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First Urine-based Cancer Mutation Monitoring Test Available From Trovagene

SAN DIEGO, Oct. 1, 2013 /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, today announced availability of the first urine test for cancer mutation monitoring through the company's CLIA laboratory. The robustness of Trovagene's ultra-sensitive assay procedure has been demonstrated for detection of the BRAF V600E mutation from cell-free DNA in urine.  This mutation commonly occurs in melanoma, as well as several other prevalent cancer types.

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Of the more than 70,000 cases of melanoma diagnosed each year in the United States, up to 70 percent harbor a BRAF-type mutation and of these, 80 percent may be positive specifically for BRAF V600E. 1 There are several FDA-approved targeted therapies for the treatment of BRAF-positive melanoma, making mutational status monitoring an area of clinical interest among treating physicians.

Trovagene's cell-free BRAF SM test is a laboratory-developed test (LDT) designed to detect and monitor this mutation in metastatic cancer patients with biopsy-proven V600E BRAF mutation in their tumor.  It is the first commercial assay within Trovagene's cancer monitoring portfolio performed using a droplet digital PCR (ddPCR) platform.  Using urine as a non-invasive, systemic sample, the cell-free BRAF test could help physicians monitor changes in mutation status for patients requiring therapy for cancers that have this mutation. For patients with difficult-to-biopsy metastatic tumors, urine-based mutation testing may also provide a viable alternative to check mutation status as part of the initial treatment workup.

"We are developing a systemic, non-invasive cancer monitoring system," said Mark Erlander, Ph.D., chief scientific officer for Trovagene. "Traditionally, the mutation status of a tumor is determined using a tissue sample – a method that has limited practicality for patient monitoring due to costs, tumor heterogeneity and potential complications from the biopsy process. The ability to detect the mutation signal in cell-free DNA isolated from urine overcomes this limitation and meets a significant technical and clinical need."

The cell-free BRAF mutation assay has been tested across a range of solid tumors including melanoma, non-small cell lung, rectal, and colon cancers, indicating that urine-based mutation detection is applicable across many cancer types.  Additional clinical studies are ongoing to further understand the full range of clinical applications for this and other Trovagene assays.

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