|By PR Newswire||
|November 28, 2012 04:31 AM EST||
SAN DIEGO, Nov. 28, 2012 /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV) today announced successful development of its first molecular diagnostic test capable of detecting KRAS mutations from a urine specimen. Transfer of the transrenal KRAS test to the company's CLIA lab is expected to be completed in December 2012 with commercial availability expected in January 2013.
"Our scientific team has developed the first commercially viable process for quantitative detection of KRAS mutations in transrenal DNA isolated from a simple urine specimen," said Charlie Rodi, Ph.D., chief technology officer of Trovagene. "This represents a breakthrough in cancer monitoring, and will provide oncologists and surgeons with the ability to frequently check mutation status before, during, and after therapy."
Cell-free nucleic acids originate from both normal and diseased cells, circulate through the bloodstream, cross the kidney barrier, and can be detected in urine as transrenal DNA. As interest in this technology grows among leading academic cancer centers, Trovagene continues to engage with new collaborators to develop a series of transrenal molecular diagnostic tests to detect and monitor cancer mutations. Trovagene's initial oncogene mutation tests will include KRAS, BRAF and PIK3CA. Potential uses of this non-invasive technology include monitoring for recurrence of disease, determining response to therapy and disease detection.
Solid tumors represent more than 90% of all cancers, and approximately 24% of these are KRAS mutation positive. Based on current cancer incidence rates in the US, each year an estimated 360,000 newly diagnosed patients are expected to have KRAS mutation-positive cancers.
"Over the next six months, we plan to introduce a variety of assays that may offer significant clinical benefits for physicians and patients, as well as potential savings for the healthcare system," stated Antonius Schuh, Ph.D., chief executive officer of Trovagene. "The ability to test, detect and confirm cancer mutation status non-invasively represents an enabling technology that can be used across a variety of clinical applications."
Clinicians interested in utilizing the transrenal KRAS test should contact Trovagene Client Services at 888-391-7992.
About Trovagene, Inc.
Headquartered in San Diego, California, Trovagene is developing its patented technology for the detection of transrenal DNA and RNA, short nucleic acid fragments, originating from normal and diseased cell death that cross the kidney barrier and can be detected in urine. Trovagene has a strong patent position as it relates to transrenal molecular testing. 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. In addition, it owns worldwide rights to nucleophosmin-1 (NPM1), an informative biomarker for acute myelogenous leukemia (AML) and mutations in the SF3B1 gene, which have been shown to be associated with chemotherapy response in chronic lymphocytic leukemia (CLL) patients.
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 third party payer reimbursement; limited sales and marketing efforts and dependence upon third 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, 2011 and other periodic reports filed with the Securities and Exchange Commission.
SOURCE Trovagene, Inc.