Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics and therapeutics, announced that the New York State Department of Health ("NYSDOH") has given the Company final approval for its Rosetta Kidney Cancer Test'" for testing on patient samples from the State. New York is the only U.S. state that requires an independent regulatory review process for laboratory-developed tests. Rosetta Genomics has been offering its Kidney Cancer Test in New York under conditional approval since December 9, 2013 and now has full approval in all 50 U.S. states. The Kidney Cancer Test is the Company's proprietary microRNA-based assay that can classify the four most common kidney tumors: Clear Cell Renal Cell Carcinoma (RCC), Papillary RCC, Chromophobe RCC and Oncocytoma. With this final approval, each of Rosetta's cancer testing services now has full New York State approval.
A blinded independent validation set of 200 samples was studied to measure the performance of the Rosetta Kidney Cancer Test. Of the 184 samples that produced a result, 174 were classified correctly demonstrating 95% accuracy or sensitivity, with 98% specificity.
''There are approximately 65,000 new cases of primary kidney tumors and 13,000 deaths per year in the United States, and the incidence is rising. Unfortunately, nearly 25% of patients, who have a kidney removed for presumptive RCC, turn out to have benign oncocytomas, which are safely monitored without nephrectomy. This failure of pre-operative diagnosis is in part the result of the small number of pre-operative biopsies, as only about 9-10% of patients have a pre-operative biopsy. We believe there is an opportunity to improve the standard-of-care in this setting through the use of our assay,” said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.
"Differential diagnosis between various types of kidney tumors remains challenging and can lead not only to unnecessary surgeries, but also the introduction of new, molecularly-targeted therapeutics makes the correct identification of these subtypes critically important for treatment choice and for patient selection for clinical trials of new therapeutics in development. With a sensitivity of 95% and a specificity of 98%, we are confident this assay can be a useful tool for pathologists and oncologists and we are very pleased to have final approval to market this important cancer diagnostic for the benefit of physicians and patients in New York," concluded Mr. Berlin.
About Rosetta Genomics
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 and therapeutics. Rosetta currently commercializes a full range of microRNA-based molecular diagnostics. Rosetta's cancer testing services are commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. For more information please visit www.rosettagenomics.com.
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta's future expectations, plans and prospects, including without limitation, Rosetta's Kidney Cancer Test TM, Rosetta's development or commercialization of molecular diagnostics, prognostic or therapeutic services or tool, the market acceptance of Rosetta's cancer testing services, particularly the Rosetta Kidney Cancer Test TM, as well as the utilization of the Rosetta Kidney Cancer Test'M by pathologists or oncologists, 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, 2013 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.
Rosetta Genomics Contact:
President & CEO
Anne Marie Fields