Rosetta Genomics Announces Final New York State Approval for Rosetta Kidney Cancer Test

Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer andprovider of microRNA-based molecular diagnostics and therapeutics,announced that the New York State Department of Health ("NYSDOH") hasgiven the Company final approval for its Rosetta Kidney Cancer Testâ„¢for testing on patient samples from the State. New York is the onlyU.S. state that requires an independent regulatory review process forlaboratory-developed tests. Rosetta Genomics has been offering itsKidney Cancer Test in New York under conditional approval sinceDecember 9, 2013 and now has full approval in all 50 U.S. states. TheKidney Cancer Test is the Company's proprietary microRNA-based assaythat can classify the four most common kidney tumors: Clear CellRenal Cell Carcinoma (RCC), Papillary RCC, Chromophobe RCC andOncocytoma. With this final approval, each of Rosetta's cancertesting services now has full New York State approval.A blinded independent validation set of 200 samples was studied tomeasure the performance of the Rosetta Kidney Cancer Test. Of the 184samples that produced a result, 174 were classified correctlydemonstrating 95% accuracy or sensitivity, with 98% specificity."There are approximately 65,000 new cases of primary kidney tumorsand 13,000 deaths per year in the United States, and the incidence isrising. Unfortunately, nearly 25% of patients who have a kidneyremoved for presumptive RCC, turn out to have benign oncocytomas,which are safely monitored without nephrectomy. This failure ofpre-operative diagnosis is in part the result of the small number ofpre-operative biopsies, as only about 9-10% of patients have apre-operative biopsy. We believe there is an opportunity to improvethe standard-of-care in this setting through the use of our assay,"said Kenneth A. Berlin, President and Chief Executive Officer ofRosetta Genomics."Differential diagnosis between various types of kidney tumorsremains challenging and can lead not only to unnecessary surgeries,but also the introduction of new, molecularly-targeted therapeuticsmakes the correct identification of these subtypes criticallyimportant for treatment choice and for patient selection for clinicaltrials of new therapeutics in development. With a sensitivity of 95%and a specificity of 98%, we are confident this assay can be a usefultool for pathologists and oncologists and we are very pleased to havefinal approval to market this important cancer diagnostic for thebenefit of physicians and patients in New York," concluded Mr.Berlin.