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Rosetta Genomics (ROSG) Announces Publication of the Development and Validation Process of miRview(TM)

Mar. 29, 2010 (Business Wire) — Rosetta Genomics, Ltd. (NASDAQ:ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces publication of an article describing the development and validation process of miRview™ mets, the company’s microRNA-based test for identification of primary origin of metastases. The article, “Validation of a microRNA-based qRT-PCR test for accurate identification of tumor tissue origin,” was published on March 26th in the online issue of Modern Pathology, a peer-reviewed publication. The abstract of the study may be viewed online at: http://www.nature.com/modpathol/journal/vaop/ncurrent/abs/modpathol201057a.html

It is estimated that more than 70,000 patients in the U.S. are diagnosed with CUP, and thousands more have metastases where the origin is difficult to identify. Knowing the origin of a metastasis affects treatment decisions, and CUP patients may undergo a wide range of costly, time-consuming and inefficient tests to identify the primary site of origin, often to no avail.

The miRview™ mets test, which included more than 850 samples in its development and validation, uses two classifiers that independently look for a primary origin. When the two classifiers reach the same answer, the test reports a single predicted origin. When the two classifiers identify two different predicted origins, both are reported. In the study described in Modern Pathology, the overall sensitivity was approximately 85%, and the sensitivity of a single answer prediction was approximately 90%. Overall specificity was 97%-99%.

“This publication is yet another validation of the significant advantage of microRNAs as biomarkers,” said Kenneth A. Berlin, President and CEO of Rosetta Genomics. “Their high tissue specificity, stability in a wide range of sample types and the large amount of biological information they carry makes microRNAs ideal biomarkers for a range of disease states and indications, including metastatic cancer. As we have previously announced, we expect to launch a second generation of our miRview™ mets in the second half of 2010. This new version is expected to be able to identify approximately twice the number of origins compared with the first generation test.”

miRview™ mets leverages Rosetta Genomics’ proprietary microRNA technologies to assign a primary site to metastases in cases where the physician is unsure of its origin. These technologies were described in-depth in a study by Rosetta Genomics, published March 2008 in Nature Biotechnology.

miRview™ mets is marketed in the U.S. by Prometheus Laboratories under the ProOnc™ mets brand, and is available outside the U.S. through various distributors under the miRview™ mets brand.

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. MicroRNAs’ unique advantage 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. It has been suggested that their small size (19-21 nucleotides) enables them to remain intact in FFPE blocks, as opposed to messenger RNA (mRNA), which tends to degrade rapidly in samples preserved by this method. 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 miRview™ Products

miRview™ are a series of microRNA-based diagnostic tests developed by Rosetta Genomics. miRview™ mets accurately identifies the primary tumor site in metastatic cancer and Cancer of Unknown Primary. miRview™ squamous accurately identifies the squamous subtype of NSCLC, which carries an increased risk of severe of fatal internal bleeding and poor response to treatment for certain therapies. miRview™ meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview™ tests are designed to provide objective diagnostic data; it is the treating physician’s responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, over 100,000 patients a year may benefit from the miRview™ mets test, 60,000 from miRview™ squamous, and 60,000 from miRview™ meso, with similar numbers of patients outside the U.S. The company’s tests are now being offered through distributors around the globe. For more information, please visit www.mirviewdx.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 CLIA-certified lab. Rosetta Genomics is the 2008 winner of the Wall Street Journal’s Technology Innovation Awards in the medical/biotech category. 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 expected launch of a second generation of miRview mets in the second half of 2010, 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: 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 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, 2008 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.

Monday, March 29th, 2010 Uncategorized
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