SOURCE: Rosetta Genomics, Ltd.

September 30, 2010 09:35 ET

Rosetta Genomics Announces Poster Presentations at the AACR's Molecular Diagnostics in Cancer Therapeutics Development Conference

Preliminary Data Presented on Two of the Company's Second Generation MicroRNA-Based Cancer Diagnostic Assays -- miRview™ mets2 and miRview™ Lung

REHOVOT, ISRAEL and PHILADELPHIA, PA--(Marketwire - September 30, 2010) -  Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, today announced that posters highlighting two of the Company's second generation microRNA-based diagnostic assays were presented by the Company's clinical laboratory director, Dr. Tina B. Edmonston, at the American Association for Cancer Research's (AACR) Molecular Diagnostics in Cancer Therapeutics Development Conference, held September 27-30, 2010 in Denver, Colorado.

The two posters presented were:

  • "A Second Generation microRNA-based Assay for Diagnosing Tumor Tissue Origin" -- Previous studies have demonstrated the high tissue-specificity of microRNA expression and their significant potential to classify human malignancies. miRview™ mets, an assay utilizing microRNA expression in a biopsy for identifying the tissue of origin, was developed by Rosetta Genomics and is commercially available. A second generation assay, miRview™ mets², is being developed by the Company, and is designed to identify more than 40 different types of primary cancers by utilizing the expression of < 70 microRNAs as measured on a custom-designed microarray.

    The data presented demonstrated the accuracy of miRview™ mets² exceeds 85%, with the vast majority of reported outcomes being a single tissue of origin. In addition, a blinded validation of the assay on more than 500 samples is ongoing.

  • "microRNAs as Clinical Biomarkers for Lung Cancer Classification" -- This poster highlighted the Company's miRview™ lung test, an assay under development designed to use small, pre-operative biopsies to differentiate neuroendocrine tumors from non-small cell lung tumors, and then further subclassify neuroendocrine tumors into small and carcinoid and non-small cell lung tumors into squamous and non-squamous.

    Small, pre-operative biopsies (e.g., fine-needle aspirate, or FNA, and core needle biopsies) are the most common method for acquiring a sample from lung tumors; however, in 20% to 30% of cases significant limitations of tumor quantity and quality prevent full sub-classification of the tumor using traditional diagnostic methods, including H&E and immunohistochemical stains. Using the expression levels of a few microRNAs, Rosetta Genomics' researchers constructed a molecular classifier with accuracy exceeding 90% in the identification of the four main sub-types of lung tumors.

"The positive findings reported in the posters Dr. Edmonston presented are the basis for the development of two of our next generation microRNA-based assays -- miRview™ mets² and miRview™ lung," commented Kenneth A. Berlin, President and CEO of Rosetta Genomics. "miRview™ mets² will be able to identify more than 40 primary tumors with high accuracy, and miRview™ lung is designed to accurately subclassify lung cancers using the limited samples available through small pre-operative biopsies. Both products have significant potential to improve the medical care for a large number of cancer patients worldwide. We are completing a validation study for both of these tests using independent cohorts of samples and plan to be ready to launch miRview™ mets² outside the U.S. by year end 2010, and miRview™ lung in the first half of 2011."

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 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, 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 company'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 company's first three microRNA-based tests, miRview™ squamous, miRview™ mets and miRview™ 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 Rosetta'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, including the treatment of HCC 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: Rosetta'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; Rosetta's ability to obtain, maintain and protect its intellectual property; Rosetta's ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosetta's need and ability to obtain additional funding to support its business activities; Rosetta's dependence on third parties for development, manufacture, marketing, sales, and distribution of products; Rosetta's ability to successfully develop its candidate tools, products and services; Rosetta'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 Rosetta's technology; competition from others using technology similar to Rosetta's and others developing products for similar uses; Rosetta's dependence on collaborators; and Rosetta's short operating history; as well as 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, 2009 as filed with the Securities and Exchange Commission. 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.

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