First urine-based cancer mutation monitoring test available from Trovagene

Cell-free DNA assay transferred to CLIA laboratory for patient testing

Trovagene, Inc. (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.

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.

"This first assay represents a significant milestone for Trovagene," said Antonius Schuh, Ph.D., chief executive officer of Trovagene. "Moving forward, our goal is to apply our technology for improved monitoring of tumor dynamics, leading to more effective management of cancer patients."

Trovagene has detected the BRAF V600E mutation in a variety of cancers, with   high levels of sensitivity and strong concordance with tissue biopsy. Further expansion of the company's monitoring capabilities will include additional mutational markers with known clinical utility, as well as known genomic alterations that indicate resistance to therapy.

The Trovagene cell-free BRAF test is now available to healthcare providers for patient testing.  Physicians interested in utilizing this test should contact Client Services at 888-391-7992. For more information, please visit www.trovagene.com/BRAF. 

¹ - Vultur A, Villanueva J, Herlyn M. Targeting BRAF in advanced melanoma: a first step toward manageable disease. Clin Cancer Res 2011; 17(7):1658-63

About Trovagene, Inc.
Headquartered in San Diego, California, Trovagene is leveraging its patented technology for the detection of cell-free DNA and RNA, short nucleic acid fragments, originating from normal and diseased cell death that can be isolated and detected from urine. Trovagene has a strong intellectual property asset as it relates to cell-free DNA and RNA testing in urine. It has U.S. and European patent applications and issued patents that cover testing for HPV and other infectious diseases, cancer, transplantation, prenatal and genetic testing.

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; 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, 2012 and other periodic reports filed with the Securities and Exchange Commission.

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Trovagene, Inc.

Stephen Zaniboni
Chief Financial Officer
Trovagene, Inc.
858-952-7594
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