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Rosetta Genomics Completes Prevalidation Phase for First Diagnostic Product

Wednesday, October 31, 2007 General News
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REHOVOT, Israel and NEW YORK, October 30 Rosetta Genomics, Ltd. (Nasdaq: ROSG), a global leader in microRNA-baseddiagnostics and therapeutics, announced today it has successfully completedthe prevalidation phase for its first diagnostic test. Using a singlemicroRNA, the test is designed to differentiate squamous from non-squamouslung cancer with high sensitivity and specificity.
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Rosetta Genomics diagnostic tests are currently undergoing validationtesting at Columbia University Medical Center at its Clinical LaboratoryImprovement Amendments (CLIA) certified laboratory. The company expects threediagnostic tests to be launched in 2008 including a test for cancer ofunknown primary, lung cancer vs. mesothelioma, and the squamous vs.non-squamous lung cancer test which has recently passed the prevalidationphase.
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"The results we have seen so far for our microRNA-based diagnostic testsare very encouraging," Said Amir Avniel, President and CEO of RosettaGenomics. "Results of the prevalidation phase showed the test differentiatedsquamous from non-squamous lung cancer using microRNA biomarkers identifiedby us, with both high sensitivity and specificity. We expect the test to beavailable for clinical use in the first half of 08."

About microRNAs

MicroRNAs (miRNAs) are recently discovered, naturally occurring smallRNAs that act as protein regulators and have the potential to form the basisfor a new class of diagnostics and therapeutics. Since many diseases arecaused by the abnormal activity of proteins, the ability to selectivelyregulate protein activity through microRNAs could provide the means to treata wide range of human diseases. In addition, microRNAs have been shown tohave different expression levels in certain diseased versus normal tissues.As a result, these differences potentially provide for a novel diagnosticstrategy for many diseases. MicroRNAs are thought to play a key role in thedifferentiation of cells into specific cell types performing variousfunctions in the body.

About Rosetta Genomics

Rosetta Genomics (Nasdaq: ROSG) is a leader in the development ofmicroRNA-based diagnostics and therapeutics. Founded in 2000, the company'sintegrative research platform combining bioinformatics and state-of-the-artlaboratory processes has led to the discovery of hundreds of biologicallyvalidated novel human microRNAs. Building on its strong IP position andstrategic alliances with leading biotechnology companies, Rosetta Genomics isworking to develop a full range of diagnostic and therapeutic products basedon microRNAs. The company's primary focus is in the development ofmicroRNA-based products to diagnose and treat different forms of cancer andother diseases

Forward-Looking Statement Disclaimer

Various statements in this release concerning Rosetta's futureexpectations, plans and prospects, including without limitation, statementsrelating to the role of microRNAs in human physiology and disease, and thepotential of microRNAs in the diagnosis and treatment of disease, and theexpected timing of validation and launch of our diagnostic tests constituteforward-looking statements for the purposes of the safe harbor provisionsunder The Private Securities Litigation Reform Act of 1995. Actual resultsmay differ materially from those indicated by these forward-lookingstatements as a result of various important factors, including risks relatedto: Rosetta's approach to discover and develop novel diagnostics products,which is unproven and may never lead to marketable products; Rosetta'sability to fund and the results of further pre-clinical and clinical trials;Rosetta's ability to obtain, maintain and protect the intellectual propertyutilized by Rosetta's products; Rosetta's ability to enforce its patentsagainst infringers and to defend its patent portfolio against challenges fromthird parties; Rosetta's ability to obtain ad
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