PHILADELPHIA and REHOVOT, Israel, Jan. 9, 2013 - Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, today announced that data from a study assessing the differences between cancer of unknown primary (CUP) and metastatic solid tumors of known primary metastases (KPM) by profiling microRNA expression were recently published in Clinical Experimental Metastasis, in an article entitled "Global microRNA profiling in favorable prognosis subgroups of cancer of unknown primary (CUP) demonstrates no significant expression differences with metastases of matched known primary tumors." The article can be viewed online at http://www.ncbi.nlm.nih.gov/pubmed/23124598.
The study assessed microRNA differences between CUP metastases with favorable prognosis and metastases of known primary tumors in order to screen for an aggressive, pro-metastatic, CUP-specific biologic signature.
The study consisted of two stages. In the first stage, metastases obtained from CUP cases were assigned to a primary tissue of origin using Rosetta's miRview® mets2 microarray assay and compared to pathological and clinical presentation. In the second stage, the expression of 733 microRNAs was examined in CUP tumors classified as breast, serous ovarian and upper squamous cancers and compared to that of matched KPMs.
The study evaluated approximately 100 CUP and KPM tumors and found no unique microRNA signature differentiating CUP presentation from that of metastases of known primaries. This supports current gold standard treatment for patients with favorable prognosis CUP, who are managed similarly to those with equivalent metastatic tumors of known primary. This study was a sub-set of a larger retrospective study assessing the performance of the miRview mets2 assay in a cohort of real CUP patients. The results of that study demonstrated that miRview mets2 assay showed agreement with pathological and clinical information in 92% of cases. Those data have been presented at medical conferences and are expected to be published in a separate peer-reviewed journal article.
Study author, George Pentheroudakis , M.D., Department of Medical Oncology at the University of Ioannina Medical School in Ioannina, Greece, noted, "This research is the first look for microRNA characteristics of CUP tumors. Study results confirmed epidemiologic evidence suggesting that patients with favorable prognosis CUP have a presentation, response to therapy and outcome no different from metastatic tumors of matched primaries."
"This publication demonstrates the utility of microRNA profiling in understanding the biology of CUP and may have important implications for the prognosis and treatment of CUP patients," stated Kenneth A. Berlin , President and CEO of Rosetta Genomics. "We look forward to the publication of the full data set which we believe continues to underscore the clinical value of our miRview mets2 assay in identifying the primary tumor type in CUP patients in order to optimize treatment protocols and potentially improve clinical outcomes."
About Cancer of Unknown Primary Origin
According to the American Cancer Society, an estimated 2 to 5 percent of all cancer patients have metastatic (secondary) tumors for which routine testing cannot locate the primary site. This is called cancer of unknown primary origin. Patients may be diagnosed with cancer of unknown primary origin if the primary tumor is too small to be identified with routine imaging tests, it regresses (disappears) before a secondary tumor arises or the secondary tumor has several possible primary sites. Cancer of unknown primary origin can appear anywhere in the body, but is most commonly found in the lymph nodes, liver, lungs, bones or skin.
The miRview mets2 assay measures the expression level of 64 microRNA biomarkers, which are then processed by an algorithm composed of two classifiers and a decision-maker that can accurately identify the origin of the patients' tumor for 42 different cancer tissue types, with 85 percent sensitivity and 99 percent specificity. Clinicians use Rosetta Genomics' assay to better diagnose CUP patients and get them on more optimal treatment plans.
About miRview® Products
miRview® are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview® mets² accurately identifies the primary tumor type in primary and metastatic cancer including CUP. miRview® meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview® lung accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. miRview® kidney accurately classifies the four most common kidney tumors: clear cell renal cell carcinoma (RCC), papillary RCC, chromophobe RCC and oncocytoma. miRview®tests 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 miRview® mets² test, 60,000 from miRview® meso, 54,000 from miRview® kidney and 226,000 patients from miRview® lung. 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.mirviewdx.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 miRview® product line is 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, statements relating to Rosetta's strategic plan, the market acceptance of Rosetta's miRview® assays, particularly miRview® mets2, Rosetta's capitalization of its microRNA platform and Rosetta's development of personalized medicine products 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, 2011 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.
Ken Berlin, President & CEO
(215) 382-9000, ext. 326
Anne Marie Fields
SOURCE Rosetta Genomics Ltd.