"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):1658-63About 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. Contact : Trovagene, Inc.