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Rosetta Genomics Announces the Availability of miRview(R) mets(2), a Second Generation Version of miRview(R) mets

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Rosetta Genomics, Ltd., a leading developer and provider of microRNA-based molecular diagnostics announces today the commercial availability of miRview® mets(2) ("miRview mets two"), a microRNA-based test that identifies the primary origin of tumors of uncertain or unknown origin. The new test, which builds on the technology and know-how of miRview® mets, offers physicians and patients a larger panel of 42 tumors that can be identified, an increase from the 25 tumors that can be identified in the previous version of the test. In addition, the new assay offers identification of sarcomas, lymphomas and other non-epithelial malignancies as well as more histologic subtypes. Furthermore, the test features improved classifiers which incorporate clinical, biological and molecular knowledge.
miRview® mets(2) leverages the proprietary technologies used in miRview® mets, described in the development and validation study published in the June 2010 issue of Modern Pathology, and in the March 2008 issue of Nature Biotechnology. Preliminary data on miRview® mets(2) were presented at the Fourth Annual AACR International Conference on Molecular Diagnostics in Cancer Therapeutic Development in September 2010. Rosetta Genomics anticipates the final data from the validation study will be presented during the first half of 2011.

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. Furthermore, in 3%-5% of all cancer cases the primary origin is not found even after extensive testing. In both scenarios, the use of miRview® mets(2) may assist physicians to rule out or rule in several suspected origins, as well as offer physicians new origins to explore.

In order to effectively direct the physicians in 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. Furthermore, to truly assist physicians in deciding which origin to further explore from their list of suspected origins, miRview® mets(2) was designed to provide only 1 or 2 most likely suspected origins, with the vast majority of cases providing just a single origin or answer.

The test's overall performance is very high, with a sensitivity for a single answer prediction of 90%, and an overall sensitivity of 85%. Overall specificity was 97-99%.

"True to our commitment to launch by the end of the year, I am pleased to announce that miRview® mets(2), our second generation test for identifying primary origins of tumors of uncertain or unknown origin, is now commercially available," said Kenneth A. Berlin, President and CEO of Rosetta Genomics. "The test builds on the technology of miRview® mets which has been published in peer-reviewed journals, and offers a significantly expanded tumor panel and enhanced classifiers. This product is the result of our continual efforts to improve and optimize our tests, and to have them address the changing needs of the medical community. The foundation for this test, and for all of our tests currently in development, are microRNAs, which continue to demonstrate their remarkable capability to act as highly sensitive markers. We are very excited to be offering this test, and look forward to the launch of our other, next generation tests in 2011."

miRview® mets(2) can be ordered directly from Rosetta Genomics' CLIA-certified, CAP accredited laboratory in Philadelphia. Parties interested in ordering the test can contact Rosetta Genomics at 215.382.9000.