PRINCETON, NJ and REHOVOT, ISRAEL - January 16, 2014 - Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces the publication of clinical data in the online edition of Urologic Oncology: Seminars and Original Investigations in an article entitled, "The role of microRNA profiling in prognosticating progression in Ta and T1 urinary bladder cancer." The publication in its entirety can be viewed at http://www.urologiconcology.org/article/S1078-1439(13)00463-8/fulltext.
The study profiled and analyzed microRNA expression levels in 86 samples of non-muscle-invasive bladder cancer to identify patterns of expression that are indicative of a high probability of disease progression. The main finding showed that in the least invasive tumors (stage Ta), low expression levels of miR-10a are correlated to later recurrence of the disease in a more invasive form (stage T1 or higher).
According to study author, Ulrika Segersten, Ph.D., Department of Surgical Sciences, Uppsala University, Uppsala, Sweden, "Profiling revealed that certain microRNAs predicted the risk of developing higher stage among patients with Ta cancers. Lower miR-10a-5p expression in Ta progressing tumors indicates that this microRNA could have a crucial role for later invasion of non-invasive bladder tumors."
"Bladder cancer is usually diagnosed at an early stage, prior to invasion into muscle tissue, thus it can be treated locally. However, in some patients the cancer can recur several times, potentially leading to muscle invasion, which may result in life threatening disease progression. Early prediction of these aggressive tumors may lead to earlier intervention, such as removal of the bladder, which may be life-saving. Helping doctors to identify patients where this condition is most likely to occur is of paramount importance as treating these patients more aggressively may save lives. While good biomarkers for risk stratification in bladder cancer have previously been lacking, these published study results are encouraging for the development of a valuable test to help improve bladder cancer outcomes," stated E. Robert Wassman, MD, Rosetta Genomics' Chief Medical Officer.
"Our leading patent position in microRNA-based diagnostics has allowed us to develop a body of scientific and clinical research in support of the role of microRNAs to detect, predict and treat a number of urologic cancers such as kidney and bladder. Specifically, these data complement our work with University of California, Davis researchers who are studying a microRNA profile for muscle-invasive bladder cancer that is predictive of patient response to neoadjuvant chemotherapy. We are pleased to be further elucidating the role of microRNAs to detect and predict bladder cancer in order to optimize treatment protocols and potentially improve patient outcomes in this era of personalized medicine," noted Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.
About Bladder Cancer
Bladder cancer forms in tissues of the bladder. Most bladder cancers are transitional cell carcinomas (cancer that begins in cells that normally make up the inner lining of the bladder), while other types include squamous cell carcinoma (cancer that begins in thin, flat cells) and adenocarcinoma (cancer that begins in cells that make and release mucus and other fluids). The cells that form squamous cell carcinoma and adenocarcinoma develop in the inner lining of the bladder as a result of chronic irritation and inflammation. The U.S. National Cancer Institute estimates there will be 72,500 new cases of bladder cancer in the U.S. in 2013, and 15,000 deaths. There is no standard or routine screening test for bladder cancer.
About Rosetta Cancer Testing Services
Rosetta Cancer Tests are a series of microRNA-based diagnostic testing services offered by Rosetta Genomics. The Rosetta Cancer Origin Test™ can accurately identify the primary tumor type in primary and metastatic cancer including cancer of unknown or uncertain primary (CUP). Rosetta Mesothelioma Test™ diagnoses mesothelioma, a cancer connected to asbestos exposure. The Rosetta Lung Cancer Test™ accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. The Rosetta Kidney Cancer Test™ accurately classifies the four most common kidney tumors: clear cell renal cell carcinoma (RCC), papillary RCC, chromophobe RCC and oncocytoma. Rosetta's assays are designed to provide objective diagnostic data; it is the treating physician's responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta Genomics estimates that 200,000 patients a year may benefit from the Rosetta Cancer Origin Test™, 60,000 from the Rosetta Mesothelioma Test™, 65,000 from the Rosetta Kidney Cancer Test™ and 226,000 patients from the Rosetta Lung Cancer Test™. The Company's assays are offered directly by Rosetta Genomics in the U.S., and through distributors around the world. For more information, please visit www.rosettagenomics.com. Parties interested in ordering the test can contact Rosetta Genomics at (215) 382-9000 ext. 309.
About Rosetta Genomics
Rosetta develops and commercializes a full range of microRNA-based molecular diagnostics. Founded in 2000, Rosetta's integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong patent position and proprietary platform technologies, Rosetta is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools. Rosetta's cancer testing services are commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. Frost & Sullivan recognized Rosetta Genomics with the 2012 North American Next Generation Diagnostics Entrepreneurial Company of the Year Award.
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta's future expectations, plans and prospects, including without limitation, Rosetta's Cancer of Origin Test™, Rosetta's development or commercialization of molecular diagnostics, the market acceptance of Rosetta's cancer testing services, particularly the Rosetta Cancer Origin Test™, Rosetta's development of personalized medicine products and services, Rosetta licensing, partnering or otherwise deriving value from microRNA technology for use in a variety of diagnostic and targeted therapeutics, the ability of microRNA profiling to predict the risk of developing higher stage bladder cancer, Rosetta developing therapeutic products, miR-10a-5p having a potential crucial role for later invasion of non-invasive bladder tumors, the development of a risk stratification or prognostication test for bladder cancer and the role of microRNAs in detection, prediction and treatment of urologic cancers, Rosetta's patent position and Rosetta optimizing treatment protocols and potentially improving patient outcomes, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those risks more fully discussed in the "Risk Factors" section of Rosetta's Annual Report on Form 20-F for the year ended December 31, 2012 as filed with the SEC. In addition, any forward-looking statements represent Rosetta's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required by law.
President & CEO
(609) 419-9000, ext. 1326
Anne Marie Fields
SOURCE: Rosetta Genomics, Ltd.