Rosetta Genomics Ltd. (Nasdaq:ROSG) and collaborators announced the results of a research study, showing for the first time that a microRNA-based diagnostic test can objectively identify squamous lung cancer with 96% sensitivity. The study, posted on the Journal of Clinical Oncology's Web site,[1] was carried out in collaboration with researchers at Columbia University, NYU Cancer Institute at NYU Langone Medical Center and Sheba Medical Center, and included 262 patients. Rosetta's miRview™ squamous test, based on the same microRNA biomarker that was evaluated by the study, offers similar accuracy (97% sensitivity) and is now commercially available through Rosetta Genomics CLIA-certified lab in Philadelphia.

"The results of this study are very encouraging," said Mahesh Mansukhani, Head of Molecular Pathology Laboratory, Columbia University Medical Center, and principal investigator of the study. "The study has demonstrated that a microRNA biomarker successfully identifies squamous lung cancer with high reproducibility, sensitivity, and specificity."

The company's scientists and collaborators have shown that a single microRNA biomarker, obtained from a routine pathological preparation (FFPE) of a biopsy, identified squamous lung carcinomas with 96% sensitivity and 90% specificity.

Lung cancer is the leading cause of cancer mortality in the US, killing over 160,000 Americans every year. In over 60,000 of these patients with non-small cell lung carcinoma (NSCLC), identification of the squamous sub-type has significant clinical implications. Squamous lung cancer carries increased risk of severe or fatal bleeding for certain targeted biological therapies, including Bevacizumab (Avastin™) and other drugs under development.[2] Other approved therapies, such as Pemetrexed (Alimta™) are indicated for non-squamous NSCLC only.[3] Yet recent studies comparing the reliability of histopathological classification found that as many as 30% of the squamous lung cancers were misclassified.[4]

"The study strongly validates the microRNA technology that underlies our miRview™ squamous test, one of three important cancer diagnostic products we launched last quarter," noted Amir Avniel, President and CEO of Rosetta Genomics. "We are now focused on marketing these diagnostic tests through distribution alliances, such as our recently announced agreement with Teva Pharmaceutical Industries Ltd, and other sales and marketing efforts, and expect to expand our distribution agreements in 2009."

To order the test, physicians may contact 1-888-522-7971, or visit the company's website at http://www.rosettagenomics.com/squamous.

[1] Lebanony et al., A diagnostic assay based on hsa-miR-205 expression distinguishes squamous from non-squamous non small-cell lung carcinoma, Journal of Clinical Oncology, March 2009

[2] Johnson et al, Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 22:2184-91, 2004

[3] Alimta website at http://www.alimta.com

[4] Field et al., Lung cancer histologic type in the surveillance, epidemiology, and end results registry versus independent review. Journal of the National Cancer Institute 96:1105-1107, July 2004

miRview™ is a registered trademark of Rosetta Genomics Ltd Avastin™ is a registered trademark of Genentech BioOncology, Inc Alimta™ is a registered trademark of Eli Lilly

About Rosetta Genomics

Rosetta Genomics (Nasdaq: ROSG) 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 IP 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 Wall Street Journal's Technology Innovation Awards in the medical/biotech category.

About miRview™ Products

miRview™ are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview™ mets accurately identifies the primary tumor site in metastatic cancer and Cancer of Unknown Primary (CUP). miRview™ squamous accurately identifies the squamous subtype of non small cell lung cancer (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 US 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 US.

About MicroRNA

MicroRNAs (miRNAs) are recently discovered, naturally occurring, small RNAs that act as master regulators and have the potential to form the basis for a new class of diagnostics and therapeutics. Since many diseases are caused by the abnormal activity of proteins, the ability to selectively regulate protein activity through microRNAs could provide the means to treat a wide range of human diseases. In addition, microRNAs have been shown to have different expression in various pathological conditions. As a result, these differences may provide for a novel diagnostic strategy for many diseases.

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, the potential of microRNAs in the diagnosis and treatment of disease, including without limitation the potential success of the miRview™ Squamous diagnostic test, 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 and develop novel diagnostics and therapeutic tools, which is unproven and may never lead to commercially accepted products or services; Rosetta's ability to fund and the results of further pre-clinical and clinical trials; Rosetta's ability to obtain, maintain and protect the intellectual property utilized by Rosetta's products; Rosetta's ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties and its ability to operate without infringing the proprietary rights of others; Rosetta's 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 and commercialize 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, 2007 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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