Clinical Study Using Trovagene's Precision Cancer Monitoring Platform Published in Cancer Discovery

Prospective blinded study demonstrates ability to accurately determine mutational status and monitor response to BRAF inhibitor therapy from urinary cell-free DNA

Oct 27, 2014, 08:10 ET from Trovagene, Inc.

SAN DIEGO, Oct. 27, 2014 /PRNewswire/ -- Trovagene, Inc., (NASDAQ:  TROV) a developer of cell-free molecular diagnostics, today announced the publication of clinical study results in a peer-reviewed journal, Cancer Discovery, featuring the Company's precision cancer monitoring technology and its ability to non-invasively determine oncogene mutation status and monitor response to BRAF inhibitor therapy in patients with histiocytic disease, a malignancy often associated with BRAF mutations. Study investigator Eli L. Diamond, M.D., a neuro-oncologist at Memorial Sloan Kettering Cancer Center, will present the clinical results at the 30th Annual Histiocyte Society Meeting on October 28 in Toronto, Canada.

The blinded prospective study in patients with systemic histiocytic disease, such as Erdheim-Chester Disease (ECD) and Langerhans Cell Histiocytosis (LCH), demonstrates that analysis of circulating cell-free DNA (cfDNA) from urine provides a convenient and reliable method to detect the presence of the BRAF V600E mutation and to monitor mutational load repeatedly for assessment of treatment response. Results showed 100% concordance of BRAF V600E status between urinary cfDNA and tissue biopsies in treatment naive patients. Study authors conclude that cfDNA BRAF V600E mutational analysis in urine provides a convenient and reliable method of detecting mutational status and can serve as a non-invasive biomarker to monitor response to therapy in LCH and ECD.

"More than 50% of patients diagnosed with ECD or LCH harbor the BRAF V600E mutation and might respond well to BRAF inhibitor therapy," stated Omar Abdel-Wahab, M.D., a hematologist/oncologist at Memorial Sloan-Kettering and principal study investigator. "This study demonstrates that we can now reliably diagnose patients quickly and non-invasively using a liquid biopsy, and that we also now have the ability to monitor treatment response over time to ensure that the targeted therapy is the right choice for the individual patient."

In addition to the very high concordance demonstrated between urinary cell-free DNA and tissue biopsy, the study demonstrated that Trovagene's assay was able to determine BRAF mutational status in all cases when the analysis of tissue biopsies provided inconclusive results. Longitudinal tracking of the BRAF V600E mutation in urine also correlated to therapeutic response as assessed by radiographic evaluation of disease.

"Both ECD and LCH are thought to be substantially under-diagnosed, often due to the difficulty in obtaining an accurate histological diagnosis," stated Carlos Rodriguez-Galindo, M.D., Dana-Farber Cancer Institute, an affiliate of Harvard Medical School, and president of the Histiocyte Society. "This non-invasive test may provide an additional tool to help in the diagnosis of those patients whose tumors harbor the BRAF V600E mutation and to monitor the response to treatment."

About The BRAF V600E Mutation in Histiocytic Disease 

Erdheim-Chester disease and Langerhans Cell Histiocytosis are histiocytic diseases 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. Mostly, ECD occurs in adults and LCH in children and adolescents. More recently, ECD and LCH have been linked to a high prevalence of BRAF V600E mutations (>50% of patients). Patients with BRAF-mutant disease 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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