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Heidelberg University Researchers Present Data on miRview mets Assay at Neuroweek Conference


Published on 2010-09-23 05:15:44 - Market Wire
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REHOVOT, Israel--([ BUSINESS WIRE ])--Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces that the results of a two-phased, post-marketing validation study using the Companya™s miRviewa" mets assay have been presented at the aNeuroweeka conference in Mannheim, Germany by lead investigator, Dr. Wolf C. Mueller from the Department of Neuropathology at Heidelberg University in Germany, aNeuroweeka is a joint meeting of German medical societies focused on neurology-related disease management and research. It consists of the Annual Congress of the German Society of Neurology, the Annual Conference of the German Society of Neuropathology and Neuroanatomy, as well as the Annual Meetings of the German Societies of Neurosurgeons, Neuropediatricians and Neuroradiologists.

The study consisted of a proof-of-concept phase and a validation phase. In the proof-of-concept phase, brain and spine metastases from known primary tumors were analyzed with the miRviewa" mets assay. In the validation phase of the study, a cohort of brain and spine metastatic samples of true Cancer of Unknown Primary (CUP) patients were studied, and concordance between results generated by miRviewa" mets and the clinical and pathological evaluation was examined.

Results from the validation phase demonstrated that primary origin prediction from miRviewa" mets was in agreement with the clinical or pathological evaluation in 80% of the cases.

aKnowing the origin of a metastasis affects treatment decisions, and CUP patients may undergo a wide range of costly and time-consuming tests to identify the primary site of origin, often to no avail. Consequently, we are extremely pleased with the positive results of this study, which demonstrate the ability of miRviewa" mets to assist physicians in accurately identifying the origin of metastases in true CUP patients,a noted Kenneth A. Berlin, President and CEO of Rosetta Genomics. aThis is the second post-marketing validation study we have completed with a leading cancer center focusing on miRviewa" mets and its ability to accurately identify the origin of metastases in CUP, and we are gratified to see the consistently strong performance of our microRNA-based assay. Literature has shown microRNAs to be highly tissue specific, and we believe that our sensitive, proprietary microRNA technology is enabling us to harness their power to develop diagnostic tools with high accuracy for the benefit of patients worldwide.a

About microRNAs

MicroRNAs (miRNAs) are recently discovered, small RNAs that act as master regulators of protein synthesis, and have been shown to be highly effective biomarkers. The unique advantage of microRNAs as biomarkers lies in their high tissue specificity, and their exceptional stability in the most routine preservation methods for biopsies, including Formalin Fixed Paraffin Embedded (FFPE) block tissue and fine needle aspirate (FNA) cell blocks. It has been suggested that their small size (19 to 21 nucleotides) enables them to remain intact in FFPE blocks, as opposed to messenger RNA (mRNA), which tends to degrade rapidly. In addition, early preclinical data has shown that by controlling the levels of specific microRNAs, cancer cell growth may be reduced. To learn more about microRNAs, please visit [ www.rosettagenomics.com ].

About Rosetta Genomics

Rosetta Genomics is a leading developer of microRNA-based molecular diagnostics. Founded in 2000, the companya™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 Genomics is working on the application of these technologies in the development of a full range of microRNA-based diagnostic tools. The companya™s first three microRNA-based tests, miRviewa" squamous, miRviewa" mets and miRviewa" meso, are commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. To learn more, please visit [ www.rosettagenomics.com ].

Forward-Looking Statement Disclaimer

Various statements in this release concerning Rosettaa™s future expectations, plans and prospects, including without limitation, statements relating to the role of microRNAs in human physiology and disease, and the potential of microRNAs in the diagnosis and treatment of disease 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 risks related to: Rosettaa™s approach to discover microRNA technology and to work on the application of this technology in the development of novel diagnostics and therapeutic tools, which may never lead to commercially accepted products or services; Rosettaa™s ability to obtain, maintain and protect its intellectual property; Rosettaa™s ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosettaa™s need and ability to obtain additional funding to support its business activities; Rosettaa™s dependence on third parties for development, manufacture, marketing, sales, and distribution of products; Rosettaa™s ability to successfully develop its candidate tools, products and services; Rosettaa™s ability to obtain regulatory clearances or approvals that may be required for its products and services; the ability to obtain coverage and adequate payment from health insurers for the products and services comprising Rosettaa™s technology; competition from others using technology similar to Rosettaa™s and others developing products for similar uses; Rosettaa™s dependence on collaborators; and Rosettaa™s short operating history; as well as those risks more fully discussed in the "Risk Factors" section of Rosettaa™s Annual Report on Form 20-F for the year ended December 31, 2009 as filed with the Securities and Exchange Commission. In addition, any forward-looking statements represent Rosettaa™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.

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