TrovaGene : Clinical Performance of Trovagene's Precision Cancer Monitoring Platform Presented at Second Annual International ECD Medical Symposium

SAN DIEGO , Oct. 1, 2014 /PRNewswire/ -- Trovagene, Inc., (NASDAQ: TROV) a developer of cell-free molecular diagnostics, announced today that Eli Diamond , MD, Assistant Attending Neurologist at Memorial Sloan Kettering Cancer Center (MSK), presented clinical data from an ongoing study demonstrating the utility of Trovagene's precision cancer monitoring platform for the determination of oncogene mutational status in cell-free DNA obtained from a liquid biopsy.  The results were presented to both treating physicians and patients at the ECD Global Alliance's Second International Medical Symposium, in collaboration with the National Institutes of Health (NIH), and expand upon clinical data presented earlier this year at the American Society of Clinical Oncology (ASCO) Annual Meeting.

"Accurately determining BRAF V600E mutation status is critical for making therapeutic decisions for patients diagnosed with ECD," stated Dr. Diamond. "Tracking the mutation using urinary cell-free DNA provides a window to see how the disease is responding, and these new data show that regardless of which drug is used, treatment response over time correlates well with BRAF V600E mutational load."

Trovagene's technology enables physicians to detect and monitor oncogene mutations in urine and plasma with high sensitivity, providing a non-invasive alternative to tissue biopsy, which in some clinical situations can be difficult or impossible to obtain. The data set presented includes numerous cases in which Trovagene's assay unequivocally determined oncogene mutational status when prior results from tissue biopsy were inconclusive. Additionally, patients in the study were monitored using Trovagene's technology, enabling physicians to determine response to therapy within days of treatment initiation. The rapid feedback on treatment effect is of great importance to clinicians as it helps ensure proper treatment and improve patient outcomes. 

"The ability to quickly and accurately determine BRAF mutational status is critically important to our ECD patients for determining whether a BRAF inhibitor is a therapeutic option," stated Kathy Brewer , president of the Erdheim-Chester Disease Global Alliance. "We are encouraged by the recent advances in molecular diagnostic testing that will hopefully allow for fast, accurate and non-invasive testing for our patients."

About The BRAF V600E Mutation in Erdheim-Chester Disease 

Erdheim-Chester disease (ECD) is a rare histiocytic disease involving the excessive production of histiocytes, a type of white blood cell. These cells, which normally help fight infection and injury, gather in different organs and tissues and can result in a variety of symptoms, including organ failure. More recently, ECD has been linked to a high prevalence of BRAF V600E mutations (>50% of patients). Patients with BRAF-mutant ECD can respond to BRAF inhibitors and other therapeutics, however, the lack of adequate biopsy tissue often precludes BRAF testing, and confirmation of the BRAF V600E mutation.

About Trovagene, Inc.

Headquartered in San Diego, California , Trovagene is leveraging its proprietary technology for the detection and monitoring of cell-free DNA in urine.  The company's technology detects and quantitates oncogene mutations in cancer patients for improved disease management. Trovagene's precision cancer monitoring platform is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property including multiple issued patents and pending patent applications globally.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on Trovagene's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or fourth party payer reimbursement; limited sales and marketing efforts and dependence upon fourth parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any medical diagnostic tests under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Trovagene does not undertake an obligation to update or revise any forward-looking statement.  Investors should read the risk factors set forth in Trovagene's Form 10-K for the year ended December 31, 2013 and other periodic reports filed with the Securities and Exchange Commission.

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