefits of using Trovagene's technology in clinical practice. Trovagene also has clinical collaboration agreements with large integrated healthcare networks that are conducting studies to further validate the technology, with potential to implement these urine-based assays into practice if clinical utility proves favorable. July 16, 2014 Clinical OMICs 25 http://www.clinicalomics.com

Table of Contents for the Digital Edition of Clinical OMICs - Issue 7

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Clinical OMICs - Issue 7