Rosetta Genomics

PHILADELPHIA, PA and REHOVOT, ISRAEL–(Marketwire – Dec 9, 2011) – Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announced that the New York State Department of Health has approved miRview^® mets² 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. With this approval, Rosetta Genomics can offer miRview^® mets^² in all 50 U.S. states. miRview^® mets^² is the Company’s proprietary microRNA-based test that identifies the primary origin of many types of tumors of uncertain or unknown origin.

Approximately one third of all cancer patients are diagnosed with metastases, and a large proportion of those cases may have metastases whose primary origin is uncertain or unknown. Furthermore, in 3% to 5% of all cancer cases the primary origin is not found even after extensive clinical and pathological work up. In both scenarios, the use of miRview^® mets^² may assist physicians by confirming suspected origins, or providing possible new origins to explore which can affect treatment options.

“With approximately 200,000 cases of cancer of unknown primary (CUP) and difficult to diagnose metastatic cancer per year in the U.S., there is a pressing clinical need for more accurate identification of the tumor of origin,” said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. “We are very pleased to have approval to market this important cancer diagnostic to the benefit of physicians and patients in New York.”

About the miRview^® mets^² Test
In order to effectively direct the diagnostic process, miRview^® mets^² offers physicians and patients a wide panel of 42 identifiable tumor origins, high accuracy and biologically motivated and easy-to-understand proprietary classifiers that provide significant advantage compared with other available technologies. Furthermore, miRview^® mets² features improved classifiers that incorporate clinical, biological and molecular knowledge that provides only one or two most likely suspected origins, with the vast majority of cases providing just a single origin or answer. In addition, the assay offers identification of sarcomas, lymphomas and other non-epithelial malignancies, as well as more histologic subtypes.

A blinded validation set of 509 samples was studied and provided an accurate result in 85% of the samples; in 82% of cases a single tissue of origin prediction was given with an accuracy of 90%. A post-marketing validation study conducted at [click to continue…]